SOURCE: Medistem

Medistem

January 23, 2012 17:56 ET

Medistem and Licensee ERCell Receive Russian Regulatory Approval for the RECOVER-ERC Trial

Dose Escalating, Double Blind, Placebo Controlled Universal Donor Stem Cell Trial for No-Option Heart Failure Patients to Be Conducted at Backulev Center

SAN DIEGO, CA--(Marketwire - Jan 23, 2012) - Medistem Inc. (PINKSHEETS: MEDS) together with its Russian Licensee, ERCell LLC, have received approval to initiate the first double-blind, placebo controlled universal donor stem cell trial in Russian history.

The clinical trial, Non-Revascularizable IschEmic Cardiomyopathy treated with Retrograde COronary Sinus Venous DElivery of Cell TheRapy (RECOVER-ERC), is being led by Principle Investigator Dr. Leo Bockeria, Chairman of the Backulev Center http://www.bakulev.ru/en/about/director/ .

The Backulev Center is Russia's premier institute for cardiovascular surgery and cardiology. Every year the Backulev Center performs approximately 30,000 diagnostic and treatment procedures, which includes 7,000 open heart surgeries and more than 12,000 angioplasties.

The RECOVER-ERC trial will recruit 60 patients with congestive heart failure, and randomize the patients 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. Each group will have 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.

"I joined Medistem and personally invested into the company because of its strong science and intellectual property position. It is this strong science that has allowed for such a rapid progression of the ERC product from discovery, to animal studies, and now to approval for initiation of efficacy finding studies," said Dr. Vladimir Bogin, President and Chairman of Medistem, and a Yale-trained physician practicing in the USA. "As a medical doctor I see the suffering and lack of options for patients with CHF. I am proud that our team is able to offer hope."

This is the second clinical trial that Medistem has been granted approvals for. In September 2011, the company received FDA clearance for beginning a 15 patient trial treating critical limb ischemia patients together with Dr. Michael Murphy at Indiana University.

"We are especially grateful to our Russian licensee ERCell LLC which has worked intensely with our CRO and the Backulev Center in laying down the groundwork for this approval," said Vladimir Zaharchook, Vice President and Vice Chairman of Medistem. "To our knowledge, ERCell is the only company in Russia working on a stem cell product that can be reproducibly manufactured, frozen, and sold as a drug, not a procedure."

"This approval is a key milestone for ERCell. Given that Russia has one of the highest incidences of heart failure per capita in the world, we are confident that we can make a difference in patients' lives and position Russia as an international leader in cell therapy," said Tereza Ustimova, CEO of ERCell.

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. 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. ERC can be purchased for scientific use through Medistem's collaborator, General Biotechnology http://www.gnrlbiotech.com/?page=catalog_endometrial_regenerative_cells.

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.

Contact Information

  • Contact:
    Thomas Ichim
    Chief Executive Officer
    Medistem Inc.
    9255 Towne Centre Drive
    Suite 450
    San Diego
    CA 92122
    858 349 3617
    858 642 0027
    www.medisteminc.com
    twitter: @thomasichim

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