SEATTLE, WA, May 30 /CNW/ - Oncothyreon Inc. (Nasdaq: ONTY) (TSX:ONY)
(the "Company") today announced that data from clinical trials for three of
the Company's product candidates were presented at the American Society of
Clinical Oncology (ASCO) 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 (NSCLC) 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.
"We are very pleased that this group of long-term survivors with advanced
NSCLC has been able to continue to receive Stimuvax with apparent safety for
up to eight years," said Robert L. Kirkman, M.D., President and Chief
Executive Officer of Oncothyreon. "These patients were treated as part of the
randomized Phase 2b trial conducted by Oncothyreon, in which the subset of
patients with Stage IIIb locoregional disease who received Stimuvax had a
median survival of 30.6 months compared with 13.3 months for similar patients
who did not receive the vaccine, a difference of 17.3 months. Long-term
follow-up of these patients was conducted by Merck KGaA of Darmstadt, Germany,
which assumed responsibility for the clinical development of Stimuvax in
2007."
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.