Colorectal Cancer Association of Canada - CCAC

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New Colon Cancer Vaccine Being Tested

FREDERICK, Md - Intracel said Wednesday it has been granted a special protocol assessment for a phase 3 study of its OncoVAX colon-cancer vaccine.

The company said its vaccine is being developed to prevent recurrence of stage II colon cancer in patients who have had surgery to remove a tumor.

The special protocol assessment is granted by the Food and Drug Administration and paves the way for FDA and the company to agree on the phase 3 study’s design, etc.

Intracel said it anticipated enrolling 560 patients in a two-year trial conducted in the United States and Europe.

"Intracel now has a clear path to drug approval," said Mitchell Finer, the company’s CEO. "OncoVAX has the potential to become the first adjuvant therapy for stage II colon carcinoma, where the current standard of care worldwide is surgery alone."

Finer said OncoVAX is the only vaccine currently being tested to treat minimal residual disease, where vaccines hold the greatest promise.

Intracel said its previous study of OncoVAX showed a 33-percent increase in overall survival and a 40-percent reduction in deaths or recurrences in treated stage II colon-cancer patients, compared to the control groups, at five years.

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