|Alnylam Completes ALN-VSP Phase I Trial. Teva And Active Biotech Announce Initial Results From Phase III BRAVO|
|By Staff and Wire Reports|
|Monday, 01 August 2011 18:40|
Alnylam Pharmaceuticals, Inc. (NASDAQ:ALNY) announced it has completed its Phase I study with ALN-VSP, a systemically delivered RNAi therapeutic for the treatment of advanced solid tumors with liver involvement.
In the Phase I study with ALN-VSP, 41 patients were enrolled and treated at doses ranging from 0.1 to 1.5 mg/kg. A total of 209 doses were administered, with a range of 1 to 28 doses per patient.
Disease control was achieved in one of 13 patients (8%) treated at doses less than or equal to 0.4 mg/kg versus 12 of 24 (50%) treated at doses greater than or equal to 0.7 mg/kg, including seven of 11 (64%) treated at the proposed Phase II dose of 1.0 mg/kg. A dose of 1.0 mg/kg administered every two weeks was identified as the regimen for further Phase II studies.
Teva Pharmaceutical Industries Ltd. (NASDAQ:TEVA) and Active Biotech AB announced initial results from the Phase III BRAVO study, which was designed to evaluate the efficacy, safety and tolerability of oral laquinimod compared to placebo and to provide a benefit-risk assessment comparing oral laquinimod and a reference arm of injectable Interferon β-1a (Avonex).
BRAVO is the second of two pivotal Phase III studies in the clinical development program for laquinimod, an investigational, oral, once-daily therapy for the treatment of relapsing-remitting multiple sclerosis (RRMS). Results showed that the BRAVO study did not achieve its primary endpoint of reducing the annualized relapse rate (p=0.075). The randomization process for BRAVO was adequately performed; however, placebo and treatment study groups showed dissimilarity in two baseline magnetic resonance imaging (MRI) characteristics.
The BRAVO findings support the direct effect of laquinimod within the central nervous system (CNS) and are in line with the results of the first laquinimod Phase III trial, ALLEGRO.
American Oriental Bioengineering, Inc. (NYSE:AOB), ("the Company" or "AOBO"), a pharmaceutical company dedicated to improving health through the development, manufacture and commercialization of a broad range of prescription and over the counter ("OTC") products, today announced that it plans to release second quarter 2011 financial results on Tuesday, August 9, 2011, after the market closes.
Biodel Inc. (Nasdaq:BIOD) will issue its third quarter fiscal year 2011 financial results on August 4, 2011.
China Biologic Products, Inc. (NASDAQ:CBPO) ("China Biologic," or the "Company"), a leading plasma-based biopharmaceutical company in China, today announced that 2 of its plasma collection stations, in Pu Ding and Huang Ping counties in the Guizhou Province, passed inspection and have been relicensed today for operation for 2 years, and will continue to operate.
Halozyme Therapeutics, Inc. (Nasdaq:HALO), a biopharmaceutical company developing and commercializing products targeting the extracellular matrix, today announced it plans to report second quarter 2011 financial results on Friday, August 5, 2011 before the open of the financial markets.
Hologic, Inc. (Hologic or the Company) (Nasdaq:HOLX), a leading developer, manufacturer and supplier of premium diagnostics products, medical imaging systems and surgical products dedicated to serving the healthcare needs of women, today announced its results for the third fiscal quarter ended June 25, 2011.
International Isotopes Inc. (OTC Bulletin Board:INIS) announces it has received certification under both ISO-9001 and ISO-13485 standards for the manufacture and design of many of its nuclear medicine and cobalt-60 products.
Oncothyreon Inc. (Nasdaq:ONTY) today announced that it will conduct a conference call to discuss its second quarter 2011 financial results and provide a review of its pipeline of products in development on Monday, August 8, 2011 at 4:30 p.m. Eastern time.
Optimer Pharmaceuticals, Inc. (Nasdaq:OPTR) today announced that the Company will present at the Canaccord Genuity Annual Growth Conference on August 10, 2011 at 11:30 a.m. Eastern Time at the InterContinental Hotel in Boston.
ThermoGenesis Corp. (NASDAQ:KOOL), a leading supplier of innovative products and services that process and store adult stem cells, said today that Mahendra Rao, M.D., Ph.D. has resigned from the board, effective July 29, 2011.
Viral Genetics, Inc. (Pinksheets: VRAL) is hosting a webcast conference call this coming Wednesday, August 3, 2011 to provide updates on the company's core strategic elements.
VIVUS, Inc. (NASDAQ:VVUS), a biopharmaceutical company dedicated to the development and commercialization of novel therapeutic products, today reported its financial results for the second quarter and six months ended June 30, 2011.