Protox doses first patient in prostate cancer trial using PRX302

By Elaine Rigoli

Tampa, Fla., May 2 - Protox Therapeutics, Inc. announced the enrollment and successful dosing of the first patient in a phase 1 clinical study evaluating PRX302 to treat localized recurrent prostate cancer.

The company said PRX302 is a targeted pro-drug that turns into a potent anticancer agent once activated by the enzyme, prostate specific antigen (PSA), produced in high levels by prostate cancer and hyperplastic prostate cells.

Once activated, PRX302 destroys the cells by punching holes in the cell membrane, according to a news release.

In preclinical studies, PRX302 has been shown to kill PSA-producing cells without harming adjacent healthy tissues or organs, the release said.

"The novel approach utilized by PRX302, along with our plans to build a solid pipeline of targeted toxin therapeutics, will allow Protox to offer a broad range of potential new therapies for the treatment of cancer and proliferative disorders," president and chief executive officer Fahar Merchant said in the release.

The first patient was treated at Scott & White Memorial Hospital in Temple, Texas. Two additional U.S. sites have been planned and will be initiated as soon as each center's internal review board approval has been granted.

Patient enrollment is expected to be completed and interim results made public by the end of 2006.

The primary objective of this open label, single arm, multiple-site trial is to assess the safety, tolerability and therapeutic activity of an ascending dose of PRX302 in about 30 patients with localized recurrent prostate cancer.

PRX302 will be injected into the prostate gland under ultrasound guidance, and changes in PSA levels will be measured and prostate biopsies performed after 30 days.

Patients will be followed for a total of three months.

Protox Therapeutics, located in Vancouver, B.C., develops targeted protein toxin therapeutics for treatment of cancer and other diseases.

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