Modigene Announces Successful Completion of Pharmacokinetic & Pharmacodynamic Pre-Clinical Experiments for Proprietary Long-Acting Human Growth Hormon

Posted : Wed, 20 Jun 2007 13:12:00 GMT

Author : Modigene Inc.

VIENNA, Va., June 20 /PRNewswire/ -- Modigene Inc., a Nevada corporation (BULLETIN BOARD: MODG) today announced the successful completion of pharmacokinetic and pharmacodynamic pre-clinical experiments for long-acting human growth hormone, long-acting interferon beta and long-acting erythropoietin.

Modigene's pharmacodynamic and pharmacokinetic pre-clinical experiments demonstrated superb durability of the long-acting proteins, indicating a potential administration protocol in patients of once per week or up to once every four weeks, pending the specific protein and disease indication. The models were conducted using the industry standard animal models and methods as well as comparative studies to the commercially available versions. Human growth hormone is used to treat growth failure in children and adults, is injected 3-7 times per week, and has an existing estimated market size of $2.2 billion; while interferon beta is prescribed for the treatment of multiple sclerosis, is injected 1-3 times per week, and has an existing estimated market size of $3.8 billion. Neither of these markets currently have a commercial long-acting version available.

In addition, Modigene's long-acting erythropoietin has demonstrated, in a pre-clinical animal model comparative study, increased durability and biological effect over Amgen Inc.'s Aranesp(R), a long-acting erythropoietin with reported sales of $4.1 billion in 2006, out of a total estimated EPO market size of $11.7 billion. Erythropoietin is prescribed for the treatment of anemia.

"We are very excited about Modigene's pre-clinical work to date," said Dr. Phillip Frost, Vice Chairman of Teva Pharmaceutical Industries, and Modigene's largest shareholder and board member. "With four CTP-modified proteins demonstrating to date exceptional results, including Schering-Plough/Organon's FSH-CTP now in Phase III clinical trial, and Modigene's human growth hormone, interferon beta and EPO in pre-clinical models, the CTP platform is gaining credibility as having the potential to become the platform of choice for developing long-acting therapeutic proteins."

"The accomplishment of this milestone was important for Modigene as it continues its long-acting protein programs, and as a key indicator that the CTP platform is universal and could be applicable to a variety of therapeutic proteins and peptides that suffer from weak durability and hence dictate short injection frequencies," said Shai Novik, Modigene's President. "We are moving forward with our preparations for GMP production of our lead protein candidates and initiation of clinical trials thereafter. We have also commenced development of a long-acting version of GLP-1, a therapeutic peptide that is prescribed for diabetes type II patients, and is currently injected twice daily, and will continue to apply the technology to several other key blockbuster therapeutic proteins."

Modigene's technology was discovered by researchers at Washington University in St. Louis, Missouri, and is based on a short amino acid sequence, the Carboxyl Terminal Peptide (CTP). CTP occurs naturally in the human body, and when attached to a therapeutic protein, extends the time that such protein can last effectively in the body. This has been demonstrated and validated by Organon -- which, on March 12 2007, announced a deal to be acquired by Schering-Plough for $14.4 billion. Organon also licenses the CTP technology from Washington University, and has attached the CTP to a Follicle- Stimulating Hormone (FSH) -- a hormone with approximately $1 billion in annual sales that is prescribed for females undergoing fertility treatments. Organon is currently in Phase III clinical trials with its FSH-CTP product, which could complete during 2007. Phase II trials demonstrated that a single injection of FSH-CTP was able to provide the same clinical effect as 7 consecutive daily injections of commercial FSH. These trials demonstrated that attaching the CTP did not affect the therapeutic activity of FSH or cause a negative immune system response in patients. Modigene has an exclusive license with Washington University for use of the CTP with all proteins except four endocrine proteins, which are licensed to Schering-Plough/Organon.

ABOUT MODIGENE

Modigene Inc. (OTCBB: MODG) is a publicly-traded biopharmaceutical company utilizing patented technology to develop longer-acting, proprietary versions of already approved therapeutic proteins that currently generate billions in annual global sales. Modigene is currently developing long-acting versions of human growth hormone, erythropoietin, interferon beta, and GLP-1 -- each representing a multi-billion dollar market. For more information on Modigene, please visit http://www.modigeneinc.com/.

Safe Harbor Statement

This press release contains forward-looking statements, including statements regarding the results of current studies and pre-clinical experiments and the effectiveness of Modigene's long-acting protein programs and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that forward-looking statements involve risks and uncertainties that may affect Modigene's business and prospects, including the risks that Modigene may not succeed in developing any commercial products based upon its long-acting protein technology, including any long-acting versions of human growth hormone, erythropoietin, interferon beta or GLP-1; that the long-acting products in development may fail, may not achieve the expected results or effectiveness and/or may not generate data that would support the approval or marketing of these products for the indications being studied or for other indications; that ongoing studies may not continue to show substantial or any activity; and other risks and uncertainties that may cause results to differ materially from those set forth in the forward-looking statements. The development of any products using the CTP platform technology could also be affected by a number of other factors, including unexpected safety, efficacy or manufacturing issues, additional time requirements for data analyses and decision making, the impact of pharmaceutical industry regulation, the impact of competitive products and pricing and the impact of patents and other proprietary rights held by competitors and other third parties. In addition to the risk factors set forth above, investors should consider the economic, competitive, governmental, technological and other factors discussed in Modigene's filings with the Securities and Exchange Commission. Modigene Inc.

CONTACT: Shai Novik, President, Modigene Inc., 1-866-644-7811,
shai@modigeneinc.com

Web site: http://www.modigeneinc.com/



Copyright © 2007 PR Newswire. All rights reserved.

Stem cells created from cloned monkey cells

U.S. scientists move step closer to human therapeutic cloning

CANBERRA, Australia - Human therapeutic cloning has moved a step closer after U.S. researchers said they had successfully created embyonic stem cells from monkey embryos.

In what would be a world-first breakthrough, scientists told a stem cell research conference in the Australian city of Cairns this week that they had successfully created two batches of embryonic stem cells from cloned rhesus monkey embryos.

“We’ve been looking for this evidence for a long time,” Australian stem cell pioneer Alan Trounson from the Melbourne-based Monash University Stem Cell Centre told Reuters.

“It’s very important to have this, to know that we can do this, because it may result in a lot of new cell lines than can help us understand some complex diseases.”

Previous efforts to obtain embryonic stem cells from cloned primate embryos have failed. Korean cloning scientist Woo Sook Hwang lost his job over fabricated successes using human eggs.

But Shoukhrat Mitalipov of the Oregon National Primate Research Centre in the United States said he had succeeded using modified Somatic Cell Nuclear Transfer, or SCNT, in which an egg cell nucleus is removed and replaced with a donor nucleus.

The cell eventually forms an early embryo, or blastocyst, with DNA almost identical to the donor organism.

Mitalipov said he used skin cells from a 10-year-old male rhesus monkey and presented the conference with proof of his success using DNA evidence. He also showed slides of the embryonic cells changing into heart cells and neurons.

A switch to using polarized light in labwork instead of dye and ultraviolet light traditionally used to identify cell chromosomes may have led to the breakthrough, he said.

Help treat diseases

Mitalipov’s still-unpublished success may bring scientists closer to producing human embryonic stem cells from cloned adult body cells, reducing the risk of eventual rejection when using external donor cells.

Scientists hope therapeutic or regenerative cloning could help treat diseases including multiple sclerosis, cardiac illnesses and even spinal damage by encouraging embryonic cells to replace damaged nerve, blood or heart cells.

While Mitalipov’s findings are yet to be confirmed, they could also bring scientists closer to cloning an adult primate, a group which includes humans, apes and monkeys.

“I remain guarded enough to want to see the process completed,” Trounson said.

Copyright 2007 Reuters Limited. All rights reserved. Republication or redistribution of Reuters content is expressly prohibited without the prior written consent of Reuters.

LIVING WITH MULTIPLE SCLEROSIS (MS): COUNTRY MUSIC STAR CLAY WALKER REFUSES TO LET MS STAND IN THE WAY OF HIS DREAMS

According to the National Multiple Sclerosis Society, every hour someone is newly diagnosed with MS, an autoimmune disease that affects the central nervous system and is the number one disease leading to disability in young adults. It usually strikes adults in the prime of their life, between the ages of 20 and 50. The most common form of this potentially devastating disease is relapsing-remitting multiple sclerosis (RRMS).

When multi-platinum country music sensation Clay Walker was first diagnosed with RRMS at age 26, his biggest fear was that the disease would halt his active lifestyle. Now, eight years later, Clay continues to record new albums, perform to sold-out crowds, ride horses and run on the beach with his daughters. His disease has also inspired him to become a voice - not just for country music fans -- but for the hundreds of thousands of people with MS and their families across the country.

Despite living with RRMS, Clay has had 11 number-one country hits to date and has placed 31 titles on Billboard's top country songs chart, with 15 of them climbing to the top ten. Clay is slated to debut another album this Spring, right on the heels of MS Awareness Week, March 5-11. He is teaming up with the National Multiple Sclerosis Society during MS Awareness Week to raise awareness about MS and help rally support for research.

Lyme Disease - The Great Imitator

Monday June 18, 2007
CityNews.ca Staff

Imagine an illness that is difficult to diagnose, last for months to years, and brings with it symptoms like crushing fatigue, neuralgias and crippling pain. Now imagine that medical doctors can't agree on who has it, how long to treat it, and if in fact the disease really is a problem in Ontario.



