GlaxoSmithKline ($GSK) has suffered a setback in its bid to broaden use of Tykerb to fight early breast cancer. The drug failed to reach its goal in a study testing it as an adjuvant treatment for HER2-positive breast cancer. It’s not the first time Tykerb has flubbed an adjuvant study, either, Deutsche Bank analysts point out. They also predict “substantial use” of the drug in that setting “is very unlikely.”
J&J unit Janssen Biotech has entered an agreement with Pharmacyclics, Inc. to jointly develop and market the anti-cancer compound, PCI-32765. Several Phase I and II studies are ongoing across a panel of B-cell malignancy disorders, including chronic lymphocytic leukemia, mantle cell lymphoma, and diffuse large B-cell lymphoma.
EnVivo Pharmaceuticals Presents Positive Comprehensive Phase 2b Study Results in Schizophrenia at American College of Neuropsychopharmacology Annual Meeting
EnVivo Pharmaceuticals, a company dedicated to developing a broad range of novel central nervous system (CNS) therapies, announced today that it is presenting the comprehensive analysis of a recently completed Phase 2b clinical trial of EVP-6124, a novel, orally bioavailable nicotinic alpha-7 agonist, in schizophrenia at the American College of Neuropsychopharmacology 50th Anniversary Annual Meeting. Data were discussed as part of the meeting’s “Hot Topics” invited panel session on Sunday, December 4 and will be presented in two posters today, Monday, December 5.
ChemoCentryx Initiates a Phase II Clinical Trial For CCX140, A Novel Inhibitor of the Chemokine Receptor CCR2 for the Treatment of Diabetic Nephropathy
ChemoCentryx, Inc. today announced the initiation of a Phase II clinical trial for CCX140, an orally-administered small molecule for the treatment of diabetic kidney disease (diabetic nephropathy). CCX140 is a novel CCR2 inhibitor with a pharmacological profile unlike that of other CCR2 compounds that have been known to be tested by other sponsors. CCX140 works by blocking the infiltration and activation of certain populations of monocyte and macrophages and other cells bearing CCR2 that occurs during inflammation. This mechanism of action provides selective treatment of the disease without compromising other immune functions.
The Avoca Group has formed the Quality Consortium, a pharmaceutical industry consortium focused on clinical quality management. Under the direction and guidance of The Avoca Group and its president and chief executive officer, Patricia Leuchten, the Quality Consortium will bring together lead sponsors Eli Lilly and Pfizer, other pharmaceutical and biotech companies, and leading CROs to create standards for quality management, initially with a focus on quality agreements and metrics. The consortium’s long-term goal is “the development of a new paradigm in the industry’s approach to quality management and partnering with CROs to ensure high quality and risk mitigation,” according to a press statement.
Zalicus Inc. ($ZLCS) is proceeding with a Phase I clinical trial of a new pain drug designed to use “multiple state-of-the-art” drug delivery techniques so it is more soluble and present in the body than in a previous version. The Cambridge, MA, company formally known as CombinatoRx said an earlier version of the novel oral N-type calcium channel blocker was tested in more than 200 patients. While that version may have been less soluble, the drug was well tolerated, Zalicus said. The new study will assess the drug’s activity and safety through the end of 2011 and into early 2012. If all goes well, a Phase II trial for the drug will commence soon after, Zalicus President and CEO Mark Corrigan said in a statement.
An AA battery may be all you need to trigger the delivery of a targeted drug. A weak charge generated by the battery, Stanford University researchers have found, releases medication combined with nanoparticles contained in an injectable gel.
Dendreon Corp. said Tuesday it is selling its shares in royalty payments on sales of the hepatitis C drug Victrelis for $125 million.
Achillion Announces Preliminary Phase 1b Proof-of-Concept Data With ACH-2928 NS5A Inhibitor for the Treatment of Hepatitis C
Achillion Pharmaceuticals, Inc. ACHN +0.14% , a leader in the discovery and development of small molecule drugs to combat the most challenging infectious diseases, today reported proof-of-concept data from its Phase 1b clinical trial of ACH-2928, a first-generation NS5A inhibitor, demonstrating that patients treated with ACH-2928 achieved a mean maximum 3.68 log10 reduction in HCV RNA after three-day monotherapy of 60 mg once daily. The compound also demonstrated good safety and tolerability both in healthy volunteers and in patients with chronic hepatitis C (HCV).
Senior Scientific, LLC announced today that it has been granted U.S. patent 8,060,179, titled “Biomagnetic Detection and Treatment of Alzheimer’s Disease”. The patent is for technology that will localize, and determine the amount, of plaque and neurofibrillary tangles in the brain, the principal characteristics of Alzheimer’s disease. Upon successful development of the technology, early and definitive localization of these effects of the disease by this method will discriminate against other types of treatable dementia while also providing a new method for delivery of treatment to remove these debilitating results of the disease.