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Biotech / Medical : MEDX ... anybody following? -- Ignore unavailable to you. Want to Upgrade?


To: Icebrg who wrote (736)9/9/2003 10:20:03 AM
From: Icebrg  Read Replies (1) | Respond to of 2240
 
IDM Has Received FDA Approval to Launch a Clinical Trial in the United States to Test Its Therapeutic Vaccine Collidem in Colorectal Cancer

PARIS--(BUSINESS WIRE)--Sept. 9, 2003--IDM (Immuno-Designed Molecules), a leading biopharmaceutical company in the field of cellular immunotherapy, today announced that it has received approval from the United States Food and Drug Administration (FDA) to launch a Phase I/II clinical trial to test its therapeutic vaccine Collidem(TM) for the treatment of colorectal cancer.

Collidem is comprised of the patient's own dendritic cells associated with a combination of selected peptides licensed from Epimmune, Inc. This Phase I/II clinical trial will provide the first opportunity to evaluate tolerance, immunologic activity, and clinical response to the vaccine. 37 patients in the US will be enrolled in the trial, which is expected to take one year to complete.

This trial is open to adult patients with measurable metastasized colorectal cancer who have not responded to standard treatments.

Two investigative centers will participate in the trial: the UCSF Medical Center in San Francisco and the City of Hope National Medical Center in Los Angeles. Collidem will be produced at IDM, Inc. in Irvine (CA).

Colorectal cancer is the second leading cause of cancer-related deaths in the US. The American Cancer Society estimates 147,500 new cases will be diagnosed in 2003. In 2002, colorectal cancer was responsible for 56,000 deaths in the US.

"This new clinical trial is particularly important for two essential reasons: IDM will be testing one of its products in a major new indication, colorectal cancer, and it is the Company's first clinical trial in the United States," stated Jean-Loup Romet-Lemonne, President and CEO of IDM.

IDM -- The Immunogenics Company(R)

IDM is a leading biopharmaceutical company developing a new family of immunotherapy products called Cell Drugs to fight cancer and other life-threatening diseases. IDM applies its proprietary technologies to selectively isolate, engineer, expand and activate specific cell populations which are involved in therapeutic vaccination. The Company's products are designed to boost the immune system, destroy residual tumor cells, and immunize patients to prevent tumor recurrence. IDM's most advanced product is in Phase III for the treatment of ovarian cancer.

For more information, please visit IDM's Web site, idm-biotech.com.