XTL Biopharmaceuticals announces results from Bicifadine in diabetic neuropathic pain trial
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XTL Biopharmaceuticals Ltd. has announced the top-line results from the Bicifadine Phase 2b clinical trial for the treatment of diabetic neuropathic pain.
The trial’s primary objective was to compare the efficacy of two doses of Bicifadine against placebo in reducing pain associated with diabetic neuropathy. The primary endpoint of the study was the reduction in pain score during the course of treatment. The company announced that the study failed to meet its primary endpoint. The trial also failed to meet key secondary analysis.
Ron Bentsur, CEO of the company, commented: “We are all very disappointed with the results of the study. We will devote the next few days to further analyze the data and decide on the appropriate course of action for the Bicifadine program, and for the company.”
ISTA Pharmaceuticals, Inc. has announced results from the Company’s recently completed Phase III clinical program of Xibrom (0.09% bromfenac sodium ophthalmic solution) QD (once-daily). The program enrolled 282 patients who underwent cataract surgery in two U.S. multi-center, randomized, double-masked, parallel-group, vehicle-controlled studies to evaluate Xibrom 0.09% dosed once daily to vehicle (placebo). The identical trials
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OncoGenex Pharmaceuticals Inc. today announced that it concluded a meeting with the U.S. Food and Drug Administration (FDA) on October 7, 2008, and that the FDA agreed that “durable pain palliation is an acceptable and desirable study endpoint” to support a product marketing approval for OGX-011 as a treatment for hormone refractory prostate cancer (HRPC).
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KAI Pharmaceuticals, Inc., a privately held drug discovery and development company, today announced preclinical results demonstrating the effectiveness of KAI-1678 in reversing pain (hyperalgesia and allodynia) in multiple preclinical models. KAI-1678 also was shown to reverse pain more effectively than gabapentin, an industry-standard comparison in pain research. The preclinical results were presented in two posters
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Allos Therapeutics, Inc. has announced preliminary top line results from PROPEL, the Company’s pivotal Phase 2 trial of pralatrexate (PDX) in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL), at the 50th Annual Meeting of the American Society of Hematology (abstract 261). The results according to central independent oncology review at the time of
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