• Adolor Corp., of Exton, Pa., said the FDA requested that the company provide information from the GlaxoSmithKline plc European Phase III study of alvimopan in postoperative ileus. The request was made as part of the FDA's review of a new drug application for Entereg (alvimopan). Adolor, which is collaborating with London-based GSK on worldwide development and commercialization of alvimopan, expects to deliver the requested information allowing for an extension of three months to the Prescription Drug User Fee Act target action date of April 25.

• Alkermes Inc., of Cambridge, Mass., plans to expand production capacity at the Wilmington, Ohio, facility for Risperdal Consta, approved to treat schizophrenia. The company's partner, Janssen-Cilag, a wholly owned division of New Brunswick, N.J.-based Johnson & Johnson, will help fund the building of the new manufacturing line.

• Biopure Corp., of Cambridge, Mass., closed a previously announced financing that raised $11.3 million, for net proceeds to Biopure of $10.4 million. Biopure sold 22.2 million shares of its common stock at 51 cents per share to institutional and individual investors. C.E. Unterberg, Towbin acted as the agent for the offering. Biopure is focused on intravenously administered oxygen therapeutics.

• Cryo-Cell International Inc., of Oldsmar, Fla., supported a study, conducted by the University of Florida and the James A. Haley Veterans Hospital, reporting regenerative effects of stem cells from umbilical cord blood in animal studies. Results published in Cell Transplantation showed umbilical cord blood injected into rats effectively treated the heart and showed a reduction in heart damage.

• Curis Inc., of Cambridge, Mass., said a recent online issue of the Journal of Biological Chemistry contains a report demonstrating that treatment with BMP-7 results in repair of kidney injury in a preclinical model of acute kidney disease. The data showed that treatment with BMP-7, even after kidney disease was well established, resulted in improved kidney function and a reversal in tissue damage and scarring. BMP-7 was discovered by scientists at Curis, the company said.

• Cytogen Corp., of Princeton, N.J., said researchers initiated a clinical trial to evaluate the use of Quadramet (samarium SM-153 lexidronam) in combination with bisphosphonates to treat pain associated with metastatic bone disease in multiple myeloma patients. The escalating-dose study will evaluate safety and its effects on painful symptoms and analgesic use. Quadramet is designed to pair the targeting ability of small-molecule, bone-seeking phosphate with the therapeutic potential of radiation.

• CytRx Corp., of Los Angeles, reported previously unreleased scientific data supporting the potential of its oral drug, iroxanadine, in endothelial dysfunction, including post-angioplasty restenosis, atherosclerosis and diabetic foot ulcers. Those results, which were generated by Biorex Research and Development Co. prior to CytRx's acquisition of iroxanadine, were included in a poster presentation Tuesday at the Protein Folding Disorders Conference in San Diego. Separately, the company also presented new data showing the potential of its oral drug arimoclomol for Type II diabetes.

• Diversa Corp., of San Diego, agreed to collaborate with Whitehouse Station, N.J.-based Merck & Co. Inc. on development of therapeutic antibodies for a key target by applying Diversa's MedEv platform. Diversa will receive an up-front payment and research funding. No additional details were disclosed. The MedEv antibody optimization platform comprises two protein engineering technology platforms combined with high-throughput screening.

• EpiCept Corp., of Englewood Cliffs, N.J., filed a registration statement with the SEC for a proposed initial offering of its stock. The number of shares and price range has not been determined. All shares will be sold be EpiCept. Wachovia Capital Markets LLC will be sole book-running manager, with C.E. Unterberg, Towbin LLC as co-lead manager. EpiCept is focused on topically delivered therapeutics for pain management.

• Geron Corp., of Menlo Park, Calif., entered a worldwide license agreement with Cambrex Bio Science Walkersville Inc., of East Rutherford, N.J., under which the Cambrex Corp. subsidiary will develop and distribute cell lines that have been immortalized using Geron's telomerase technology. Cambrex will develop telomerized cell lines and associated products.

• IGI Inc., of Buena, N.J., said assuming a successful completion of the merger between New York-based companies Manhattan Pharmaceuticals Inc. and Tarpan Therapeutics, Manhattan Pharma plans to pursue a Phase II trial of PTH (1-34) using IGI's Novasome nanovesicular topical delivery technology. IGI signed a sublicense agreement with Tarpan for the clinical use of PTH (1-34) relating to the regulation of cell differentiation and proliferation for treatment of skin disorders. IGI's technology enhances the transdermal absorption of polypeptides, it said.

• InterMune Inc., of Brisbane, Calif., said CHEST, the journal of the American College of Chest Physicians, published an analysis of variables that measure clinical outcomes in patients with idiopathic pulmonary fibrosis (IPF). The analysis was derived from a database of a Phase III trial of Actimmune that treated 330 patients with IPF. It influenced the company's decisions regarding the entry criteria, endpoints, study size and duration of the ongoing Phase III Inspire trial, it said.

• Narhex Life Sciences, of Sydney, Australia, will partner with the U.S. National Institute of Allergy and Infectious Diseases to evaluate its protease inhibitor Nar DG 35 Prodrug aimed at hepatitis C and severe acute respiratory syndrome. The company said Phase I trials in Australia and early Phase II trials in Brazil show reductions of viral loads, improvement in immune cell markers and a lack of toxicity.