Lyme disease brings not only those challenges, but a whole lot more. The Canadian Lyme Disease Foundation lists over 70 different signs and symptoms of the disease. It has purportedly been misdiagnosed as Juvenile Arthritis, Rheumatoid Arthritis, Reactive Arthritis, Infectious Arthritis, Osteoarthritis, Fibromyalgia, Raynaud's Syndrome, Chronic Fatigue Syndrome, Multiple Sclerosis, Scleroderma, Lupus, early ALS, early Alzheimers Disease, Crohn's disease, Ménières syndrome, and Reynaud's syndrome amongst others.

Detection

To further complicate matters, detection and testing is challenging at best. According to Health Canada, about 70% of individuals bitten by a tick carrying the bacteria will develop the characteristic "bull's-eye" rash - erythema migrans or EM. However, other sources peg this number much lower - at only 30% of those bitten. The offending organism, the Ixodes scapularis (Deer Tick), is the main vector for the bacteria, but Borrelia burgdorferi (Lyme Disease) has been found in Ixodes pacificus (Western Black Legged Tick), Amblyomma americanum (Lone Star Tick), and Ixodes Angustus. These ticks are easily transported by songbirds and have grown from a small area in Lyme Connecticut (hence the name) to far flung locations all across North America. Lyme has been detected in ticks all over the province of Ontario.

Just across the border in New York State, reported cases of Lyme disease are at 28.9 cases per 100,000 people in 2005, according to the Centers for Disease Control. Pennsylvania tracks at a whopping 34.5 cases per 100,000. And here in Ontario? According to the Ministry of Heath, between January 1, 2006 and April 2007, there were only 38 reported cases, meaning we're at 0.3125 cases per 100,000. So what's responsible for the disparity? In a word, testing. Ontario's ELISA test for Lyme isn't foolproof and can miss early and late disseminated cases.

Diagnosis

Lyme Disease is a clinical diagnosis, according to Richard Sadovsky, M.D., American Academy of Family Physicians, "The diagnosis of Lyme disease is clinical. Early infection is often accompanied by false-negative serologic tests, although this can occur late in the disease. The positive predictive value of serologic testing is low in patients with vague symptoms unaccompanied by any objective signs."

According to Public Health, other than the "bull's-eye rash" there are other symptoms of Lyme Disease:

fatigue
chills
fever
headache
muscle and joint pain
swollen lymph nodes.

If the infection goes untreated, the second stage of the disease can last up to several months with possible symptoms including:

central and peripheral nervous system disorders
multiple skin rashes
arthritis and arthritic symptoms
heart palpitations
Extreme fatigue and general weakness

If the infection continues to go untreated, the third stage of the disease can last months to years with possible symptoms including, chronic arthritis and neurological symptoms. If contracted during pregnancy, adverse effects on the fetus, including stillbirth, can occur.

Treatment

Treatment for Lyme disease is dependent on the stage at which it is diagnosed. If caught early, treatment can be as short as 3-4 weeks with an antibiotic like Amoxicillin or Doxycycline. If the diagnosis is delayed, as is so often the case, treatment can take months to resolve the disease and requires high doses of a combination of antibiotic therapies. A knowledgeable practitioner is crucial in the successful treatment of Lyme disease.

Prevention

Prevention is definitely the best medicine with Lyme disease. In early summer, ticks can be as small as a poppy seed and their bite can go undetected for days. If you do find a tick on your body, remove it immediately.

From Health Canada:

Carefully remove attached ticks using tweezers. Grasp the tick's head and mouth parts as close to the skin as possible and pull slowly until the tick is removed. Do not twist or rotate the tick and try not to damage the tick (i.e., squash or crush it) during removal.

Testing on the tick itself is possible, so take the tick with you when you see your doctor (suggested preservation of the sample is to put it in a plastic baggie with a moist paper towel). Prompt treatment for Lyme disease is crucial, so if you know you were bitten and have the characteristic rash, get to your doctor quickly and don't take no for an answer.

Lyme disease is most prevalent in the late summer and early fall.

Other Resources

For other tips from the CDC on avoiding tick bites, click here.

Follow these links for more information on Lyme Disease, its symptoms and diagnosis from Health Canada, and Public Health.

To visit the Mayo Clinic's site on Lyme Disease click here.

For more information, including support groups and discussion boards, visit the Canadian Lyme Disease Foundation.

Photo courtesy of Canlyme.com.

Merle's Miles for M.S.

Reported by Mike Conneen

mconneen@fox21news.com

(Aired 6-18-07)

One very determined biker pedaled through Florence Monday on his cross country journey for a special cause. Merle Knotts is 68-years old. He is traveling more than 3,000 miles to raise awareness and raise money for multiple sclerosis research.

For four weeks and three days, he has been riding a a 2005 Catrike recumbent tricycle. He has peddled through rain in Illinois and tornado watches in Kansas.

In Colorado, he has enjoyed blue skies and sunshine. He said, "The day before yesterday I was given the honor of riding with a herd of horses. They were running along the fence for about half a mile."

On May 19th, he started peddling from Atlanta to his 50th high school reunion in Oak Harbor, Washington. Monday, he crossed the halfway point, just outside Florence.

In the end, he will have traveled through twelve states, crossing more than 3,000 miles, with his wife Jan behind him each and every mile. She said, "You can go for 58 miles, 68 miles and not see another person."

Merle has conquered the Appalachians and the Ozarks. "They were just straight up and straight down and nothing level," he said.

Now, he faces the Rocky Mountains. "I think I've got a lot of work to do," he said.

Merle is a hero. His journey is heroic. Merle himself has M.S. He said, "It was diagnosed in 1980 so I've had it about 30 years."

His symptoms are less severe. He has no motor control problems. "And I almost feel obligated to do all I can to help the people who are not so lucky," he said.

He said everyone they have met along the way knows someone with M.S. He said he tells them to hold out hope. "M.S. is not a death sentence... Just because you've been diagnosed doesn't mean life stops; you just go on and do what you've got to do."

His knees and feet hurt, but he said he feels great.

Make a donation to the National Multiple Sclerosis Society in Merle's name. Go to www.merlesmilesforms.com.

As of Monday, Merle had raised $8,000. He is 300 miles ahead of schedule. He should arrive in Oak Harbor by early August, just in time for his 50th high school reunion. You can bet, he will be the best in shape of all his classmates.

Major Breakthrough Speeds Therapies to the Brain

BOSTON, June 17, 2007-New technology promises to open new avenues for treatment of viral infections, Alzheimer’s and Parkinson’s disease, and many other neurological illnesses


Researchers at the Immune Disease Institute—formerly the CBR Institute for Biomedical Research—have overcome a major hurdle in the delivery of therapeutics to the brain: getting past the blood-brain-barrier (BBB) which excludes most large and small molecule drugs. Their breakthrough research is published in the June 17, 2007 issue of Nature magazine, with Manjunath Swamy, M.D., as principal investigator and Priti Kumar, Ph.D., as first author on the paper, with collaboration from scientists at the University of Iowa and Hanyang University in South Korea.

The BBB—comprised of the endothelial walls of 100 billion capillaries in the brain—is a superfine filter that prevents transport of harmful pathogens and beneficial drugs alike. To overcome the BBB in situations of disease, IDI researchers in the Swamy lab employed a modified Rabies virus glycoprotein peptide name CORVUS that slipped past the BBB and, in mice, delivered small interfering RNAs as a therapy to neuronal cells in the brain. The siRNAs effected specific gene silencing in the brain, without side effects.

A visionary discovery, this new technology from the Swamy lab provides a non-invasive, intravenous means of delivering, throughout the brain, the powerful therapy known as RNA interference (which suppresses disease-causing genes) as well as, potentially, DNA for gene therapy. The CORVUS technology also promises to be a brain delivery system for a wide slate of conventional drugs in the form of antibodies, proteins, and other compounds.


Many late-stage clinical trials have failed when candidate drugs are frustrated at the BBB; this new ability to send therapies selectively to the brain may revolutionize the treatment of diseases including Alzheimer’s, Parkinson’s, multiple sclerosis, psychiatric illnesses such as schizophrenia, fatal infections including encephalitis and meningitis, and central nervous system traumas, among other illnesses.

Previously, Swamy, Priti Kumar, and colleagues had used RNAi to defeat brain infection caused by Japanese encephalitis and West Nile virus. With the breakthrough CORVUS technology, they will be able to prevent such deadly infections in mice by administering the same siRNAs intravenously.

In addition, there is a great need for new therapeutics for Alzheimer’s and other “neuronal” diseases associated with aging, as the U.S. population becomes older. Effective delivery of therapies to the brain is a vital component for making progress against these diseases.

###

Founded in 1953, the Immune Disease Institute—formerly known as The CBR Institute for Biomedical Research—is an independent, nonprofit biomedical research institute in Boston, Mass., affiliated with Harvard Medical School. Its world-class investigators conduct breakthrough research on the immune system and inflammation—work leading to new therapies for millions of patients suffering from illnesses such as cancer, heart disease, HIV/AIDS, lupus, Alzheimer's disease, and immune deficiencies. Visit www.idi.harvard.edu to learn more.


