• Amarin Corp. plc, of London, announced positive data from a third exploratory Phase IIa trial using Miraxion as an adjunct therapy, with either SSRIs or tricyclics, to treat depression in 115 patients. The 12-week study used the Hamilton Depression Rating Scale to measure for the primary efficacy endpoint. While the entire Miraxion group did not show a significant difference vs. the placebo group, the company reported that the exploratory analysis demonstrated superiority in the subgroup of depression patients with melancholic characteristics using a repeated measurements design. Amarin said it is estimated that depressed patients who are unresponsive to standard treatment and have melancholic symptoms might represent about 20 percent to 30 percent of all depression patients.

• Antares Pharma Inc., of Exton, Pa., filed an investigational new drug application on Monday for its first pharmaceutical product, AP-1034, oxybutynin ATD gel, for overactive bladder syndrome. Based on evidence provided by the company in its pre-IND meeting with the FDA, Antares was granted the right to proceed directly into a Phase II dose-ranging study upon concurrence with the protocol submitted, as well as conduct a single Phase III study.

• BioCryst Pharmaceuticals Inc., of Birmingham, Ala., completed a Phase I trial of BCX-4208 involving 84 healthy volunteers. Results indicate that single doses of the drug ranging from 0.5 mg/kg to 3 mg/kg were well tolerated, and that BCX-4208 achieved a dose-related inhibition of the target enzyme purine nucleoside phosphorylase. BioCryst intends to initiate a randomized, double-blind, escalating multidose Phase I trial in 60 healthy volunteers in the second quarter.

• BioLineRx Ltd., of Jerusalem, signed a worldwide, exclusive license agreement with the European company Galmed International Ltd. for the development and commercialization of BL-1060, a small molecule for the treatment of fatty liver disease. BioLineRx said it plans to develop the project through BioLine Innovations Jerusalem and then submit it for funding by the Israeli Office of the Chief Scientist under the National Biotech Grant the company received in November. The primary indication of BL-1060, designed to modify the metabolism and storage of cholesterol and fat, is fatty liver disease, including nonalcoholic steatohepatitis associated with obesity and diabetes.

• Callisto Pharmaceuticals Inc., of New York, began a second clinical trial of Atiprimod, its lead drug, which is in a Phase I/IIa trial in relapsed multiple myeloma patients. The trial is designed to find the maximum tolerated dose of Atiprimod in advanced cancer patients and to assess the drug's activity in solid tumors and hematologic malignancies. The trial is being conducted at the University of Texas M.D. Anderson Cancer Center, and patient screening and dosing will begin this month.

• Carrington Laboratories Inc., of Irving, Texas, said its subsidiary, DelSite Biotechnologies Inc., initiated a Phase I trial of the GelVac nasal powder vaccine delivery system. The study is intended to evaluate the nasal deposition of the GelVac powder, as well as to assess the safety and determine the nasal retention characteristics of the GelVac system.

• Celestar Lexico-Sciences Inc., of Westwood, Mass., announced the completion of a validation study of its Large-Scale In Situ Hybridization (LisH) technology, in partnership with Genomics Collaborative Inc., a division of Oceanside, Calif.-based SeraCare Life Sciences Inc., designed to determine methods of using human tissue samples for high-throughput gene expression. To evaluate the effectiveness of LisH using frozen human tissue, Celestar selected 26 genes to examine in breast cancer tissue samples provided by GCI.

• Chromos Molecular Systems Inc., of Burnaby, British Columbia, entered a letter of intent to acquire Seattle-based Anosys Inc., and expects to finalize a definitive agreement before March 25. Chromos, which focuses on cellular engineering to develop immune-based cell therapies, said the acquisition of privately held Anosys will provide a "cash infusion" and expand the shareholder base. The Canadian company also would gain Anosys' cancer vaccine program, which has completed Phase I trials for melanoma and lung cancer. Terms of the proposed acquisition call for Chromos to issue a convertible note in the principal amount of C$2.1 million (US$1.7 million) to Anosys shareholders. Chromos said it also will purchase from one shareholder of Anosys an outstanding debenture in the principal amount of up to $1.5 million in consideration for the issuance of up to 3.1 million common shares and 1.6 million share purchase warrants exercisable into a common share of Chromos at a price of 60 cents per share for two years.