• Newron Pharmaceuticals SpA, of Milan, Italy, said that treatment with its investigational new drug, safinamide, resulted in a significant improvement in all efficacy parameters studied when it was administered to patients with restless legs syndrome. Safinamide also was found to be well tolerated and did not exhibit any clinically relevant side effects, the company said.

• Nucleonics Inc., of Horsham, Pa., filed with the European Patent Office prior art citations it said are relevant to consideration of a patent application filed by Benitec Ltd., of Queensland, Australia, titled "Control of Gene Expression." Nucleonics said the pending claims are unclear and are invalid as they lack novelty and/or did not involve an inventive step at the time of filing. The company previously filed with the commissioner of patents in Australia requesting re-examination of patents filed by Benitec and the Commonwealth Scientific and Industrial Research Organization, as well as with the U.S. Patent and Trademark Office on another patent.

• Perlegen Sciences Inc., of Mountain View, Calif., said it will begin a pharmacogenomics collaboration with Johnson & Johnson Pharmaceutical Research and Development LLC, a Johnson & Johnson company. The goal of the collaboration is to identify genetic markers for patient response to a therapeutic agent in the J&JPRD portfolio. Perlegen will individually genotype single nucleotide polymorphisms, or SNPs, in hundreds of patients, analyze the results to determine the genetic variations associated with differential therapeutic response, and determine the populations that might best response to that agent. Terms of the collaboration were not disclosed.

• Raven Biotechnologies Inc., of South San Francisco, began enrollment in a Phase I/IIa trial of RAV12, a therapeutic monoclonal antibody, in patients with advanced-stage colon, stomach and pancreatic cancers at multiple centers in the U.S. RAV12 is a high-affinity IgG1 chimeric antibody recognizing a primate restricted N-linked carbohydrate epitope expressed on a number of human carcinomas, especially adenocarcinomas.

• Samaritan Pharmaceuticals Inc., of Las Vegas, is preparing to move its antiviral HIV drug, SP-01A, into late-stage trials. Patient enrollment is set to begin during the next quarter. The company said SP-01A appears to stop viral entry early in the infection process, reducing HIV-1 virus replication by interfering with cholesterol-dependent regulation mechanisms.

• Serenex Inc., of Durham, N.C., signed an agreement with London-based GlaxoSmithKline plc in which Serenex will use its Proteome Mining technology to elucidate the mechanism of action targets that generate broad selectivity information for compounds that GSK is developing. GSK scientists can submit compounds to Serenex for profiling against specific tissues and cell lines. The goal is to enable GSK to determine the best compounds to take forward into preclinical and clinical development.

• Serono SA, of Geneva, and Ivax Corp., of Miami, plan to initiate a Phase III study with Mylinax (cladribine) this quarter. The multicenter, multinational study will assess the effectiveness of Mylinax in patients with relapsing forms of multiple sclerosis. The two-year, double-blind, placebo-controlled study will involve more than 1,200 patients.

• Sirna Therapeutics Inc., of Boulder, Colo., and Targeted Genetics Corp., of Seattle, established a collaboration to develop a therapy to treat Huntington's disease. The companies will use Targeted Genetics' adeno-associated virus delivery platform to develop the product. The collaboration will focus on developing a therapeutic short interfering RNA targeting the gene that encodes the Huntington's disease protein. Development costs and revenue will be shared.

• The Immune Response Corp., of Carlsbad, Calif., completed two Phase II trials, one in Italy and one in Spain, evaluating its HIV immune-based therapeutic, Remune, in HIV-positive patients. The company said preliminary results of the Spain trial, involving 39 patients who previously received Remune, showed no safety concerns with long-term use. Preliminary results of the Italy trial, involving 51 antiretroviral-na ve patients over 28 weeks, suggested that Remune can induce HIV-specific T cells and might stabilize total DC4+ T-cell counts. Final results will be submitted to the FDA and will determine the next steps in the clinical program.

• Trubion Pharmaceuticals Inc., of Seattle, initiated the company's first Phase I study. The study is designed to evaluate the safety of increasing doses of TRU-015. TRU-015 is designed to deplete B lymphocytes. Trubion is testing TRU-015, the first small modular immunopharmaceutical, in patients with rheumatoid arthritis.

• Vaxin Inc., of Birmingham, Ala., demonstrated in a Phase I trial that its recombinant influenza vaccine provides a potential alternative to traditional flu vaccines. In an article published in the Jan. 11, 2005, issue of Vaccine, the authors concluded that Vaxin's flu vaccine, which is produced in cell culture, was immunogenic and well tolerated. Sixty-seven percent of the nasal vaccine recipients developed a fourfold antibody rise after one dose, which increased to 83 percent after a second dose. There was no correlation between pre-existing levels of antibody to adenovirus and the ability to achieve a fourfold rise in antibody to the influenza antigen, the company said.

• Vion Pharmaceuticals Inc., of New Haven, Conn., said that the shelf registration statement filed on Dec. 14 with the SEC was declared effective Monday. The registration statement allows Vion, from time to time, to sell up to an aggregate of $75 million of common stock and/or warrants to purchase common stock. Vion is developing agents for cancer treatment.

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