The CORVUS technology (CBRI ID 06-001) is a patent pending, novel drug delivery and neuronal cell transfection method utilizing a small peptide to selectively deliver drug payloads across the BBB and spread the drug evenly throughout the brain. IDI is currently evaluating collaborative research and licensing opportunities with industry. For more information and licensing terms, please contact Ryan Dietz, at 617-278-3463 or dietz@cbrinstitute.org.

Contacts:
Manjunath Swamy, M.D., 617-278-3240 or swamy@cbr.med.harvard.edu
Priti Kumar, Ph.D., 617-278-6623 or kumar@cbr.med.harvard.edu
Hal LaCroix, Public Affairs, 617-278-3321 or lacroix@cbrinstitute.org
Ryan Dietz, Office of Tech. Development, 617-278-3463 or dietz@cbrinstitute.org

Genmab to start Phase III studies of HuMax-CD20 in rheumatoid arthritis

06.18.07, 9:18 AM ET

COPENHAGEN (Thomson Financial) - Genmab AS said it expects to initiate Phase III studies of ofatumumab (HuMax-CD20) in rheumatoid arthritis (RA) by the end of 2007.

HuMax-CD20 is is being developed under a worldwide co-development and commercialisation agreement between Genmab and GlaxoSmithKline (nyse: GSK - news - people ).

Genmab said the group also plans to expand the development programme through a Phase II study in relapsing remitting multiple sclerosis (RRMS) in the first quarter of 2008.

There is potential to pursue indications in a wide range of autoimmune disease settings,' Genmab said.

The Danish pharma group added the development plans for ofatumumab will be described at GSK's Oncology Seminar.

Ofatumumab is currently in late stage development for chronic lymphocytic leukemia (CLL), follicular non-Hodgkin's lymphoma (NHL) and in Phase II for RA.

Genmab said a clear demonstration of the efficacy and safety of ofatumuamb in two late stage trials for CLL and follicular NHL could provide the initial regulatory applications.

The company has received a Fast Track designation for the CLL study.

Under these circumstances, it said, 'ofatumumab could potentially enter the market in 2008 first for the treatment of refractory CLL and subsequently for rituximab-refractory follicular NHL.'

The group has planned initiation of clinical studies for ofatumumab in diffuse large B-cell lymphoma (DLBCL) by the end of 2007 and randomised Phase III studies in CLL and follicular NHL in the first half of 2008.

michael.delaine@thomson.com

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Scientists try to reactivate silent genes

CHICAGO, June 14 (UPI) -- U.S. medical scientists are developing a therapy to reactivate silenced genes in patients suffering from stroke or neurodegenerative diseases.

Researchers at the University of Illinois-Chicago and Cornell University note that during and after a stroke, certain cellular events take place that lead to the death of brain cells. Compounds that inhibit a group of enzymes called histone deacetylases can modulate gene expression, and in some cases produce cellular proteins that are actually neuroprotective -- are able to block cell death.

"For the first time, we show which one of the 11 histone deacetylase enzymes might be the best target to achieve cellular neuroprotection," said the study's lead investigator, University of Illinois Professor Alan Kozikowski. "This work gives us a good direction to follow in testing histone deacetylase inhibitors in animal models for diseases such as Parkinson's and Huntington's disease and even stroke."

Kozikowski said the study, in collaboration with Dr. Brett Langley at the Burke-Cornell Medical Research Institute in White Plains, N.Y., may lead to "other exciting" results.

"This is a new area of drug discovery for the 22nd century," Kozikowski said.

The study appears in the Journal of Medicinal Chemistry.

Copyright 2007 by United Press International. All Rights Reserved.

Giving Patients Control 'Won't Cut Costs'

Friday, 15th June 2007, 00:35


Giving patients more control over managing their illness will not reduce healthcare costs, according to new research.

The government's Expert Patient Programme offers courses to help people cope with their long term conditions and diseases.

These include arthritis, asthma, back pain, diabetes, heart conditions, multiple sclerosis, mental health issues and many others.

The scheme which has already cost £18 million has been heavily promoted as part of a drive to deliver NHS savings and will be rolled out to 100,000 patients by 2012.

But researchers say four trials in the UK suggest there is little evidence to date that they make an important impact on either hospital admissions or the use of other healthcare resources.

In 2001 the chief medical officer, Sir Liam Donaldson, concluded that self management programmes for chronic diseases would improve health status, slow the progression of disease, and reduce healthcare use, and that the NHS should invest heavily in the Expert Patient Programme.

But the researchers, whose findings are published in the British Medical Journal, say that although lay led programmes may increase patients' confidence to manage their disease, questions remain about their impact on health in patients.

Dr Stephanie Taylor, senior clinical lecturer at Queen Mary's School of Medicine and Dentistry, London, said lay led programmes in the UK need evaluation before they can be recommended over other programmes with established impact.

She said: "Considerable hyperbole has surrounded the UK expert patient programme, and some patients attending courses have given powerful personal accounts of their benefits.

"However, these accounts must now be seen in the context of the modest results of four well powered randomised trials in the UK.

"Although early results suggest that the programme can improve patients’ confidence, questions remain about its impact on health in patients in the UK."

The researchers also point out primary care trusts or general practice commissioning groups will need to consider carefully the costs of investing in this programme compared with other rehabilitation programmes for chronic disease.

The courses are designed to run alongside medical treatments, and benefits can include a reduction in symptoms, less pain, greater self confidence and a better quality of life.

The free programme is aimed at helping patients find information, develop problem solving skills, communicate with health professionals and cope with depression and their own pain management. It will be led by other people with long term conditions or experience of caring.

Volunteers will be recruited and given the opportunity to receive accredited training, to enable them to deliver self management courses to others in similar circumstances

Copyright © 2006 National News +44(0)207 684 3000

MS Treatment May Lie in the Eye

Protein Found in the Human Eye Shows Promise as a Multiple Sclerosis Treatment in Mice

By Miranda Hitti

WebMD Medical News

Reviewed by Louise Chang, MD

June 13, 2007 -- A protein called CRYAB, which is found in the eye, may help treat multiple sclerosis (MS).

That's according to preliminary lab tests done on mice. It's too soon to know if the same strategy will work in people. But if it does, it may lead to new MS treatments.

The researchers included Stanford University's Lawrence Steinman, MD, and Shalina Ousman, PhD. Steinman is a professor in Stanford's neurology and neurosciences department, where Ousman also works.

With colleagues from various other institutions, Steinman and Ousman studied CRYAB, which is found in the eye's lens.

Previous research has shown that when MS develops, CRYAB turns up in the brain. That's a problem -- but it also inspired an intriguing solution that may help tame MS.

Protein Power

In MS, the body's immune system attacks myelin, the fatty sheath that insulates nerves. As a result, nerves can't communicate as well as they normally would.

The new study focuses on mice with a brain condition similar to MS. Some of the mice were genetically unable to make CRYAB.

The researchers found that the mice that couldn't make CRYAB had more brain inflammation and a hypersensitive immune system response to that inflammation than normal mice.

The scientists injected human CRYAB into those mice. That eased the mice's symptoms and even reversed paralysis caused by their disease.


How It Works

In their study, the scientists argue that when CRYAB first appears in the brain, it's a troublemaker.

"For some reason, the protein [CRYAB] gets turned on in the brain where it's not expected to be," Steinman says in a Stanford news release.

Because CRYAB isn't expected in the brain, the immune system attacks it. That spurs a cascade of inflammatory chemicals, making matters worse.

But adding more CRYAB to the brain has the opposite effect. Additional CRYAB calms brain inflammation, according to the researchers.

"Remarkably, addition of that very same stress protein, akin to restoring the brakes that were failing, returns control," they write, calling CRYAB a "critical tipping point" in the development of MS.

The study appears in the advance online edition of the journal Nature.

SOURCES: Ousman, S. Nature, June 13, 2007; advance online edition. News release, Stanford University Medical Center.

© 2007 WebMD, Inc. All rights reserved.

Seeing the brain like never before

by Kara Gavin


The brain is a very complicated place. From the outside, it may look like a gray lump of tissue, covered with ridges and bumps. But inside, an incredibly complex network of thread-like white fibers carries signals back and forth between areas of the brain and the spinal cord. Each fiber is crucial to a particular aspect of how our mind communicates with our body.

But until now, brain surgeons haven't been able to see those fibers, called white-matter tracts. Invisible to the naked eye, and impossible to see on normal brain scans, they fall victim to even the most careful surgeon's hand during operations to remove tumors or calm severe epilepsy. And the result can be permanent, unintended damage to the senses, movement, or thinking ability.

Now, advanced medical imaging is making it possible for surgeons to know where those tracts are - and even to see them in their field of vision while they operate.

A University of Michigan Health System team is one of the first in the world to offer this type of image-guided surgery. Already, it has helped them plan the operations of patients, and reduce their risk of damage. And the technique holds great promise for other uses as it is developed further.

"In the past, we had a pretty good idea of what different parts of the brain do, but we've never been able to see the direct connections from one part of the brain to another, or from one part of the brain to the spinal cord," says one of the team's leaders, Suresh Mukherji, M.D. "We can see those connections now, by looking at the sub-cellular level to see how the water molecules in the tissue move."

Mukherji directs the U-M Division of Neuroradiology - a team of brain-imaging specialists. They work closely with U-M neurosurgeons, who perform thousands of brain and spine operations a year, and with neurologists who diagnose and treat brain and nerve disorders ranging from epilepsy and multiple sclerosis to cancer.

