¿ A.M. Pappas & Associates, of Research Triangle Park, N.C., said it closed TechAMP II, a $102 million venture capital fund focused on the life sciences sector. It will invest in emerging early and late-stage biopharmaceutical companies developing therapeutics, platform technologies and tools for accelerating development and approvals.
¿ Advanced Pharma, of Gaithersburg, Md., changed its name to Advancis Pharmaceutical Corp. The company applies its Pulsys methods and formulations to marketed antibiotics to increase efficacy and limit antibiotic resistance. The company has three Pulsys products in Phase I trials and seven in preclinical testing.
¿ Alteon Inc., of Ramsey, N.J., said the Phase IIa study of its drug, ALT-711, has been selected for Rapid Track publication in Circulation: Journal of the American Heart Association. The manuscript will be published in the Sept. 28 issue. In the study, ALT-711 was shown to restore the cardiovascular system to a younger state by reversing the stiffening of arteries that occurs in aging patients, the company said.
¿ Applied Molecular Evolution Inc., of San Diego, was awarded a grant from the National Institutes of Health under Phase II of the Small Business Innovation Research Program, to support the development of a potential treatment for acute cocaine toxicity and chronic cocaine addition. The grant provides about $1 million and will support the preclinical development of butyrylcholinesterase optimized by the AMEsystem, the company¿s directed molecular evolution technology.
¿ Atrix Laboratories Inc., of Fort Collins, Colo., said it will call for redemption the remainder of its 7 percent convertible notes due 2004. The redemption date has been set for Oct. 22, and it will clear the remaining $7.3 million in debt remaining from a $50 million offering of convertible subordinated notes issued in November 1997. The notes can be converted into common shares at $19 per share.
¿ Boston Life Sciences Inc., of Boston, announced completion of the GMP commercial manufacturing process for Altropane for diagnosis of early stage Parkinson¿s disease. Completion will allow the company to finish compilation of its new drug application, it said.
¿ Cell Genesys Inc., of Foster City, Calif., said it completed the acquisition of Calydon Inc. Cell Genesys will now have three cancer therapeutic product platforms and as many as three late-stage product candidates with the potential to enter Phase III trials during the next 18 months. The acquisition was a stock-for-stock transaction in which Calydon shareholders will receive about 935,000 shares of Cell Genesys stock valued at $17.4 million when the deal was disclosed last month. The deal included the assumption of up to about $2.6 million in Calydon liabilities by Cell Genesys. (See BioWorld Today, Aug. 3, 2001.)
¿ Cellegy Pharmaceuticals Inc., of South San Francisco, submitted a marketing authorization application with the Medicines Control Agency requesting UK approval of Rectogesic (nitroglycerin ointment) for the treatment of anal fissures. Rectogesic has been marketed in Australia since 1999 and was acquired by Cellegy in the summer of 2000. The company plans to use the UK filing, if approved, for filings in additional European Union countries.
¿ Cell-Matrix Inc., of Los Angeles, said that data confirming the antitumor effects of its lead antibody therapeutic were published in the Journal of Cell Biology. Peter Brooks, Cell-Matrix founder, is senior author of the paper titled ¿Proteolytic Exposure of a Cryptic Site Within Collagen Type IV is Required for Angiogenesis and Tumor Growth in Vivo.¿ The paper reveals angiogenesis as the underlying mechanism of the antitumor effects of one of Cell-Matrix¿s lead antibodies.
¿ Curis Inc., of Cambridge, Mass., said it received approval to start a Phase I trial of Cur-61414 in patients with sporadic basal cell carcinoma. The drug candidate is a small molecule that inhibits the Hedgehog pathway, and is being developed as a locally administered and tissue-sparing alternative to surgery. It will be an open-label, sequential dose-escalation study of intralesional injection.
¿ Durect Corp., of Cupertino, Calif., said results from its Phase II trial of Chronogesic, a three-month continuous infusion subcutaneous implant for chronic pain, produced dose-conversion data and data showing patients had better pain control and a reduction in certain opioid side effects. The 66-patient study showed 60 percent of patients preferred Chronogesic to their pre-study treatment. The company said it now plans to increase development efforts for the product.
¿ Genomics Collaborative Inc., of Cambridge, Mass., and Specialty Laboratories Inc., of Santa Monica, Calif., entered a research collaboration to study the clinical significance of new laboratory markers of disease. It will combine GCI¿s high-throughput genetic analysis tools and specimen resources with Specialty¿s test development and commercialization expertise.
