Key Developments: Oncothyreon Inc (ONTY.O)
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23 May 2013
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Latest Key Developments (Source: Significant Developments)
Oncothyreon Inc's L-BLP25 (Stimuvax) Did Not Meet Primary Endpoint Of Improvement In Overall Survival In Pivotal Phase 3 Trial In Patients With Non-Small Cell Lung Cancer
Oncothyreon Inc announced that the pivotal Phase 3 clinical trial of L-BLP25 (formerly referred to as Stimuvax) known as START did not meet primary endpoint of an improvement in overall survival in patients with unresectable, locally advanced stage IIIA or stage IIIB non-small cell lung cancer (NSCLC). The trial was conducted by Merck Serono, a division of Merck KGaA of Darmstadt, Germany, under a license agreement with Oncothyreon. Despite not meeting the primary endpoint, notable treatment effects were seen for L-BLP25 in certain subgroups. START was a randomized, multicenter, double-blind, placebo-controlled trial that assessed the efficacy, safety and tolerability of L-BLP25 in patients with unresectable stage III NSCLC who achieved a response or stable disease after chemoradiotherapy. Patients were randomized to receive either a single low dose of cyclophosphamide followed by L-BLP25 (weekly injections for eight weeks followed by injections every six-weeks until progression) plus best supportive care (BSC) or placebo plus BSC. Full Article
Oncothyreon Inc Announces Presentation of PX-866 Clinical Data
Oncothyreon Inc announced data from two clinical trials of PX-866, a pan-isoform phosphatidylinositol-3-kinase (PI-3K) inhibitor. Oncothyreon also provided an update on the status of its ongoing Phase 2 development program for PX-866. The Phase 1 trial enrolled 43 patients with advanced cancer for whom docetaxel was considered standard of care. Patients were treated at three different dose levels of PX-866 administered daily in combination with the standard dose of docetaxel (75 mg/m2) administered once every three weeks. No dose-limiting toxicities were identified, and the recommended Phase 2 daily dose of PX-866 to be given in combination with docetaxel was determined to be the same as the single agent daily maximum tolerated dose of 8 mg. The Phase 1/2 trial of PX-866 in combination with docetaxel mentioned above has advanced to the Phase 2 portion, which is an open-label, randomized evaluation of the antitumor activity and safety of PX-866 administered at the recommended daily dose in combination with docetaxel, versus docetaxel alone, in two groups of patients. Group 1 is enrolling patients with non-small cell lung cancer (NSCLC) receiving second or third line treatment. Group 2 is enrolling patients with locally advanced, recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) after failure of prior therapy. The two groups will be randomized and evaluated independently. Full Article
Oncothyreon Inc Initiates Phase 1/2 Trial of PX-866 in Combination with Vemurafenib
Oncothyreon Inc announced the initiation of a Phase 1/2 trial of PX-866 in combination with vemurafenib (Zelboraf). PX-866 is Oncothyreon's investigational small molecule compound designed to inhibit the activity of phosphatidylinositol-3-kinase (PI-3K), a component of an important cell survival signaling pathway. Vemurafenib is a kinase inhibitor indicated for the treatment of unresectable or metastatic melanoma with the BRAFV600E mutation. The Phase 1 portion of this trial will evaluate the safety and tolerability of PX-866 in combination with twice daily oral administration of vemurafenib in up to 36 patients with any BRAF-mutant cancer. The trial will use a dose-escalation design to evaluate up to three dose levels of PX-866 with up to two dose levels of vemurafenib to determine the maximally tolerated or recommended dose of both PX-866 and vemurafenib to be used in Phase 2. The Phase 2 portion of the trial will compare the anti-tumor activity and safety of PX-866 and vemurafenib at the doses recommended from Phase 1 with vemurafenib alone administered at the approved dose. This randomized Phase 2 trial is expected to enroll 110 patients with advanced BRAF-mutant melanoma and has a primary endpoint of progression-free survival. This Phase 1/2 trial is being conducted in collaboration with the Melanoma Research Foundation Breakthrough Consortium (MRFBC). Full Article
UPDATE 2-Merck KGaA, Oncothyreon hit as cancer vaccine fails
* Stimuvax fails to improve survival of lung cancer patients
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