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Business and Finance
Tue, January 31, 2012
Mon, January 30, 2012 Medistem and ERCell Initiate Phase II RECOVER-ERC Heart Failure Trial
January 30, 2012 16:47 ET
Medistem and ERCell Initiate Phase II RECOVER-ERC Heart Failure Trial
First Three Patients Successfully Treated With ERC Stem Cell Using Novel "Retrograde Procedure"
SAN DIEGO, CA--(Marketwire - Jan 30, 2012) - Medistem Inc. (
The trial is aimed at assessing safety and efficacy of the company's Endometrial Regenerative Cell (ERC) stem cell product in 60 heart failure patients who have no available treatment options. The "Universal Donor" adult stem cells will be administered using a novel catheter-based retrograde administration methodology that directly implants cells in a simple, 30 minute, procedure. A recent publication describing 2-year follow-up of angina patients administered bone marrow cells treated with the "retrograde procedure" authored by Dr. Amit Patel of the University of Utah, the International Principle Investigator of the trial, may be obtained at [ http://www.translational-medicine.com/content/pdf/1479-5876-9-183.pdf ].
"We are honored to have had the opportunity to present at the prestigious Cardiovascular Stem Cell Research Symposium, alongside companies such as Athersys, Aastrom, Pluristem, Cardio3, Cytori, and Mesoblast," stated Thomas Ichim, CEO of Medistem. "The RECOVER-ERC trial is the first trial combining a novel stem cell, with a novel administration procedure. Today cardiac administration of stem cells is relatively invasive and can only be performed at specialized institutions, we feel the retrograde procedure will circumvent this hurdle."
Medistem's ERC stem cell product is different from other adult stem cells in that it is derived from the endometrium (lining of the uterus). The endometrium grows every month before menstruation, in anticipation of implantation. The growth of the endometrium is associated with a very high degree of new blood vessel production, a process called angiogenesis. Conditions such as heart failure, and peripheral artery disease occur because of reduced circulation to the heart or legs. Medistem believes that by implanting ERC, the body will generate new blood vessels that will increase circulation. Proof of concept animal studies supporting the use of these cells in critical limb ischemia [ http://www.translational-medicine.com/content/pdf/1479-5876-6-45.pdf ], and cardiac damage [ http://onlinelibrary.wiley.com/doi/10.1634/stemcells.2007-0826/pdf ] have been published in the peer reviewed literature.
Medistem recently obtained FDA clearance to begin Phase I trials in the US for treatment of critical limb ischemia, an advanced form of peripheral artery disease, which causes approximately 150-200,000 amputations per year in the USA. The trial will be conducted by Dr. Michael Murphy at Indiana University.
"Heart failure is one of the major scourges on the Russian population. We are extremely pleased that that the pioneering work Medistem has been performing in the USA, is now being conducted in Russia through Medistem's licensee ERCell LLC," said Dr. Olga Bockeria, Professor of Cardiology at the Bakulev Center for Cardiovascular Surgery, the site conducting the trial.
Tereza Ustimova, CEO of ERCell LLC, who has signed an exclusive license/technology transfer agreement for use of Medistem's ERC product in Russia, stated, "It has been a pleasure to work with the teams of Dr. Leo Bockeria, Principle Investigator and Dr. Amit Patel the International Principle Investigator begin the first clinical trial of a 'Universal Donor' stem cell in Russian history."
"It is critical to emphasize that the stem cells used here are from healthy adult volunteers that have been screening according to strict criteria and do not involve embryonic or fetal tissue," said Sergey Volzhenkin, Board Member of ERCell. "Given that under current manufacturing processes one donor generates 20,000 patient doses, we believe that we are not only developing a stem cell therapy, but an actual drug that can be manufactured inexpensively, distributed extensively, and administered at the patient's bedside without need for complicated procedures."
Although this is the first formal clinical trial assessment of the ERC stem cell in cardiac conditions, Medistem and international collaborators published a peer reviewed paper in 2010 describing the first use of ERC in a heart failure patient. The manuscript is freely available at the following link: [ http://www.intarchmed.com/content/pdf/1755-7682-3-5.pdf ].
"I am pleased with the smooth technology transfer process and agility that ERCell exhibited in working with Bakulev on making our clinical trial a reality," stated Vladimir Zaharchook, Vice Chairman and Vice President of Medistem.
The RECOVER-ERC TRIAL
The clinical trial will recruit 60 patients with congestive heart failure, which will be randomized into 3 groups of 20 patients each. Group 1 will receive 50 million ERC, Group 2 will receive 100 million and Group 3 will receive 200 million. Cells will be administered via catheter-based retrograde administration into the coronary sinus, a 30 minute procedure developed by Dr. Amit Patel's Team. Each group will comprise of 15 patients receiving cells and 5 patients receiving placebo. Efficacy endpoints include ECHO and MRI analysis, which will be conducted at 6 months after treatment. The trial design is similar to the recent Mesoblast Phase II cardiac study, in order to enable comparison of efficacy.
About Medistem Inc.
Medistem Inc. is a biotechnology company developing technologies related to adult stem cell extraction, manipulation, and use for treating inflammatory and degenerative diseases. The company's lead product, the endometrial regenerative cell (ERC), is a "universal donor" stem cell being developed for critical limb ischemia and heart failure. A publication describing the support for use of ERC for this condition may be found at [ http://www.translational-medicine.com/content/pdf/1479-5876-6-45.pdf ].
Cautionary Statement
This press release does not constitute an offer to sell or a solicitation of an offer to buy any of our securities. This press release may contain 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. 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. Factors which may cause actual results to differ from our forward-looking statements are discussed in our Form 10-K for the year ended December 31, 2007 as filed with the Securities and Exchange Commission.