¿ Inex Pharmaceuticals Corp., of Vancouver, British Columbia, said the clinical development program for the cancer product Onco TCS, being developed with Elan Corp. plc, of Dublin, Ireland, has been expanded to include two pilot Phase II trials evaluating it with the approved drug Rituxan. Each pilot study will involve 14 patients with relapsed B-cell aggressive non-Hodgkin¿s lymphoma.
¿ InSite Vision Inc., of Alameda, Calif., initiated a Phase I study with ISV-401, a formulation of a broad-spectrum antibiotic, in the DuraSite system. DuraSite is the company¿s drug-delivery vehicle that allows controlled time-release of an active ingredient. The study will evaluate the ocular safety and comfort of topical administration of ISV-401 in two concentration levels. Forty-eight healthy volunteers will be enrolled at a single U.S. site and will receive twice-daily doses of either 1.0 percent ISV-401, 0.5 percent ISV-401 or the delivery solution without ISV-401, for two weeks.
¿ Memory Pharmaceuticals Corp., of Montvale, N.J., appointed Tony Scullion as its CEO. Scullion most recently was vice president and head of global business development at GlaxoWellcome plc, of London. Privately held Memory is developing a pipeline of cognition enhancers.
¿ MediChem LifeSciences Inc., of Chicago, and Rigel Pharmaceuticals Inc., of South San Francisco, entered into a two-year collaboration in structural proteomics for drug development, initially focused on ubiquitin ligases, which are involved in cell division and the progression of certain cancers. MediChem scientists will express, purify and co-crystallize Rigel protein complexes, and then determine their structures. MediChem also will co-crystallize several Rigel small molecule drug leads with protein complexes, providing 3-dimensional pictures of the drug leads bound to the target protein complexes. Rigel will pay MediChem for research, as well as milestones. MediChem will retain rights to certain technology, data and improvements to its technology platform, and gains a rights of discussion on all future medicinal chemistry partnering opportunities related to the targets.
¿ NeoTherapeutics Inc., of Irvine, Calif., said it completed enrollment of 521 patients at 51 sites in a double-blind, placebo-controlled pivotal study of Neotrofin in Alzheimer¿s disease patients. All patients are expected to complete the first 12 weeks of study by November, with results expected in the first quarter of 2002. Enrollment and randomization was completed in four months, two months ahead of projection.
¿ Nexell Therapeutics Inc., of Irvine, Calif., closed its transaction with Baxter Healthcare Corp., of Deerfield, Ill., giving Baxter worldwide sales, marketing and distribution rights and responsibilities for Nexell¿s cell processing products, including the Isolex 300I Magnetic Cell Selection System. Baxter now has acquired certain assets and liabilities of Nexell¿s cell processing systems sales, marketing and distribution business, as well as worldwide sales, marketing and distribution rights for the related products, for an estimated net purchase price of $4.3 million and royalties on future product sales.
¿ Repligen Corp., of Needham, Mass., said the FDA granted fast-track designation for secretin for the treatment of pediatric autism. In April, Repligen completed a Phase II trial that evaluated three doses of secretin or placebo in 126 children, 3 to 6 years of age, with moderate to severe symptoms of autism and reported gastrointestinal symptoms. Data from the trial were communicated to the FDA to help decide the next step in development of secretin for autism, the company said.
¿ Structural Bioinformatics Inc., of San Diego, and ChemNavigator Inc., also of San Diego, signed an agreement to combine SBI¿s technologies in 3-dimensional computational proteomics with ChemNavigator¿s technologies in chemistry. SBI and its customers can use ChemNavigator¿s 3-dimensional database of 2 million drug-like compounds to screen in silico against the 2,600 3-dimensional proprietary protein structures in SBI¿s drug target database. The companies will share any generated revenues.
¿ Tripos Inc., of St. Louis, and Schering AG, of Berlin, agreed to build a global Enhanced Chemical Information Management System (ECIMS) that integrates Schering¿s compound research data and inventory data, and is designed to improve efficiency in new chemical entity production. Tripos will deploy its ChemCore technology in a customized solution at Schering, according to the agreement.
¿ ViroLogic Inc., of South San Francisco, has been awarded a $1.2 million Ryan White CARE grant for HIV drug resistance testing in Washington. The grant will provide testing access to low-income individuals in the Washington metropolitan area who have HIV and limited or no health coverage. The grant is effective through February 2002.