Oncothyreon shares routed as Stimuvax PhIII trial soldiers on

Posted under Blog, Companies, Diagnostics, Funding, lung cancer, Medical Devices, Medical Supply, Merck KgAA, Oncothyreon, Pharmaceuticals, Startups, Stimuvax, Universities, Videos by John Carroll

Merck KGaA told analysts today that after assessing its late-stage study for the lung cancer vaccine Stimuvax in a second interim analysis, investigators were told to push on to an ultimate read-out in 2013, dashing hopes that the treatment could find a shortcut to market approval and raising fears of failure. A few minutes later, shares of Oncothyreon--which out-licensed the cancer therapy--began to slide and the slide quickly turned into a rout. By mid-morning its stock ($ONTY) had plummeted 43% as investors fretted over the implications.

Cowen's Simos Simeonidis didn't find it hard to understand the rationale for the plunge. Many investors had been praying that the company would stop the trial at this stage--which occurred after 75% of the projected patient "events" tracked in the study had occurred--and tell the world they had the efficacy data needed for an approval of the blockbuster hopeful. Continuing to the trial's projected conclusion point had to spell trouble. But he wasn't buying the argument.

"We were never believers of the argument that 'the longer the trial goes on, the better the chances of success,' given a number of high-profile failures in oncology, where trials ran much longer than expected, with the trial ending up being a failure," Simeonidis dashed off in a quick note to investors. "On the other hand, given that the p-value that this trial would have to hit in order to be stopped for efficacy at this second interim look was, in theory, less than 0.025, we are not surprised that the trial was not stopped for efficacy at this point. We definitely hear the argument that 'we are close to the completion of the trial, and the fact that the trial wasn't stopped for efficacy at 75% of the events, decreases the chances that the trial will ultimately work.'" But he went on to note that the "chances of a successful START outcomes are still intact."

The fretting and speculation can now continue until 2013.

- here's the AP report

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Cancer immunotherapy partners face big test with Phase III program

Posted under Blog, Bristol-Myers Squibb, Companies, Dendreon, Diagnostics, Funding, Medical Devices, Medical Supply, Merck KgAA, Oncothyreon, Pharmaceuticals, Provenge, Startups, Stimuvax, Universities, Videos, Yervoy by Ryan McBride

Merck KGaA and Oncothyreon ($ONTY) will learn soon whether their lung cancer vaccine has a shot at being one of the next bright lights in the cancer immunotherapy arena, with an interim analysis set for this quarter expected to determine whether the pivotal trial for the program will continue, Reuters reported.

Cancer immunotherapies are among the most closely watched in oncology, and the approvals of Dendreon's ($DNDN) Provenge and Bristol-Myers Squibb's ($BMY) Yervoy have given developers of the immune-stimulating agents some faith that commercial opportunities—however fraught with challenges in the case of Provenge—await.

For Oncothyreon's lung cancer vaccine Stimuvax, which it licensed to Merck, the commercial prospects of the experimental treatment will be tested with the interim analysis. The analysis, which takes place once a certain number of patients in the trial have died, will determine whether the drug is working and the big trial should continue, or that its lack of effectiveness doesn't warrant further study, Reuters reported. The 1,514-patient study is testing whether Stimuvax provides at least a 6-month improvement in survival in people newly diagnosed with lung cancer.

"We would be perfectly content if the decision is to continue the trial to its end," Oncothyreon CEO Robert Kirkman told Reuters. "We still expect to have top-line data in 2012. If the trial continues, we would have those results in the second half."

If Stimuvax falls short, there are a bevy of players in the cancer immunotherapy field such as Roche ($RHHBY), GlaxoSmithKline ($GSK) and smaller outfits that are making progress with their own programs.

- get more in the Reuters article

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