|ARIAD Publishes Phase 1 Trial Results of Ponatinib; Teva Increases Stake in Rexahn|
|By Staff and Wire Reports|
|Wednesday, 28 November 2012 19:48|
ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) announced publication of results from the Phase 1 study of ponatinib, its investigational, tyrosine kinase inhibitor in heavily pretreated patients with resistant and refractory chronic myeloid leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). The paper was published today in the New England Journal of Medicine (Vol. 367, No. 22, Pages 2075-88). The article is accompanied by an editorial by John M. Goldman, D.M., F.R.C.P. of the Department of Haematology, Imperial College London (Pages 2148-49).
The Phase 1 dose-escalation study of ponatinib enrolled 81 patients with resistant hematologic cancers, including 60 patients with CML and five patients with Ph+ ALL. With median follow-up at 73 weeks, 72 percent of patients (31 of 43) with chronic-phase CML enrolled in the study had a major cytogenetic response (MCyR), including 92 percent (11 of 12) who had the T315I gatekeeper mutation, which is the most common mutation among resistant patients. It was estimated that 89 percent of patients with chronic-phase CML who had a MCyR would remain in response at 1 year (95% confidence interval, 69% to 96% by Kaplan–Meier analysis). Of 22 patients with accelerated-phase or blast-phase CML or Ph+ ALL, 36 percent (8 of 22) had a major hematologic response, and 32% (7 of 22) had a MCyR.
Dose-limiting toxicities reported in the study included elevated lipase or amylase levels and pancreatitis. The most common treatment-related adverse events included rash (32%), thrombocytopenia (27%), arthralgia (17%), increased lipase (15%), fatigue (14%), acneiform dermatitis (14%), dry skin (14%), and nausea (14%). Neutropenia, headache, hypertriglyceridemia and myalgia occurred less frequently. The incidence of pancreatitis was 14% across all dose levels in the trial. The onset of pancreatitis, elevated amylase, and elevated lipase was dose-related with regard to both incidence and timing.
Rexahn Pharmaceuticals, Inc. (NYSE:RNN), a clinical stage pharmaceutical company commercializing potential best-in-class oncology and central nervous system (CNS) therapeutics, today announced that Teva Pharmaceutical Industries Ltd. (Teva) will provide an additional funding to Rexahn pursuant to the terms of its agreements with Teva.
Pursuant to the Securities Purchase Agreement with Teva, Teva will invest $750,000 to purchase Rexahn's common stock at 120% of closing price of common stock on the last trading day preceding the closing. This will complete the third closing agreed to by the parties in the Securities Purchase Agreement.
Teva has agreed to commit additional research funding for development of RX-3117. Under a new amendment to the Research and Exclusive License Option Agreement, Teva will have the right to file the IND for RX-3117 with the FDA.
Almirall, S.A. (ALM:MC) and Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD) announced today that the European Commission has granted marketing authorization to Constella® (linaclotide 290mcg) for the symptomatic treatment of moderate to severe Irritable Bowel Syndrome with Constipation (IBS-C) in adults.
Anthera Pharmaceuticals, Inc. (Nasdaq: ANTH), a biopharmaceutical company developing drugs to treat serious diseases associated with inflammation and autoimmune disorders, today announced additional data from its Phase 2b PEARL-SC study was presented in a poster at the 2012 Asian Lupus Summit.
Bernstein Liebhard LLP today announced that a class action has been commenced in the United States District Court for the District of Massachusetts on behalf of a class (the "Class") of purchasers of Abiomed, Inc. (NASDAQ: ABMD) common stock between August 5, 2011 and October 31, 2012, inclusive (the "Class Period").
BioNeutral Group, Inc. (OTCBB: BONU) a specialty life science technology based company announced today that it has received positive test results from a global laboratory which is the world's largest private, independent research and development organization for its Ygiene Sterilant against fully virulent Bacillus anthracis Ames Spores.
Cadence Pharmaceuticals, Inc. (NASDAQ: CADX), a biopharmaceutical company focused on acquiring, in-licensing, developing and commercializing proprietary products principally for use in the hospital setting, today announced that the company will host an Analyst and Investor Day for financial analysts on Thursday, December 6, 2012, from 9:00 am to 12:00 pm EST in New York, NY.
Cadence Pharmaceuticals, Inc. (Nasdaq: CADX) today announced that it has entered into settlement and license agreements with Perrigo Company (Nasdaq: PRGO; TASE), and its subsidiary, Paddock Laboratories, LLC, to resolve pending patent litigation involving OFIRMEV® (acetaminophen) injection.
