Showing posts with label Mbp8298. Show all posts
Showing posts with label Mbp8298. Show all posts

Wednesday, October 01, 2008

BIOMS MEDICAL ANNOUNCES RECEIPT OF MILESTONE PAYMENT FROM ELI LILLY AND COMPANY





~ US$10 million received based on the positive review of interim analysis for international pivotal multiple sclerosis trial ~

Edmonton, Alberta, September 22, 2008 – BioMS Medical Corp. (TSX: MS), a leading developer in the treatment of multiple sclerosis (MS), today announced that it has received the US$10 million milestone payment from its partner, Eli Lilly and Company.

The milestone payment is based on the previously announced positive review of the scheduled interim analysis of the Company’s pivotal phase II/III Canadian and European trial (MAESTRO-01) of dirucotide (MBP8298) in patients with secondary progressive MS. The independent Data Safety Monitoring Board (DSMB) for the MAESTRO-01 trial recommended that the trial proceed to completion based on the interim analysis which included efficacy and safety data from the first 200 patients to complete the trial.

To date, BioMS has received a total of US$97 million in payments from Eli Lilly and Company, based on the licensing and development agreement for dirucotide (MBP8298). An additional $400 million in milestone payments are possible under the terms of the licensing agreement, in addition to escalating royalties on sales.

“We are pleased that our partner has recognized the outcome of the interim analysis as a significant positive event,” said Kevin Giese, President and CEO of BioMS Medical. “We look forward to completing the MAESTRO-01 trial and reviewing the complete data set in the second half of 2009.”

About BioMS Medical Corp.

BioMS Medical is a biotechnology company engaged in the development and commercialization of novel therapeutic technologies. BioMS Medical’s lead technology, dirucotide (MBP8298), is for the treatment of multiple sclerosis and is being evaluated in two pivotal phase III clinical trials for secondary progressive MS patients, MAESTRO-01 in Canada and Europe and MAESTRO-03 in the United States. It additionally is being evaluated for relapsing remitting MS patients in a Phase II trial in Europe entitled MINDSET-01. In December 2007, BioMS entered into a licensing and development agreement granting Eli Lilly and Company exclusive worldwide rights to dirucotide (MBP8298) in exchange for an $87 million upfront payment, milestone payments and escalating royalties on sales. For further information please visit our website at www.biomsmedical.com.

This press release may contain forward-looking statements, which reflect the Corporation’s current expectation regarding future events. These forward-looking statements involve risks and uncertainties that may cause actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements. Such factors include, but are not limited to, changing market conditions, the successful and timely completion of clinical studies, the establishment of corporate alliances, the impact of competitive products and pricing, new product development, uncertainties related to the regulatory approval process and other risks detailed from time to time in the Corporation’s ongoing quarterly and annual reporting. Certain of the assumptions made in preparing forward-looking statements include but are not limited to the following: that dirucotide (MBP8298) will continue to demonstrate a satisfactory safety profile in ongoing and future clinical trials; and that BioMS Medical Corp. will complete the respective clinical trials within the timelines communicated in this release. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Ryan Giese
VP Corporate Communications
Phone: 780-413-7152
rgiese@biomsmedical.com

Tony Hesby
Executive VP Corporate Affairs
Phone: 780-413-7152
tony.hesby@biomsmedical.com

Amanda Stadel
Investor Relations Manager
Phone: 780-413-7152
astadel@biomsmedical.com

Thursday, September 04, 2008

BIOMS MEDICAL’S LEAD DRUG, DIRUCOTIDE (MBP8298) FOR THE TREATMENT OF MULTIPLE SCLEROSIS, RECEIVES FAST TRACK DESIGNATION FROM FDA





Edmonton, Alberta, September 4, 2008 – BioMS Medical Corp. (TSX: MS), a leading developer in the treatment of multiple sclerosis (MS), today announced that the Food and Drug Administration (FDA) of the United States has granted fast track designation for the Company’s lead drug, dirucotide (MBP8298), for the treatment of secondary progressive MS (SPMS). Dirucotide (MBP8298) is currently being evaluated in a U.S. pivotal phase III trial, named MAESTRO-03, at 68 sites with approximately 510 patients.

Fast track designation is an FDA status reserved for products that are intended to treat a serious or life-threatening condition and that demonstrate the potential to address unmet medical needs for that condition. Fast track designation can potentially facilitate development and expedite the review process.

“Our receipt of fast track designation for dirucotide in the U.S. is a significant milestone for both BioMS Medical and the MS community," said Kevin Giese, President and CEO of BioMS Medical. “Based on previous clinical results, we believe dirucotide is well-positioned to become a first-in-class treatment for secondary progressive MS patients, a large patient population with very limited treatment options.”

About MAESTRO-03
The MAESTRO-03 U.S. pivotal phase III clinical trial is a randomized, double-blind study that has completed recruitment of approximately 510 patients at 68 clinical sites who will be administered either dirucotide (MBP8298) or placebo intravenously every six months for a period of two years. The primary clinical endpoint for the trial is defined as a statistically and clinically significant increase in the time to progression of the disease as measured by the Expanded Disability Status Scale (EDSS), in patients with HLA-DR2 and/or HLA-DR4 immune response genes (up to 75% of all MS patients are HLA-DR2 and/or HLA-DR4 positive).



