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Thursday, November 15, 2012

Dynavax’s Heplisav Safety Gets Thumbs-Down from Adcom, Not Enough Data

Dynavax Technologies Corp. halted trading as the FDA’s Vaccines and Related Biological Products Advisory Committee deliberated on the hepatitis B vaccine Heplisav. Odds favored the candidate going in, but panelists voted 8-5 against the safety profile, with one abstention. The adcom wants a larger database to make certain the adjuvant is safe. There was better – but not saving – news with regard to immunogenicity data, which the panel found adequate by 13-1 in a separate vote.

 

Top-Line Phase IIb Results Devastate Tranzyme

Shares of Tranzyme Pharma Inc. plunged on release of top-line results from the first of two Phase IIb trials of its gastroparesis candidate, TZP-102, showing that it did not meet its primary efficacy endpoint at either tested dose. The trial measured reduction in the main symptoms of gastroparesis in diabetic patients – nausea, early satiety, bloating and upper abdominal pain – by means of the Gastroparesis Symptom Daily Diary composite score. Patients’ baseline score across all groups was 3.56, and after 12 weeks of treatment, scores dropped by 1.70 for the 10-mg group and 1.43 for the 20-mg group, but did not reach statistical significance compared to the placebo group, which dropped by 1.46. Tranzyme’s stock (NASDAQ:TZYM) fell 75 percent by midday.

 

AcelRx Moves Sublingual Analgesic Toward Goal Line

After toiling in the trenches for nearly five years, AcelRx Pharmaceuticals Inc. reported positive top-line data from the first Phase III study of its lead product candidate, the sublingual Sufentanil NanoTab PCA (patient-controlled analgesia) System (ARX-01), compared to intravenous (I.V.) morphine in postoperative pain. The combination drug/device system met its primary endpoint of noninferiority in patient global assessment (PGA) of pain control method compared to I.V. PCA with morphine, and additional analyses showed statistical significance in suggesting superiority of the NanoTab system over I.V. morphine in the PGA measurement. Two additional Phase III studies of ARX-01 are under way, with data scheduled to report in the first quarter of 2013. Provided those findings concur, AcelRx is poised to file a new drug application in the third quarter of next year, with potential FDA approval in late 2014 and commercialization early the following year.

 

NewCo News: G-Zero Cedes to G1 in Small-Molecule Inhibitors

Based on discoveries licensed from the University of North Carolina at Chapel Hill, privately held G1 Therapeutics Inc. is trained on the discovery and development of small molecules targeting proteins associated with cell proliferation and growth – specifically, in cancer therapy and biodefense. The resulting therapies are expected to help protect bone marrow and other organs, including the kidneys and lungs, from toxic insult.

 

Also in the News

BioSpecifics Technologies, CytRx, Dara BioSciences, Evotec, Galen, Gilead, Haplogen, Incyte, Janssen, Lilly, Merck Omeros, OncoSec, Peregrine, RXi Pharmaceuticals, TG Therapeutics, Threshold Pharmaceuticals, Ziopharm

 

See Friday's BioWorld Today for More on These and Many Other Stories.