FDA Approves New U.S. Labeling for ISENTRESS® (raltegravir); Oxygen Announces Progress in its Phase IIb Clinical Trial of Oxycyte Print E-mail
By Staff and Wire Reports   
Monday, 01 July 2013 19:35
Below is a look at some of the headlines for companies that made news in the healthcare sector on July 1, 2013.

Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has approved new labeling for ISENTRESS® (raltegravir) Film-coated Tablets, Merck's integrase inhibitor for the treatment of HIV-1 infection in adult patients as part of combination HIV therapy. The updated prescribing information now includes 240-week results from the STARTMRK study, the longest double-blind Phase III non-inferiority study evaluating an integrase inhibitor in treatment-naïve adult patients with HIV-1 infection. The results show that the regimen containing ISENTRESS in combination therapy demonstrated long-term viral suppression and a greater immunologic response than the efavirenz-containing regimen, as well as a proven, long-term safety and tolerability profile through 240 weeks in previously untreated (treatment-naïve) adult HIV-1 infected patients.

ISENTRESS is an integrase inhibitor indicated in combination with other antiretroviral (ARV) agents for the treatment of HIV-1 infection in adults. This indication is based on analyses of plasma HIV-1 RNA levels in three double-blind controlled studies of ISENTRESS. Two of these studies were conducted in clinically advanced, three-class ARV [non-nucleoside reverse transcriptase inhibitor (NNRTI), nucleoside reverse transcriptase inhibitor (NRTI), protease inhibitor (PI)] treatment-experienced adult patients through 96 weeks and one was conducted in treatment-naïve adults through 240 weeks.

The use of other active agents with ISENTRESS (raltegravir) is associated with a greater likelihood of treatment response.

Severe, potentially life-threatening and fatal skin reactions have been reported with ISENTRESS. Additionally, during the initial phase of combination ARV treatment, immune reconstitution syndrome may occur. (See Important Selected Safety Information below.)

“As the care of HIV evolves, ISENTRESS continues to be an important treatment option for adult patients with HIV-1,” said Jürgen Rockstroh, M.D., University of Bonn, Bonn-Venusberg, Germany. “These 240-week results are important for physicians to consider when initiating treatment with ISENTRESS in combination therapy in treatment-naïve adult patients with HIV-1.”

“Merck has been at the forefront of HIV research for close to 30 years. The discovery of ISENTRESS and its clinical development program are a testament to Merck's long-term commitment to the research and development of medicines for HIV,” said Daria Hazuda, Ph.D., vice president of Early Development and Discovery Sciences Research for infectious diseases, Merck.


Oxygen Biotherapeutics, Inc., (NASDAQ: OXBT)
announced enrollment of the first subject in the second cohort of its global Phase IIb clinical trial to investigate the safety and tolerability of Oxycyte® in patients with severe, non-penetrating traumatic brain injury (“STOP-TBI”). The first patient of the second cohort was enrolled in Israel at the Rambam Health Care Campus (RHCC) - the only Level 1 trauma center in the north of Israel. The RHCC's neurotrauma center treats approximately 200 severe brain injuries annually and is recognized as a teaching center of excellence for the region. The neurotrauma center is led by Dr. Leon Levi who, together with Department of Neurosurgery Chief, Professor Menashe Zaaroor, serve as co-principal investigators in the STOP-TBI trial.

The first cohort, of the three-cohort study, concluded with an independent safety monitoring board recommending, unanimously, advancement to Cohort 2. In addition to the 5 study centers receiving ethics committee approval in Israel, the study is expected to include sites in Switzerland, France and Spain, as well as other countries to be named later.

Dr. Levi, who is Oxygen Biotherapeutics' National Advisor in Israel for the study, recently commented, “The neurosurgical department at RHCC is proud to be a part of the research with Oxycyte as a treatment for TBI. We look forward to productive work on this important study.”

“With this first patient, we've officially begun our second cohort in the Phase IIb clinical trial in Israel and Switzerland,” stated Michael Jebsen, Interim CEO, President and Chief Financial Officer. “Each milestone that moves us towards regulatory approvals for Oxycyte® is a result of the commitment we've made to focus on this critical TBI indication for treatment markets both in the U.S. and internationally, where there are currently no approved treatments for any phase of TBI. We are pleased to be working with the top neurosurgeons and thought leaders in the world who seek advanced methods to treat and prevent critical medical conditions resulting from TBI.”

The STOP-TBI trial is a randomized, double-blind, placebo-controlled dose-escalation study of Oxycyte®. The primary objective of the trial is to evaluate the safety and tolerability of Oxycyte® in patients with severe non-penetrating traumatic brain injury. The secondary objective is to assess the potential of Oxycyte® in ameliorating the severity of TBI and represents an opportunity for the collection of placebo-controlled efficacy data, specifically, clinical and functional improvement. Functional status will be measured by the Glasgow Outcome Scale - Extended (GOS-E), a validated tool that helps to assess progress in patient recovery from their injury.

