IDRA Phase 2 trial failure. Pipeline updates for GERN CLDX NBY ONCY + SNSS news

May 03, 2012 No Comments by

Geron Corporation (Nasdaq: GERN) today announced that it has completed enrollment of its Phase 2 trial of imetelstat, as maintenance therapy following platinum-based induction therapy for patients with advanced non-small cell lung cancer (NSCLC). Top-line results are expected by before the end of 4Q 2012.

Synta Pharmaceuticals Corp. (NASDAQ: SNTA) today provided an update on its Phase 2b/3 GALAXY trial comparing standard-of-care docetaxel with or without ganetespib in a second-line advanced NSCLC treatment setting. Interim data are due later in 2Q 2012, with the Phase 3 part of the trial to commence by the end of 2012.

Celldex Therapeutics, Inc. (NASDAQ: CLDX) said today that it intends to initiate a Phase 2 trial of CDX-1135  in dense deposit disease (DDD) in 2H 2012. Earlier in the week it also announced that topline data from its EMERGE Phase 2b trial of CDX-011 will be released on May 23rd.

Idera Pharmaceuticals, Inc. (NASDAQ: IDRA) today announced that it failed its Phase 2 clinical trial of IMO-2055 for the treatment of recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) in patients who previously progressed on chemotherapy. The trial did not meet its primary endpoint of improved progression-free survival following treatment with IMO-2055 in combination with cetuximab compared to treatment with cetuximab alone.

NovaBay Pharmaceuticals, Inc. (NYSE Amex:NBY) gave a pipeline update noting that it intends to initiate a Phase 2b trial in of a gel formulation of NVC-422 for treating the highly contagious skin infection, impetigo, during 3Q 2012. It intends to initiate a Phase 2b trial of an eye drop formulation of NVC-422 for treating viral conjunctivitis, during 2Q 2012. Topline data from Part B of its Phase 2 trial of NVC-422, for reducing the incidence of urinary catheter blockage and encrustation (UCBE) and the associated urinary tract infections, are due in 3Q 2012.

Oncolytics Biotech Inc. (TSX:ONC, NASDAQ:ONCY) announced that the NCIC Clinical Trials Group (CTG) will sponsor and conduct a randomized Phase 2 study of REOLYSIN in patients with advanced or metastatic colorectal cancer.

Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) today announced that the European Commission has granted orphan drug designation to vosaroxin, for the treatment of acute myeloid leukemia (AML). The designation provides for 10 years of marketing exclusivity in all EU member countries following product approval.

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About the author

Currently residing in New Zealand, Mr. A.Burden holds a Master of Commerce in International Business from the University of Sydney and used these skills together with his passion for investing to establish BioPharmCatalyst in June 2010 as a tool for investing decisions in the US pharmaceutical market. He spends much of his free time mountain biking, playing squash and hiking.
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