Neurosurgeon Oren Sagher, M.D., says this teamwork makes it possible for him to operate with the best possible information about each patient's brain. "Thoroughly imaging the brain is one of the keys to successful brain surgery. We have to be able to see all the structures that we're going after, and all the structures that are in our way and need to be avoided," he says.

That's what the new imaging technique, called tractography, makes possible for the first time.

The technique relies on powerful MRI (magnetic resonance imaging) scanners, which create images of patients' brains, one thin slice at a time. U-M has several extremely powerful MRI machines, call 3T scanners.

Then, ultra-fast computers equipped with special software compile all of those slices into a three-dimensional image of the brain. Lastly, the neuroimaging team uses special techniques to see how water molecules are moving inside every area of that virtual 3D brain.

It's that water-movement imaging that allows the white-matter tracts to come into view. Inside the tracts, water can only move in a lengthwise direction, back and forth along the length of the thin strand. But in the rest of the brain tissue, the water can move around more freely.

In fact, U-M brain imaging specialists already use this kind of information to tell them if cancer cells are dying in response to chemotherapy or radiation, because water can move faster in dead or dying areas of cancer tissue than it can in healthy brain cells.




In tractography imaging, Mukherji explains, "How the water molecules are oriented, how they move, is something we can now detect, and as a result we can now see parts of the brain that we were never able to see before."

Add that together with the ability to create 3D maps of the brain, and the result is spectacular images that just show the entire network of white-matter tracts and the individual nerve fibers that they're made of.

These images become a roadmap for surgeons like Sagher, especially when they're superimposed on other images that show the specific areas of ‘gray matter’ where epileptic seizures begin or where tumors lurk.

This cross-registration, as it is called, fuses the information about the areas of the brain that the surgeon needs to remove or destroy in order to treat the patient's condition, with the information about what that the surgeon needs to avoid in order to preserve a patient's vision, for instance, or her ability to move her right arm.

Surgeons like Sagher can use these images in the operating room, and even have them fed digitally into the special eyepiece that they use to perform surgery on very tiny areas of the brain.

"The computers can decipher the direction of the fibers, and then assign a color to them so we know that this group of fibers belongs to this tract, which has this function by virtue of where it is," explains Sagher, who directs the U-M Image-Guided Surgery Program. "It essentially makes the invisible visible."

He contrasts this kind of imaging with what was used even a decade ago. Back then, the neurosurgeon might be able to have a series of CT (computed tomography) scans showing the structure of the brain in individual slices. These transparent films would be hung on a lightbox in the operating room, and give the surgeon a sense of what to expect when he or she cut into the patient's head.

Since that time, scanners have gotten better and the computers needed to create 3D images have gotten more powerful, which has allowed surgeons to see the gray matter better and allow the computer to guide their hands to some extent. But only tractography allows them to see the white-matter tracts.

Now, he and his colleagues use the images to plan their operations ahead of time - for instance, when operating on a patient with epilepsy who has decided to have surgery after medicines have failed to control their seizures.

If the origin of the seizures is in a part of the brain that controls memory or learning, for example, the tracts that lead in and out of that area are key connectors that, if cut, can change the patient's life forever. And if a tumor is deep within the brain, the operation needed to get to it can cut across many important areas. But the tractography images can let the surgeon see areas where there aren't any tracts, and plan the route he or she will take to get to the area of the problem.

Mukherji, Sagher and their colleagues predict that tractography will change brain surgery and the way we see the brain's function forever, just like the first CT and MRI scans of the brain changed the diagnosis and treatment of many disorders. The team is pursuing research to improve the technique and show how it can best be used - and how it helps spare patients from unintended consequences.

"Instead of imaging the brain, we're essentially able to image the mind," says Mukherji. "We're able to image how a person's thoughts and brain impulses travel, and this is just the beginning."

One patient's story about image-guided surgery

At the age of 25, Kimberly Carothers was tired of having her life limited by her epilepsy. Though she'd been taking medications to control her seizures for over a decade, they weren't working anymore. After suffering a serious ‘grand mal’ seizure, she lost her right to drive for six months - a crushing blow for a young adult who wants to start life on her own.

So, she decided to explore the idea of surgery. Like the 20 per cent of people with epilepsy whose condition resists all attempts at medication, she was a candidate to have a surgeon operate on the tiny area of her brain that was giving rise to the haywire electrical signals that caused her seizures.

She turned to the U-M Comprehensive Epilepsy Program, which includes neurologists and neurosurgeons who help nearly 100 patients each year achieve a cure for their condition through surgery. The fact that U-M offers special brain-imaging techniques that can help reduce the risk of damage to healthy brain tissue during surgery helped put her mind at ease. "The doctors have just made me so confident about it, and never having to take medicine again would be the greatest thing for me."

The operation, early this spring, was a success. "Since the surgery, I've not had any seizures," Kimberly says. "In the future, I'm looking forward to someday having kids, and going back to school. I feel really good about it."


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Source: University of Michigan Health System

Breakthrough in multiple sclerosis research

Scientists detect protein that may be key to the disease

Kavita Mishra, Chronicle Staff Writer
Thursday, June 14, 2007

Stanford researchers reported new findings Wednesday that they say bring them closer to understanding what causes multiple sclerosis.

In the report published in the online version of the journal Nature, the researchers implicated a protein that they believe normally regulates the human immune system, but doesn't do so in people with the lifelong illness.

The researchers, led by Stanford neurologist Lawrence Steinman, said they are optimistic their discovery will lead to new treatments for patients and possibly a way to stop the disease's progression.

For Joyce Bruno, one of the 400,000 people in United States with multiple sclerosis, the report was good news.

"Even if it isn't the answer for me, I have a feeling it's going to be an answer for someone," the Walnut Creek resident said.
In 1990, Bruno started to drag her left leg and felt intense muscle cramps in both legs. An MRI of her brain revealed she had signs of multiple sclerosis, and her doctor told her the haunting word "incurable."

She was forced to retire from managing funds at a mortgage company four years later, at the age of 44, and now uses a cane to walk.

Most people with multiple sclerosis experience a range of symptoms -- from daily fatigue and weakness to blindness and paralysis. They are diagnosed early in adulthood and experience symptoms, as the immune system attacks nerve cells, intermittently throughout life. To avoid a whirlwind progression of these symptoms, they take steroids and other drugs to suppress the immune system and control the disease.

Siblings and close relatives have a higher risk of the disease. Doctors currently tell patients that the disease is caused by a mixture of bad genes and environmental factors. But the work by Steinman and his team is putting new focus on a protein in the body called alphaB-crystallin.

The researchers found that people with multiple sclerosis had more alphaB-crystallin in their bodies than people without the disease. They looked at the protein, usually found in high levels in the lens of the eye and in muscle, in both humans and mice.

In mice that were designed to lack the protein and had a multiple sclerosis-type illness, the disease worsened. When the protein was given back to the diseased mice, the illness improved, showing that the protein could help check the hallmark inflammation of the disease.

But scientists then looked at the fluid in multiple sclerosis patients that cushions the brain and spinal cord, where the disease manifests. There, they found more protein and surprisingly more antibodies to the protein, said lead author and Stanford neuroscientist Shalina Ousman. The antibodies, they concluded, prevent the protein from working properly, causing more inflammation.

The researchers don't know yet if giving more protein to a multiple sclerosis patient would overwhelm the antibodies to fight the disease or if getting rid of these antibodies would help patients, she said.

Steinman said he believed people with multiple sclerosis developed antibodies to the protein like an allergic reaction to a bee sting. Giving people small amounts of the protein when they didn't have symptoms could sensitize the body to make less antibodies. That would free up the protein to quell the immune system when there is inflammation with the disease.

Dr. Douglas Goodin, director of the UCSF Multiple Sclerosis Center, who was not involved in the study, said he could see how a drug could be made from the protein but wanted more research into how it contributed to the disease before recommending it to patients.

Multiple sclerosis gained some attention in recent years on the TV show "The West Wing" when Martin Sheen's character, the president, survived impeachment over charges that he hid his disease.

People who live close to the equator tend not to develop it. Scientists think those who get more sun at a younger age have more vitamin D in their bodies, which may keep them from developing the disease. Despite these promising correlations, several common viruses, like Epstein Barr, which causes mononucleosis, have also been linked to multiple sclerosis, Goodin said.

E-mail Kavita Mishra at kmishra@sfchronicle.com.

Costs Increase for Multiple Sclerosis Therapies; Tiering, Usage Expected to Rise

Reprinted from the June 2007 issue of SPECIALTY PHARMACY NEWS, a monthly newsletter designed to help health plans, PBMs, providers and employers manage costs more aggressively and deliver biotechs and injectables more effectively.

A pair of recent drug reports shows that while the usage of multiple sclerosis (MS) treatments seems fairly even from 2005 to 2006, the costs of those therapies are rising strongly. With this in mind, more payers are continuing to designate preferred therapies among the four self-injected drugs on the market. But industry experts anticipate MS treatment usage increasing further, which could push already-high costs even higher.

A chronic, autoimmune disease that affects the central nervous system, MS can occur as one of four types, each of which may be mild, moderate or severe. While MS affects approximately 400,000 people in the U.S., the National Multiple Sclerosis Society estimates that "the average annual direct and indirect cost of MS is estimated at $57,500 per person due to lost wages, increased medical care and other expenses."

