|Flexion Therapeutics Announces Clinical Hold Of FX006 Phase 2B Clinical Trial; OXiGENE Initiates Phase 2 Study of Fosbretabulin|
|By Marilyn Mullen|
|Wednesday, 17 September 2014 19:43|
Flexion Therapeutics, Inc. (Nasdaq: FLXN) announced the FDA informed the company that a clinical hold has been placed on patient enrollment and dosing in an ongoing Phase 2b clinical trial evaluating FX006 in patients with osteoarthritis (OA) of the knee. FX006 is a novel, non-opioid, sustained-release, intra-articular (IA) formulation of triamcinolone acetonide (TCA) targeting moderate-to-severe OA pain.
Flexion has not yet received written notice of its clinical hold from the FDA, but based on the verbal communication yesterday afternoon, the FDA indicated that the clinical hold is due to a single occurrence of an infection in the injected knee joint of a patient in the Phase 2b clinical trial.
"We will work closely with FDA to provide the agency with all appropriate information and data required to expedite their review and evaluation of this event," said Michael Clayman, M.D., President and CEO of Flexion. "Once the FDA has completed its review, we can better assess the impact this clinical hold will have on our development program timeline for FX006."
OXiGENE, Inc. (Nasdaq:OXGN), a biopharmaceutical company developing novel cancer therapeutics, announced the first patient has been enrolled in a Phase 2 study to evaluate the safety and activity of fosbretabulin monotherapy in patients with locally advanced, recurrent or metastatic gastrointestinal neuroendocrine tumors, or GI-NETs, with elevated biomarkers. GI-NETs are slow-growing, often invasive tumors that produce excessive amounts of hormones and other peptides which enter the blood stream and cause debilitating symptoms.
"Based on our preclinical NET study which showed a statistically significant decrease in a relevant biomarker when treated with fosbretabulin, this study of fosbretabulin in GI-NETs is a potentially meaningful advance, as these tumors are increasing in incidence and very few treatment options exist beyond surgery or radiation," said Steven K. Libutti, MD, FACS, Professor of Surgery and Genetics, Albert Einstein College of Medicine, and Montefiore Medical Center. "Fosbretabulin's unique mechanism of action specifically targets the tumor vasculature in order to cut off the blood supply at the tumor's core, which may result in reduction in biomarkers and symptoms for these patients. We are hopeful that this novel approach may be effective in reducing the debilitating symptomatology of this cancer."
The Phase 2 study will evaluate the safety and activity of fosbretabulin monotherapy in approximately 20 GI-NET patients with increased biomarkers and/or clinical symptoms. The study will evaluate the impact of fosbretabulin on certain biological mediators over time, following the patient's baseline measurements at the study start. The primary endpoint of the trial is the reduction of biomarkers, and secondary endpoints include improvement in symptoms and quality of life as assessed by validated measures. The study will be conducted at five sites in the U.S.
"We are pleased to add GI-NET as a new tumor type that may benefit from treatment with fosbretabulin given the significant need for alternative new treatment options in patients with these tumors," said Dai Chaplin, president and chief executive officer at OXiGENE. "We hope to build on the growing body of evidence suggesting fosbretabulin's meaningful biological activity in various indications. We look forward to enrolling this important study and obtaining the data to evaluate the potential of this novel treatment approach for patients with GI-NETs."
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Flexion Therapeutics, Inc. (Nasdaq:FLXN) today announced that the United States Food and Drug Administration (FDA) informed the company yesterday that a clinical hold has been placed on patient enrollment and dosing in an ongoing Phase 2b clinical trial evaluating FX006 in patients with osteoarthritis (OA) of the knee.
Integra LifeSciences Holdings Corporation (Nasdaq:IART) and Medtronic, Inc. today announced an agreement in which Integra will acquire Medtronic's MicroFrance and Xomed manual ENT and laparoscopy instrumentation lines for approximately $60 million in cash.
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Novadaq® Technologies Inc. (Nasdaq:NVDQ) (TSX:NDQ), the leading developer and provider of clinically relevant fluorescence imaging solutions for use in surgical and diagnostic procedures, will host an Analyst & Investor Day on Monday, November 17, 2014.
OncoMed Pharmaceuticals, Inc. (Nasdaq:OMED), a clinical-stage company developing novel therapeutics that target cancer stem cells (CSCs), or tumor-initiating cells, today announced that it will present new and emerging data from its most advanced clinical programs at the upcoming European Society for Medical Oncology (ESMO) 2014 Congress to be held September 26-30, 2014 in Madrid, Spain.
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