Also Monday:

Accelerate Diagnostics, Inc. (NASDAQ: AXDX)
, today announced that it has appointed Pete Bantock to the position of Chief Commercial Officer, effective today.

Align Technology, Inc. (NASDAQ: ALGN)
announced today that the Company will report second quarter 2013 financial results on Thursday, July 18, 2013 after the close of market.

Alimera Sciences, Inc. (NASDAQ: ALIM)
(Alimera), a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, announced today that it has been added to the Russell 2000® Index, Russell 3000® Index and Russell Global Index as part of the annual reconstitution by Russell Investments of its comprehensive set of U.S. and global equity indexes on June 28, 2013.

The Myelin Repair Foundation (MRF) today has granted a non-exclusive sublicense to Biogen Idec (NASDAQ: BIIB) for the use of MRF’s technologies to generate a novel mouse model for all demyelinating diseases, including multiple sclerosis (MS).

BioMarin Pharmaceutical Inc. (Nasdaq:BMRN)
today announced that it has submitted the Vimizim Marketing Application (MA) to the Agência Nacional de Vigilancia Sanitaria (ANVISA), or the National Health Surveillance Agency Brazil.

BioTech Medics, Inc., (PINKSHEETS: BMCS)
announced that it has signed a $5 million U.S. cross-marketing licensing non-exclusive contract for its patented SHBAN Alcohol Free Persistent Hand & Body Sanitizer with LifeBionix, Inc.

Celldex Therapeutics, Inc. (Nasdaq:CLDX)
today reported that the first patient has been dosed in the Company's pilot study of CDX-1135 (a soluble form of human complement receptor type 1) in dense deposit disease (DDD).

ChromaDex Corp.® (OTCBB: CDXC)
, an innovative natural products company that provides proprietary, science-based solutions and ingredients to the dietary supplement, food & beverage, animal health, cosmetic and pharmaceutical industries, announced today it has entered into a material transfer agreement (MTA) with The Scripps Research Institute ("TSRI") whereby ChromaDex will provide TSRI with quantities of its recently launched Niagen™ nicotinamide riboside (NR).

Covance Inc. (NYSE:CVD)
, a global leader of drug development services, has partnered with the National Association of Free and Charitable Clinics (NAFC) to bring a large one-day free medical clinic to New Orleans on July 3, where the uninsured and underinsured patients will be able to receive free medical care as well as be connected to local resources.

Cytori Therapeutics (NASDAQ: CYTX)
entered into a four-year, $27 million term loan with Oxford Finance Corporation and Silicon Valley Bank. The loan provides for an interest-only payment period of at least 12 months with the potential to be extended up to 18 months.

Digirad Corporation (NASDAQ: DRAD)
announced today that as part of a planned transition from its previously announced restructuring plan, President Matthew G. Molchan will assume the role of Chief Executive Officer, effective July 1.

Enanta Pharmaceuticals, Inc., (NASDAQ: ENTA)
, a research and development-focused biotechnology company dedicated to creating small molecule drugs in the infectious disease field, today announced that it has been added to the Russell 3000® Index and the Russell 2000® Index as part of the annual reconstitution of the Russell indexes.

Enanta Pharmaceuticals, Inc., (NASDAQ: ENTA)
, a research and development-focused biotechnology company dedicated to creating small molecule drugs in the infectious disease field, today announced that Jay R. Luly, Ph.D., President and Chief Executive Officer, will present a corporate overview followed by a Q&A session at 10:30 a.m. ET on July 9, 2013 during the 8th Annual JMP Securities Healthcare Conference in New York.

Fibrocell Science, Inc. (NYSE MKT:FCSC)
, an autologous cell therapy company focused on the development of innovative products for aesthetic, medical and scientific applications, and Intrexon Corporation, a leader in synthetic biology, announced today an expansion of their Exclusive Channel Collaboration (ECC) for development of a potentially new class of therapeutics.

Generex Biotechnology Corporation (OTCBB:GNBT)
today announced that it will be hosting a conference call featuring members of the Antigen Express, Inc. (www.antigenexpress.com) Scientific Advisory Board.

Genzyme, a Sanofi company (EURONEXT: SAN and NYSE: SNY)
, today announced that the first international meeting focused on bone disease in patients with Gaucher disease will take place July 5 and 6 in Rio de Janeiro, Brazil.

Idera Pharmaceuticals, Inc. (Nasdaq: IDRA)
announced results of a Phase 1 clinical trial of IMO-8400, a first-in-class antagonist of Toll-like Receptors (TLRs) 7, 8, and 9 being developed for potential applications in autoimmune and inflammatory diseases.

IDS Industries (OTCQB: IDST)
announced today receiving confirmation of its first patent filing from the United States Patent and Trademark Office (USPTO).

Insmed Incorporated (Nasdaq CM: INSM)
, a biopharmaceutical company focused on developing and commercializing an inhaled anti-infective to treat patients battling serious lung diseases that are often life-threatening, announces positive developments in both of its clinical development programs for ARIKACE®, or liposomal amikacin for inhalation (LAI).