Data show that the costs are rising substantially. PBM Express Scripts, Inc.'s 2006 Drug Trend Report, which includes only those specialty drugs adjudicated under the pharmacy benefit, showed that among its covered lives, the cost per prescription for the MS therapies class increased 15.1% to $1,469.93 in 2006, from $1,277.27 in 2005. In addition, the per-member, per-year cost rose 19%, from $11.43 to $13.60.

Medco Health Solutions, Inc.'s 2007 Drug Trend

Report (which also looks at only the drugs adjudicated on the pharmacy side) shows that for Medco's covered lives in 2006, MS therapy utilization has essentially remained the same (an increase of 0.6%), but both the cost for the plan and the cost per day of the therapy have climbed, 14.8% and 14.2%, respectively. The combined result made it the third largest contributor to specialty drug trend in 2006 for Medco covered lives. The primary reason that the PBM points to for this trend is "price inflation for the leading brand-name products" - the same reason that Express Scripts cited for its data.

This refers to "manufacturer-driven pricing," explains Steve Russek, vice president of clinical product development for Accredo Specialty Services, a Medco company. "There are limited products in this category."

In an April 2006 poll of 102 managed care executives on specialty pharmacy management, MS ranked sixth out of 19 categories offered for responding to the question of which condition was in greatest need of management, says Tom Baker, senior vice president at The Zitter Group. The data are in an upcoming Zitter Group specialty pharmacy trend report created in conjuction with Wyeth Healthcare Systems. And the EMD Serono Injectables Digest, which gathered data from 69 health plans across the U.S. in the first quarter of 2007, found that MS drugs, both under the pharmacy benefit and the medical benefit, are among those therapies that plans require to be obtained from a specialty pharmacy provider.

Debbie Stern, vice president of managed care consulting firm Rxperts, Inc., says that "more emphasis on 'treatment optimization' — finding the right drug and managing the side effects so the patient stays on therapy" — may also be contributing to the cost increases.

Four of the immunomodulating agents that the FDA has approved for the treatment of MS — Betaseron (interferon beta-1b), Avonex (interferon beta-1a), Rebif (interferon beta-1a) and Copaxone (glatiramer acetate) — can be given intramuscularly and/or subcutaneously, but all may be self-administered. There is a pair of infusible treatment options: Tysabri (natalizumab) is an immunomodulating agent, while Novantrone (mitoxantrone) is both an immunomodulator and an immunosuppressant.

Coverage on Medical or Pharmacy Side?

Plans will usually, but not always, cover the infusi-bles on the medical side, but the other four drugs' coverage may differ from plan to plan, falling under both the medical and the pharmacy benefits. Many plans, however, have begun offering the self-administered MS therapies under the pharmacy benefit, which may give plans more control over utilization and lessen the cost burden for patients. Russek says Medco is seeing that "a lot of companies are moving all self-injectables - not just the MS drugs — to the pharmacy side."

In fact, the EMD Serono Injectables Digest also notes that among its respondents, MS drugs are one of the therapy classes most likely to require prior authorization under both the pharmacy and the medical benefit.

Some health plans have begun selecting a preferred MS therapy among the interferons and placing the interferons on different tiers for their patient populations. Commonly done with generic drugs that offer a less expensive option to traditional retail pharmacy, this is an idea that has not been very common in the specialty pharmacy arena, but is gaining some traction, says Russek, and not just in MS but also in areas such as rheumatoid arthritis therapies and growth hormones.

These conditions have multiple branded therapies that are somewhat similar in terms of their effectiveness and safety. When the drugs are "near-perfect substitutes adjudicated as pharmacy benefits," category management is most effective, said Baker at a 2006 Pharmaceutical Care Management Assn. (PCMA) convention, referring to research from The Zitter Group's biannual Managed Care Injectables Index.

More than half of the respondents in the Wyeth survey either agreed or strongly agreed that specialty pharmacy providers were "best for managing crowded classes," such as the main MS treatments, says Baker. About one-third of respondents said that specialty pharmacy providers "have helped them with cost savings through category 'narrowing' or management."

Data from the Managed Care Injectables Index show three of the four self-injectable therapies are often covered in plans' middle tiers, with the other agent usually in the highest tier. Drug placement in lower tiers will usually translate into lower copayments — the same survey showed these copays were, on average, about $34 — which also may translate into greater patient adherence to the therapy. That survey also broke down estimated patient cost-sharing levels for various disease states at which patient compliance will fall. For MS, it was $181.36.

Plans also can negotiate better pricing for preferred therapies and can incentivize patients to use these lower-tier products as well, noted Baker in his PCMA presentation. These therapies are considered first-line treatments for MS, says Stern.

Specialty pharmacy providers may also supply these self-administered therapies through mail order, which requires less interaction on the part of the specialty pharmacy.

Still, though, the treatments are not cheap. According to 2005 data from Caremark Rx, Inc., the average annual cost of therapy for Betaseron, Avonex, Rebif and Copaxone among Caremark covered lives is in the $20,000 to $24,000 range. That category ranked second among specialty therapeutic classes by gross cost in the PBM's 2005 book of business.

The infusibles, which also have a more severe adverse-effect profile, are considered a second-line agent for patients who are not responding to treatment, says Stern. Tysabri entered the market in November 2004 to great anticipation following promising trial data.

Manufacturers Biogen Idec, Inc. and Elan Corp. withdrew the drug, though, in February 2005 in the wake of reports of patients in clinical trials acquiring progressive multifocal leukoencephalopathy (PML), a viral infection of the brain that often causes death or disability. When Tysabri returned to the market in July 2006, it was at an annual cost of almost $30,000 — without taking into account service costs for the infusions themselves. The companies said in early May that there have been no new reports of confirmed PML cases. Novantrone's annual price tag starts at around $10,000.

Adding to inflation "are studies coming out that recommend MS patients start on the drug earlier," says Russek. "We think utilization [of MS therapies] will go up with patients starting these treatments earlier."

Costs are also expected to continue to rise, as new therapies make their way onto the marketplace. According to a 2006 report by the Pharmaceutical Research and Manufacturers of America trade group, there are 27 medicines in development for MS. Datamonitor predicts that the MS market "will more than double in value across the seven major markets from 2006 to reach $10.7 billion in 2016."

Patients who either have not responded to current MS therapies or have discontinued the therapies due to their side effects will be among those waiting to try the new treatments. Those patients who dislike the injectable aspects of the current drugs will also have some options, as the first oral MS drugs are expected to begin hitting the market over the next few years. "Orals will obviously be better for compliance and for treating patients who don't want to inject," contends Stern.

Among those anticipated oral therapies are IVAX Corp. and Serono's Mylinax (cladribine), Novartis' Fingolimod (FTY720), sanofi-aventis' Teriflunomide (HMR 1726) and Pepgen Corp.'s Tauferon (interferon-tau). Some drugs that are approved for other indications, such as Genentech, Inc.'s Rituxan (rituximab), are also being explored as possible MS treatments.

A Co-Development Contract Between 'Dong-A Pharm' and 'Genexine' as Win-Win Model to Prepare the International Competition After the FTA Between Korea

Posted : Wed, 13 Jun 2007 07:01:59 GMT
Author : Genexine Co., Ltd.

SEOUL, South Korea, June 13 /PRNewswire/ -- Dong-A Pharmaceutical (CEO Won-Bae Kim), the leading Pharmaceutical company, and Genexine (CEO, Young Chul Sung), a drug development biotech, entered into an collaboration agreement by signing a contract of the Product co-development. The contract encompasses co-commercialization of 1st generation protein drugs under developing in Dong-A and co-development of 2nd generation protein drugs using Genexine's propriotery hybrid Fc-fusion technology. To prepare for the intensive competition after KORUS FTA ratification, Dong-A has spent a lot of efforts to reinforce its development pipelines for new drugs. Genexine is hoping to launch products in the market as soon as possible after its planned Initial public offering (IPO). Thus, this contract can be considered as strategic alliances which can be beneficial for both companies.

Through the contract, both companies will make efforts to commercialize 'Gonadopin' for foreign markets which is rolled out in the domestic market last year. Gonadopin is a recombinant human follicle-stimulating hormone (rFSH) used for infertility treatment. Furthermore, both companies agreed to collaborate for co-development and co-commercialization of rFSH and recombinant IFN-B, a drug for multiple sclerosis, which comply with the guidelines of EMEA (European Agency for the Evaluation of Medical Products) and FDA (Food and Drug Administration). As of 2006, the global markets for rFSH and rIFN-B are estimated at $10.4 billion and $44 billion, respectively. We expect to launch rFSH and rIFN-B at 2014 with the estimate sales of $38 Million (2% of the global market) and 46 Million (1% of the global market), respectively. Furthermore, the agreement for the co-development of 2nd generation of FSH and IFN-B using hybrid Fc fusion, a Genexine's proprietary technology will be beneficial to both companies in terms of the development period and risk-management. At 2017 when the 2nd generation drugs of FSH and IFN-B are expected to be launched, both companies would lead the global markets for FSH and IFN-B.

Dong-A Pharmaceutical Co., Ltd.

Since founded at 1932, Dong-A Pharm is the leading pharmaceutical company in the country in terms of revenues with Bacchus as its primary product, which has the largest sales volume as a single item. Dong-A became the first pharmaceutical company with its revenues more than KRW 500 billion at 2002 and recorded revenues of KRW 576.7 billion. The affiliates include Dong-A Pharmtech, DAC, Dong-A Otsuka, Sooseok Agricultural Products, Sozhou dong-A Beverages, Yongma Logis, Qingdao Jin-A Glass, Korea Shinto, DA Information etc.

