|Alcobra Announces Enrollment Of First Patient In Phase IIb Clinical Trial Of MDX; Zogenix's Zohydro ER Shows Sustained 12-Hour Pain Relief|
|By Staff and Wire Reports|
|Tuesday, 02 September 2014 18:53|
Below is a look at some of the headlines for companies that made news in the healthcare sector on September 2, 2014.
Alcobra Ltd. (Nasdaq: ADHD), an emerging pharmaceutical company focused on the development of new medications to help patients with cognitive disorders, including Attention Deficit Hyperactivity Disorder (ADHD) and Fragile X Syndrome, announced the first patient has been enrolled in a Phase IIb study of MDX in adolescents with ADHD. The trial is expected to complete enrollment and report topline data by the end of 2014.
The Phase IIb trial is a multi-center, randomized, double-blind, fixed dose study designed to evaluate the safety and tolerability of MDX in up to 82 adolescents (aged 13-17) with predominantly inattentive ADHD (PI-ADHD). The primary endpoint will be safety, tolerability and pharmacokinetics. Secondary endpoints include change in efficacy measures such as TOVA (Test of Variables of Attention), Wechsler Intelligence Scale for Children (WISC-IV) subtests, and working memory and processing speed. ClinicalTrials.gov Identifier: NCT02189772
Zogenix, Inc. (Nasdaq: ZGNX), a pharmaceutical company developing and commercializing products for the treatment of pain-related and central nervous system (CNS) disorders, today announced new post-hoc analysis data showing that the indicated 12-hour dose of Zohydro® ER, (hydrocodone bitartrate) Extended-Release Capsules, CII, provided durable pain relief over the entire dosing interval. This finding is important because a major concern for all extended-release pain medications is the potential for lack of consistent pain relief throughout the entire day, especially at the end of the dosing.
"In this study, we saw that most of the chronic pain patients taking Zohydro ER achieved effective pain relief for the entire duration of 12 hours for each administered dose. In particular, most patients did not experience dose failures during the night, meaning they did not wake up to take additional medication for their pain," said Srinivas Nalamachu, MD, President and Medical Director, International Clinical Research Institute, Overland Park, Kansas.
The goal of extended-release opioids is to provide sustained delivery of medication and continuous pain relief over the entire dosing interval, reducing or eliminating the need to take rescue pain medication. Chronic pain patients experiencing interruptions in sleep frequently have higher degrees of pain and reduced functioning the following day.
These data will be presented at PAINWeek, the national conference on pain for clinicians specializing in pain management taking place this week in Las Vegas.
"Zohydro ER was developed specifically for the subset of severe chronic pain patients currently managing their pain with short-acting hydrocodone/acetaminophen medication but who need true sustained 12-hour pain relief and are at risk for acetaminophen toxicity. These data further support that Zohydro ER fulfills this medical need," said Bradley Galer, MD, chief medical officer of Zogenix. "This analysis of our pivotal Phase 3 data demonstrated that pain relief with Zohydro ER was durable throughout the entire 12-hour dosing interval without any observation of end of dose failure. This finding, coupled with the lack of the need to wake up at night to take rescue pain medication, is particularly important, since minimizing the amount of rescue medication and providing around-the-clock pain relief are often overlooked factors in the effective treatment of severe chronic pain."
Zohydro® ER is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
Zohydro ER is the first and only extended-release hydrocodone for around-the clock management of severe chronic pain without acetaminophen, lowering the risk for liver toxicity due to overexposure of acetaminophen, which can be fatal or require a liver transplant.
Alder BioPharmaceuticals, Inc. (Nasdaq:ALDR), a clinical-stage company developing antibody therapeutics, today announced that it has regained the worldwide rights to clazakizumab, a humanized monoclonal antibody to the pro-inflammatory cytokine IL-6, from Bristol-Myers Squibb based on BMS' decision to end further development following a portfolio prioritization and not based on any new or unexpected efficacy or safety data or technical issues.
Aldeyra Therapeutics, Inc. (Nasdaq:ALDX), a biotechnology company focused on the development of products to treat diseases related to free aldehydes, today announced the expansion of its drug development team with three strategic hires to support upcoming studies for its lead product candidate, NS2.
Alliqua BioMedical, Inc. (Nasdaq:ALQA), today announced that Company management will participate in the following investor conference: The Rodman & Renshaw 16th Annual Global Investment Conference in New York, New York.
Amarantus Bioscience Holdings, Inc. (OTCQB:AMBS), a biotechnology company focused on the development of diagnostic and therapeutic interventions for Alzheimer's disease, Parkinson's disease and orphan ophthalmological disorders, announced it has entered into a Master Services Agreement with ICON for global therapeutic and diagnostic clinical development services.
