BELLEVUE, WA, June 11 /PRNewswire-FirstCall/ - Oncothyreon Inc. (the "Company") today announced that the first patient has been treated in a Phase 1b clinical trial of PX-12 in patients with advanced metastatic cancer. PX-12 is a proprietary small molecule inhibitor of thioredoxin, a protein that regulates diverse molecular pathways that contribute to the growth, survival and drug resistance of many cancers.
The primary objective of the Phase 1b dose-escalation trial is to determine the safety and tolerability of a 72-hour continuous infusion of PX-12 given on the first three days of a 21-day cycle. Other objectives of the trial include an evaluation of the pharmacokinetics and pharmacodynamics of the prolonged infusion, together with identification of any anti-tumor activity. The trial is expected to enroll up to 28 patients at three centers in the United States.
About PX-12
PX-12 is a small molecule designed to inhibit thioredoxin-1. Increased levels of thioredoxin-1 have been noted in many types of cancer cells, including hepatoma, lung cancers, squamous cervical carcinoma, primary gastric cancers and colorectal carcinomas. Increased levels of thioredoxin-1 are associated with decreased sensitivity to a variety of common chemotherapy agents and may cause or contribute to drug resistance.
An initial Phase 1 trial of PX-12 in 38 patients with advanced metastatic cancer showed that PX-12 was well tolerated and produced a decrease in plasma concentrations of thioredoxin that was significantly correlated with increased patient survival. Fifteen of the 38 patients achieved stable disease of up to 322 days. Oncothyreon is also currently conducting a Phase 2 trial of PX-12 given as a 3-hour infusion daily for five days of a 21-day cycle in patients with advanced pancreatic cancer who have progressed on gemcitabine or a gemcitabine-containing regimen.
About Oncothyreon
Oncothyreon is a biotechnology company specializing in the development of innovative therapeutic products for the treatment of cancer. Oncothyreon's goal is to develop and commercialize novel synthetic vaccines and targeted small molecules that have the potential to improve the lives and outcomes of cancer patients. For more information, visit www.oncothyreon.com.
Forward-Looking Statements
In order to provide Oncothyreon's investors with an understanding of its current intentions and future prospects, this release contains statements that are forward looking, including statements related to the therapeutic and commercial potential of PX-12; future clinical development plans; the details of 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 and assessment of historical and future trends and the application of key assumptions relating to future events and circumstances.
Forward-looking statements involve risks and uncertainties, including risks and uncertainties related to Oncothyreon's business and the general economic environment. Many of these risks and uncertainties are beyond Oncothyreon's control. These risks, uncertainties and other factors could cause our actual results to differ materially from those projected in forward-looking statements. Risks, uncertainties, and assumptions include those predicting the timing, duration and results of clinical trials, the timing and results of regulatory reviews, and the safety and efficacy of PX-12. There can be no guarantee that the results of earlier trials will be predictive of either safety or efficacy in future trials. These and other risks and uncertainties are described in the reports and other documents filed by Oncothyreon Inc. with the SEC and/or Canadian regulatory authorities.
Although Oncothyreon believes that any forward-looking statements contained herein are reasonable, it can give no assurance that its expectations are correct. All forward-looking statements are expressly qualified in their entirety by this cautionary statement. For a detailed description of the risks and uncertainties associated with Oncothyreon, you are encouraged to review the official corporate documents filed by Oncothyreon Inc. with the securities regulators in United States and Canada with the SEC and on SEDAR. Oncothyreon is under no obligation to (and expressly disclaims any such obligation to) update or alter its forward-looking statements whether as a result of new information, future events, or otherwise.
Additional Information
Additional information relating to Oncothyreon can be found on U.S. EDGAR at www.sec.gov and on SEDAR at www.sedar.com.
CONTACT: Investor and Media Relations Contact: Julie Rathbun, Rathbun
Communications, (206) 769-9219, ir@oncothyreon.com
