|ARIAD Begins Phase 1/2 Trial of Ponatinib in Japan; Novartis Fights India for Cancer Pill Patent|
|By Staff and Wire Reports|
|Monday, 20 August 2012 18:42|
ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) announced the initiation of a multi-center Phase 1/2 clinical trial in Japan of ponatinib, the Companys investigational BCR-ABL inhibitor. The trial is being conducted in Japanese patients with chronic myeloid leukemia (CML) who have failed treatment with dasatinib or nilotinib or with Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL) who have failed prior tyrosine kinase inhibitors. The trial is designed to establish the recommended dose for ponatinib and confirm its anti-leukemic activity in Japanese patients. The Company expects that this trial should provide the incremental clinical data needed for initial regulatory approval of ponatinib in Japan. Japan is the third largest CML market in the world with an annual incidence of 1,300 new patients reported in 2010.
Many of the worlds foremost thought leaders on CML are in Japan, and we are delighted to be collaborating with many of them to advance the potential uses of ponatinib among Japanese patients with refractory CML, stated Timothy P. Clackson, Ph.D., president of research and development and chief scientific officer of ARIAD. We are working closely with these CML experts and anticipate that this trial will confirm the results seen with ponatinib in our ongoing Phase 1 and pivotal Phase 2 trials of ponatinib.
The Phase 1 dose-escalation portion of the trial will have two dose cohorts: 30 mg and 45 mg administered orally once daily. At least six patients will be enrolled in each dose cohort. Once the recommended dose of ponatinib for Japanese patients is determined and safety evaluations have been completed, the Phase 2 portion of the trial will be initiated. The first patient in the trial has been dosed.
The single-arm, open-label Phase 2 component of the trial is expected to begin in the first quarter of 2013 and to enroll an additional 25 adult patients. ARIAD expects to fully enroll the study by mid-year 2013. In the Phase 2 portion of the trial, the primary efficacy endpoint for CML patients in chronic phase will be major cytogenetic response. For CML patients in accelerated phase or blast phase and for Ph+ ALL patients, the primary endpoint will be major hematologic response, defined as complete hematologic response or no evidence of leukemia. The studys secondary endpoints for all patients will include major molecular response, time to response, duration of response, progression-free survival and overall survival.
Novartis AG (NYSE:NVS) goes to India's Supreme Court on Wednesday to seek patent protection for its blockbuster cancer drug Glivec in a case that could deliver far-reaching ramifications for multinational pharmaceutical companies operating in India.
The Swiss company's legal fight, which began after India rejected its application for a patent six years ago, is the most prominent of several high-stakes drug-patent battles that will determine how much protection foreign companies can get from Indian competitors that make lower-cost, generic versions of their products.
Allezoe Medical Holdings (OTCBB:ALZM) which previously announced that it has entered into an agreement for the merger of HealthWatchSystems, Inc., a Florida corporation, with and into HWS Acquisition Corp., a Florida corporation and wholly-owned acquisition subsidiary of ALZM, today announced that the merger was approved by the shareholders of OVWatch on August 13, 2012.
Axia Group (PINKSHEETS:AGIJ) is pleased to provide the following update regarding the merger / buy out candidate Artist MSS of Seoul, Korea. www.artistmss.com.
BioDelivery Sciences International, Inc. (Nasdaq: BDSI) announced that enrollment and the clinical portion of the pivotal pharmacokinetic study for BEMA Buprenorphine/Naloxone (BNX) for the treatment of opioid dependence has been completed.
InspireMD, Inc. (OTCBB: NSPR) (the "Company" or "InspireMD"), a medical device company focusing on the development and commercialization of its proprietary MGuard™ embolic protection stent platform technology for use in patients with Acute Myocardial Infarctions, announced today that a multi-center randomized trial of its MGuard™ embolic protection stent demonstrated a positive outcome in treating patients suffering heart attacks when compared to commercially-approved bare metal or drug-eluting stents.
Itonis, Inc. (PINKSHEETS: ITNS) and Charles Hensley, Ph.D., the inventor of the Zicam® cold remedy, are pleased to announce plans to introduce their first product offering since the creation of Itonis Pharmaceuticals, a division of Itonis.
Medbox, Inc. (Pinksheets: MDBX) (www.medboxinc.com) released their end of 2nd quarter 2012 financials, which showed earnings of over $820,000 for the three-month period ending June 30.
MMRGlobal, Inc. (OTCBB: MMRF) ("MMR," the "Company"), a leading provider of Personal Health Records (PHRs), MyEsafeDepositBox storage solutions and MMRPro electronic document management and imaging systems for healthcare professionals, today announced it is pursuing claims for infringement against healthcare providers and other organizations based on the Company's health IT patent portfolio.
Pharmacyclics, Inc. (Nasdaq: PCYC) announced today that the clinical trial, SPARK (MCL2001), of ibrutinib in patients with relapsed or refractory mantle cell lymphoma (MCL) has enrolled its fifth patient.
Regulus Therapeutics Inc., a biopharmaceutical company founded by Alnylam Pharmaceuticals (NASDAQ: ALNY) and Isis Pharmaceuticals (NASDAQ: ISIS), announced today that it has filed a registration statement on Form S-1 with the U.S. Securities and Exchange Commission (SEC) relating to a proposed initial public offering of shares of its common stock.
ShangPharma Corporation (NYSE: SHP) ("ShangPharma" or the "Company"), a leading China-based pharmaceutical and biotechnology research and development outsourcing company, today announced its unaudited financial results for the second quarter ended June 30, 2012.
Rosetta Genomics Ltd. (NASDAQ: ROSG), a leading developer and provider of microRNA-based molecular diagnostics, today announced the completion of three executive hires and an expansion of its commercial operations in preparation for expected sales growth of its microRNA diagnostic assays, specifically its flagship product miRview® mets2.
WellQuest Medical & Wellness Corporation (PINKSHEETS: WEQL), delivering a unique model for healthcare that helps customers get well, stay well, and look well, has issued a Shareholder Report outlining the Company's achievements for the six month period ended June 30, 2012.
The board of directors of Westlake Chemical Corporation (NYSE: WLK) declared on Friday a dividend of 18.75 cents per share, an increase of over 150% from the 7.375 cents per share paid in the second quarter of 2012.
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, in July 2012, over 4 times the sales revenues that it recorded in July 2011.