Flexion Therapeutics Announces Clinical Hold Of FX006 Phase 2B Clinical Trial; OXiGENE Initiates Phase 2 Study of Fosbretabulin Print E-mail
By Marilyn Mullen   
Wednesday, 17 September 2014 19:43
Below is a look at some of the headlines for companies that made news in the healthcare sector on September 17, 2014.
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."



 
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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."


 
Also Wednesday:


 
Aastrom Biosciences, Inc. (Nasdaq:ASTM), a leading developer of patient-specific expanded cellular therapies for the treatment of severe diseases and conditions, today announced the closing of its previously announced underwritten public offering of 15,784,313 shares of its common stock at a price to the public of $2.55 per share, including 2,058,823 shares sold pursuant to the full exercise of the underwriters' option to purchase additional shares, resulting in gross proceeds from the offering of approximately $40.3 million before deducting underwriting discounts and commissions and other estimated offering expenses.

American Green, Inc. (OTC: ERBB)
, headquartered in Tempe, Arizona is a technology based company that operates in the medical marijuana space.

Amarantus Bioscience Holdings, Inc. (OTCQB:AMBS)
, a biotechnology company focused on the development of diagnostics and therapeutics for Alzheimer's disease, Parkinson's disease and orphan ophthalmological disorders, today provided a program update on its Phase 2b-ready Eltoprazine program for Parkinson's disease levodopa-induced dyskinesia patients ("PD LID") and adult attention deficit and hyperactivity disorder ("Adult ADHD").

BioBlast Pharma Ltd (Nasdaq:ORPN), a clinical-stage biotechnology company committed to developing clinically meaningful therapies for patients with rare and ultra-rare genetic diseases, announced today positive preclinical and clinical pharmacokinetic (PK) data on Cabaletta, its drug candidate for patients suffering from oculopharyngeal muscular dystrophy (OPMD).

BioCorRx, Inc. (BICX), a leader in addiction treatment, announces a 111% increase in patients being treated with its Start Fresh Program since July 2014 by independent clinics.  

Cara Therapeutics, Inc. (Nasdaq:CARA), a biopharmaceutical company focused on developing and commercializing new chemical entities designed to alleviate pain and pruritus by selectively targeting kappa opioid receptors, today announced it is sponsoring and participating in a lunch symposium titled, "Kappa: Myths / misconceptions, and moving beyond Mu," at the 25th Annual Clinical Meeting of the American Academy of Pain Management.

Celator Pharmaceuticals, Inc. (Nasdaq:CPXX), a pharmaceutical company developing new and more effective therapies to treat cancer, today announced that the Celator team, led by Scott Jackson, Chief Executive Officer, will ring the NASDAQ Stock Market Closing Bell this afternoon.

Corium International, Inc. (Nasdaq:CORI)
, a commercial-stage biopharmaceutical company focused on the development, manufacture and commercialization of specialty transdermal products, today announced the appointment of Paul Goddard, Ph.D. to the Company's Board of Directors.

Ekso Bionics Holdings, Inc. (OTCQB:EKSO), a robotic exoskeleton company, announced today that Bergmannstrost Center in Halle, Germany, a leader in rehabilitation research, presented data today at The International Workshop on Wearable Robotics, WeRob2014 in Baiona, Spain showing the benefits of the Ekso™ robotic suit compared to ReWalk and Cyberdyne.

Everlert, Inc. (OTC:EVLI)
, is pleased to announce that it will be exhibiting the FLATSCAN DF-80 Forensic X-Ray Scanner at three major US Trade Shows / Conferences this month at the following locations:  CSCA2014 – California State Coroner's Association – Sept. 15 – 16, Visalia, CA; NAME2014 – National Association of Medical Examiners – Sept. 19 – 22, Portland, OR; PSCA2014 – Pennsylvania State Coroner's Association Meeting and Convention, Sept. 24 – 25, Pittsburgh, PA.

Five Prime Therapeutics, Inc. (Nasdaq:FPRX)
, a clinical-stage biotechnology company focused on discovering and developing novel protein therapeutics for cancer and inflammatory diseases, today announced the appointment of Robert Sikorski, M.D., Ph.D., as Vice President of Global Clinical Development.

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.

Intersect ENT, Inc. (Nasdaq:XENT), a company dedicated to improving the quality of life for patients with ear, nose and throat conditions, today announced the enrollment of the first patient in PROGRESS, a prospective, randomized, blinded, multi-center trial to assess the safety and efficacy of the PROPEL® mini steroid eluting sinus implant to treat patients with frontal sinusitis.

Momenta Pharmaceuticals, Inc. (Nasdaq:MNTA)
, a biotechnology company specializing in the characterization and engineering of complex drugs, today announced that it will present at the BioCentury NewsMakers in the Biotech Industry Conference on Friday, September 26 at 3:00 p.m. ET.

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.

Pacific Biosciences of California, Inc., (Nasdaq:PACB) provider of the PacBio® RS II DNA Sequencing System, announced the publication of several recent papers highlighting the advantages of Single Molecule, Real-Time (SMRT®) Sequencing over short-read sequencing technologies for infectious disease applications.

Pain Therapeutics, Inc. (Nasdaq:PTIE)
today announced that Remi Barbier, Chairman, President & CEO, will present at the 2014 BioCentury "NewsMakers in the Biotech Industry" Conference. The Company will present on Friday, September 26th, at 9:30 a.m. Eastern Time at the Millennium Broadway Hotel Conference Center in New York City.

Prosensa Holding N.V. (NASDAQ: RNA)
, the biopharmaceutical company focusing on RNA-modulating therapeutics for rare diseases with high unmet need, today announced that a comprehensive program of re-dosing has commenced, with the first patients now re-dosed in the United States.

QLT Inc. (Nasdaq:QLTI) (TSX:QLT)
announces that it has been advised by Auxilium Pharmaceuticals, Inc. that Auxilium has received an unsolicited offer from Endo International plc  to acquire all of the issued and outstanding shares of Auxilium (the "Endo Proposal").

ReWalk Robotics Ltd. (Nasdaq:RWLK)
, an innovative medical device company that designs, develops and markets wearable robotic exoskeletons for individuals with spinal cord injury, today announced the closing of its initial public offering of 3,450,000 ordinary shares at $12.00 per share, which includes 450,000 ordinary shares purchased pursuant to the full exercise of the underwriters' option to purchase additional shares.

Sagent Pharmaceuticals, Inc. (Nasdaq:SGNT)
today announced the launch of Ketorolac Tromethamine Injection, USP, a nonsteroidal anti-inflammatory agent, in three preservative-free glass vials.

ZS Pharma (Nasdaq:ZSPH)
, a biopharmaceutical company developing novel treatments for kidney, cardiovascular, liver and metabolic disorders, today announced that management will present at the 21st Annual BioCentury NewsMakers Conference at the Millennium Broadway Hotel in New York City on Friday, September 26, 2014, from 3:30-3:55 p.m. ET in Presentation Room 311.



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