BioWorld International Correspondent
PARIS - Immuno-Designed Molecules SA has been authorized by the FDA to conduct a Phase I/II trial in the U.S. of Collidem, its therapeutic vaccine for treating colorectal cancer.
The trial will start before the end of this month and will be carried out at two centers - the UCSF Medical Center in San Francisco and City of Hope National Medical in Los Angeles. It is planned to enroll 37 patients suffering from metastatic and measurable colorectal cancer who have not responded to conventional treatment. The study is expected to last a year.
Paris-based IDM is specialized in the development of cell therapies and therapeutic vaccines for cancer, and Collidem is the sixth product it will have taken into clinical development. It is composed of dendritophages (monocyte-derived dendritic cells taken from the patient) associated with a combination of selected peptides (licensed from Epimmune Inc., of San Diego). IDM already has two dendritophage-based vaccines in Phase II clinical development - Eladem for prostate cancer and Uvidem for melanoma.
The clinical batches of Collidem required for the trial will be produced at IDM's manufacturing facility in Irvine, Calif., which it took over from Baxter Healthcare in June 2002. The premises previously were occupied by Baxter's immunology subsidiary Nexell Therapeutics, but when Baxter decided to wind up the venture, IDM took over the lease on Nexell's premises and recruited a number of its staff.
This will be IDM's first clinical trial in the U.S., although in May 2002 the FDA authorized the company to carry out a Phase III study of its lead product candidate, Osidem, a cell therapy based on the use of MAK (monocyte-derived activated killer) cells in association with antibodies, which is being developed for advanced ovarian cancer.
Phase III trials of Osidem have been going on in France, Belgium, the UK, Canada and Australia since early 2001, but they have not been extended to the U.S. as yet because, as a spokesperson for IDM told BioWorld International, "the company has had trouble enrolling patients due to the stringent protocol. There are not many women suffering from ovarian cancer who have survived both surgery and two courses of chemotherapy."
IDM has two other MAK-based cell drugs in Phase II trials - Bexidem for bladder cancer and IDM-1 for chronic lymphocytic leukemia.