BioWorld International Correspondent

PARIS - Immuno-Designed Molecules SA has been authorized by the FDA to conduct a Phase III trial in the U.S. of a cell therapy for ovarian cancer.

The product, IDM-1 (or Osidem), is a cellular immunotherapy designed to eliminate residual tumoral cells following surgery and chemotherapy. It consists of MAK (monocytes-derived activated killer) cells associated with a bispecific antibody (HER-2/neu) supplied by Medarex Inc., of Princeton, N.J., with which IDM signed a licensing and distribution agreement in October 2000.

Osidem is IDM's most advanced "cell drug" and has been undergoing Phase III trials in France, Belgium, the UK, Canada and Australia since early 2001. It is being tested on patients suffering from advanced ovarian cancer to determine whether it extends the duration of remission following a positive response to the classic treatment protocol (surgery plus two courses of chemotherapy).

The U.S. trial is to be conducted in several cell therapy research centers. The centers will start enrolling patients in the coming months, and for that they will have the support of IDM's North American clinical development center in Montreal.

Paris-based IDM is specialized in the development of cell therapies and therapeutic vaccines for cancer. It has six products in clinical development, four of which are antibody-based cell drugs and two that are therapeutic vaccines. The other three cell drugs are for the treatment of bladder cancer, chronic lymphocyte leukemia and metastatic cancers, the first two of which are in Phase II and the second in Phase I. The vaccines are for the treatment of prostate cancer and melanoma and both are in Phase II.