Oncothyreon initiates Phase 1b trial of PX-12 in patients with advanced metastatic cancer
The primary objective of the Phase 1b dose-escalation trial is todetermine the safety and tolerability of a 72-hour continuous infusion ofPX-12 given on the first three days of a 21-day cycle. Other objectives of thetrial include an evaluation of the pharmacokinetics and pharmacodynamics ofthe prolonged infusion, together with identification of any anti-tumoractivity. The trial is expected to enroll up to 28 patients at three centersin the United States.
PX-12 is a small molecule designed to inhibit thioredoxin-1. Increasedlevels of thioredoxin-1 have been noted in many types of cancer cells,including hepatoma, lung cancers, squamous cervical carcinoma, primary gastriccancers and colorectal carcinomas. Increased levels of thioredoxin-1 areassociated with decreased sensitivity to a variety of common chemotherapyagents and may cause or contribute to drug resistance.
An initial Phase 1 trial of PX-12 in 38 patients with advanced metastaticcancer showed that PX-12 was well tolerated and produced a decrease in plasmaconcentrations of thioredoxin that was significantly correlated with increasedpatient survival. Fifteen of the 38 patients achieved stable disease of up to322 days. Oncothyreon is also currently conducting a Phase 2 trial of PX-12given as a 3-hour infusion daily for five days of a 21-day cycle in patientswith advanced pancreatic cancer who have progressed on gemcitabine or agemcitabine-containing regimen.
Oncothyreon is a biotechnology company specializing in the development ofinnovative therapeutic products for the treatment of cancer. Oncothyreon'sgoal is to develop and commercialize novel synthetic vaccines and targetedsmall molecules that have the potential to improve the lives and outcomes ofcancer patients. For more information, visit www.oncothyreon.com.
In order to provide Oncothyreon's investors with an understanding of itscurrent intentions and future prospects, this release contains statements thatare forward looking, including statements related to the therapeutic andcommercial potential of PX-12; future clinical development plans; the detailsof clinical trials; and the anticipated future size of the market for PX-12.These forward-looking statements represent Oncothyreon's intentions, plans,expectations and beliefs and are based on its management's experience andassessment of historical and future trends and the application of keyassumptions relating to future events and circumstances.
Forward-looking statements involve risks and uncertainties, includingrisks and uncertainties related to Oncothyreon's business and the generaleconomic environment. Many of these risks and uncertainties are beyondOncothyreon's control. These risks, uncertainties and other factors couldcause our actual results to differ materially from those projected inforward-looking statements. Risks, uncertainties, and assumptions includethose predicting the timing, duration and results of clinical trials, thetiming and results of regulatory reviews, and the safety and efficacy ofPX-12. There can be no guarantee that the results of earlier trials will bepredictive of either safety or efficacy in future trials. These and otherrisks and uncertainties are described in the reports and other documents filedby Oncothyreon Inc. with the SEC and/or Canadian regulatory authorities.
Although Oncothyreon believes that any forwar
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