|Gilead's Cobicistat as Effective as Ritonavir; Pfizer-J&J Alzheimer’s Drug Fails to Aid Cognition|
|By Staff and Wire Reports|
|Tuesday, 24 July 2012 18:14|
Gilead Sciences, Inc. (Nasdaq: GILD) announced full clinical trial results from a pivotal Phase 3 study evaluating cobicistat, a pharmacoenhancing or “boosting” agent for HIV therapy, compared to ritonavir, which is currently the only agent used to boost certain antiretroviral treatment regimens. The study found that an HIV regimen containing a cobicistat-boosted protease inhibitor was non-inferior to a regimen containing a ritonavir-boosted protease inhibitor at 48 weeks of therapy. The findings will be presented today in an oral session (abstract #TUAB0103) at the 19th International AIDS Conference (AIDS 2012) taking place in Washington, D.C.
“These data demonstrate that cobicistat may be an effective option for boosting the potency of HIV regimens that are based on protease inhibitors,” said Joel Gallant, MD, MPH, Professor of Medicine and Epidemiology at Johns Hopkins University, and principal investigator of the study.
In the trial (Study 114), treatment-naïve adult patients received either cobicistat or ritonavir for 48 weeks. All patients also received atazanavir (a protease inhibitor) plus Truvada® (emtricitabine and tenofovir disoproxil fumarate). At 48 weeks, the study found that 85 percent of patients on the cobicistat-containing regimen compared to 87 percent of patients on the ritonavir-containing regimen achieved HIV RNA (viral load) levels less than 50 copies/mL, based on the U.S. Food and Drug Administration (FDA) snapshot algorithm (95 percent CI for the difference: -7.4 percent to +3.0 percent; predefined criterion for non-inferiority was a lower bound of a two-sided 95 percent CI of -12 percent). Twenty-five patients (7 percent) discontinued treatment due to adverse events in each arm of the study.
Pfizer Inc. (NYSE:PFE), Johnson & Johnson (NYSE:JNJ) and Elan (NYSE:ELN) experimental Alzheimer’s treatment failed to improve symptoms of dementia in the first of four pivotal studies testing the drug.
Bapineuzumab, designed to target the brain plaques that serve as a hallmark of Alzheimer’s, didn’t aid cognitive or functional ability in patients who carry a gene, called ApoE4, that makes them more likely to get the disease, Pfizer said yesterday in a statement. Doctors now await results from trials in patients without the higher genetic risk.
“There was no reason to believe, unless there was a miracle, that this would be positive,” said Rudolph Tanzi, professor of neurology at Harvard Medical School in Boston. “It will only be the results of the non-ApoE4 carriers that will inform us about the future.”
Bapineuzumab is in a race with a similar product from Indianapolis-based Eli Lilly & Co. (LLY) to become the first therapy to target a cause for Alzheimer’s, rather than just its symptoms. While patients in the failed study, dubbed 302, have now been taken off the drug, the other trials will continue, New York-based Pfizer said in its statement.
Elan fell 12 percent to 9.79 euros in Dublin trading, its largest one-day drop in two years. Pfizer fell 1 percent to $23.38 at 4 p.m. New York time, and J&J, based in New Brunswick, NJ, fell 1.1 percent to $67.35.
China Botanic Pharmaceutical Inc. (NYSE AMEX: CBP) ("China Botanic" or the "Company"), a developer, manufacturer and distributor of botanical products, bio-pharmaceuticals and Traditional Chinese Medicines ("TCM") in China, today announced that the Company was recently granted a new patent (Patent No: ZL 201010119871.7) on its advanced proprietary Schisandra Lignin Extraction Method.
IntelliCell BioSciences, Inc. (OTCQB: SVFC) announced today that it has received the results of its independent laboratory audit by Biologic Consultant Group and the audit showed that the new lab at 460 Park Avenue, New York, NY was cGTP compliant.
Life Technologies Corporation (NASDAQ: LIFE) today announced a collaboration with the Southern African Treatment and Resistance Network (SATuRN – http://www.bioafrica.net/saturn) on sequencing-based diagnostics for HIV-infected individuals in Africa.
Medicago Inc. (TSX: MDG; OTCQX: MDCGF), a biopharmaceutical company focused on developing highly effective and competitive vaccines based on proprietary manufacturing technologies and Virus-Like Particles (VLPs), today announced the successful completion of a key milestone under an agreement with the Defense Advanced Research Projects Agency (DARPA).
OncoSec Medical Inc. (OTCBB: ONCS), a company developing its advanced-stage OMS ElectroOncology therapies to treat solid tumor cancers, was spotlighted on Oakland television station KTVU-TV on July 20 and in the San Francisco Chronicle on July 18.
Oncothyreon Inc. (Nasdaq: ONTY) today announced the appointment of Guy F. Cipriani as Vice President, Business Development, effective July 23, 2012.
TNI BioTech, Inc. (PINKSHEETS: TNIB) took a major step forward in signing a Memorandum of Agreement with GB Oncology and Imaging Group LTD. ("GB") to equip and operate oncology and infectious diseases clinics in Equatorial Guinea.
Vista Partners announced today that it has initiated coverage on Auxilio Inc. (OTCBB: AUXO) ("The Company," "Auxilio" or "AUXO"); with a twelve month target price of $3.35.