Amedisys, Inc. (Nasdaq:AMED), one of America's leading healthcare at home companies, today announced that Ronald A. LaBorde, President and Interim Chief Executive Officer, will present at the Baird 2014 Health Care Conference in New York, NY on Wednesday, September 3, 2014.
athenahealth, Inc. (Nasdaq:ATHN), a leading provider of cloud-based services and mobile tools for medical groups and health systems, and University of Toledo Physicians (UTP) today announced that UTP has selected the athenaOne® suite of electronic health record (EHR), revenue cycle management, and patient engagement services for its 260-provider network, including 214 specialty and primary care physicians.
Aurinia Pharmaceuticals Inc. (Nasdaq:AUPH) (TSX:AUP) today announced that the Company has received approval by the NASDAQ Listing Qualifications Department to list its common shares on the NASDAQ Global Market ("NASDAQ").
BioCorRx, Inc. (OTCQB: BICX), a leader in addiction treatment and rehabilitation programs, announces the scheduled opening of a new location next week in Las Vegas, Nevada that will treat people using the company's Start Fresh Program.
Cancer Genetics, Inc. (Nasdaq:CGIX), an emerging leader in DNA-based cancer diagnostics, announced today that their proprietary DNA-probe based test for cervical cancer (FHACT®) has received the CE Marking.
Capstone Therapeutics (OTCQB:CAPS) and its joint venture affiliate, LipimetiX Development, LLC ("JV"), announced today the completion of dosing and patient follow-up for its investigational AEM-28 (Apo E mimetic peptide) Phase 1a human clinical trial in cholesterol and lipid reduction.
Catalyst Pharmaceutical Partners, Inc. (Nasdaq:CPRX), a biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating diseases, today announced the initiation of its second Phase 1 safety and tolerance study for CPP-115, a novel GABA aminotransferase (GABA-AT) inhibitor.
Cellular Biomedicine Group Inc. (Nasdaq:CBMG), a biomedicine firm engaged in the development of new treatments for degenerative and cancerous diseases, today announced the launch of a study on human adipose derived mesenchymal progenitor cell (haMPC) therapy for Cartilage Defects (CD) resulting from osteoarthritis (OA) or sports injury.
Chimerix, Inc. (Nasdaq:CMRX), a biopharmaceutical company developing novel, oral antivirals, today announced an award of $17.0 million through the extension of its contract with the Biomedical Advanced Research and Development Authority (BARDA) for the development of its broad spectrum antiviral brincidofovir (BCV, CMX001) as a medical countermeasure to treat smallpox.
Chimerix, Inc. (Nasdaq:CMRX), a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, today announced that M. Michelle Berrey, M.D., M.P.H., President, Chief Executive Officer, and Chief Medical Officer, will be presenting at the Morgan Stanley Health Care Conference 2014 on Tuesday, September 9, 2014 at 12:20pm ET at The Grand Hyatt New York in New York.
Chimerix, Inc. (Nasdaq:CMRX), a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, today announced that new data on its investigational broad-spectrum antiviral brincidofovir (BCV, CMX001) will be presented at the 54th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) being held September 5-9, 2014 at the Walter E. Washington Convention Center in Washington, DC.
Conatus Pharmaceuticals Inc. (Nasdaq:CNAT), a biotechnology company focused on the development and commercialization of novel medicines to treat liver disease, today announced the initiation of a Phase 2 clinical trial of its lead drug candidate, emricasan, in patients with liver cirrhosis (LC), and the initiation of a separate exploratory Phase 2 trial in cirrhosis patients with portal hypertension (PH).
CONMED Corporation (Nasdaq:CNMD) today issued an open letter to its shareholders in connection with the Company's September 10, 2014 Annual Meeting of Shareholders. CONMED's Board of Directors unanimously recommends that shareholders follow the recommendations of leading proxy advisory firms Institutional Shareholder Services ("ISS") and Egan-Jones Proxy Services ("Egan-Jones") by voting "FOR" ALL of CONMED's eight highly qualified and experienced director nominees: Brian Concannon, Charles Farkas, Jo Ann Golden, Curt Hartman, Dirk Kuyper, Jerome Lande, Stephen Mandia and Mark Tryniski, as well as supporting the other proposals contained in the definitive proxy materials.
Cyclacel Pharmaceuticals, Inc. (Nasdaq:CYCC) (Nasdaq:CYCCP), a biopharmaceutical company developing oral therapies that target the various phases of cell cycle control for the treatment of cancer and other serious disorders today announced that the Company will present at the 16th Rodman & Renshaw Annual Global Investment Conference being held at the New York Palace Hotel, New York, NY.
Cytomedix (OTC:CMXI), a pioneer in biodynamic therapies, today announced that Martin Rosendale, CEO, will present a corporate overview at the 16th Annual Rodman & Renshaw Global Investment conference, being held September 8-10, 2014 at the New York Palace Hotel in New York, NY.
