Protox receives FDA clearance for phase 1 prostate cancer trial

By Lisa Kerner

Erie, Pa., Jan. 17 - Protox Therapeutics Inc. announced that the Investigational New Drug application filed in December for PRX302 for the treatment of recurrent localized prostate cancer has been cleared by the U.S. Food and Drug Administration.

Protox may now proceed with its phase 1 clinical trial, according to a company release.

The phase 1 clinical trial will be an open-label, dose-escalation study of PRX302 in patients with locally recurrent prostate cancer. Enrollment of approximately 24 patients is scheduled to begin in the next few weeks. The phase 1 trial will be conducted at Scott & White Memorial Hospital in Temple, Texas and at least one additional site in the United States.

PRX302 is the first of a novel class of targeted prodrugs based on the company's PORxin platform. It is a therapeutic pore-forming toxin designed to be activated by prostate-specific antigen (PSA), an enzyme which is produced and is active only in the prostate.

At present there are no licensed drugs available for salvage therapy of purely local recurrence of prostate cancer, said company officials.

"Receiving FDA approval to proceed with our first phase 1 clinical trial is a significant and exciting milestone for the growth of Protox and its clinical development program," stated Dr. Fahar Merchant, president and chief executive officer of Protox, in a news release.

The company expects to leverage its advances with PRX302 and file an additional Investigational New Drug application this year for the treatment of benign prostatic hyperplasia (or enlarged prostate).

It is estimated that nearly 250,000 men in North America will be diagnosed with prostate cancer this year. Current treatment options for localized prostate cancer include surgery, brachytherapy, and external beam irradiation. These therapies can result in erectile dysfunction, incontinence, urinary toxicity and rectal toxicity.

Vancouver, B.C.-based Protox Therapeutics is developing novel targeted cancer therapeutics based on engineered protein toxins.

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