About Dirucotide (MBP8298)
Dirucotide (MBP8298) is a synthetic peptide that consists of 17 amino acids having a sequence identical to that of a portion of human myelin basic protein (MBP). Dirucotide is being developed for the potential treatment of multiple sclerosis (MS), an autoimmune disease caused by immune attack against normal components of the central nervous system. The sequence of dirucotide is associated with the autoimmune process in MS patients with certain immune response genes (HLA types DR2 and/or DR4); MS patients having these genes represent 65 to 75 percent of all MS patients.

The drug’s apparent mechanism of action is the induction or restoration of immunological tolerance with respect to ongoing immune attack as a result of high doses of peptide periodically delivered intravenously. The potential benefit of the drug for any individual patient is therefore expected to be related to the role this peptide plays in that patient’s immune system. The degree of immunomodulation achieved will depend on the relationship among the peptide, HLA molecules and T cells.

The results of phase II and long-term follow-up treatment of MS patients with MBP8298 (dirucotide), published in 2006 in the European Journal of Neurology (EJN), showed that MBP8298 (dirucotide) safely delayed median time to disease progression for five years (versus placebo) in progressive MS patients with HLA types DR2 and/or DR4. Thus, dirucotide (MBP8298), if approved, has the potential to be used as a tailored therapy for patients genetically determined to express the appropriate HLA molecules.

Dirucotide (MBP8298) is being studied in four late-stage clinical trials:

• MAESTRO-01: A pivotal phase II/III trial for secondary progressive MS (SPMS) patients in Canada and Europe.
• MAESTRO-02: An open-label safety extension study to MAESTRO-01.
• MAESTRO-03: A pivotal phase III trial for SPMS patients in the United States.
• MINDSET-01: A phase II trial for relapsing-remitting MS (RRMS) patients in Europe.



About BioMS Medical Corp.
BioMS Medical is a biotechnology company engaged in the development and commercialization of novel therapeutic technologies. BioMS Medical’s lead technology, dirucotide (MBP8298), is for the treatment of multiple sclerosis and is being evaluated in two pivotal phase III clinical trials for secondary progressive MS patients, MAESTRO-01 in Canada and Europe and MAESTRO-03 in the United States. It additionally is being evaluated for relapsing remitting MS patients in a Phase II trial in Europe entitled MINDSET-01. In December 2007, BioMS entered into a licensing and development agreement granting Eli Lilly and Company exclusive worldwide rights to dirucotide (MBP8298), in exchange for an $87 million upfront payment, milestone payments and escalating royalties on sales. For further information please visit our website at www.biomsmedical.com.

This press release may contain forward-looking statements, which reflect the Corporation’s current expectation regarding future events. These forward-looking statements involve risks and uncertainties that may cause actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements. Such factors include, but are not limited to, changing market conditions, the successful and timely completion of clinical studies, the establishment of corporate alliances, the impact of competitive products and pricing, new product development, uncertainties related to the regulatory approval process and other risks detailed from time to time in the Corporation’s ongoing quarterly and annual reporting. Certain of the assumptions made in preparing forward-looking statements include but are not limited to the following: that dirucotide (MBP8298) will continue to demonstrate a satisfactory safety profile in ongoing and future clinical trials; and that BioMS Medical Corp. will complete the respective clinical trials within the timelines communicated in this release. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Ryan Giese
VP Corporate Communications
Phone: 780-413-7152
rgiese@biomsmedical.com

Tony Hesby
Executive VP Corporate Affairs
Phone: 780-413-7152
tony.hesby@biomsmedical.com

Amanda Stadel
Investor Relations Manager
Phone: 780-413-7152
astadel@biomsmedical.com

Thursday, August 14, 2008

BIOMS MEDICAL ANNOUNCES POSITIVE INTERIM ANALYSIS ON PHASE III TRIAL OF DIRUCOTIDE (MBP8298) FOR MULTIPLE SCLEROSIS





- Milestone triggers $10 million payment from Eli Lilly and Company -


Edmonton, Alberta, August 13, 2008 – BioMS Medical Corp. (TSX: MS), a leading developer in the treatment of multiple sclerosis (MS), today announced that the independent Drug Safety Monitoring Board (DSMB) for the MAESTRO-01 trial has conducted the scheduled interim analysis of efficacy and safety and has recommended that the trial continue to completion. MAESTRO-01 is the pivotal phase II/III Canadian and European study of dirucotide (MBP8298) in patients with secondary progressive MS.

The interim analysis included patients from the first 200 to complete MAESTRO-01 and assessed the likelihood of the study reaching its primary endpoint at the end of the trial in MS patients with the target HLA-DR2 and/or HLA-DR4 immune response genes. The DSMB analysis also included a scheduled review of safety information.

Based on the DSMB decision, Eli Lilly and Company has agreed to provide the $10 million milestone payment to BioMS as part of the terms of the licensing and collaboration agreement.

“We are very encouraged by the safety board’s recommendation,” said Kevin Giese, President and CEO of BioMS Medical. “This positive review is an important milestone for BioMS and our partner, Eli Lilly and Company, and moves us one step closer to our goal of bringing this important therapy to multiple sclerosis patients.”

"We are pleased by the results of the interim analysis and look forward to final efficacy and safety data from this trial next year," said Dr. Mark Freedman, Professor of Neurology at the University of Ottawa and Director of the MS Research Clinic at the Ottawa Hospital. "If successful, this novel therapy administered only twice per year, could help a large underserved population with late stage MS."