Integra LifeSciences Holdings Corporation (Nasdaq:IART) today announced that it has made changes to the leadership of its Orthopedics and Tissue Technologies business.
K2M Group Holdings, Inc. (Nasdaq:KTWO), a global medical device company focused on designing, developing and commercializing innovative and proprietary complex spine technologies, techniques and minimally invasive procedures, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market MESA Hooks, the latest implant addition to the MESA® Deformity Spinal System.
LHC Group, Inc. (Nasdaq:LHCG), a national provider of home health, hospice and comprehensive post-acute healthcare services, announced today that it has completed the previously announced asset purchase from Life Care Home Health, Inc. acquiring 13 home health agencies across six states for $10 million in cash.
Lombard Medical, Inc. (Nasdaq:EVAR), a medical device company focused on Endovascular Aneurysm Repair (EVAR) of abdominal aortic aneurysms (AAA), today announced that the first two post approval procedures using Lombard Medical's flagship Aorfix™ endovascular stent graft were performed in Japan.
Macrocure Ltd. (Nasdaq:MCUR), a clinical-stage biotechnology company focused on developing a novel therapeutic platform to address chronic and hard-to-heal wounds, today announced that it has completed enrollment in its pivotal, double-blind, Phase III clinical trial of CureXcell in Diabetic Foot Ulcers ("DFUs").
Merit Medical Systems, Inc. (Nasdaq:MMSI), a leading manufacturer and marketer of proprietary disposable devices used primarily in cardiology, radiology and endoscopy, today announced that it will participate in CL King's 12th Annual Best Ideas Conference being held September 9, 2014 at the Omni Berkshire Place Hotel in New York City.
Nanosphere, Inc. (Nasdaq:NSPH), a company enhancing medicine through targeted molecular diagnostics, today announced that three outcomes studies demonstrating the clinical and economic impact of the Verigene® Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) will be presented at the 54th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC), to be held in Washington, DC on September 5 – 9, 2014.
Novadaq® Technologies Inc. (Nasdaq:NVDQ) (TSX:NDQ), the leading developer and provider of clinically relevant imaging solutions for use in surgical and diagnostic procedures, today announced that Robert "Bob" S. White has been appointed to the Company's Board of Directors.
Nuvilex, Inc. (OTCQB:NVLX), a clinical-stage, international biotechnology company providing cell and gene therapy solutions for the treatment of diseases, announced today that it has submitted an application to the European Medicines Agency (EMA) for an Orphan Drug Designation for its Cell-in-a-Box® treatment for pancreatic cancer. Nuvilex's pancreatic cancer treatment consists of the combination of Cell-in-a-Box® with low doses of the anticancer drug ifosfamide.
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 Paul J. Hastings, Chairman and Chief Executive Officer of OncoMed, will speak on Monday, September 8, 2014 beginning at 11:05 a.m. EDT at the Morgan Stanley Global Healthcare Conference being held in New York City.
Portola Pharmaceuticals (Nasdaq:PTLA) today announced that William Lis, chief executive officer, will present at the 2014 Morgan Stanley Global Healthcare Conference on Tuesday, September 9, at 2:55 p.m. Eastern Time in New York City.
Quotient Limited (Nasdaq:QTNT), a commercial-stage diagnostics company, today announced that Paul Cowan, Chairman and Chief Executive Officer, will present at the Baird 2014 Healthcare Conference in New York City at 2:20 p.m. Eastern Time on Wednesday, September 3.
Revance Therapeutics, Inc. (Nasdaq:RVNC), a biopharmaceutical company developing botulinum toxin products for use in aesthetic and therapeutic indications, today announced that the Compensation Committee of its Board of Directors granted an inducement award pursuant to Rule 5635(c)(4) of the NASDAQ Listing Rules to Dr. Arthur P. Bertolino in connection with his employment as the Executive Vice President and Chief Medical Officer of Revance.
Swisher Hygiene Inc. (Nasdaq:SWSH), a leading service provider of essential hygiene and sanitizing solutions, announced today it has closed on a $20 million revolving credit facility with Siena Lending Group LLC.
T2 Biosystems, Inc. (Nasdaq:TTOO) today announced that John McDonough, president and chief executive officer, is scheduled to present at the Morgan Stanley Global Healthcare Conference on Wednesday, September 10, 2014, at 1:30 p.m. E.T. in New York City.
Versartis, Inc. (Nasdaq:VSAR), an endocrine-focused biopharmaceutical company that is developing a novel, long-acting form of recombinant human growth hormone (rhGH), today announced that Jeffrey L. Cleland, PhD, Chief Executive Officer, is scheduled to present at the Morgan Stanley Global Healthcare Conference on Tuesday, September 9, 2014 at the Grand Hyatt New York in New York City.