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
(firmenpresse) - SAN DIEGO, CA -- (Marketwire) -- 01/23/12 -- 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-evascularizable
Ischmic ardiomyopathy treated with Retrograde
Cronary Sinus enous Dlivery of
Cell Theapy (RECOVER-ERC), is being led by Principle
Investigator Dr. Leo Bockeria, Chairman of the Backulev Center
.
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 . ERC can be purchased for
scientific use through Medistem's collaborator, General Biotechnology
.
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:
Thomas Ichim
Chief Executive Officer
Medistem Inc.
9255 Towne Centre Drive
Suite 450
San Diego
CA 92122
858 349 3617
858 642 0027
twitter: (at)thomasichim
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Datum: 23.01.2012 - 16:56 Uhr
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