About MAESTRO-01
Dirucotide (MBP8298) is being studied in four late-stage clinical trials:

• MAESTRO-01: A pivotal phase II/III trial for secondary progressive MS (SPMS) patients in Canada and Europe.
• MAESTRO-02: An open-label safety extension study to MAESTRO-01.
• MAESTRO-03: A pivotal phase III trial for SPMS patients in the United States.
• MINDSET-01: A phase II trial for relapsing-remitting MS (RRMS) patients in Europe.

MAESTRO-01 is a multi-center, double-blind, placebo-controlled trial designed to evaluate the safety and efficacy of dirucotide (MBP8298) in patients with secondary progressive MS. The study is being conducted at 47 sites across Canada and nine countries in Europe and includes 611 patients being administered either dirucotide (MBP8298) or placebo intravenously every six months for a period of two years. The primary clinical endpoint for the trial is defined as a statistically and clinically significant increase in the time to progression of the disease, as measured by the Expanded Disability Status Scale (EDSS), in patients with HLA-DR2 and/or HLA-DR4 immune response genes. Time to disease progression in patients with other HLA-DR types will be assessed separately as an exploratory arm of the same study.

About Dirucotide (MBP8298)
Dirucotide (MBP8298) is a synthetic peptide that consists of 17 amino acids having a sequence identical to that of a portion of human myelin basic protein (MBP). Dirucotide is being developed for the potential treatment of multiple sclerosis (MS), an autoimmune disease caused by immune attack against normal components of the central nervous system. The sequence of dirucotide is associated with the autoimmune process in MS patients with certain immune response genes (HLA types DR2 and/or DR4); MS patients having these genes represent 65 to 75 percent of all MS patients.

The drug’s apparent mechanism of action is the induction or restoration of immunological tolerance with respect to ongoing immune attack as a result of high doses of peptide periodically delivered intravenously. The potential benefit of the drug for any individual patient is therefore expected to be related to the role this peptide plays in that patient’s immune system. The degree of immunomodulation achieved will depend on the relationship among the peptide, HLA molecules and T cells.

The results of phase II and long-term follow-up treatment of MS patients with MBP8298 (dirucotide), published in 2006 in the European Journal of Neurology (EJN), showed that MBP8298 (dirucotide) safely delayed median time to disease progression for five years (versus placebo) in progressive MS patients with HLA types DR2 and/or DR4. Thus, dirucotide (MBP8298), if approved, has the potential to be used as a tailored therapy for patients genetically determined to express the appropriate HLA molecules.

About Multiple Sclerosis
Multiple sclerosis (MS) is thought to affect as many as 2.5 million people worldwide, including approximately 75,000 in Canada, 400,000 in the United States and more than 500,000 in Europe. It is a disease that affects more women than men, with onset typically occurring between 20 and 50 years of age. MS is caused by damage to myelin, the protective sheath surrounding nerve fibers in the central nervous system, which interferes with messages from the brain to the body. Symptoms of MS may include vision problems, loss of balance, numbness, difficulty walking and paralysis. Approximately 40 percent of all MS patients have the secondary progressive form of the disease.


About BioMS Medical Corp.
BioMS Medical is a biotechnology company engaged in the development and commercialization of novel therapeutic technologies. BioMS Medical’s lead technology, dirucotide (MBP8298), is for the treatment of multiple sclerosis and is being evaluated in two pivotal phase III clinical trials for secondary progressive MS patients, MAESTRO-01 in Canada and Europe and MAESTRO-03 in the United States. It additionally is being evaluated for relapsing remitting MS patients in a Phase II trial in Europe entitled MINDSET-01. In December 2007, BioMS entered into a licensing and development agreement granting Eli Lilly and Company exclusive worldwide rights to dirucotide (MBP8298), in exchange for an $87 million upfront payment, milestone payments and escalating royalties on sales. For further information please visit our website at www.biomsmedical.com.

This press release may contain forward-looking statements, which reflect the Corporation’s current expectation regarding future events. These forward-looking statements involve risks and uncertainties that may cause actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements. Such factors include, but are not limited to, changing market conditions, the successful and timely completion of clinical studies, the establishment of corporate alliances, the impact of competitive products and pricing, new product development, uncertainties related to the regulatory approval process and other risks detailed from time to time in the Corporation’s ongoing quarterly and annual reporting. Certain of the assumptions made in preparing forward-looking statements include but are not limited to the following: that dirucotide (MBP8298) will continue to demonstrate a satisfactory safety profile in ongoing and future clinical trials; and that BioMS Medical Corp. will complete the respective clinical trials within the timelines communicated in this release. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Ryan Giese
VP Corporate Communications
Phone: 780-413-7152
rgiese@biomsmedical.com

Tony Hesby
Executive VP Corporate Affairs
Phone: 780-413-7152
tony.hesby@biomsmedical.com

Amanda Stadel
Investor Relations Manager
Phone: 780-413-7152
astadel@biomsmedical.com

Thursday, July 24, 2008

BIOMS MEDICAL’S RELAPSING-REMITTING MULTIPLE SCLEROSIS TRIAL RECEIVES POSITIVE REVIEW FROM DATA SAFETY MONITORING BOARD





Edmonton, Alberta, July 17, 2008 – BioMS Medical Corp. (TSX: MS), a leading developer in the treatment of multiple sclerosis (MS), today announced that the independent Data Safety Monitoring Board (DSMB) for the Company's phase II MINDSET-01 trial of MBP8298 (dirucotide) in patients with relapsing-remitting MS has completed a safety analysis and recommended that the trial continue as per the protocol.

