Oncothyreon (ONTY) Reports Data from 3 Product Candidates Presented at ASCO

June 1, 2009 9:40 AM EDT

Oncothyreon Inc. (Nasdaq: ONTY) today announced that data from clinical trials for three of the Company's product candidates were presented at the American Society of Clinical Oncology Annual Meeting on May 30, 2009 in Orlando, Florida. The presentations included long-term safety data from the Phase 2b trial of Stimuvax(R) in patients with stage IIIB/IV non-small cell lung cancer, preliminary results from the Phase 1 trial of the phosphoinositide-3-kinase (PI-3 kinase) inhibitor PX-866 in patients with advanced malignancy, and final results from two Phase 1b trials of the thioredoxin inhibitor PX-12 in advanced cancer patients.

Stimuvax

Data concerning the long-term safety of Stimuvax (BLP25 liposomal vaccine) were presented by Dr. Charles Butts, Cross Cancer Institute, Edmonton, Alberta. Sixteen patients who received Stimuvax for between 2 and 8.2 years as part of the Phase 2b trial in patients with stage IIIb/IV non-small cell lung cancer were studied. Ten of these patients have been treated for more than five years, and eight continue to receive therapy with Stimuvax. Prolonged treatment with Stimuvax was well-tolerated in this trial. The most common treatment-related adverse events were injection site reactions, which tended to diminish after the first year of treatment. There was no evidence of autoimmune reactions with prolonged use.

Merck KGaA is conducting a global Phase 3 trial of Stimuvax known as START (Stimulating Targeted Antigenic Responses To NSCLC). START is a randomized, double-blind, placebo-controlled study that will evaluate patients with documented unresectable stage III NSCLC who have had a response or stable disease after at least two cycles of platinum based chemo-radiotherapy.

PX-866

Preliminary results of Oncothyreon's ongoing Phase 1 trial of PX-866, an inhibitor of PI-3 kinase, were presented by Dr. Antonio Jimenez, University of Colorado Cancer Center, Aurora, Colorado. Twenty-six patients have been treated in this trial at once daily doses ranging from 0.5 mg to 10 mg. The maximally tolerated dose has not yet been identified. The most common treatment-related adverse events at the doses tested include low-grade nausea, vomiting and diarrhea. Of 24 evaluable patients, six patients with previously progressive disease have had stable disease as their best response. Three of these patients remain on therapy. Pharmacodynamic monitoring has demonstrated inhibition of PI-3 kinase activity at doses as low as 1 mg per patient.

"We are excited to have seen stabilization of disease in previously progressing patients, as well as clearcut inhibition of PI-3 kinase activity, even in the early cohorts in this dose escalation trial," said Dr. Kirkman. "We believe these findings may reflect the fact that PX-866 is an irreversible inhibitor of PI-3 kinase, which distinguishes it from other PI-3 kinase inhibitors currently in clinical development."

PX-12

Final results from two Phase 1b trials of PX-12, an inhibitor of thioredoxin, were presented by Dr. R.K. Ramanathan, Scottsdale Clinical Research Center, Scottsdale, Arizona. These trials in 32 patients were designed to assess the tolerability and pharmacodynamic activity of both 24-hour and 72-hour infusions of PX-12. In both trials, doses up to 400 mg/m(2)/day were well-tolerated. PX-12 was shown to lower levels of circulating thioredoxin in patients whose starting levels were at least three-fold greater than normal. Three patients achieved stable disease.

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