|Nabi Announces Results Of First NicVAX Phase III Clinical Trial. Nektar Receives Positive Opinion From European Medicines Agency.|
|By Staff and Wire Reports|
|Monday, 18 July 2011 18:18|
Nabi Biopharmaceuticals, (NASDAQ:NABI), announced NicVAX (Nicotine Conjugate Immunotherapeutic) did not meet its primary endpoint in the Company's first of two confirmatory Phase III clinical trials.
A preliminary assessment of the trial data showed that subjects treated with NicVAX quit smoking at a similar rate of approximately 11% compared to subjects who received placebo. As in previous trials, NicVAX was well-tolerated with a clinically acceptable safety and tolerability profile. The study was a double-blinded, placebo-controlled trial of 1,000 patients.
The primary endpoint of the study was the abstinence rate for 16 weeks ending at 12 months. Abstinence was evaluated by self-reported cigarette consumption and biologically verified by exhaled carbon dioxide. Secondary endpoints included the abstinence rate at various time intervals, safety and immunogenicity, and the effect of NicVAX on withdrawal symptoms, cigarette consumption, smoking satisfaction and nicotine dependency.
Nektar Therapeutics, (NASDAQ:NKTR), announced the European Medicines Agency Committee for Orphan Medicinal Products (COMP) has issued a positive opinion on its application for orphan medicinal product status for the Company's lead oncology candidate, NKTR-102, for the treatment of women with ovarian cancer.
Nektar has a multi-national Phase 2 study ongoing for NKTR-102 that is enrolling approximately 125 patients with platinum-resistant ovarian cancer whose disease has progressed following treatment with pegylated liposomal doxorubicin (PLD) therapy.
ARC (NYSE: ARC), one of the nation's leading document solutions company, today announced that John E.D. Toth, former strategy consultant to Chiquita Brands International, Inc., and Chief Financial Officer of Bell-Carter Foods, Inc., has been named Chief Financial Officer of the Company, replacing Jonathan Mather, who retires today.
Arrhythmia Research Technology, Inc. (NYSE Amex: HRT) today announced the retirement of Dr. Julius Tabin (91) from the Company's Board of Directors and his appointment as the Company's first Director Emeritus, effective immediately.
Auxilium Pharmaceuticals, Inc. (NASDAQ:AUXL), a specialty biopharmaceutical company, will release results for the second quarter 2011 on Monday, August 1, 2011 before the opening of the U.S. financial markets.
Caliper Life Sciences, Inc. (NASDAQ:CALP), a leading provider of tools and services for life science companies, today announced that Kevin Hrusovsky, President and CEO, has been invited to ring The NASDAQ Stock Market Opening Bell on Tuesday, July 19th and will be joined by family, management and several strategic customers to participate in this special event.
China Medical Technologies, Inc. (Nasdaq:CMED), a leading China-based advanced in-vitro diagnostic ("IVD") company, today announced the filing of its annual report on Form 20-F for the fiscal year ended March 31, 2011 with the U.S. Securities and Exchange Commission (the "SEC").
Cord Blood America, Inc. (OTC Bulletin Board:CBAI), the umbilical cord blood stem cell preservation company focused on bringing the life saving potential of stem cells to families nationwide and internationally, said today that co-founder and CEO Matthew Schissler was interviewed by analyst Francis Gaskins about the Company's international successes.
Genesis Biopharma, Inc. (OTC/BB: GNBP), a biotechnology company developing targeted cancer therapies, today announced it has named David Voyticky to its Board of Directors.
Insmed Incorporated (Nasdaq CM: INSM), a biopharmaceutical company, today announced that Andrea ("Andi") Holtzman Drucker, J.D. has been appointed to the newly created position of Senior Vice President, General Counsel and Corporate Secretary, effective as of July 18, 2011.
Luminex Corporation (NASDAQ:LMNX) today announced that it expects to report results for the second quarter of 2011 on Monday, August 8, 2011.
NeoStem, Inc., (NYSE-Amex:NBS) today announced that it intends to offer and sell shares of its common stock and warrants in an underwritten public offering.
Optimer Pharmaceuticals, Inc. (NASDAQ:OPTR) today announced the commercial launch of DIFICID™ (fidaxomicin) tablets for the treatment of Clostridium difficile-associated diarrhea (CDAD) in patients 18 years of age and older.
QRxPharma Limited (ASX: QRX and OTCQX: QRXPY) announced today initiation of the New Drug Application (NDA) approval process for MoxDuo IR with the United States Food and Drug Administration (FDA).
Sanofi Pasteur, the vaccines division of Sanofi (EURONEXT: SAN and NYSE:SNY), announced today that it began shipping its 2011-2012 Fluzone® Influenza Virus Vaccine in the U.S.
Shire plc (LSE: SHP; NASDAQ:SHPGY), the global specialty biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) approved Lialda® (mesalamine) Delayed Release Tablets for the maintenance of remission in patients with ulcerative colitis.