This was the fifth of several regularly scheduled reviews by the DSMB that will occur over the duration of the trial. The purpose of the DSMB is to provide objective, independent safety monitoring of the trial.

MINDSET-01 Trial
The MINDSET-01 phase II, double-blind, placebo-controlled trial is designed to evaluate the safety and efficacy of MBP8298 (dirucotide) in patients with relapsing-remitting MS. The fifteen month trial is fully enrolled with 218 patients at 24 sites in 6 countries. The objectives of the study are to demonstrate safety and efficacy of MBP8298 (dirucotide) versus placebo as measured by relapse rate, MRI activity and disease progression.




This press release may contain forward-looking statements, which reflect the Corporation’s current expectation regarding future events. These forward-looking statements involve risks and uncertainties that may cause actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements. Such factors include, but are not limited to, changing market conditions, the successful and timely completion of clinical studies, the establishment of corporate alliances, the impact of competitive products and pricing, new product development, uncertainties related to the regulatory approval process and other risks detailed from time to time in the Corporation’s ongoing quarterly and annual reporting. Certain of the assumptions made in preparing forward-looking statements include but are not limited to the following: that dirucotide (MBP8298) will continue to demonstrate a satisfactory safety profile in ongoing and future clinical trials; and that BioMS Medical Corp. will complete the respective clinical trials within the timelines communicated in this release. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.




Ryan Giese
VP Corporate Communications
Phone: 780-413-7152
rgiese@biomsmedical.com

Tony Hesby
Executive VP Corporate Affairs
Phone: 780-413-7152
tony.hesby@biomsmedical.com

Amanda Stadel
Investor Relations Manager
Phone: 780-413-7152
astadel@biomsmedical.com

Wednesday, June 04, 2008

BIOMS MEDICAL’S RELAPSING-REMITTING MULTIPLE SCLEROSIS TRIAL RECEIVES POSITIVE REVIEW FROM DATA SAFETY MONITORING BOARD





Edmonton, Alberta, May 27, 2008 – BioMS Medical Corp. (TSX: MS), a leading developer in the treatment of multiple sclerosis (MS), today announced that the independent Data Safety Monitoring Board (DSMB) for the Company's phase II MINDSET-01 trial of MBP8298 (dirucotide) in patients with relapsing-remitting MS has completed a safety analysis and recommended that the trial continue as per the protocol.

This was the fourth of several regularly scheduled reviews by the DSMB that will occur over the duration of the trial. The purpose of the DSMB is to provide objective, independent safety monitoring of the trial.

MINDSET-01 Trial
The MINDSET-01 phase II, double-blind, placebo-controlled trial is designed to evaluate the safety and efficacy of MBP8298 (dirucotide) in patients with relapsing-remitting MS. The fifteen month trial is fully enrolled with 218 patients at 24 sites in 6 countries. The objectives of the study are to demonstrate safety and efficacy of MBP8298 (dirucotide) versus placebo as measured by relapse rate, MRI activity and disease progression.


About BioMS Medical Corp.
BioMS Medical is a biotechnology company engaged in the development and commercialization of novel therapeutic technologies. BioMS Medical’s lead technology, MBP8298 (dirucotide), is for the treatment of multiple sclerosis and is being evaluated in two pivotal phase III clinical trials for secondary progressive MS patients, MAESTRO-01 in Canada and Europe and MAESTRO-03 in the United States. It additionally is being evaluated for relapsing remitting MS patients in a Phase II trial in Europe entitled MINDSET-01. In December 2007, BioMS entered into a licensing and development agreement granting Eli Lilly and Company exclusive worldwide rights to MBP8298 (dirucotide) in exchange for an $87 million upfront payment, milestone payments and escalating royalties on sales. For further information please visit our website at www.biomsmedical.com.



Ryan Giese
VP Corporate Communications
Phone: 780-413-7152
rgiese@biomsmedical.com Tony Hesby

Executive VP Corporate Affairs
Phone: 780-413-7152
tony.hesby@biomsmedical.com

Amanda Stadel
Investor Relations Manager
Phone: 780-413-7152
astadel@biomsmedical.com

Thursday, January 31, 2008

BioMS Medical Completes Licensing Deal with Lilly




- BioMS receives $87 million upfront payment -

Edmonton, Alberta, January 25, 2008 – BioMS Medical Corp. (TSX: MS) reported today that it has completed the previously-announced licensing and development agreement with Eli Lilly and Company. As part of the agreement, BioMS has received an upfront cash payment of US$87 million. In December, 2007 BioMS Medical entered into a global licensing and development agreement granting Lilly exclusive worldwide rights to BioMS Medical's lead drug, MBP8298, for the treatment of multiple sclerosis (MS).

“We look forward to a productive and successful relationship with Lilly,” said Kevin Giese, President and CEO of BioMS. “With these resources and the support from a world-class pharmaceutical company, we are well positioned to realize our shared goal of developing MBP8298 to bring new hope to patients suffering from MS.”


About BioMS Medical Corp.
BioMS Medical is a biotechnology company engaged in the development and commercialization of novel therapeutic technologies. BioMS Medical's lead technology, MBP8298, is for the treatment of multiple sclerosis and is being evaluated in two pivotal phase III clinical trials for secondary progressive MS patients, MAESTRO-01 in Canada and Europe and MAESTRO-03 in the United States . It additionally is being evaluated for relapsing remitting MS patients in a Phase II trial in Europe entitled MINDSET-01. For further information please visit our website at www.biomsmedical.com .



