|OncoGenex Announces Initiation Of A Phase 3 For Custirsen; ARIAD Completes Rolling Submission of NDA for Ponatinib|
|By Staff and Wire Reports|
|Thursday, 27 September 2012 19:22|
OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) announced the initiation of ENSPIRIT, a Phase 3 trial evaluating custirsen for the treatment of advanced or metastatic non-small cell lung cancer (NSCLC) in patients who have progressed after initial chemotherapy treatment has failed. The trial will investigate if combining custirsen with docetaxel, a standard second-line NSCLC chemotherapy, has the potential to improve survival outcomes compared to docetaxel alone in these patients.
Two formal interim analyses are planned for stopping the trial early based on inadequate evidence of clinical benefit or futility. No interim analyses for claiming efficacy are planned.
ARIAD Pharmaceuticals (NASDAQ: ARIA) announced it has completed the rolling submission of the New Drug Application (NDA) for its investigational BCR-ABL inhibitor, ponatinib, to the U.S. FDA. ARIAD provided the FDA with remaining chemistry, manufacturing, and controls (CMC) data. ARIAD is seeking U.S. marketing approval of ponatinib in patients with resistant or intolerant chronic myeloid leukemia (CML) and Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL). The Company has requested accelerated approval and a priority review of the ponatinib application by the FDA.
“In late July, we submitted the NDA for ponatinib ahead of schedule and, at the request of the FDA, in advance of having the final CMC data. We look forward to continuing our progress towards making ponatinib available to patients with CML and Ph+ ALL,” stated Harvey J. Berger, M.D., chairman and chief executive officer of ARIAD. “If approved, we believe that ponatinib will become an important new medicine for CML and Ph+ ALL patients who have become resistant or intolerant to prior tyrosine kinase inhibitor therapy.”
ARIAD anticipates approval and commercial launch of ponatinib in the U.S. in the first quarter of 2013. Also, the Marketing Authorization Application (MAA) for ponatinib, submitted in August, has been validated by the European Medicines Agency (EMA), commencing their review of the application. The Committee for Medicinal Products for Human Use (CHMP) has granted ARIAD's request for accelerated assessment of the MAA.
AspenBio Pharma, Inc. (Nasdaq: APPY), an in vitro diagnostic company, today provided its shareholders and the broader investment community with an update on its clinical and business activities.
Biodel Inc. (Nasdaq: BIOD) will present experimental data from its ultra-rapid-acting prandial insulin analog program at the 48th annual meeting of the European Association for the Study of Diabetes (EASD) being held October 1-5, 2012 in Berlin, Germany.
Champions Oncology, Inc. (OTC: CSBR) notes an article by Andrew Pollack on the front page of The New York Times, dated September 26, 2012, titled "Seeking Cures, Patients Enlist Mice Stand-Ins."
CytoSorbents Corporation (OTCBB: CTSO), a critical care focused company using blood purification to modulate the immune response, control inflammation, and prevent or treat organ failure, continues to expand market awareness of its CytoSorb® and HemoDefend technologies through exhibits, posters and presentations at a number of key conferences through the end of 2012.
Life Technologies Corporation (NASDAQ: LIFE) today announced it has received FDA 510(k) clearance for its OpTmizer™ CTS™ T-Cell Expansion Tissue Culture Medium – a reagent that is now cleared as a Class II medical device and offers cost- and time-saving advantages for transitioning studies from the research bench to clinical trials.
NutraCea (OTCQB: NTRZ), a global leader in the production and marketing of value added products derived from rice bran, today highlighted a new study presented by a team of scientists at the American Heart Association's High Blood Pressure Research 2012 Scientific Sessions linking a rice bran oil and sesame oil blend to lower blood pressure and improved cholesterol.
Omeros Corporation (NASDAQ: OMER) today announced that its Board of Directors has elected Arnold C. Hanish to serve on the Company's Board.
OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) announced today the initiation of ENSPIRIT, a Phase 3 trial evaluating custirsen for the treatment of advanced or metastatic non-small cell lung cancer (NSCLC) in patients who have progressed after initial chemotherapy treatment has failed.
SpectraScience, Inc. (OTCQB: SCIE), a San Diego-based medical device company, recently completed training of the PENTAX Europe sales teams in Germany and Belgium on the WavSTAT4 Optical Biopsy System.