To: Icebrg who wrote (622 ) 11/24/2002 1:06:13 PM From: Icebrg Read Replies (1) | Respond to of 2240 IDM Presents the Results of the Phase I/II Trial With Eladem -- TM --, its Therapeutic Vaccine for the Treatment of Prostate Cancer Friday November 22, 3:36 am ET PARIS--(BUSINESS WIRE)--Nov. 22, 2002--IDM Immuno-Designed Molecules is announcing its presentation of the results of a Phase I/II anti-tumor vaccine trial in which autologous dendritic cells loaded with recombinant PSA are injected to patients with recrudescent cancer after prostatectomy. The presentation dates are 21 November 2002 at the 96th French Urology Conference in Paris, and on 22 November at the 14th EORTC-NCI-AACR Symposium in Frankfurt. The trial was conducted between 1999 and 2001 at four French university hospitals, on a total of 24 patients with recrudescent prostate cancer after prostatectomy. Following a procedure patented by IDM, monocytes were isolated from the patient by apheresis, cultured for 7 days in the presence of GM-CSF and Interleukin 13, and then loaded with recombinant human PSA. The resulting cells (Dendritophages®-rPSA) were administered back to the patient in nine sessions which took place over a period of five months; administration was via intradermal, sub-cutaneous and intravenous routes. All 24 patients received the entire course of treatment. No serious adverse reactions (either clinical or in terms of test results) were recorded. In six patients, the circulating prostate cancer cells that could be detected upon patient admission into the study had disappeared by six months. Eleven patients had a temporary decrease in PSA levels (6% - 39%). In five patients, a PSA-specific T lymphocyte response could be detected in vitro. Seven patients were withdrawn from the study after Month 6 because of progressive disease. "This trial shows very good tolerance to our vaccines based on dendritic cells," affirms Jean-Loup Romet-Lemonne, President and CEO of IDM. "The observation of the disappearance of circulating prostate cancer cells from the blood of patients who had such cells on admission represents an intriguing result which we will continue studying in our next clinical trials," he added.