Ryan Giese
VP Corporate Communications
Phone: 780-413-7152
rgiese@biomsmedical.com

Tony Hesby
Executive VP Corporate Affairs
Phone: 780-413-7152
tony.hesby@biomsmedical.com

Amanda Stadel
Investor Relations Manager
Phone: 780-413-7152
astadel@biomsmedical.com

Monday, December 31, 2007

Lilly and BioMS Medical Announce Global Licensing and Development Agreement





Lilly to Acquire Exclusive Rights to Novel Late-Stage Molecule for the Treatment of Multiple Sclerosis

INDIANAPOLIS, IN and EDMONTON, ALBERTA – Eli Lilly and Company (NYSE:LLY) and BioMS Medical Corp. (TSX:MS) today announced that the two companies have entered into a licensing and development agreement granting Lilly exclusive worldwide rights to BioMS Medical's lead multiple sclerosis (MS) compound, MBP8298. The compound is currently being evaluated in two pivotal phase III clinical trials in secondary progressive MS (SPMS) and one phase II clinical trial in relapsing-remitting MS (RRMS).

Under the terms of the agreement, Lilly and BioMS Medical will collaborate on the development of MBP8298 and will also share in certain development costs with Lilly being responsible for future R&D, manufacturing and marketing activities. BioMS Medical will receive an upfront payment of $87 million, as well as potential development and sales milestones up to $410 million and escalating royalties on sales commensurate with the current stage of development of the product if MBP8298 is successfully commercialized. BioMS Medical will continue to oversee the current clinical trials. Other terms of the deal were not disclosed.

"Lilly is pleased to add yet another promising late-stage compound to our portfolio,” said Dr. William W. Chin, M.D., vice president of discovery research and clinical investigation for Lilly. "Multiple sclerosis is a disease with significant unmet patient needs. MBP8298 has shown potential in slowing the progression of secondary progressive MS, and thus may provide an effective therapeutic option for patients with this debilitating disease. We are also hopeful that MBP8298 may prove beneficial in treating patients with relapsing remitting MS. We intend to fully leverage our expertise in neuroscience to continue the development of this novel molecule."

“We are very pleased to collaborate with Lilly on the worldwide development of MBP8298,” said Kevin Giese, President and CEO at BioMS Medical. “Lilly’s well established leadership in the neurology arena and considerable resources, expertise and proven ability to launch first-in-class drugs will help MBP8298 to realize its full development and commercial potential.”

The transaction is expected to become effective in the first quarter of 2008, contingent upon clearance under the Hart-Scott-Rodino Anti-Trust Improvements Act, if required. At closing, Lilly would expect a charge to earnings for acquired in-process research and development. The exact amount of the charge has not yet been determined, but is estimated to be $0.05 per share. Lilly's 2008 pro forma adjusted earnings per share guidance remains unchanged at $3.85 to $4.00. On a reported basis, including the charge for this transaction with BioMS Medical, Lilly now expects its 2008 earnings per share to be in the range of $3.80 to $3.95.

About MBP8298
MBP8298 is a synthetic peptide that consists of 17 amino acids having a sequence identical to that of a portion of human myelin basic protein (MBP). MBP8298 is being developed for the potential treatment of multiple sclerosis (MS), an autoimmune disease caused by immune attack against normal components of the central nervous system. The sequence of MBP8298 is associated with the autoimmune process in MS patients with certain immune response genes (HLA types DR2 and/or DR4); MS patients having these genes represent 65 to 75 percent of all MS patients.

The apparent mechanism of action of MBP8298 is the induction or restoration of immunological tolerance with respect to ongoing immune attack as a result of high doses of peptide delivered periodically by the intravenous route. The potential benefit of MBP8298 for any individual patient is therefore expected to be related to the role this peptide plays in that patient’s immune system. The degree of immunomodulation achieved will depend on the relationship among the peptide, HLA molecules and T cells.

The results of phase II and long-term follow-up treatment of MS patients with MBP8298, published in 2006 in the European Journal of Neurology (EJN), showed that MBP8298 safely delayed median time to disease progression for five years (versus placebo) in progressive MS patients with HLA types DR2 and/or DR4. Thus, MBP8298 has the potential to be used as a tailored therapy for patients genetically determined to express the appropriate HLA molecules.

MBP8298 is being developed in three late-stage clinical trials:

MAESTRO-01: A pivotal phase II/III trial for secondary progressive MS (SPMS) patients in Canada and Europe.
MAESTRO-03: A pivotal phase III trial for SPMS patients in the United States.
MINDSET-01: A phase II trial for relapsing-remitting MS (RRMS) patients in Europe.
About Multiple Sclerosis
Multiple sclerosis (MS) is thought to affect as many as 2.5 million people worldwide, including approximately 75,000 in Canada, 400,000 in the United States and more than 500,000 in Europe. It is a disease that affects more women than men, with onset typically occurring between 20 and 50 years of age. MS is caused by damage to myelin, the protective sheath surrounding nerve fibers in the central nervous system, which interferes with messages from the brain to the body. Symptoms of MS may include vision problems, loss of balance, numbness, difficulty walking and paralysis. Approximately 40 percent of all MS patients have the secondary progressive form of the disease.

BioMS Medical Conference Call
BioMS Medical management will host a conference call at 8:30 a.m. (EST) on Tuesday December 18, 2007 to discuss the global licensing and development agreement with Lilly. Participants may listen via an audio web cast, accessible through the Company’s website at www.biomsmedical.com or via telephone. The telephone conference number is 416-644-3420 or toll-free at 1-800-731-6941.

