|Gilead's Investigational Antiretroviral Quad Regimen Meets 48-Week Primary Objective. Impax And GlaxoSmithKline Announces Positive Results Of ASCEND-PD.|
|By Staff and Wire Reports|
|Monday, 15 August 2011 19:34|
Gilead Sciences, Inc. (NASDAQ:GILD) announced a Phase 3 clinical trial (Study 102) of its investigational fixed-dose, single-tablet “Quad” regimen of elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate, being evaluated for HIV-1 infection in treatment-naïve patients, met its primary objective, which was non-inferiority at week 48 as compared to Atripla® (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg).
The primary endpoint analysis indicated 88% of patients in the Quad arm compared to 84% in the Atripla (95% CI for the difference: -1.6% to 8.8%) achieved HIV RNA (viral load) of less than 50 copies/mL through week 48. The predefined criterion for non-inferiority was a lower bound of a two sided 95% CI of -12 percent. The mean 48-week increase in CD4 cell count from baseline was 239 cells/mm3 in the Quad arm compared to 206 cells/mm3 in the Atripla arm (p=0.009).
The frequency of Grade 3-4 adverse events and laboratory abnormalities was similar between the Quad-treated and the Atripla-treated arms. Discontinuation rates due to adverse events were comparable in both arms of the study. Gilead plans to submit these data for presentation at a scientific conference early next year.
Impax Pharmaceuticals, the branded products division of Impax Laboratories, Inc., (NASDAQ:IPXL), and GlaxoSmithKline plc, (NYSE:GSK), announced positive results of the ASCEND-PD Phase III clinical study of IPX066 versus carbidopa-levodopa plus entacapone (CLE), in patients with advanced Parkinson’s disease (PD).
IPX066 is an extended release capsule formulation of carbidopa-levodopa (CD-LD) under investigation for the treatment of the motor symptoms of PD. The primary endpoint of this double blind crossover study was the percentage of off time during waking hours as measured by patient diary. Off time is the functional state when patients’ medication effect has worn off and there is a return of the motor symptoms of PD.
Patients entered the study with a baseline off time of 36.1% (5.9 hours), and at the end of the randomized IPX066 treatment phase patients had off time of 24.0% (3.8 hours) during waking hours compared to 32.5% (5.2 hours) for CLE (p<0.0001). This represents a 33.5% decrease in percent off time for IPX066 from baseline vs. a 10% decrease for CLE.
Adeona Pharmaceuticals, Inc. (AMEX:AEN), a developer of innovative medicines for serious central nervous system diseases, today reported its second quarter 2011 financial results for the period ended June 30, 2011, as well as updates since the beginning of the second quarter.
diaDexus, Inc. (OTC Bulletin Board:DDXS), a diagnostics company focused on the development and commercialization of patent-protected in vitro diagnostic products addressing unmet needs in cardiovascular disease, today announced financial results for the second quarter of 2011.
Delcath Systems, Inc. (NASDAQ:DCTH) announced that the Company recently hosted a symposium at the Interventional Radiology and Endovascular Surgery Society Meeting (SOBRICE) in Buzios, Brazil.
Emdeon Inc. (NYSE:EM), a leading provider of healthcare revenue and payment cycle management and clinical information exchange solutions, today announced its support for the U.S. Drug Enforcement Administration's (DEA's) quicker-to-market option for electronic prescribing of controlled substances (EPCS).
NeoStem, Inc. (NYSE Amex:NBS) ("NeoStem" or the "Company"), an international biopharmaceutical company with a focus on cell based therapeutics development, today reported on important progress toward the commencement of a Phase II clinical trial for AMR-001, the lead product candidate of Amorcyte, Inc. ("Amorcyte") for the treatment of acute myocardial infarction.
Nile Therapeutics, Inc. (OTCQB: NLTX), a company focused on the development of novel therapeutics for cardiovascular disease, today announced its second quarter financial results for 2011.
ShangPharma Corporation (NYSE:SHP) ("ShangPharma" or the "Company"), a leading China-based pharmaceutical and biotechnology research and development outsourcing company, today announced that its senior management will be participating in the following upcoming conferences in September 2011.