Merck (NYSE: MRK)
, known as MSD outside the United States and Canada, announced today that the company has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application for suvorexant, Merck’s investigational medicine for the treatment of insomnia.

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 has received multiple regulatory approvals from various regulatory bodies.

MMRGlobal, Inc. (OTCQB: MMRF)
, through its wholly owned subsidiary MyMedicalRecords, Inc. (collectively, "MMR"), today announced that it will seek a stipulation or order to file an amended complaint against Walgreens Co. to include claims for infringement of its "Method for Providing a User with a Service for Accessing and Collecting Prescriptions" patent currently in the process of being issued under Notice of Allowance application number 13/714,720 which the Company received on June 19, 2013.

Neurocrine Biosciences, Inc. (NASDAQ: NBIX)
announced today that it has completed recruitment in the Phase IIb clinical trial (Kinect Study) of its proprietary Vesicular Mono-Amine Transporter 2 compound, NBI-98854.

OvaScienceSM, (NASDAQ: OVAS)
, a life sciences company focused on the discovery, development and commercialization of new treatments for infertility, announced today that the Company has been added to the Russell 2000® Index.

Oxygen Biotherapeutics, Inc., (NASDAQ: OXBT)
, today announced enrollment of the first subject in the second cohort of its global Phase IIb clinical trial to investigate the safety and tolerability of Oxycyte® in patients with severe, non-penetrating traumatic brain injury (“STOP-TBI”).

pSivida Corp. (NASDAQ:PSDV)
, a specialty pharmaceutical company that is a leader in developing sustained release drugs for treatment of back-of-the-eye diseases, today announced that it has initiated the first of two planned pivotal Phase III trials of its micro-insert for the treatment of chronic, non-infectious uveitis affecting the posterior segment of the eye, a major cause of vision loss in the U.S.

Quintiles Transnational Holdings Inc. (NYSE: Q)
will release its financial results for the second quarter of 2013 on Thursday, August 1, 2013, before the market opens.

Sabra Health Care REIT, Inc. (Nasdaq:SBRA) (Nasdaq:SBRAP)
announced the origination of a mezzanine loan investment for $12.4 million and the acquisition of a 32-unit assisted living facility located in Woodstock, Virginia for $6.2 million.

Sorrento Therapeutics, Inc. (OTCQB: SRNE)
and IGDRASOL announced today that the companies will present Phase III interim data analysis of Cynviloq in metastatic breast cancer (MBC) patients showing significantly improved overall response rate (ORR) compared to generic paclitaxel as well as updates of their nanomedicine platform, which is being developed for multiple cancer indications in late-stage clinical trials, at the 4th International Nanomedicine Conference in Sydney Australia (July 1st- 3rd, 2013).

StemCells, Inc. (Nasdaq:STEM)
today announced its addition to the Russell Microcap Index following Russell Investments' reconstitution of its comprehensive set of U.S. and global equity indexes.

Tengion, Inc. (OTCQB: TNGN)
, a leader in regenerative medicine, today announced the closing of transactions totaling $33.6 million to fund its two lead clinical programs, the Neo-Kidney Augment™ and the Neo-Urinary Conduit™.

Teva Pharmaceutical Industries Ltd. (NYSE: TEVA)
announced today that data from the Glatiramer Acetate Low-frequency Administration (GALA) study, published in the Annals of Neurology, show that a 40mg/ 1mL dose of COPAXONE® (glatiramer acetate injection) administered subcutaneously three times per week significantly reduced relapse rates at 12 months and demonstrated a favorable safety and tolerability profile in patients with relapsing-remitting multiple sclerosis (RRMS).

Urologix®, Inc. (OTCQB:ULGX)
, the leading provider of in-office BPH therapy, announces the restructuring of payment obligations to Medtronic related to the licensing agreement with Medtronic for the Prostiva® Radio Frequency (RF) Therapy System and reports preliminary revenue and cash results for its fourth quarter and fiscal year 2013 ended June 30, 2013.

ViroPharma Incorporated (Nasdaq: VPHM)
today announced that Vincent Milano, president and chief executive officer of ViroPharma, will present at the JMP Securities 2013 Healthcare Conference at 10:00 AM ET on Wednesday July 10, 2013.

Z Trim Holdings, Inc. (OTC Markets: ZTHO)
, a bio-technology company providing value-added ingredients to a variety of industries, today announced that it recorded, for the quarter ended June 30, 2013, sales growth of 18% over the quarter ended June 30, 2012.

"Featured Content" profiles are meant to provide awareness of these companies to investors in the small-cap and growth equity community and should not in any way come across as a recommendation to buy, sell or hold these securities. BiomedReports is not paid or compensated by newswires to disseminate or report news and developments about publicly traded companies, but may from time to time receive compensation for advertising, data, analytics and investor relation services from various entities and firms. Full disclosures should be read in the 'About Us Section'.

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