Medistem Announces Preclinical Data on Type 1 Diabetes and Filing of Intellectual Property
SAN DIEGO, Oct. 3, 2013 (GLOBE NEWSWIRE) -- Medistem, Inc. (Pink Sheets: MEDS), announced today that it filed patent application #61/885909 covering immune modulatory aspects of ERC-124, the Company's clinical-stage stem cell product.
The provisional patent titled, "TOLEROGENIC USES OF ENDOMETRIAL REGENERATIVE CELLS", was invented by Thomas Ichim, Ph.D., Chief Scientific Officer of Medistem, and Hugh Taylor, M.D., Professor of Molecular, Cellular, and Developmental Biology at Yale University and a member of the Company's Scientific Advisory Board.
The patent application includes data that defines the mechanism by which ERC-124 therapy prevented Type 1 Diabetes and other autoimmune conditions in animal models. Specifically, the animal study demonstrated that ERC-124 activates T regulatory cells, a cell type known to block autoimmunity by controlling pathological autoreactive T cells.
"The ERC-124 product has been cleared by the FDA for clinical trials in another indication and we are optimistic about the potential of clinically developing our product as a therapy to treat conditions in the field of autoimmunity," said Alan Lewis, Ph.D., the Company's Chief Executive Officer.
Medistem has been active in the area of autoimmune diseases, with the first human use of ERC-124 being reported in 4 patients with multiple sclerosis (link to publication http://www.translational-medicine.com/content/pdf/1479-5876-7-15.pdf).
"The data filed as part of the patent application is further validated by results published from the National Institutes of Health (NIH), which demonstrated that the Company's ERC-124 product is superior to other types of stem cells in modulating the immune system," said Dr.
Ichim (link to publication
About Medistem, Inc.
Medistem, Inc., is developing ERC-124, a universal stem cell product derived from the endometrium. ERC-124 possesses specialized abilities to stimulate new blood vessel formation and can differentiate into lung, liver, heart, brain, bone, cartilage, fat and pancreatic tissue.
These unique properties have applications for treatment of critical limb ischemia (CLI), congestive heart failure (CHF), neurodegenerative diseases, liver failure, kidney failure, and diabetes. ERC-124 has been cleared by the FDA to begin a CLI clinical trial in the United States.
In January 2012, the Company announced the initiation of its RECOVER-ERC (Non-Revascularizable IschEmic Cardiomyopathy treated with Retrograde COronary Sinus Venous DElivery of Cell TheRapy) a double blind, placebo controlled, clinical trial. This trial is being conducted at the Bakulev Scientific Center for Cardiovascular Surgery, Moscow, Russia. The trial is a 60 patient double blind placebo controlled study evaluating safety and efficacy of ERC-124 in end stage CHF patients.
Certain statements herein may be forward-looking and involve risks and uncertainties. Such forward-looking statements involve assumptions, known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Medistem, Inc.
These can be identified by the use of forward-looking words, such as "believes", "expects", "may", "intends", "anticipates", "plans", "estimates", or any other analogous or similar expressions intended to identify forward-looking statements. These forward-looking statements and estimates as to future performance, estimates, and other statements contained herein regarding matters that are not historical facts, are only predictions and actual events or results may differ materially. We cannot assure or guarantee that any future results described in this press release will be achieved, and actual results could differ materially as a result of a variety of factors. Such potential risks and uncertainties include, without limitation, that Company may not be able to secure financing, that the company may not be able to successfully commercialize ERC-124, that the FDA will not approve the initiation of the Company's future clinical programs or provide market clearance of the Company's products, future human studies whether revenue or non-revenue generating from either compassionate use or non-compassionate use of the ERC-124 as a therapy to treat patients with Critical Limb Ischemia, Congestive Heart Failure, Type 1 Diabetes, or any other diseases or disorders, the Company's ability to raise capital when needed, the Company's ability to complete the development of its planned products, the Company's ability to manufacture its products either internally or through outside companies and provide its services, the impact of government regulations, patent protection on the Company's proprietary technology, product liability exposure, uncertainty of market acceptance, competition, technological change, and other risk factors. In such instances, actual results could differ materially as a result of a variety of factors, including the risks associated with the effect of changing economic conditions and other risk factors detailed in the Company's Securities and Exchange Commission filings. The Company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.
CONTACT: John P. Salvador
Posted: October 2013