PARIS--(BUSINESS WIRE)--March 23, 2004--IDM (Immuno-Designed Molecules), a biopharmaceutical company specialized in immunotherapy for the treatment of cancer, announces the launching of a new Phase II/III trial on Bexidem(TM), its cell therapy product candidate for the treatment of bladder cancer.
This randomized trial will be carried out in Europe, primarily in France, Belgium, Luxembourg and Germany. Half of the patients will receive 12 intra-bladder instillations of Bexidem over a period of 6 months. The other half will receive Bacillus Calmette-Guerin (BCG), the standard treatment for superficial cancers of the bladder.
The intermediate analysis of the results on the first 138 patients will be used to define the exact number of patients for Phase III.
Bexidem is a cell therapy product comprised of activated macrophages obtained from the patient's own white blood cells. IDM carried out a Phase II pilot trial on 17 patients with superficial cancer of the bladder who had a high probability of cancer recurrence. 112 instillations of Bexidem were administered without any serious adverse reactions attributed to Bexidem. The total number of recurrences in the 17 patients included in the trial decreased from 34 the year before treatment to 8 during the year of administration of Bexidem.
All of the Bexidem cell therapy preparations required for this new trial will be produced in IDM's facilities in Paris and sent to the different investigator centers participating in the trial.
This trial has received approval from the French and Belgian drug regulatory agencies as well as the ethics committee at Necker Hospital where the coordinating investigator for the French trial, Professor Nicolas Thiounn, works.
IDM -- The Immunogenics Company(R)
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.
For more information, please visit IDM's Web site, http://www.idm-biotech.com.
IDM Nadine Sciacca, +33(0)1-40-09-04-11 firstname.lastname@example.org