ProlX Pharmaceuticals Corp. Initiates Phase 1B Trial in Gastrointestinal Cancer for Novel Thioredoxin Inhibitor PX-12
Posted on: Friday, 20 January 2006, 15:00 CST
ProlX Pharmaceuticals Corp. announced today that it has enrolled the first patient in a Phase IB clinical trial to study a novel thioredoxin inhibitor, PX-12, in patients with advanced gastrointestinal cancers. This trial is designed to explore a new schedule of delivery with PX-12 given as a 24-hour infusion every two weeks, evaluating its safety, pharmacokinetic profile, and antitumor activity. The study will be conducted by Dr. Tomislav Dragovich at the Arizona Cancer Center in Tucson, Ariz.
PX-12 is a small molecule designed to inhibit thioredoxin, a protein which can stimulate cell growth and block apoptosis. The increased thioredoxin levels in cancer cells have been linked to the aggressive proliferation of solid tumors including colon, lung and gastric cancers. PX-12 has shown excellent activity in animal models against these tumors as well as breast and prostate cancers.
The initial Phase I trial treated 38 patients, having advanced metastatic cancer, with PX-12 given as a 1- or 3-hour infusion daily for five days every three weeks. The trial established that PX-12 was well tolerated up to doses of 226 mg/m2 and produced a significant decrease in plasma concentrations of the target protein, thioredoxin, especially when delivered by the 3-hr infusion. Seven of the 38 patients achieved stable disease of up to 322 days.
"PX-12 has shown encouraging safety and efficacy data from the initial Phase I trial. It is hoped that a prolonged infusion of PX-12 will result in extended target inhibition with a well-tolerated schedule of delivery." said Dr. Lynn Kirkpatrick, CEO of ProlX Pharmaceuticals. "We look forward to exploring this novel approach to treating gastrointestinal cancers as well as evaluating PX-12 in other disease settings."
ProlX Pharmaceuticals Corp. is a privately held biotechnology company dedicated to the discovery of novel therapies for the treatment of cancer. The company plans to initiate a Phase II study with PX-12 in 2006. Other agents in the ProlX pipeline are moving through pre-clinical development and will enter trials in the next 12 to 24 months.
Source: Business Wire
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