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From the Wires
t2cure Acquires Patent Family on In Vitro Potency Testing of Stem Cells for Cardiovascular Application
By: PR Newswire
Nov. 25, 2008 08:00 AM
The patents cover a technology that allows for the rapid characterization of the potency of bone marrow-derived cells in the treatment of cardiovascular diseases. The potency of stem cells characterizes their potential to induce or perform repair processes in adult tissue. Recent drafts and guidelines from EMEA and FDA have made clear that potency testing will be a key criterion for batch release, and thus for market approval, of stem cell-based therapies. "This acquisition of patent rights is a significant contribution to our
regulatory strategy, as our lead product is advancing into a pivotal Phase
III study in acute myocardial infarction," said Each year, 40,000 patients are hit by a severe heart attack in t2cure will use its technology for potency testing to confirm product specifications in the course of its upcoming pivotal Phase III study in acute myocardial infarction. This study, which will enroll up to 1,400 patients, is scheduled to enroll its first patients in the second quarter of 2009. About t2cure GmbH t2cure GmbH is a biopharmaceutical company engaged in the field of stem
cell-based regenerative medicine. It develops autologous bone marrow-derived
progenitor cells as regenerative therapeutics for cardiovascular disease
including ischemic heart disease (acute myocardial infarction and chronic
ischemic heart disease, non-ischemic heart failure, peripheral arterial
occlusive disease, and diabetic polyneuropathy). The most advanced project
(t2c001-AMI) has successfully passed Phase II of clinical development and is
now prepared to enter Phase III. t2cure is privately financed with
Entrepreneurs Fund BV,
Contact
Manfred Ruediger, CEO
t2cure GmbH
Bettinastrasse 35-37
D-60325 Frankfurt am Main
Tel: +49-69-75-61-46-87-0
Fax: +49-69-75-61-46-87-9
Email: info@t2cure.com
http://www.t2cure.com
SOURCE t2cure GmbH
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