NW Biotherapeutics' Phase III Trial of DCVAX®-L for GBM Brain Cancer Approved to Proceed in Canada; FDA Grants Genentech’s Cobimetinib Priority Review for Use in Combination with Zelboraf Print E-mail
By Josh Gee   
Thursday, 19 February 2015 19:56
Below is a look at some of the headlines for companies that made news in the healthcare sector on February 19, 2015.
Northwest Biotherapeutics (NASDAQ: NWBO), a U.S. biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, announced the Company's ongoing Phase III clinical trial of DCVax-L for Glioblastoma multiforme (GBM) brain cancer has been approved by Health Canada (the Canadian regulatory authority) to proceed in Canada, has completed the approval processes at two sites, and is under way screening patients for enrollment.

The two open trial sites are the Institut et hôpital neurologiques de Montréal (Montreal Neurological Institute and Hospital) and the Centre Hospitalier Universitaire de Sherbrooke, Hôpital Fleurimont, in Sherbrooke, Quebec.  The Montreal Neurological Institute and Hospital is the largest specialized neuroscience research and clinical center in Canada, and one of the largest in the world.  It is connected with McGill University, an important research center.  The Sherbrooke Hospital is a major regional medical center for Quebec, serving over a million people, and is also a quaternary care center (i.e., a center for advanced and specialized medical treatments). 

"We are very pleased to have been given a green light for our Phase III trial of DCVax-L by another highly respected regulator, in Canada, and to again be working with the leading institutions in the country," commented Linda Powers, CEO of NW Bio.  "As we have regularly said, adding further countries and trial sites, even as we reach the late stages of our Phase III trial, provides a double benefit:  it will help accelerate the completion of the trial and, importantly, it will expand the pool of sites that are trained, experienced and prepared in advance for commercialization of DCVax-L.


 
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Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review for the company’s New Drug Application (NDA) for cobimetinib in combination with Zelboraf® (vemurafenib) for the treatment of people with BRAF V600 mutation-positive advanced melanoma. The FDA will make a decision on approval by August 11, 2015.

“We are pleased the FDA has accepted our application for cobimetinib in combination with Zelboraf and granted it Priority Review status,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “We look forward to working with the FDA to bring this new treatment option to people with BRAF mutation-positive advanced melanoma as soon as possible.”

A Priority Review designation is granted to medicines that the FDA determines have the potential to provide significant improvements in the treatment, prevention or diagnosis of a disease. The NDA is based on results of the coBRIM Phase III study, which showed the MEK inhibitor cobimetinib plus Zelboraf reduced the risk of disease worsening or death by half in people who received the combination (hazard ratio [HR]=0.51, 95 percent confidence interval [CI] 0.39-0.68; p<0.0001), with a median PFS of 9.9 months for cobimetinib plus Zelboraf compared to 6.2 months with Zelboraf alone. The safety profile was consistent with a previous study of the combination. The most common Grade 3 or higher adverse events in the combination arm included liver lab value abnormalities, elevated creatine phosphokinase (CPK, an enzyme released by muscles) and diarrhea. The most common adverse events seen in the combination arm included diarrhea, nausea, rash, photosensitivity and lab value abnormalities.




Also Thursday:


 
Air Methods Corporation (Nasdaq:AIRM)
will report financial results for the fourth quarter ended December 31, 2014 after the close of the market on Thursday, February 26, 2015.

Citing innovation, interoperability and better business intelligence and reporting, Home Care by Black Stone (Black Stone), a home health agency with locations across Ohio, has chosen Allscripts (Nasdaq:MDRX) Homecare™, a fully integrated solution.

Amedica Corporation (Nasdaq:AMDA)
, a company that develops and commercializes silicon nitride ceramics as a biomaterial platform, announced today that it will release financial results for its fourth quarter and full year 2014 on Thursday, March 5, 2015, before the market opens.

Amedisys, Inc. (Nasdaq:AMED)
, one of America's leading home health and hospice care companies, announced today that it will host a conference call to discuss results for the fourth quarter ended December 31, 2014 on Wednesday, March 4, 2015 at 10:00 a.m. Eastern Time (9:00 a.m. Central Time).

AXIM Biotechnologies, Inc. (OTC:AXIM)
, an industry leader in cannabinoid research and industrial hemp product development, is proud to announce that it has plans to revitalize the cosmetics industry with the launch of its new hemp cannabinoid-based Cosmetics Division.

Bellerophon Therapeutics, Inc. (Nasdaq:BLPH)
announced today the closing of its initial public offering of 5,000,000 shares of common stock at a public offering price of $12.00 per share, before underwriting discounts.