Genexine Co., Ltd.

Genexine is a drug developing company founded at 1999 as a spin-off from Postech (Dr. Young Chul Sung's lab). Genexine has been devoted to develop therapeutic vaccines using DNA and Adenovirus vectors and 2nd generation protein drugs using hybrid Fc fusion technology for difficult-to-treat and incurable diseases such as AIDS, chronic HBV infection, cancers etc. Recently, Genexine licensed out hybrid Fc-fusion technology-based 2nd generation protein drugs for autoimmune diseases, such as rheumatoid arthritis, and anemia. Fc-fusion technology

Fc-fusion technology is one of the technologies for 2nd generation protein drugs. It can prolong the in vivo half-life of the target proteins by fusing the Fc portion of antibodies.

Contact Person Dr. Dong-Jin Yoo E-mail: dyoo36@gmail.com or djyoo@genexine.com Genexine Co., Ltd.

CONTACT: Dr. Dong-Jin Yoo, of Genexine, dyoo36@gmail.com or
djyoo@genexine.com



Copyright © 2007 PR Newswire. All rights reserved.

MabThera shows stable long-term arthritis safety

BARCELONA, June 13 (Reuters) - Roche Holding AG's (ROG.VX: Quote, Profile, Research) MabThera can deliver sustained benefits to rheumatoid arthritis patients and, significantly, its safety profile is unchanged even after multiple treatments, researchers said on Wednesday.

MabThera, already a top-selling cancer drug, is now also approved for use in rheumatoid arthritis and could be used in several other autoimmune diseases, such as lupus and multiple sclerosis.

It is likely to be given for longer periods in these conditions, raising concerns about potential side effects -- particularly infections, since the drug works by targeting B-cells in the immune system.

Data presented at the annual European Congress of Rheumatology, however, showed a low and unchanging rate of serious infections in patients receiving up to seven treatment courses at six- to 12-month intervals.

Follow-up results from a clinical study involving more than 1,000 patients also found the effectiveness of the drug in relieving symptoms was sustained or further improved with subsequent doses.

The data showed that after three courses of MabThera in patients who had an inadequate response to another class of biotech drugs, known as TNF inhibitors, the number achieving a 70-percent improvement in symptoms rose to 25 percent from 11 percent.

Edward Keystone, professor of medicine at the University of Toronto, who has worked with Roche in researching MabThera, said the long-term findings would allow physicians to make treatment decisions with confidence.

MabThera -- known as Rituxan in the United States, where it is sold by Genentech Inc. (DNA.N: Quote, Profile, Research) and Biogen Idec Inc. (BIIB.O: Quote, Profile, Research) -- is one of a number of new drugs for rheumatoid arthritis -- is one of a number of new drugs for rheumatoid arthritis recently approved or in late-stage development.

Roche believes worldwide sales of MabThera, already a blockbuster in cancer, could also eventually top $1 billion a year in rheumatoid arthritis and other autoimmune diseases.

The Swiss group has made rheumatoid arthritis a priority for the future and hopes it will become a major driver of the business in the years ahead.

Roche is also developing a second novel medicine for the crippling disease, called Actemra, which could get to market in 2008. Behind that, it has an antibody drug called ocrelizumab that is just entering final Phase III development.

((Reporting by Ben Hirschler; Editing by Louise Ireland; email: ben.hirschler@reuters.com; Reuters Messaging: ben.hirschler.reuters.com@reuters.net; +44 20 7542 5082)) Keywords: ARTHRITIS ROCHE/

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Obesity Pill From Sanofi Gets Review

By JENNIFER CORBETT DOOREN

WASHINGTON -- The Food and Drug Administration Monday said Acomplia, a proposed weight-loss drug by Sanofi-Aventis SA, was effective at promoting weight loss but appeared to double the rate of suicidal thoughts and behavior.

Acomplia is sold in several European countries and the Paris company is seeking approval to sell the drug in the U.S., a key market that would likely propel it to blockbuster status of $1 billion or more in annual sales. Acomplia, which would be sold under the brand name Zimulti in the U.S., faces a review Wednesday by an FDA panel of outside medical experts. Acomplia is also known by its generic name, rimonabant.


WSJ's health blogger Jacob Goldstein discusses new FDA documents that state Acomplia from Sanofi-Aventis was effective at promoting weight loss but appeared to double the rate of suicidal thoughts and behavior.

The FDA typically follows its panels' advice but isn't required to do so. The FDA is set to make a final decision on whether to approve the drug by the end of July. The panel will be asked to decide several questions, including whether rimonabant should be approved or if additional studies are needed. The panel will also have to decide if it believes rimonabant increases the incidence of "suicidality," psychiatric and neurological adverse events, or side effects and seizures.

Suicidality is a term used to describe an increase in suicidal thoughts and behaviors and doesn't refer to completed suicides.

In briefing documents posted to its Web site Monday, the FDA said the 20-milligram dose of rimonabant was "associated with statistically and clinically significant weight loss." However, the FDA said it was concerned about an increase in psychiatric side effects as well as seizures. Sanofi had studied a 5- and a 20-milligram dose. The FDA said the 5-milligram dose wasn't effective at helping people lose weight.

Sanofi is seeking FDA approval to sell a 20-milligram dose to people considered obese and to people who are overweight who have at least one cardiovascular disease risk factor such as high blood pressure. Studies of the drug typically showed patients on the drug lost about 15 pounds over the course of a year while those in the placebo group lost about three pounds. They also had gains in HDL, or "good," cholesterol and declines in decline in triglyceride levels, or a type of fat found in the blood.

Rimonabant is designed to help block a chemical in the endocannabinoid system, a physiological system in the body that is believed to play a role in how the body regulates food intake. The FDA is concerned, however, that blocking the same chemical could increase the risk for other problems including mood disorders and neurodegenerative disorders like multiple sclerosis.

The FDA reviewed clinical studies of the drug as well as post-marketing reports of the drug from Europe. The agency said the 20-milligram dose of rimonabant is "statistically, significantly increased suicidality" compared to placebo or a fake drug.

The agency said a detailed meta-analysis of the suicidality data will be presented to the advisory panel Wednesday, but noted that patients on rimonabant were twice as likely to report an increase in "suicidality."

The FDA also said there was a higher rate of other psychiatric side effects among rimonabant users and the drug increased the risk of seizures. The agency said one set of studies showed 26% of patients on the 20-milligram dose of rimonabant reported a psychiatric side effect -- ranging from depression to insomnia -- compared to 14% of patients in the placebo group.

"We anticipate that much of the discussion at the advisory committee meeting will center on the relationship between rimonabant and depression, and on the methodology, results and interpretation of FDA's meta-analytic assessment of suicidality from completed rimonabant studies," the FDA said in a letter to panel members.

In its briefing document, Sanofi said that the "overall benefits in body weight, waist circumference and metabolic parameters...outweigh the risks that are manageable in clinical practice." The company said it would recommend that rimonabant not be used in patients with an existing psychiatric disorder like major depression and that the drug be used "cautiously" in patients with epilepsy, which causes seizures.

Last February, the FDA rejected Acomplia as a smoking-cessation product and said it needed more information on psychiatric side effects before it would consider approving the drug as a weight-loss treatment.

Sanofi shares edged lower on the New York Stock Exchange, falling 36 cents, or 0.8%, to $45.14.

Write to Jennifer Corbett Dooren at jennifer.corbett-dooren@dowjones.com

Nastech Announces Issuance of a U.S. Patent for Nascobal(R) Nasal Spray

Triggers $2 Million Milestone Payment from QOL Medical

BOTHELL, Wash., June 12 /PRNewswire-FirstCall/ -- Nastech Pharmaceutical Company Inc. (Nasdaq: NSTK) announced today the issuance of a U.S. patent, No. 7,229,636, from the U.S. Patent and Trademark Office, titled "Cyanocobalamin Low Viscosity Aqueous Formulations for Intranasal Delivery." Issuance of this patent triggers an obligation by QOL Medical LLC to pay Nastech a $2 million milestone under the license agreement granting QOL Medical commercialization rights to Nascobal(R) (Cyanocobalamin, USP) Nasal Spray. Nastech manufactures Nascobal Nasal Spray for QOL Medical at its manufacturing facility in Hauppauge, New York.

"The issuance of this patent significantly strengthens the competitive position of Nascobal Nasal Spray, which has an established position in the marketplace," stated Steven C. Quay, M.D., Ph.D., Chairman, President and CEO of Nastech. "We are pleased with the progress QOL Medical continues to make in providing patients and physicians with this innovative product."

About Nascobal and Vitamin B-12 Deficiency

Nascobal Nasal Gel had been approved and marketed in the U.S. since 1997 for the treatment of malabsorptive and diet-related vitamin B-12 deficiencies. A nasal spray dosage form, Nascobal Nasal Spray, was developed by Nastech and approved by the FDA in February 2005 and was launched by QOL Medical in February 2006, replacing the gel formulation. Nascobal Nasal Spray is indicated for use in patients with pernicious anemia and other malabsorptive conditions that may be caused by Crohn's Disease, HIV/AIDS, Multiple Sclerosis and other diseases.

Left untreated, vitamin B-12 deficiency may lead to anemia, intestinal problems, and irreversible nerve damage. Symptoms of vitamin B-12 deficiency can include fatigue, weakness, sore tongue, forgetfulness, weight loss, lack of coordination and difficulty walking.