About Lilly
Lilly, a leading innovation-driven corporation, is developing a growing portfolio of first-in-class and best-in-class pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers – through medicines and information – for some of the world's most urgent medical needs. Additional information about Lilly is available at www.lilly.com.

About BioMS Medical Corp.
BioMS Medical is a biotechnology company engaged in the development and commercialization of novel therapeutic technologies. BioMS Medical's lead technology, MBP8298, is for the treatment of multiple sclerosis and is being evaluated in two pivotal phase III clinical trials for secondary progressive MS patients, MAESTRO-01 in Canada and Europe and MAESTRO-03 in the United States . It additionally is being evaluated for relapsing remitting MS patients in a Phase II trial in Europe entitled MINDSET-01. For further information please visit our website at www.biomsmedical.com .



Ryan Giese
VP Corporate Communications
Phone: 780-413-7152
rgiese@biomsmedical.com Tony Hesby
Executive VP Corporate Affairs
Phone: 780-413-7152
tony.hesby@biomsmedical.com Amanda Stadel
Investor Relations Manager
Phone: 780-413-7152
astadel@biomsmedical.com

Tuesday, December 11, 2007

BioMS Medical's phase III U.S. multiple sclerosis trial receives positive safety review from Data Safety Monitoring Board





EDMONTON, Dec. 11 /CNW/ - BioMS Medical Corp. (TSX: MS), a leading developer in the treatment of multiple sclerosis (MS), today announced that the independent Data Safety Monitoring Board (DSMB) has reviewed data from the Company's on-going MAESTRO-03 U.S. pivotal phase III clinical trial of MBP8298 for the treatment of secondary progressive MS and recommended that the trial continue.

This was the first of several regularly scheduled reviews by the DSMB that will occur over the duration of the trial. The purpose of the DSMB is to provide objective, independent safety monitoring of the trial.

About MAESTRO-03
----------------
The MAESTRO-03 U.S. pivotal phase III clinical trial is a randomized, double-blind study enrolling approximately 510 patients at more than 60 clinical sites who will be administered either MBP8298 or placebo intravenously every six months for a period of two years. The primary clinical endpoint for the trial is defined as a statistically and clinically significant increase in the time to progression of the disease as measured by the Expanded Disability Status Scale (EDSS), in patients with HLA-DR2 and/or
HLA-DR4 immune response genes (up to 75% of all MS patients are HLA-DR2 and/or HLA-DR4 positive).

Recently the Company announced that more than 133 patients have been enrolled in its MAESTRO-03 trial. An interim safety and efficacy analysis will be performed on data from the first 133 patients enrolled when they have completed 24 months of the clinical trial.

About BioMS Medical Corp.

BioMS Medical is a biotechnology company engaged in the development and commercialization of novel therapeutic technologies. BioMS Medical's lead technology, MBP8298, is for the treatment of multiple sclerosis and is being evaluated in two pivotal phase III clinical trials for secondary progressive MS patients, MAESTRO-01 in Canada and Europe and MAESTRO-03 in the United States. It additionally is being evaluated for relapsing remitting MS patients in a Phase II trial in Europe entitled MINDSET-01. For further information please visit our website at www.biomsmedical.com.

This press release may contain forward-looking statements, which reflect the Company's current expectation regarding future events. These forward-looking statements involve risks and uncertainties that may cause actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such
forward-looking statements. Such factors include, but are not limited to, changing market conditions, the successful and timely completion of clinical studies, the establishment of corporate alliances, the impact of competitive products and pricing, new product development, uncertainties related to the regulatory approval process and other risks detailed from time to time in the Company's ongoing quarterly and annual reporting. Certain of the assumptions made in preparing forward-looking statements include but are not limited to the following: that MBP8298 will continue to demonstrate a satisfactory safety
profile in ongoing and future clinical trials; and that BioMS Medical Corp. will complete the respective clinical trials within the timelines communicated in this release. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.



For further information: Tony Hesby, Ryan Giese, Corporate
Communications, BioMS Medical Corp., (780) 413-7152, (780) 408-3040 Fax, E-mail: rgiese@biomsmedical.com, Internet: www.biomsmedical.com; James Smith, Investor Relations, (416) 815-0700 ext. 229, (416) 815-0080 Fax, E-mail: jsmith@equicomgroup.com

Tuesday, July 24, 2007

BIOMS MEDICAL’S RELAPSING-REMITTING MULTIPLE SCLEROSIS TRIAL RECEIVES POSITIVE REVIEW FROM DATA SAFETY MONITORING BOARD

Edmonton, Alberta, July 24, 2007 – BioMS Medical Corp. (TSX: MS), a leading developer in the treatment of multiple sclerosis (MS), today announced that the independent Data Safety Monitoring Board (DSMB) for the Company's phase II MINDSET-01 trial of MBP8298 in patients with relapsing-remitting MS has completed a safety analysis and recommended that the trial continue as per the protocol.

This was the first of several regularly scheduled reviews by the DSMB that will occur over the duration of the trial. The purpose of the DSMB is to provide objective, independent safety monitoring of the trial.

MINDSET-01 Trial
The MINDSET-01 phase II, double-blind, placebo-controlled trial is designed to evaluate the safety and efficacy of MBP8298 in patients with relapsing-remitting MS. The fifteen month trial is fully enrolled with approximately 215 patients at 24 sites in 6 countries. The objectives of the study are to demonstrate safety and efficacy of MBP8298 versus placebo as measured by relapse rate, MRI activity and disease progression.

