Thursday, March 22, 2007
Medistem Laboratories Announces Tolerostem(TM) Platform as Second Pipeline Product for Potential U.S. Commercialization
Product Aims to Reprogram Immune System, Providing New Therapy for Autoimmune Diseases and Transplant Rejection
SCOTTSDALE, AZ -- (MARKET WIRE) -- March 21, 2007 -- Medistem Laboratories, Inc. (OTCBB: MDSM) (FRANKFURT: S2U) announced today its second pipeline candidate, Tolerostem™, a cellular therapy platform aimed at controlling harmful immunological responses through the use of adult stem cells undergoing a proprietary modification.
If approved for human use, the Tolerostem™ platform could make a significant contribution in the treatment of multiple autoimmune diseases ranging from rheumatoid arthritis, to multiple sclerosis, to Type I diabetes. Additionally, Tolerostem™ offers the possibility of "tricking" the immune system of transplant recipients, so as to prevent the need for chronic immune suppression, which has been shown to cause significant adverse effects.
The Tolerostem™ platform is based on the fundamental concept that the regulatory T cell, a type of anti-inflammatory cell in the immune system is activated by stem cells of specific lineages. Regulatory T cells subsequently home to areas of pathological inflammation and "teach" the inflammatory cells to stop attacking the host's tissue. If successful, Tolerostem™ opens the door to a therapeutic approach whereby the body regulates itself without the need for other types of medical intervention.
"Proof-of-principle that stem cells are capable of controlling harmful immune responses is being demonstrated by companies such as Osiris Therapeutics who are in Phase III clinical trials" said Neil Riordan Ph.D, President and CEO of Medistem. "Our Tolerostem™ platform leverages these prior successes with the aim of introducing a simple, patient-specific solution that could be widely commercialized."
Thomas Ichim, Medistem's Chief of Scientific Development, added, "While circumstantial evidence of stem cell mediated immune modulation has been suspected for some time, we believe based on clinical data from our licensees, that we have identified a completely novel use for manipulated stem cells. This application is covered directly and indirectly in several Medistem patent applications."
Currently Medistem is in discussions with immunology laboratories for performing preclinical safety and efficacy experiments to hopefully enable Investigational New Drug (IND) filing with the FDA in the last quarter of 2007. If accepted by the FDA, the company will then work towards initiating U.S. clinical trials.
About Medistem Laboratories, Inc.
Medistem Laboratories (www.medisteminc.com) is an innovative biotechnology company committed to the creation and commercialization of advanced medical therapies based on non-controversial adult stem cells. Medistem's corporate mission is to transform these stem cells into valuable medical treatments. The Company's business strategy calls for the licensing of a series of clinics and laboratories around the world to deliver unprecedented, next-generation cell therapies to help millions of patients while seeking to commercialize products in the U.S. market. Clinic treatments use proprietary technology and cells sourced from umbilical cords, fat, bone marrow, and muscle for the treatment of cerebral palsy, stroke, cardiovascular disease and orthopedic diseases. Medistem believes it may hold a substantial competitive edge in the worldwide emerging market for stem cell-sourced medical solutions, positioning it to become a leading global provider of stem cell treatments on a fee-for-service basis, while accumulating intellectual property based on clinical and laboratory findings.
This document does not constitute an offer to sell or a solicitation of an offer to buy any of our securities. This document contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements may include projections of matters that affect revenue, the ability to develop or license certain technologies; operating expenses or net earnings; projections of capital expenditures; projections of growth; hiring plans; plans for future operations; financing needs or plans; plans relating to the company's products and services; and assumptions relating to the foregoing.
Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. Future events and actual results could differ materially from those set forth in, contemplated by, or underlying the forward-looking information.
Some of the important factors that could cause the company's actual results to differ materially from those projected in forward-looking statements made by the company include, but are not limited to, the following: technology development limitations, intense competition, risk of business interruption, management of rapid growth, need for additional financing, regulatory approvals and requirements, dependence on key personnel and research, management and other administrative costs.
These factors are discussed in greater detail in the company's quarterly and annual periodic reports, all as filed with the Securities and Exchange Commission.
Medistem Laboratories, Inc.
SOURCE: Medistem Laboratories