About Nastech

Nastech is a biopharmaceutical company developing innovative products based on proprietary molecular biology-based drug delivery technologies. Nastech and our collaboration partners are developing products for multiple therapeutic areas including osteoporosis, obesity, diabetes, autism, respiratory diseases and inflammatory conditions. Additional information about Nastech is available at http://www.nastech.com.

About QOL Medical

QOL Medical acquires FDA approved specialty pharmaceuticals and uses its unique operational and marketing model to ensure more people who suffer from rare diseases or rare events have access to medications that can improve their quality of life. We are dedicated to improving quality of life for the patients we serve, their families and caregivers. www.qolmed.com

Nastech Forward-Looking Statements

Statements made in this press release may be forward-looking statements within the meaning of Federal Securities laws that are subject to certain risks and uncertainties and involve factors that may cause actual results to differ materially from those projected or suggested. Factors that could cause actual results to differ materially from those in forward-looking statements include, but are not limited to: (i) the ability of Nastech to obtain additional funding; (ii) the ability of Nastech to attract and/or maintain manufacturing, research, development and commercialization partners; (iii) Nastech's and/or a partner's ability to successfully complete product research and development, including preclinical and clinical studies and commercialization; (iv) Nastech's and/or a partner's ability to obtain required governmental approvals; and (v) Nastech's and/or a partner's ability to develop and commercialize products that can compete favorably with those of competitors. Additional factors that could cause actual results to differ materially from those projected or suggested in any forward-looking statements are contained in Nastech's most recent periodic reports on Form 10-K and Form 10-Q that are filed with the Securities and Exchange Commission. Nastech assumes no obligation to update and supplement forward-looking statements because of subsequent events.

Contacts:
Nastech
Ed Bell
Director, Investor Relations
(425) 908-3639
ir@nastech.com

Russo Partners, LLC
Matthew Haines (Investors/Media)
(212) 845-4235
SOURCE Nastech Pharmaceutical Company Inc.
-0- 06/12/2007
/CONTACT: Ed Bell, Director, Investor Relations of Nastech,
+1-425-908-3639, ir@nastech.com; or Investors-Media, Matthew Haines of Russo
Partners, LLC, +1-212-845-4235 /
/Web site: http://www.nastech.com
http://www.qolmed.com /
(NSTK)

CO: Nastech Pharmaceutical Company Inc.; QOL Medical
ST: Washington
IN: MTC HEA
SU: PLW LIC

CL-AA
-- NYTU009 --
2514 06/12/2007 09:15 EDT http://www.prnewswire.com

On sale in the UK: unproven goats' blood treatment for MS patients

· Remedy 'promoted like a religion' by charity
· Patients paying £19,000 a year for unproven product

Sarah Boseley, health editor
Monday June 11, 2007
The Guardian

Multiple sclerosis sufferers are spending their life savings and running up large debts to pay for a treatment derived from goats' blood that is being sold in Britain without any scientific proof that it works.

The MS Society is concerned about promotion and sales of the treatment, called Aimspro, to people with the progressive disease who have few other options. It has called on the firm selling it, Daval International, to put the drug through trials.

There are also concerns about a registered charity called Proventus, which was set up to lobby for greater access to Aimspro, but now says that it has broadened its field to a range of largely alternative products for MS.

Proventus, many of whose trustees and officers have small shareholdings in Daval, organises road shows to talk about Aimspro to people with MS. A recent event in Wimborne, Dorset, was described by one man who attended as reminiscent of a religious rally. "It was a very evangelical meeting. Others who were there said it was like a Billy Graham sermon," said Tim Worner, who runs a support group in Bournemouth for people with MS and invited Proventus to speak to it.

"A guy at the back of the hall stood up and said he took Aimspro once a week and was better. He said he had been in a wheelchair and used two sticks. He walked to the front and gave us a short talk on how he spent £180 to inject it once a week and how he wished he could afford to spend twice that. That's a good-sized mortgage payment."

Aimspro is made of the blood of goats that have been injected with killed HIV virus. The theory is that the antibodies produced stimulate the body's immune system against MS and other neurological and inflammatory diseases.

In the seven years since Daval was set up only two very small trials of Aimspro have been done. One was inconclusive and the other was stopped early.

Daval insists it will soon launch another small-scale trial, but in the meantime supplies of the drug - which has to be kept in a freezer until just before it is injected under the skin - are being shipped around the country to patients who pay £180 a vial. Two injections a week are recommended, which means some patients are paying out almost £19,000 a year. Proventus estimates that around 300 people are taking Aimspro, although as many as 500 may have tried it. "The society has always said that Daval International, like any other organisation that wishes to bring a therapeutic product to market, has to go through the current processes like anybody else," said Lee Dunster of the MS Society.

"There is a structure in place to protect people. There has been almost a flat refusal to go down that route. To make this available off-licence to people who are vulnerable borders on exploitation."

The MS Society accuses Daval of exploiting a loophole in the law to sell the drug. Aimspro has a "specials" licence, which means it can be supplied to an individual named patient if the patient's doctor agrees to write a prescription. It received the licence because it has an "orphan drug" status in Australia - granted after it was tried in four children with a rare and fatal disease called Krabbe's, for which there is no treatment. But a "specials" licence exists so that a drug can be manufactured to the specific needs of a single patient at the behest of a doctor - and is not intended for general marketing.

The Medicines and Healthcare Products Regulatory Authority, which grants licences and oversees drug safety, said that the company was under investigation, but could not comment further.

Bryan Youl, Daval's clinical director, told the Guardian that he had applied to the MHRA for a trial in January to study the effects of Aimspro in alleviating bladder symptoms of MS. "It has taken a long time. The documentation is pretty complex." He was waiting for a response from the MHRA, and planned further studies. "It has not been through lack of intention that we haven't trialled this."

Dr Youl added Aimspro was not an MS cure, but a palliative medicine, intended to treat symptoms. He said it was not unusual for medicines to be made available to patients "off-label" - outside the terms of the licence. "It is up to the doctor prescribing it to decide whether the patient truly requires the medication," he said.

The Charity Commission is looking into Proventus. Concerns have been raised with the commission over its administration and management, and possible conflicts of interest. In a statement the commission said: "We are currently considering these concerns to determine what action, if any, it might be appropriate for us to take." It is understood to have particular concern about the role of Proventus in public appeals for funds by MS patients who desperately want to buy Aimspro.

A Dorset newspaper ran a story about a woman who was dependent on benefits and had spent all her savings on the drug. At the foot of the article a request was made for cheques to be sent to Proventus.

Dr Dunster also went to a Proventus rally. "It clearly was a sales pitch - no bones about it at all."

"They had someone in the audience who talked about how much of a difference goat's serum makes to them. The guy walked to the front and said that was not possible a few years ago. I am really sad and disappointed that this kind of activity goes on. When you are sitting in an audience of 50-60 people, the majority of whom have a progressive condition, with inexorable decline in mobility ... it gives a very hopeful message for individuals who have very little else at the moment."

John Slack, Proventus's chairman of the trustees, was diagnosed with MS 15 years ago and says he believes Aimspro helped him. "We are a group of volunteers who are desperately trying to find a treatment for MS sufferers. There is virtually nothing out there - that is the sad thing. There are 100,000 people with MS in this country. We feel as if we are totally forgotten. If we are promoting Aimspro, we're simply saying there is a future out there because there is something on the horizon." He had a few shares in Daval - but had bought them out of gratitude when he was supplied with Aimspro for nothing as one of the earliest patients by the managing director, David Shotton. He now has to pay.

Pipex Pharmaceuticals' Oral TRIMESTA Initiates Enrollment of Phase II/III Clinical Trial for Multiple Sclerosis

$5 Million Grant From National Multiple Sclerosis Society, With Support From NIH

Previous Phase II Demonstrated 79% Reduction in Gadolinium Enhancing Brain (MS Lesion) Volumes (p=0.02) and Exceptional 14% Increase in Cognitive Function (p=0.04)

ANN ARBOR, MI--(Marketwire - June 11, 2007) - Pipex Pharmaceuticals, Inc. (OTCBB: PPEX), a specialty pharmaceutical company developing innovative late-stage drug candidates for the treatment of neurologic and fibrotic diseases, announced today that TRIMESTA (oral estriol), its proprietary therapy for multiple sclerosis (MS) has entered a multi-center, Phase II/III clinical trial for the treatment of women with relapsing-remitting MS. This clinical trial has received a $5 million grant from the National Multiple Sclerosis Society (NMSS) in partnership with the National MS Society's Southern California chapter, with support from the National Institutes of Health (NIH).

Previous Phase II Clinical Trial Results in Relapsing Remitting Multiple Sclerosis

TRIMESTA (oral estriol) has completed an initial 22 month, single-agent, crossover phase II clinical trial in the U.S. for the treatment of MS in relapsing remitting patients, with highly encouraging results. The results showed the total volume and number of enhancing pathogenic myelin lesions (established neuroimaging measurements of disease activity in MS) decreased during the treatment period as compared to a six-month pretreatment baseline period. The median total enhancing lesion volumes decreased by 79 percent (p=0.02) and the number of lesions decreased by 82 percent (p=0.09) within the first three months of treatment with TRIMESTA.

