Gamida Cell Signs Collaboration Agreement With Biologics Delivery Systems
Biologic Delivery Systems Will Supply Catheters for Gamida Cell's Upcoming Phase I/II Study of CardioCure(TM) for Heart Attack Patients
Last update: 7:00 a.m. EDT July 14, 2008
JERUSALEM, Jul 14, 2008 (BUSINESS WIRE) -- Gamida Cell Ltd. announced today a collaboration agreement with Biologics Delivery Systems Group, Cordis Corporation. Under the terms of the agreement, Biologics Delivery Systems will supply catheters for the upcoming Phase I/II clinical trial of Gamida Cell's CardioCure product for the treatment of post-myocardial infarction (heart attack) patients. CardioCure is a proprietary ex-vivo expanded autologous (from the patient's body) bone marrow product.
The randomized, controlled multi-center Phase I/II clinical trial, due to start in Q4 2008 in Israel, will evaluate the safety and efficacy of Gamida Cell's CardioCure in 48 post-MI patients. CardioCure will be injected directly into the myocardium using the latest generation of Biologics Delivery Systems' NOGA(R) Cardiac Navigation System and MyoStar(R) Injection Catheter.
"The NOGA(R) XP Cardiac Navigation System is a highly sophisticated and accurate electro-guided methodology, which creates precise, 3-dimensional images of the heart. This will enable us to identify damaged myocardial tissue and accurately deliver the CardioCure injections into the relevant area in order to assist with functional restoration of the damaged heart," said Professor Ran Kornowski, Director of Interventional Cardiology and Cardiac Catheterization Laboratories at the Rabin Medical Center and a leading principal investigator in the Gamida Cell CardioCure clinical study.
Pre-clinical results demonstrate that CardioCure may offer a better therapeutic alternative to existing treatments. The data indicate that it may prevent or lessen some of the damage caused to the heart muscle as a result of a heart attack.
"More than one million new patients with heart attacks are treated annually in the United States alone, representing a multi-billion dollar market opportunity. The supply commitment today by Biologics Delivery Systems Group validates the significance of the CardioCure program and its potential as a therapeutic treatment for this very large patient population," said Gamida Cell CEO Dr. Yael Margolin.