• Corautus Genetics Inc., of Atlanta, selected PPD Inc., of Wilmington, N.C., to provide certain clinical research services for the GENASIS (Genetic Angiogenic Stimulation Investigational Study) trial, a Phase IIb trial to evaluate the safety and efficacy of vascular endothelial growth factor-2 for the treatment of severe angina. PPD will provide Corautus with medical monitoring, data management, biostatistics services and final study reporting. Financial terms were not disclosed.

• Gen-Probe Inc., of San Diego, said that the FDA granted marketing clearance for the company's Aptima assay for Neisseria gonorrhoeae, an amplified nucleic acid test that detects, on a stand-alone basis, the bacterium that causes gonorrhea.

• Genta Inc., of Berkeley Heights, N.J., said the FDA granted orphan drug designation to LR3001, an antisense compound directed against the c-myb gene, for the treatment of chronic myelocytic leukemia. The company obtained rights to the product in December from Temple University. It has been tested in two Phase I trials in patients with myeloid leukemias, and Genta plans to pursue clinical development in patients with both hematologic cancers and solid tumors.

• GTx Inc., of Memphis, Tenn., completed a Phase I trial of ostarine, its second selective androgen receptor modulator (SARM) clinical product candidate. Results of the trial, which enrolled 96 healthy volunteers, indicated that ostarine appears to be safe and was well tolerated. The company plans to start a multiple ascending-dose Phase I trial of ostarine in April.

• Icagen Inc., of Research Triangle Park, N.C., received a milestone payment from Yamanouchi Pharmaceutical Co. Ltd., of Tokyo, related to the selection of a compound for advanced preclinical studies. The companies formed their collaboration in 2000 to focus on an ion channel target to find therapies for dementia, including Alzheimer's disease. The deal included an up-front payment, research funding, milestone payments and royalties to Icagen in return for worldwide development rights to lead compounds generated.

• ID Biomedical Corp., of Vancouver, British Columbia, was advised by the FDA's Center for Biologics Evaluation and Research (CBER) that its injectable influenza vaccine is eligible for accelerated approval and priority review, allowing possible licensure of the vaccine in time to manufacture product for the 2006-07 season. ID Biomedical and CBER have outlined a clinical trial program that will allow the company to submit a biologics license application later this year.

• Illumina Inc., of San Diego, began shipment of two Sentrix BeadChips that are designed to enable whole-genome and RefSeq-based expression profiling of multiple samples on the same microarray. The new expression offerings, which have undergone testing at customer locations, are designed to deliver high sensitivity, throughput and ease of use for gene discovery, pathway research and molecular characterization of disease, the company said.

• Isis Pharmaceuticals Inc., of Carlsbad, Calif., initiated a Phase I study of an oral capsule formulation of ISIS 301012, a second-generation antisense inhibitor of apoB-100, for the lowering of high cholesterol. The trial is designed to evaluate the oral bioavailability of the drug, and determine pharmacological effects in healthy volunteers over a one-month period. The subcutaneous form of the drug is completing a Phase I study and is expected to enter Phase II clinical trials later this year.

• Lantibio Inc., of Chapel Hill, N.C., said the FDA accepted its investigational new drug application for clinical testing of Molil901 in dry eye syndrome. The company expects to begin Phase I work this quarter. Administered via ocular instillation, Molil901 is designed to hydrate the surface of the eye to prevent irritation, relieve discomfort and reverse or prevent long-term ocular injury. Lantibio announced that it also formed a scientific advisory board for ophthalmic development.

• MicroIslet Inc., of San Diego, and Mayo Foundation for Medical Education and Research entered an agreement under which Mayo will supply designated pathogen-free pigs to MicroIslet for use in development of MicroIslet-P. The product is a vialed suspension of microencapsulated porcine islets for injection into the abdominal cavity for transplantation in patients with insulin-dependent diabetes. Mayo will supply its non-transgenic pig product for six to nine months, and MicroIslet will hold exclusive rights to the supply in the field of research and treatment of diabetes.

