FDA grants Special Protocol Assessment to IDM's phase 2/ 3 trial of Bexidem for bladder cancer

By Lisa Kerner

Charlotte, N.C., June 13 - IDM Pharma Inc. said it has received a Special Protocol Assessment from the Food and Drug Administration for the planned phase 2/ 3 U.S. clinical trial of Bexidem for the treatment of superficial bladder cancer.

"The SPA for our phase 2/ 3 trial in the United States provides IDM with a well-defined pathway for regulatory submission for our second lead product candidate, Bexidem, to treat superficial bladder cancer," chairman and chief executive officer Jean-Loup Romet-Lemonne said in a company news release.

"We reached agreement with FDA on the clinical trial design several months ago and have now successfully addressed the remaining manufacturing and product characterization questions raised by the FDA with regard to the trial that would delay the start of the study."

About 300 patients with superficial bladder cancer will be enrolled in the randomized, controlled, multi-center pivotal trial with the primary endpoint of time to recurrence.

IDM's first phase 2/ 3 trial of Bexidem for superficial bladder cancer is ongoing in Europe.

Bexidem is comprised of Monocyte-derived Activated Killer cells from the patient's own white blood cells, IDM said. After surgery, Bexidem is delivered directly into the patient's bladder.

Located in Irvine, Calif., IDM is a biopharmaceutical company developing products that activate the immune system to treat cancer.

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