Keats Healthcare Ltd.

Over four times as many patients with a rapidly fatal type of brain cancer, glioblastoma multiforme (GBM), who are treated with the chemotherapy drug temozolomide (TMZ) and radiation therapy, can live for four years after diagnosis, compared to those who receive only radiation treatment, according to updated results of a large international trial.

Actemra is the first humanized interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody seeking approval to treat rheumatoid arthritis

Roche announced the submission of a biologics license application (BLA) to the U.S. Food and Drug Administration (FDA) seeking approval for Actemra (tocilizumab) to reduce the signs and symptoms in adults with moderate to severe rheumatoid arthritis (RA).

Gilead Sciences, Inc. (Nasdaq:GILD) today announced detailed results of its Phase III AIR-CF1 (CP-AI-007) study of aztreonam lysine for inhalation, an investigational therapy in development for the treatment of people with cystic fibrosis (CF) who have pulmonary Pseudomonas aeruginosa (P. aeruginosa). In this study, a 28-day treatment course of aztreonam lysine improved respiratory symptoms as assessed by the Cystic Fibrosis Questionnaire-Revised (CFQ-R), a patient-reported outcome (PRO) tool. Aztreonam lysine also improved pulmonary function in this study, as measured by relative improvement of forced expiratory volume in one second (FEV1), a standard measure of lung function. The data were presented by George Z. Retsch-Bogart, MD, Associate Professor of Pediatrics at the University of North Carolina, Chapel Hill, at the 21st Annual North American Cystic Fibrosis Conference (NACFC) in Anaheim, California. Topline results from this study were previously announced on May 29, 2007.

In Phase IIb study results presented by Merck & Co., Inc., anacetrapib (formerly known as MK-0859), its investigational selective cholesteryl ester transfer protein (CETP) inhibitor, significantly reduced LDL-cholesterol (LDL-C) and Apolipoprotein B (Apo B) and increased HDL-cholesterol (HDL-C) and Apolipoprotein A-1 (Apo A-1) both as monotherapy and in combination with atorvastatin 20 mg compared to placebo in patients with dyslipidemia. These results were presented today at the 16th International Symposium on Drugs Affecting Lipid Metabolism (DALM).

Eli Lilly researchers believe they have discovered a new class of schizophrenia medication that avoids key adverse effects seen in current treatments, not least the firm’s own blockbuster Zyprexa.

A clinical trial in the September issue of Nature Medicine describes a drug, LY2140023, that works effectively in people with schizophrenia by targeting glutamate-mediated neurotransmission. All current drugs target dopamine receptors, and it is this mode of action that is thought to be responsible for unpleasant extrapyramidal side effects such as involuntary movement – effects that cause some psychotic patients to shun their medication.

In Phase IIb study results presented by Merck & Co., Inc., anacetrapib (formerly known as MK-0859), its investigational selective cholesteryl ester transfer protein (CETP) inhibitor, significantly reduced LDL-cholesterol (LDL-C) and Apolipoprotein B (Apo B) and increased HDL-cholesterol (HDL-C) and Apolipoprotein A-1 (Apo A-1) both as monotherapy and in combination with atorvastatin 20 mg compared to placebo in patients with dyslipidemia. These results were presented today at the 16th International Symposium on Drugs Affecting Lipid Metabolism (DALM).

Roche’s Avastin has received yet another approval, this time from regulators in the European Union for the first-line treatment of patients with advanced lung cancer.

Having received a positive recommendation from the Committee for Medicinal Products for Human Use last month, the European Union has now given the go-ahead to market Avastin (bevacizumab) for the first-line treatment of patients with advanced non-small cell lung cancer in combination with platinum-based chemotherapy. The approval is based on data from the Phase III E4599 trial in the USA and the ‘Avastin in Lung’ (AVAiL) late-stage study, is for the use of Avastin at a dose of 7.5 or 15 mg/kg.

SOUTH SAN FRANCISCO, Calif., Aug. 23 /PRNewswire-FirstCall/ -- Exelixis, Inc. (Nasdaq: EXEL - News) today announced that it has agreed to a request from GlaxoSmithKline (GSK) to initiate its review of XL880 before the compound reaches proof-of-concept. Exelixis expects to deliver the appropriate diligence information to GSK in mid-September, at which point GSK will begin its review to determine whether or not to select XL880 for further development and commercialization. Both companies have agreed to expedite the review of XL880 in order to build on its position as a leading MET inhibitor, which is believed to be the most advanced in clinical development. Under the terms of the product development and commercialization agreement between the parties, GSK's review period would have otherwise commenced once proof-of-concept data became available. In addition, the companies have initiated preliminary transition activities in the event that GSK decides to select XL880 for further clinical development and commercialization.

