Celsion (CLSN): Top-line results from the phase III trial of Thermodox in liver cancer expected before the end of the year. The "HEAT" study compares Thermodox plus radiofrequency thermal ablation (RFA) versus RFA alone in patients with primary liver cancer. The primary endpoint of the study is improvement in progression-free survival.
Clovis Oncology (CLVS): Top-line results from a phase III study of CO-011 in pancreatic cancer expected before year's end. The "LEAP" study compares CO-011 versus gemcitabine in metastatic, chemo-naive pancreatic cancer patients whose tumors express low levels of hENT1, a protein which gemcitabine requires to enter cells. Survival is the study's primary endpoint.
Dynavax (DVAX) brings its hepatitis B vaccine Heplisav in front of an FDA advisory panel on Nov. 14.
FDA will announce an approval decision for Exelixis' (EXEL) medullary thyroid cancer drug cabozantinib on or before Nov. 29.Gilead Sciences (GILD) presents important new data on its all-oral hepatitis C combination regimens at the American Association for the Study of Liver Disease annual meeting beginning Saturday, Nov. 10. An FDA advisory panel convenes Dec. 20 to review Hemispherx Biopharma's (HEB) Ampligen as a treatment for chronic fatigue syndrome. Nektar Therapeutics (NKTR) will release results from a phase III studies of NKTR-118 in opioid-induced constipation before the end of the year. The "KODIAC" trials, consisting of two phase III placebo-controlled efficacy and an open-label, placebo-controlled long-term safety study, are designed to determine the efficacy and safety of NKTR-118, a once-daily tablet, for the treatment of constipation in patients taking prescription opioid medications. NPS Pharmaceuticals (NPSP) is expecting an FDA approval decision for Gattex on Friday, Dec. 28. Gattex treats patients with short-bowel syndrome. An FDA advisory panel voted last month to recommend the drug's approval. Pfizer (PFE) awaits an FDA decision on Nov. 21 for tofacitinib, the first rheumatoid arthritis pill. Vical (VICL): Top-line results before the end of the year for the phase III melanoma study of Allovectin (injected directly into melanoma lesions) versus dacarbazine or temozolomide in patients with recurrent metastatic melanoma. The primary endpoint of the study is durable response rate at 24 weeks but the more important and necessary (for approval) secondary endpoint is overall survival. Vivus (VVUS) reports third-quarter financial results on Tuesday, Nov. 6, including the first reported sales for its weight-los pill Qsymia. Ziopharm (ZIOP) set to announced results from the phase III study of palifosfamide in sarcoma. The "PICASSO III" study compares palifosfamide plus doxorubicin to doxorubicin alone in patients with front-line metastatic soft-tissue sarcoma. The study's primary endpoint is improvement in progression-free survival (for accelerated approval) and overall survival (for full approval.) Sources: TheStreet research; BioMedTracker, a provider of independent research on biotechnology and pharmaceutical developments; and company and analyst reports.
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