CDEX Inc. (OTCQB: CDEX), a leading developer of chemical detection products using patented technologies for use in healthcare, safety and security markets, today announced the company will participate at the 47th Annual Midyear ASHP Clinical Meeting and Exhibition to demonstrate the ValiMed™ G4 medication safety, and narcotic detection system.
Connectyx Technologies Holdings Group, Inc. (PINKSHEETS: CTYX) ("Connectyx"), www.connectyx.com, manufacturer and distributor of the MedFlash®, the nation's premier Personal Health and Wellness Management System (ePHM) for maintaining personal health records (PHR), announced today that the Platinum Marketing Group, a leader in data and Internet marketing services, is offering MedFlash as an additional member benefit.
Genomic Health, Inc. (Nasdaq: GHDX) today announced that the company will present results from six Oncotype® DX breast cancer test studies at the 34th Annual CTRC-AACR San Antonio Breast Cancer Symposium (SABCS), taking place December 6-8, 2012 at the Henry B. Gonzalez Convention Center.
Immunotech Laboratories, Inc. (PINKSHEETS: IMMB) Pursuant to significantly positive results with its patient population targeting full blown AIDS patients, the company has completed numerous clinical contracts with Mexican hospitals to initiate a full blown effort of clinical trial protocol preparation for its HIV/AIDS Vaccine drug candidate.
IntelliCell BioSciences, Inc. ("Company") (OTCQB: SVFC) announced today that it has entered a sponsored research agreement with the New Jersey Center for Biomaterials at Rutgers-The State University of New Jersey.
Misonix, Inc. (NasdaqGM: MSON), an international surgical device company that designs, manufactures and markets innovative therapeutic ultrasonic products for spine surgery, skull-based surgery, neurosurgery, wound debridement, cosmetic surgery, laparoscopic surgery and other surgical applications, was prominently referred to in an article published by Becker's Orthopedic & Spine Review on November 16, 2012, entitled "5 Spine Experts on Most Exciting Technology for Spinal Surgery."
MMRGlobal, Inc. (OTCQB: MMRF) ("MMR") today announced that the Company has agreed to the terms of patent license agreements with three EMR and PHR vendors and has already begun making licensed services available to more than 30,000 physician accounts belonging to one of the licensees.
Rapid Fire Marketing (PINKSHEETS: RFMK), a developer and producer of vapor inhaler products, announced today that the Company expects to receive the first half of the shipment this week in Los Angeles, including the new Cumulus Vapor Inhalers.
Selecta Biosciences, Inc., a clinical-stage biopharmaceutical company developing a new class of synthetic vaccines and immunotherapies, today announced that it has entered into a strategic global collaboration with Sanofi (EURONEXT: SAN and NYSE: SNY) to discover highly targeted, antigen-specific immunotherapies for life-threatening allergies.
Smith & Nephew (LSE: SN, NYSE: SNN), the global medical technology business, announced today that it has signed an agreement to acquire substantially all of the assets of Healthpoint Biotherapeutics for $782 million in cash.
SpectraScience, Inc. (OTCQB: SCIE), a San Diego based medical device company, today announced that Chief Executive Officer Michael Oliver is scheduled to present to investors at the 5th Annual LD Micro Growth Conference on Thursday, December 6, 2012 at 11:30 a.m. Pacific.
Stellar Pharmaceuticals Inc. (OTCQB:SLXCF)(OTCBB:SLXCF)(PINKSHEETS:SLXCF) ("Stellar" or the "Company") and its operating division, Tribute Pharmaceuticals announced today the appointment of Dr. Bernard Chiasson, Ph.D. to the newly created position of Chief Scientific Officer.
TRIMEDYNE, INC. (OTCBB: TMED) today announced it has patented and filed patent applications covering several new laser devices ("Devices") designed to treat medical conditions that affect millions of people in the United States and many more millions of people throughout the world.
Valeant Pharmaceuticals International, Inc. (NYSE: VRX and TSX: VRX) announced today that Ryan Weldon and Jason Hanson will be named to Valeant's Executive Management Team.
Verisante Technology, Inc. (TSX VENTURE:VRS) (OTCQX:VRSEF)(FRANKFURT:V3T) (the "Company" or "Verisante"), a leader in cancer detection technology, announced today that the research team at the BC Cancer Agency is presenting a poster on study results for lung cancer at the BC Cancer Agency 2012 Annual Cancer Conference, November 29-December 1, 2012; and making an oral presentation at a clinical imaging session at SPIE Photonics West 2013, February 2-7, 2013.