BioTelemetry, Inc. (Nasdaq:BEAT)
, the leading wireless medical technology company focused on the delivery of health information to improve quality of life and reduce cost of care, today reported results for the fourth quarter and full year ended December 31, 2014.

Celldex Therapeutics, Inc. (Nasdaq:CLDX)
will release fourth quarter and year-end 2014 financial results on Tuesday, February 24, 2015 before the U.S. financial markets open.

Connecture, Inc. (Nasdaq:CNXR)
, a provider of web-based information systems used to create health insurance marketplaces, will release its 2014 fourth quarter and full year financial results on Tuesday, March 10, 2015 after market close and will host a conference call to follow at 5:00 p.m. Eastern Time.

Hemp, Inc. (OTC:HEMP)
is sponsoring the 1st Annual Ascent Expo at the Los Angeles Convention Center, February 27 – March 1, 2015.

Hyperion Therapeutics, Inc. (Nasdaq:HPTX)
today announced that it will report fourth quarter and full year 2014 financial results after market closes on Thursday, February 26, 2015.

Immunomedics, Inc., (Nasdaq:IMMU)
today announced that 33% of patients with small cell lung cancer (SCLC) and 31% with non-small cell lung cancer (NSCLC) had their tumor reduced in size by 30% or more, after being treated with sacituzumab govitecan, the Company's lead investigational antibody-drug conjugate (ADC).

Intercept Pharmaceuticals, Inc. (Nasdaq:ICPT)
, a clinical stage biopharmaceutical company focused on the development and commercialization of novel bile acid therapeutics to treat chronic liver diseases, today announced that Lisa Bright has been promoted to the newly-created position of Chief Commercial and Corporate Affairs Officer.

IPC Healthcare, Inc. (Nasdaq:IPCM)
, a leading national acute hospitalist and post-acute provider organization, announced today that it has acquired Capital Internal Medicine, LLC (Capital).

IPC Healthcare, Inc. (Nasdaq:IPCM)
, a leading national acute hospitalist and post-acute provider group practice, today announced financial results for the fourth quarter and full year ended December 31, 2014.

Oxford Immunotec Global PLC (Nasdaq:OXFD)
today announced that it plans to release fourth quarter and full year 2014 financial results prior to market open on Tuesday, March 3, 2015.

Merrimack Pharmaceuticals, Inc. (Nasdaq:MACK)
today announced the initiation of a global, open-label, biomarker-selected, randomized Phase 2 clinical trial of MM-121, a fully human monoclonal antibody targeting ErbB3, in combination with docetaxel or pemetrexed versus docetaxel or pemetrexed alone in patients with heregulin positive, locally advanced or metastatic non-small cell lung cancer.

Novavax, Inc. (Nasdaq:NVAX)
, a clinical-stage vaccine company focused on the discovery, development and commercialization of recombinant nanoparticle vaccines and adjuvants, today announced it will report its fourth quarter and full year 2014 financial and operating results after the close of U.S. financial markets on Thursday, February 26, 2015.

Nuo Therapeutics, Inc. (OTCQX:NUOT)
, a pioneer in biodynamic therapies, today announced the initiation of a new clinical study (Au Study) that is comprised of three randomized controlled protocols that examine the efficacy of Aurix™, a biodynamic hematogel, for use in diabetic foot ulcers, venous leg ulcers and pressure ulcers (bed sores).

PharmaCyte Biotech, Inc. (OTCQB: PMCB)
, a clinical stage biotechnology company focused on developing targeted treatments for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box®, today announced the commencement of an expanded, follow-up study of the effectiveness of its pancreatic cancer treatment (a combination of low doses of the cancer prodrug ifosfamide and Cell-in-a-Box® capsules containing live cells capable of converting ifosfamide into its cancer-killing form) on the accumulation of malignant ascites fluid.

Prothena Corporation plc (Nasdaq:PRTA)
, a late-stage clinical biotechnology company focused on the discovery, development and commercialization of novel protein immunotherapy programs, announced today that it will report its fourth quarter and full year 2014 financial results on Thursday, March 5, 2015, after the close of the U.S. financial markets.

Radius Health (Nasdaq:RDUS)
announced today that it will release its fourth quarter and full year 2014 financial results on Tuesday, March 10, 2015.

The Spectranetics Corporation (Nasdaq:SPNC)
today reported financial results for the three months and year ended December 31, 2014.

TearLab Corporation (Nasdaq:TEAR) (TSX:TLB)
expects to announce its Q4 and full year 2014 financial results after market closes on Thursday, March 12, 2015.

TESARO, Inc. (Nasdaq:TSRO)
, an oncology-focused biopharmaceutical company, today reported financial results for fourth-quarter and full-year 2014 and provided an update on the Company's pipeline programs.



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