By Kim Coghill

Washington Editor

Intracel Corp. said Tuesday it has received FDA approval to begin a pivotal Phase III trial to test Keyhole Limpet Hemocyanin (KLH) in bladder cancer patients who have failed conventional therapy.

KLH will target patients who fail bacillus Calmette-Guerin (BCG), or are refractory or intolerant to the agent in the treatment of superficial bladder cancer, according to Nicholas Pomato, vice president of research and development for Rockville, Md.-based Intracel. The trial should be completed in a year to 18 months.

"We're working with the FDA now because the way we were performing the trial wasn't accruing enough patients, so we are modifying it," he said.

The Phase III trial is a randomized, multicenter study to determine the efficacy and safety of KLH vs. Adriamycin (doxorubicin hydrochloride) in patients with carcinoma in situ or without resected superficial papillary bladder cancer. Co-sponsored by Mentor Corp., the study will evaluate 150 patients and is being conducted at 15 U.S. institutions including West Virginia University School of Medicine, Columbia Presbyterian Medical Center, Vanderbilt University School of Medicine and the M.D. Anderson Cancer Center.

Pomato said the endpoints are "disease-free intervals and disease-free survival."

KLH is an immune stimulator. Preclinical and initial clinical data suggest that intravesical instillation of KLH may represent a useful salvage therapy for the treatment of patients with superficial bladder cancer who have failed or are intolerant to BCG therapy.

According to the American Cancer Society, about 12,000 people die annually due to bladder cancer.

Intracel also has other drugs in clinical trials, including HumaRAD, a human monoclonal antibody-based product. HumaRAD is designed to deliver a dose of radiation directly to tumors.

Pomato said a HumaRAD antibody geared toward head and neck cancers is in Phase I/II studies and trials of the antibody used for ovarian cancer should be entering Phase I studies soon.

Intracel is working with the FDA on filing an application seeking approval of OncoVax, a colon cancer vaccine that is manufactured using the patient's own cancer cells. The product is being sold in Holland by Intracel BV, the company's European affiliate.

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