ALAMEDA, Calif., Aug. 13, 2007 (PRIME NEWSWIRE) -- Avigen, Inc. (Nasdaq:AVGN), a biopharmaceutical company developing innovative therapies for the treatment of chronic neurological conditions, today announced it received approval from the U.S. Food and Drug Administration (FDA) to proceed with the U.S. clinical development of AV411 (ibudilast). The initial U.S. clinical trial for AV411, which is treated as a New Chemical Entity in the United States, will be a Phase I maximum tolerated dose study that is designed to build on data from Avigen's Phase I and exploratory Phase IIa studies in Australia. This larger U.S. Phase I trial is designed to assess the safety and tolerability of AV411. This trial is also intended to assess the effect of food on AV411 pharmacokinetics and tolerability. In parallel, Avigen's Australian Phase IIa trial is expected to provide safety and initial efficacy data of AV411 in patients with neuropathic pain and is expected to report by the end of 2007.

NEW YORK--(BUSINESS WIRE)--Aug 9, 2007 - ImClone Systems Incorporated (NASDAQ: IMCL) today announced that the first of its disease-directed clinical trials of IMC-11F8, a potent fully human IgG1 monoclonal antibody to the epidermal growth factor receptor (EGFR), has commenced patient enrollment.

This open label, multicenter European Phase II study of IMC-11F8 is enrolling patients with treatment-naive locally-advanced or metastatic colorectal cancer. A total of 40 patients are expected to be enrolled. This Phase II study is designed to evaluate the efficacy and safety of IMC-11F8 administered every two weeks by intravenous infusion in combination with mFOLFOX-6 (5-FU/FA/oxaliplatin) therapy.

Cancer drug developer Antisoma plc (LSE: ASM; USOTC: ATSMY) today announces that it has started a randomised phase II trial of AS1411 in AML (acute myeloid leukaemia). Around 70 patients will be recruited at major cancer centres in the USA.

Pfizer said today that it now has a total of 47 programs in its Phase II Research and Development pipeline, which is the largest Phase II cohort in its history and represents continued progress toward its target of tripling the company’s Phase III portfolio by 2009.

Leverkusen, Germany, and Tarrytown, NY (August 03, 2007) – Bayer HealthCare AG and Regeneron Pharmaceuticals, Inc. announced today that the companies have initiated a Phase 3 study of the VEGF Trap-Eye in the neovascular form of age-related macular degeneration (wet AMD). The study will be a non-inferiority comparison of the VEGF Trap-Eye and ranibizumab (Lucentis®, a registered trademark of Genentech, Inc.), an anti-angiogenic agent approved for use in wet AMD. The study will be conducted pursuant to a Special Protocol Assessment from the U.S. Food and Drug Administration (FDA). This trial, known as VIEW 1 (VEGF Trap: Investigation of Efficacy and safety in Wet age-related macular degeneration), is the first study in the companies’ Phase 3 global development program in wet AMD which is planned to be carried out in the U.S., Europe and other parts of the world.

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Aug 3, 2007 - Hana Biosciences (NASDAQ:HNAB), a biopharmaceutical company focused on advancing cancer care, today announced the initiation of a multi-center, multi-national Phase 2 clinical trial of Marqibo(R) (vincristine sulfate injection, OPTISOME(TM)) in adult patients with relapsed acute lymphoblastic leukemia (ALL), also known as the rALLy study. Earlier this year, Marqibo was granted Orphan Drug Designation by the U.S. Food and Drug Administration for the treatment of adult ALL.

BOULDER, Colo., Aug. 2 /PRNewswire-FirstCall/ -- Pharmion Corporation today announced topline results from the multi-institutional, international, randomized, Phase 3 controlled trial of Vidaza(R) (azacitidine for injection) versus conventional care regimens (CCR) in the treatment of patients with higher-risk myelodysplastic syndromes (MDS). In the primary endpoint analysis, Vidaza treatment was associated with a median survival of 24.4 months versus 15 months for those receiving CCR treatment, an improvement of 9.4 months with a stratified log-rank p-value of 0.0001. The hazard ratio describing this treatment effect was 0.58 (95 percent confidence interval of 0.43 to 0.77). Two-year survival rates were 50.8 percent versus 26.2 percent for patients receiving Vidaza versus CCR (p<0.0001). Median number of treatment cycles was nine for Vidaza.