About BioMS Medical Corp.
BioMS Medical is a biotechnology company engaged in the development and commercialization of novel therapeutic technologies. BioMS Medical's lead technology, MBP8298, is for the treatment of multiple sclerosis and is being evaluated in two pivotal phase III clinical trials for secondary progressive MS patients, MAESTRO-01 in Canada and Europe and MAESTRO-03 in the United States . It additionally is being evaluated for relapsing remitting MS patients in a Phase II trial in Europe entitled MINDSET-01. For further information please visit our website at www.biomsmedical.com .



Ryan Giese
VP Corporate Communications
Phone: 780-413-7152
rgiese@biomsmedical.com

Tony Hesby
Executive VP Corporate Affairs
Phone: 780-413-7152
tony.hesby@biomsmedical.com

Amanda Stadel
Investor Relations Manager
Phone: 780-413-7152
astadel@biomsmedical.com

Wednesday, June 06, 2007

BIOMS MEDICAL INITIATES ENROLLMENT IN PIVOTAL U.S. PHASE III MULTIPLE SCLEROSIS TRIAL

Edmonton, Alberta, June 5, 2007 - BioMS Medical Corp (TSX: MS), a leading developer of products for the treatment of multiple sclerosis (MS), today announced that the first patients have been enrolled in MAESTRO-03, its U.S. pivotal phase III clinical trial of MBP8298, a proprietary synthetic peptide for the treatment of multiple sclerosis. The randomized, double-blind study is enrolling approximately 510 secondary progressive MS patients at approximately 60 sites across the U.S. who will be administered either MBP8298 or placebo intravenously every six months for a period of two years.

“This is an important milestone in our strategy to commercialize MBP8298 on a global basis,” said Kevin Giese, President and CEO of BioMS Medical. “The U.S. represents nearly half of the MS market and a successful outcome to this trial would put BioMS in a strong position to capture a significant portion of this and other major MS markets.”

The primary clinical endpoint for the MAESTRO-03 trial is defined as a statistically significant time to disease progression as measured by the Expanded Disability Status Scale (EDSS), in patients with HLA-DR2 and/or HLA-DR4 immune response genes. Up to 75% of all MS patients are HLA-DR2 and/or HLA-DR4 positive.

MBP8298 is being assessed in two additional ongoing trials:

• MAESTRO-01 is a pivotal phase III trial being conducted in Canada and Western Europe evaluating MBP8298 for the treatment of secondary progressive multiple sclerosis (SPMS). The trial is a randomized, double-blind study and is fully recruited with 611 patients.

• MINDSET-01 is a phase II trial evaluating MBP8298 for the treatment of relapsing-remitting multiple sclerosis (RRMS). The trial is a randomized, double-blind study and is fully recruited with approximately 215 patients.

Patients who are interested to learn more about these trials should visit: http://www.biomsmedical.com/maestro_03.asp

About MBP8298 - Novel Mechanism of Action

In MS patients, the body's immune system inappropriately attacks the myelin coating around the nerves in the brain and spinal column, whereas healthy people are otherwise “tolerant” of such common body components. The proposed mechanism of action of MBP8298 is, by design, to re-introduce such a state of “tolerance” to a critical portion of the nerve's Myelin Basic Protein that is an immunological site of attack in many MS patients. This is accomplished by the I.V. injection of MBP8298 every six months.

Phase II and long-term follow-up treatment of MS patients with MBP8298, recently published in the European Journal of Neurology showed that MBP8298 safely delayed the median time to disease progression for five years in progressive MS patients with HLA-DR2 or HLA-DR4 immune response genes.


About BioMS Medical Corp.
BioMS Medical is a biotechnology company engaged in the development and commercialization of novel therapeutic technologies. BioMS Medical's lead technology, MBP8298, is for the treatment of multiple sclerosis and is being evaluated in two pivotal phase III clinical trials for secondary progressive MS patients, MAESTRO-01 in Canada and Europe and MAESTRO-03 in the United States . It additionally is being evaluated for relapsing remitting MS patients in a Phase II trial in Europe entitled MINDSET-01. For further information please visit our website at www.biomsmedical.com .



Ryan Giese
VP Corporate Communications
Phone: 780-413-7152
rgiese@biomsmedical.com

Tony Hesby
Executive VP Corporate Affairs
Phone: 780-413-7152
tony.hesby@biomsmedical.com

Amanda Stadel
Investor Relations Manager
Phone: 780-413-7152
astadel@biomsmedical.com

Friday, March 02, 2007

BioMS Medical Trial Update: 14 Months to Interim Data





EDMONTON, Alberta, March 1, 2007--On May 9th, 2006 BioMS announced enrolment of the 200th patient in its pivotal phase II/III clinical trial of MBP8298, a synthetic peptide drug for the treatment of multiple sclerosis (MS). Under the terms of the trial protocol, an interim safety and efficacy analysis will be performed on data from the first 200 patients enrolled when they have completed 24 months of the clinical trial. This interim analysis is now just 14 months away.



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Big news from BioMS!
Recently we announced two major milestones…

BioMS cleared by the FDA to initiate a pivotal phase III MS trial

What does this mean for BioMS? The clearance to proceed with a phase III trial in the U.S. is a significant step towards bringing MBP8298 to the worldwide market. There are approximately 400,000 Americans with MS and close to 50% of patients have secondary progressive MS.

