|Bristol Myers Announces Phase 3 First-Line Study of Nivolumab Stopped Early; Raptor Pharma Reports Data of Pediatrics Showed Procysbi Improved Life Quality|
|By Staff and Wire Reports|
|Tuesday, 24 June 2014 23:23|
Bristol-Myers Squibb Company (NYSE: BMY) announced a randomized blinded comparative Phase 3 study evaluating nivolumab versus dacarbazine (DTIC) in patients with previously untreated BRAF wild-type advanced melanoma was stopped early because an analysis conducted by the independent Data Monitoring Committee (DMC) showed evidence of superior overall survival in patients receiving nivolumab compared to the control arm. Patients in the trial will be unblinded and allowed to cross over to nivolumab. The Company will share these data with health authorities.
“The outcome of CheckMate -066 is an important milestone in the field of immuno-oncology as it represents the first well-controlled, randomized Phase 3 trial of an investigational PD-1 checkpoint inhibitor to demonstrate an overall survival benefit,” said Michael Giordano, MD, Head of Oncology Development. “Bristol-Myers Squibb is committed to continuing to lead advances in immuno-oncology and to executing our strategy to provide patients with the best opportunity to achieve the potential for long term survival.”
CheckMate -066 investigators have been informed of the decision to stop the blinded comparative portion of the trial. Bristol-Myers Squibb will ensure that patients are informed of the opportunity to continue or start treatment with nivolumab in an open-label extension as part of the Company's commitment to characterize long-term survival. The study, which was designed in consultation with the Committee for Medicinal Products for Human Use (CHMP), was primarily conducted in countries where DTIC is a commonly-used treatment in the first-line setting, including Canada, but not at U.S. trial sites. The Company will complete a full evaluation of the final CheckMate -066 data and work with investigators on the future presentation and publication of the results.
Raptor Pharmaceutical Corp. (Nasdaq: RPTP) today announced that data from its open label extension study of delayed-release cysteamine bitartrate (PROCYSBI^®) has been published in the Journal of Pediatrics [DOI: 10.1016/j.jpeds.2014.05.013]. The study demonstrated that patients with nephropathic cystinosis who took PROCYSBI for two years were able to sustain optimal cystine control in their white blood cells and preserve kidney function over the long term, and had significant improvements in social, school and total functioning based on validated quality of life measurement scales.
The prospective, controlled, open label, single-arm study followed 40 patients with nephropathic cystinosis treated with PROCYSBI for two years to assess efficacy in cystine depletion in peripheral white blood cells, to assess the dose required to maintain white blood cell (WBC) content of cystine below 1 nmol ½ cystine/mg protein, to measure quality of life using the Pediatric Quality of Life Inventory (PedsQL™), change in estimated glomerular filtration rate, and change in height Z-score. The objective was to determine the long-term effects of PROCYSBI therapy in patients with the disease.
Aastrom Biosciences, Inc. (Nasdaq:ASTM), the leading developer of patient-specific expanded cellular therapies for the treatment of severe diseases and conditions, today announced the initiation of commercial sales of bone marrow by Marrow Donation, LLC, the company's wholly owned bone marrow collection center located in San Diego, CA.
ActiveCare, Inc. (OTCQB:ACAR), a leader in diabetes management and wellness services for self-insured employers nationwide, today announced June growth increasing its membership base of diabetics by 12%.
Air Methods Corporation (Nasdaq:AIRM), the global leader in air medical transportation, announced today that it acquired the four bases of Baptist LifeFlight, owned by Baptist Health Care (BHC) of Pensacola, Fla.
athenahealth, Inc. (Nasdaq:ATHN), a leading provider of cloud-based services for electronic health record (EHR), practice management, and care coordination, today announced that Kristi Matus has been appointed executive vice president and chief financial & administrative officer, effective July 21, 2014.
Diversicare Healthcare Services, Inc. (Nasdaq:DVCR) today announced the Company's most recent growth activities.
Inogen, Inc. (Nasdaq:INGN) announced today that it has received FDA clearance for an innovative home oxygen concentrator called the Inogen At Home™.
MedAssets (Nasdaq:MDAS) today announced the introduction of Contract Analytics, the first module of Revenue Cycle Analytics, a robust analytical discovery product suite designed to improve revenue cycle efficiency and visibility into reimbursement performance.
Mission Ready Services Inc. (TSX-V:MRS) is pleased to announce that it has entered into a Representation Agreement with Heapsylon, LLC through its wholly-owned subsidiary, Protect The Force Inc.
Nanosphere, Inc. (Nasdaq:NSPH), a company enhancing the practice of medicine through targeted molecular diagnostics, today announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the bacterial portion of its Verigene® Enteric Pathogens Nucleic Acid Test (EP).
Premier, Inc. (Nasdaq:PINC) has introduced PremierConnect™ Price Lookup, a mobile app allowing its member healthcare providers and contracted suppliers instant and secure access to product pricing on all types of purchasing contracts.
Receptos, Inc. (Nasdaq:RCPT), a biopharmaceutical company developing therapeutic candidates for the treatment of immune and metabolic diseases, announced today closing of the previously announced underwritten public offering of 4,433,000 shares of its common stock at a price to the public of $40.25 per share.
Ultragenyx Pharmaceutical Inc. (Nasdaq:RARE), a biopharmaceutical company focused on the development of novel products for rare and ultra-rare diseases, today announced the presentation of results from a multiple-dose study, conducted by Kyowa Hakko Kirin Pharma, Inc. (KKP), of the investigational anti-FGF23 monoclonal antibody KRN23 (UX023) in adult patients with X-linked hypophosphatemia (XLH). XLH is an inherited metabolic bone disease characterized by short stature, skeletal deformities, bone pain, fractures, and muscle weakness.