Protox submits IND to test lead product PRX302 in phase 1 trial for prostate cancer

By E. Janene Geiss

Philadelphia, Dec. 14 - Protox Therapeutics Inc. announced Wednesday that it has submitted an Investigational New Drug application to the U.S Food and Drug Administration for its lead product, PRX302, to treat prostate cancer.

Protox said it plans to initiate phase 1 clinical trials of PRX302 early next year upon approval of the IND.

"Filing our first IND with the FDA is the most important milestone for 2005 and brings us closer to fulfilling the unmet needs resulting from a cancer that afflicts more than 230,000 North American men every year," Fahar Merchant, president and chief executive officer, said in a company news release.

"This accomplishment reflects our company's capability and commitment to advance PRX302 for not only prostate cancer, but also benign prostatic hyperplasia and, ultimately, to commercialize the PORxin platform for these and other cancers."

The company said there are no licensed drugs available for salvage therapy of purely local recurrence of prostate cancer.

PRX302 is a first-in-class, pore-forming prodrug that is activated by prostate specific antigen, an enzyme produced by - and only active in - the prostate, Protox said.

The company said the combined use of image-guided local delivery and a pro-toxin targeted for prostate specific antigen-producing cells may effectively treat localized prostate cancer without the side effects usually associated with current treatments.

The phase 1 trial will be an open-label, dose-escalation clinical trial of PRX302 in patients with locally recurrent prostate cancer and enrollment of patients is planned to begin immediately after IND activation by the FDA, officials said.

Phase 1 trials will be conducted at Scott & White Memorial Hospital in Temple, Texas, and at least one additional site in the United States.

The trial is expected to enroll 18 to 24 patients and has been designed to determine the safety, tolerability and therapeutic activity of PRX302.

The company said it plans to file an IND for PRX302B for the treatment of benign prostatic hyperplasia in 2006.

Protox Therapeutics, based in Vancouver, B.C., develops novel targeted cancer therapeutics based on engineered protein toxins.

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