The German-based Merck got clearance from the FDA and local ethics review boards to resume two of three large pivotal trials, after the case of encephalitis appeared in March in a separate exploratory study, forcing all three pivotal trials to go on hold until researchers could figure out whether it was really safe to continue. The FDA hold applied to two lung cancer trials known as Start and Inspire as well as a breast cancer study called Stride; the breast cancer trial remains on hold, while the lung cancer trials are resuming, Oncothyreon said. The three trials, all of which involve the BLP25 liposomal vaccine (Stimuvax), include a combined 2,600 patients.
“The resumption of the BLP25 liposome vaccine clinical program is very good news for the oncology community and non-small cell lung cancer patients. If the Start and Inspire Phase III trials are successful, BLP25 liposome vaccine could play an important role in the treatment of these currently underserved patients,” said Dr. Frances Shepherd, director of the Medical Oncology Princess Margaret Hospital in Toronto, Canada, and an investigator of the Start trial, in an Oncothyreon statement.
Oncothyreon has no marketed products, but it has other cancer drugs in its pipeline besides the BLP25-based immune booster. Even though its partner is primarily responsible for the development of this program, and Oncothyreon just stands to collect royalties on product sales if the treatment is successful, it still accounts for a large portion of the value investors assign to the company. That’s partly because of renewed interest in immune-based therapies for cancer, as investors seek the next home-run opportunity following the success of Seattle-based Dendreon.
So, Oncothyreon (on-KOH-thear-ee-on) saw its stock go up today. Shares climbed by about 15 percent to $4.15 at 10 a.m. Eastern time.
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Luke Timmerman is the National Biotechnology Editor for Xconomy, and the Editor of Xconomy Seattle. You can e-mail him at email@example.com, or call 206-624-2374.