Oncothyreon Says ONT-380 Showed Acceptable Safety Profile


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Oncothyreon Inc. (NASDAQ: ONTY) todayannounced the presentation of final results from the first Phase 1 trial ofONT-380 at the American Association for Cancer Research Special Conference onAdvances in Breast Cancer Research in San Diego.  The results were presentedby Virginia F. Borges, M.D., Associate Professor in the Division of MedicalOncology, University of Colorado School of Medicine.  ONT-380 (also known asARRY-380) is an orally active, reversible and selective small-molecule HER2inhibitor being developed by Oncothyreon in collaboration with Array BioPharmaInc. (Nasdaq:  ARRY), Boulder, Colorado.The first-in-human Phase 1 trial, with both dose-escalation and expansioncomponents, enrolled a total of 50 patients, 43 of whom had HER2+ metastaticbreast cancer.  In this study, ONT-380 demonstrated an acceptable safetyprofile; treatment-related adverse events were primarily Grade 1.  BecauseONT-380 is selective for HER2 and does not inhibit EGFR, there was a lowincidence and severity of treatment-related diarrhea, rash and fatigue, sideeffects which have been associated with EGFR inhibition.  A single patientexperienced Grade 2 treatment-related diarrhea and no patient developedtreatment-related Grade 3 diarrhea; one patient had a Grade 3 rash.Additionally, there were no treatment-related cardiac events or Grade 4treatment-related adverse events reported. The maximum tolerated dose ofONT-380 established in this Phase 1 trial was 600 mg twice daily.  Thedose-limiting toxicity was reversible elevation in liver enzymes.In this trial, 22 HER2+ breast cancer patients with measurable disease weretreated with ONT-380 at doses greater than or equal to 600 mg BID. In thisheavily pretreated patient population, there was a clinical benefit rate(partial response [n = 3] plus stable disease for at least 6 months [n = 3])of 27%. Notably, two of the patients with partial responses during treatmentwith ONT-380 had confirmed progressions while on prior lapatinib- andtrastuzumab-containing regimens.

27% profit every 20 days?

This is what Nic Chahine averages with his option buys. Not selling covered calls or spreads… BUYING options. Most traders don’t even have a winning percentage of 27% buying options. He has an 83% win rate. Here’s how he does it.


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