Following a three month drug holiday during which the patients weren't on any drug therapies, TRIMESTA therapy was reinitiated during a retreatment phase of this clinical trial. The relapsing-remitting MS patients again demonstrated a decrease in enhancing lesion volumes of 88 percent (p=0.008) and a decrease in the number of lesions by 48 percent (p=0.04) compared with original baseline scores (1),(2).

Improvement in Cognitive Testing Scores

During this phase II clinical trial, a 14 percent improvement in Paced Auditory Serial Addition Test ("PASAT") cognitive testing scores (p=0.04) was observed in these MS patients at six months of therapy. PASAT is a routine cognitive test performed in patients with a wide variety of neuropsychological disorders such as MS. The PASAT scores were expressed as a mean percent change from baseline and were significantly improved in the relapsing-remitting group.

Dr. Rhonda Voskuhl, Professor of Neurology at the University of California, Los Angeles and inventor of TRIMESTA, commented, "Due to its rapid onset of action, oral activity and high response rate seen in relapsing-remitting MS patients in the initial Phase II clinical trial, TRIMESTA may have an important clinical advantage over current injectable MS treatments. As a neurologist, the improvement in cognitive testing scores may also represent a new paradigm in treating MS patients as well as other neurodegenerative diseases with TRIMESTA."

Dr. John R. Richert, Executive Vice President of Research and Clinical Programs at the National MS Society, stated, "We're encouraged that the National MS Society's funding of the original pilot trial of estriol, which emerged from targeted research on gender differences in MS, has led to this new trial. We are pleased that Pipex and Dr. Voskuhl are committed to advancing the development of this novel approach which could potentially lead to an affordable, oral disease-modifying therapy for this debilitating disease."

Dr. Charles Bisgaier, Pipex's President, stated that, "The active ingredient in TRIMESTA has been marketed for over 40 years in Europe and Asia for the treatment of post-menopausal hot flashes. As we enter this Phase II/III clinical trial of TRIMESTA for treatment of MS, the product's known historical efficacy and tolerability coupled with the promising Phase II clinical trial results in MS patients an exciting new approach to treating this devastating disease with a targeted orally active drug candidate."

Dr. Bisgaier went onto say, "The exceptional increase in cognitive function together with the rapid reduction in lesion volumes and numbers positions TRIMESTA to become therapy of choice in the $10 billion global MS market. We are grateful for this $5 million grant and the support of the NMSS/NIH. We are excited about working with the National MS Society, Dr. Voskuhl and her team in furthering this promising new approach."

About the Phase II/III Clinical Trial

The clinical study is a double-blind, placebo-controlled trial that will take place at seven sites in the U.S., enrolling up to 150 female MS patients. Investigators will administer TRIMESTA to women between the ages of 18-50 who have been recently diagnosed with relapsing-remitting MS. TRIMESTA will be given in combination with subcutaneously injected Copaxone®, a standard treatment for MS. The team is evaluating effects of the treatment combination on relapse rates using several clinical and magnetic resonance imaging measures of disability progression.

The study sites include the University of California, Los Angeles (UCLA), Ohio State University (OSU), Rutgers University (UMDNJ), Washington University, St. Louis, University of Chicago, University of Utah and Wayne State University. For further information on this Phase II/III clinical trial, please visit www.clinicaltrials.gov/.
Pregnancy and MS

Doctors have known for decades that women often experience a sharp drop in MS disease symptoms during the course of pregnancy, specifically in the third trimester when the levels of estriol is being produced at their highest level by the placenta. The list of autoimmune diseases that improve during pregnancy includes multiple sclerosis, rheumatoid arthritis, thyroiditis, uveitis, juvenile rheumatoid arthirits, ankylosing spondylitis with peripheral arthritis and psoriatic arthritis.

A landmark clinical study published in the New England Journal of Medicine, known as the PRIMS study (Pregnancy in Multiple Sclerosis) followed 254 women with MS during 269 pregnancies and for up to one year after delivery. The PRIMS study demonstrated that relapse rates were significantly reduced by 71 percent (p < 0.001) through the third trimester of pregnancy from prebaseline levels and relapse rates then increased by 120 percent (p < 0.001) during the first three months postpartum before returning to prepregnancy rates (3).

About TRIMESTA

TRIMESTA is an orally active, immunomodulatory and anti-inflammatory molecule the has been approved and marketed throughout Europe and Asia for approximately 40 years for the treatment of post-menopausal hot flashes, but has never been introduced in North America. Estriol, the active ingredient in TRIMESTA, is a weak estrogenic-based molecule that is produced in the placenta by women during pregnancy. Estriol is considered to play an important role in the immunologic privilege offered to the fetus during pregnancy and is also thought to be responsible for the spontaneous remission of Th1-mediated autoimmune diseases of women (such as multiple sclerosis and rheumatoid arthritis) during pregnancy, especially during the third trimester. Pipex has an exclusive worldwide license with UCLA (through the Regent of the University of California) to the intellectual property rights surrounding TRIMESTA.

About Multiple Sclerosis (MS)

MS is a chronic, usually progressive disease of the central nervous system in which the immune system attacks and destroys the structure, and therefore degrades the function, of nerve cells. Approximately 400,000 Americans have MS, and virtually every hour someone is newly diagnosed. Most are between the ages of 20 and 50, and women are affected two to three times more often than men. Worldwide, MS may affect 2.5 million individuals.

According to the National MS Society, the economic cost of care for MS patients in the United States including medical and non-medical care, production losses, and informal care exceeds $23 billion annually, or more than $57,000 per U.S. patient per year. Complications from MS may make it harder for people to work and may interfere with their ability to perform common, daily activities. During 2006, combined sales estimates of FDA-approved injectable MS therapies, which include Avonex®, Betaseron®, Copaxone®, and Rebif®, totaled approximately $5.0 billion.

For most people with MS, the disease slowly progresses with a series of unpredictable flare-ups, also called relapses or exacerbations. But for some, the progression of the disease is rapid. Relapses often lead to increasing disabilities such as walking impairment, muscle weakness or speech or vision impairments.

About the National MS Society

The National MS Society is committed to building a movement by and for people with MS that will move us closer to a world free of this disease. The Society funds more MS research, provides more services to people with MS, offers more professional education and furthers more advocacy efforts than any other MS organization in the world. The Society has approximately 500,000 members, including more than 300,000 people with MS, and over 460,000 volunteers who carry out the Society's mission. For further information on the National MS Society, please visit www.nationalmssociety.org.

About Pipex Pharmaceuticals, Inc.

Pipex Pharmaceuticals Inc. is a specialty pharmaceutical company that is developing proprietary, late-stage drug candidates for the treatment of neurologic and fibrotic diseases. Pipex's strategy is to exclusively in-license proprietary, clinical-stage drug candidates and complete the further clinical testing, manufacturing and regulatory requirements sufficient to seek marketing authorizations via the filing of New Drug Applications (NDAs) with the FDA in the US and Marketing Application Authorizations (MAAs) with the European Medicines Evaluation Agency (EMEA). For further information please visit www.pipexpharma.com.

(1) Sicotte NL, Liva SM, Klutch R, Pfeiffer P, Bouvier S, Odesa S, Wu TC, Voskuhl RR. Treatment of multiple sclerosis with pregnancy hormone estriol. Ann Neurol. 2002 Oct. 52(4):421-8.

(2) Soldan SS, Alvarez Retuerto AI, Sicotte NL, Voskuhl RR. Immune modulation in multiple sclerosis patients treated with pregnancy hormone estriol. J Immunol. 2003 Dec 1:171(11):6267-74.

(3) Confavreux, C., Hutchinson, M., Hours, M.M., Cortinovis-Tourniaire, P., and Moreau, T. Rate of pregnancy-related relapse in multiple sclerosis. 1998. Pregnancy in Multiple Sclerosis Group. N Engl J Med 339:285-291.

Copaxone® is a registered trademark of Teva Pharmaceuticals.

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, that reflect Pipex Pharmaceuticals, Inc. (the "Company," "we" or "our" "Pipex") current expectations about its future results, performance, prospects and opportunities, including statements regarding the potential use of TRIMESTA ™ for the treatment of Multiple Sclerosis. Where possible, the Company has tried to identify these forward-looking statements by using words such as "anticipates," "believes," "intends," or similar expressions. These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements, including the risks set forth in our most recent filing on Form 10-QSB and Form 10-KSB filed with the Securities and Exchange Commission. We cannot assure you that we will be able to successfully develop or commercialize products based on our technologies, including COPREXA™, TRIMESTA™, Anti-CD4 802-2, CORRECTA™, EFFIRMA™ and SOLOVAX™ particularly in light of the significant uncertainty inherent in developing, manufacturing and conducting preclinical and clinical trials of new pharmaceuticals and obtaining regulatory approvals, that our technologies will prove to be safe and effective, that our cash expenditures will not exceed projected levels, that we will be able to obtain future financing or funds when needed, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that we will be able to successfully obtain any further grants and awards, maintain our existing grants which are subject to performance, that we will be able to patent, register or protect our technology from challenge and products from competition or maintain or expand our license agreements with our current licensors, or that our business strategy will be successful. All forward-looking statements made in this press release are made as of the date hereof, and the Company assumes no obligation to update the forward-looking statements included in this news release whether as a result of new information, future events, or otherwise.
For Further Information Contact:

Steve H. Kanzer, CPA, Esq.
Chairman and Chief Executive Officer
Tel (734) 332-7800

Or

Thomas Redington (investor relations)
Redington, Inc.
Tel: (203) 222-7399
www.redingtoninc.com