IDM Announces the Opening of Its cGMP Production Center in The United States
Tuesday April 20, 2:00 am ET
PARIS--(BUSINESS WIRE)--April 20, 2004--IDM (Immuno-Designed Molecules), a biopharmaceutical company specialized in immunotherapy for the treatment of cancer, today announced the opening of its first cGMP* production center in the United States, based at its North American facility in Irvine, Calif. The center will be dedicated to the production of Cell Drugs(TM) intended for IDM sponsored clinical trials in North America.
The IDM facility has received a Drug Manufacturing License from the State of California Department of Health Services, which allows IDM to produce Cell Drugs for therapeutic clinical trials. The site is equipped to handle the complete Cell Drug manufacturing process, from the receipt of cells following their removal from a patient's blood, to cell processing and freezing, storage and shipment of the final product back to hospitals participating in the clinical trial.
The first Cell Drugs being prepared in Irvine are for the clinical trial utilizing Collidem(TM), IDM's product candidate to treat colorectal cancer. The production process began in January 2004.
Collidem is a therapeutic vaccine made up of the patient's dendritic cells combined with a combination of selected peptides present on the cancer cells. Three hospitals are taking part in this Phase I/II trial: the UCSF Medical Center in San Francisco, the City of Hope National Medical Center in Duarte, Calif., and the University of Pittsburgh Cancer Institute.
"Following the IND (Investigational New Drug) approval we received from the FDA in late 2003 for this clinical trial in colorectal cancer, this certification of our production center in Irvine by the State of California constitutes a significant step in our development in the United States," said Jean-Loup Romet-Lemonne, President and CEO of IDM. "We are now able to produce our Cell Drugs in North America as well as Europe thanks to our cGMP centers in Irvine and Paris," he added.
* current Good Manufacturing Practices
IDM -- The Immunogenics Company®
IDM is a biopharmaceutical company focused on the development of innovative products to treat and control cancer. IDM is currently developing two lines of products: one aiming at the destruction of residual cancer cells after the use of traditional therapies, and the other to prevent tumor recurrence by triggering an immune response. IDM's product portfolio includes one that has completed a Phase III trial, one in Phase II/III and three products in Phase II trials. |