Details: The trial named MAESTRO-03 will be a pivotal phase III clinical trial in the US, and will evaluate MBP8298 for the treatment of secondary progressive MS.

The trial is a randomized, double-blind study enrolling approximately 510 patients who will be administered either MBP8298 or placebo intravenously every six months for a period of two years. The primary clinical endpoint for the trial is defined as a statistically and clinically significant increase in the time to progression of the disease as measured by the Expanded Disability Status Scale (EDSS), in patients with HLA-DR2 and/or HLA-DR4 immune response genes (up to 75% of all MS patients are HLA-DR2 and/or HLA-DR4 positive).



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BioMS completes patient recruitment in MAESTRO-01 MS trial

What does this mean for BioMS? This brings BioMS one step closer to the objective of offering patients a safe and effective first line therapy for the treatment of secondary progressive MS.

Details: The MAESTRO-01 pivotal phase II/III, multi-center, double-blind, placebo-controlled trial is designed to evaluate the safety and efficacy of MBP8298 in patients with SPMS. The study is being conducted at 48 sites across Canada and Europe (10 countries) and will include approximately 550 patients being administered either MBP8298 or placebo intravenously every six months for a period of two years.

To date the trial has successfully passed six safety reviews by its independent Data Safety Monitoring Board.

For more information please contact:
BioMS Medical Corp ? Phone: 780-413-7152 ? www.biomsmedical.com or email info@biomsmedical.com

This information may contain certain forward-looking statements that reflect the current views and/or expectations of BioMS Medical with respect to its performance, business and future events. Such statements are subject to a number of risks, uncertainties and assumptions. Actual results and events may vary significantly.

Tuesday, February 27, 2007

BioMS Medical Initiates Follow-On Open-Label MAESTRO-02 Multiple Sclerosis Trial Of MBP8298

BioMS Medical Initiates Follow-On Open-Label MAESTRO-02 Multiple Sclerosis Trial Of MBP8298


EDMONTON, Alberta, Feb. 27, 2007 - BioMS Medical Corp (TSX: MS), a leading developer of products for the treatment of multiple sclerosis (MS), today announced that it has initiated MAESTRO-02, the open-label follow-on portion to its MAESTRO-01 pivotal phase II/III clinical trial of MBP8298 for the treatment of secondary progressive MS.


Eligible patients who have successfully completed the blinded, placebo controlled MAESTRO-01 trial, may choose to receive MBP8298 on an un-blinded basis in MAESTRO-02 regardless of whether they were previously on placebo or drug. The trial will primarily evaluate the long-term safety of MBP8298.

“Now that the first patients who participated in our MAESTRO-01 pivotal trial have completed the study, we are pleased to offer MBP8298 on an open-label basis,” said Kevin Giese, President and CEO of BioMS Medical. “We believe MBP8298 has the potential to become the only safe and effective first line therapy for the treatment of secondary progressive MS. While MAESTRO-01 was designed to evaluate the safety and efficacy of MBP8298, MAESTRO-02 will provide additional important long-term safety and efficacy data to support regulatory submissions.”

About late-stage clinical trials for MBP8298:

BioMS recently announced that patient recruitment has been completed in the MAESTRO-01 trial. This trial includes approximately 550 patients at 48 trial sites in 10 countries. The Company remains on track to receive interim data in mid-2008.

Patients are being administered either MBP8298 or placebo intravenously every six months for a period of two years. The primary clinical endpoint for the trial is defined as a statistically and clinically significant increase in the time to progression of the disease as measured by the Expanded Disability Status Scale (EDSS), in patients with HLA-DR2 and/or HLA-DR4 immune response genes. Time to disease progression in patients with other HLA-DR types will be assessed separately as an exploratory arm of the same study.

To date the trial has successfully passed six safety reviews by its independent Data Safety Monitoring Board.

MBP8298 is being studied in two additional late-stage clinical trials:

MAESTRO-03: A pivotal phase III U.S. trial of similar design to MAESTRO-01, evaluating MBP8298 for the treatment of secondary progressive MS. The trial is a randomized, double-blind study enrolling approximately 510 patients that will be initiated in 2007.

MINDSET-01: A phase II trial evaluating MBP8298 for the treatment of relapsing remitting multiple sclerosis (RRMS). The trial is a randomized, double-blind study enrolling up to 215 patients

About MBP8298 - Novel Mechanism of Action

In MS patients, the body’s immune system inappropriately attacks the myelin coating around the nerves in the brain and spinal column, whereas healthy people are otherwise “tolerant” of such common body components. The proposed mechanism of action of MBP8298 is, by design, to re-introduce such a state of “tolerance” to a critical portion of the nerve’s Myelin Basic Protein that is an immunological site of attack in many MS patients. This is accomplished by the I.V. injection of MBP8298 every six months.

Phase II and long-term follow-up treatment of MS patients with MBP8298, recently published in the European Journal of Neurology showed that MBP8298 safely delayed the median time to disease progression for five years in progressive MS patients with HLA-DR2 or HLA-DR4 immune response genes.


BioMS Medical is a biotechnology company engaged in the development and commercialization of novel therapeutic technologies. BioMS Medical's lead technology, MBP8298, is for the treatment of multiple sclerosis and it has two pivotal phase III clinical trials for SPMS patients, MAESTRO-01 in Canada and Europe and MAESTRO-03 in the United States . It additionally has a Phase II MINDSET-01 trial in Europe for RRMS patients. For further information please visit our website at www.biomsmedical.com .