Frankfurt, Germany (Nov 25, 2008) – t2cure, a biopharmaceutical company developing regenerative medicine therapeutics from a patient’s own stem cells, today announced that it has acquired a family of patents and patent applications from Innovectis, the technology transfer arm of Frankfurt University.
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 Manfred Ruediger, CEO t2cure. “These patent rights complement our existing IP portfolio, supporting our commitment to make stem cell-based therapeutics a clinical reality for patients suffering from an acute heart attack or chronic heart failure”.
Each year, 40,000 patients are hit by a severe heart attack in Germany alone and many more are suffering from chronic heart disease. Currently there is no treatment available that can reverse the damage to diseased heart muscle. In clinical trials, stem cell-based therapies under development by t2cure have demonstrated the potential to repair damaged tissue.
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.
Manfred Ruediger, CEO
D-60325 Frankfurt am Main
Tel: +49-69- 75 61 46 87 0
Fax: +49-69- 75 61 46 87 9
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, Amsterdam as lead investor.