• NicOx SA, of Sophia-Antipolis, France, reported results from a Phase IIa study revealing a trend in activity and promising pharmacokinetic profile for NCX 1020 in asthma patients, the company said. The results suggest NCX 1020 might have enhanced activity at counteracting bronchoconstriction and the potential for reduced systemic side effects compared to existing inhaled corticosteroids. The primary objective of the trial was to compare the ability of NCX 1020, budesonide and placebo to relax the bronchial smooth muscle of the airways following methacholine challenge. NCX 1020 showed a trend at the four-hour time point in protecting against bronchoconstriction. NCX 1020 is a nitric oxide-donating derivative of budesonide, a corticosteroid.

• Odyssey Pharmaceuticals Inc., of Florham Park, N.J., and Indevus Pharmaceuticals Inc., of Lexington, Mass., announced plans to initiate a Phase IV study this month to evaluate the safety and efficacy of Sanctura (trospium chloride) in patients with overactive bladder symptoms. The SECURE trial (Sanctura to Evaluate Control of Urinary Symptoms Resulting from Overactive Bladder) will enroll about 4,000 patients. Sanctura was approved by the FDA in May for the treatment of overactive bladder.

• Pharming Group NV, of Leiden, the Netherlands, presented clinical results of its recombinant human C1 inhibitor (rhC1IHN) for the treatment of hereditary angioedema at its investigator meeting in Madrid, Spain. The company said patients treated with rhC1INH showed rapid time to beginning of relief - about 15 minutes - and time to complete resolution - usually within 24 hours - and showed favorable evaluation by both patients and physicians. No allergic or clinically relevant immune responses were noted. The company is conducted a placebo-controlled Phase III study in Europe and recently has expanded clinical studies to the U.S. and Canada. Preclinical studies have started to test rhC1INH in cardiovascular and inflammatory diseases, as well.

• Psiron Ltd., of North Ryde, Australia, said that its cancer therapy based on the use of a common cold virus to control cancer cell growth has begun safety testing in humans. That information was presented to the third international meeting on Replicating Oncolytic Virus Therapeutics in Banff, Alberta. The research involved the injection of a single dose of Coxsackie A21 directly into advanced melanoma tumors of patients with end-stage disease. The technology is licensed to Psiron.

• QuatRx Pharmaceuticals Co., of Ann Arbor, Mich., acquired exclusive worldwide rights to an orally active compound for the treatment of lipid disorders and obesity. QuatRx licensed the compounds from EndoChem Inc., of Berkeley, Calif. The new compound, called QRX-431, is designed to treat lipid abnormalities involving LDL cholesterol and Lp(a), both recognized as risk factors for cardiovascular disease. QRX-431 is a thyroid hormone agonist shown to reduce both LDL cholesterol and Lp(a), as well as weight, in primate models and is expected to enter clinical trials within a year.

• Schiffrin & Barroway LLP, of Radnor, Pa., filed a class-action lawsuit against Dublin, Ireland-based Elan Corp. plc on behalf of securities purchasers of the company's stock between Feb. 18, 2004, and Feb. 25, 2005. The complaint alleges that the company failed to disclose material adverse facts related to its multiple sclerosis drug, Tysabri, which Elan and its partner, Cambridge, Mass.-based Biogen Idec Inc., pulled off the market following a patient's death from progressive multifocal leukoencephalopathy. (See BioWorld Today, March 1, 2005.)

• Seattle Genetics Inc., of Bothell, Wash., achieved a milestone under its antibody-drug conjugate collaboration agreement formed in April 2002 with South San Francisco-based Genentech Inc., triggering an undisclosed payment. The milestone is based on Genentech's continued progress in preclinical development with an ADC that uses Seattle Genetics' technology. The technology uses the targeting ability of monoclonal antibodies to deliver cell-killing payloads to specific cells. (See BioWorld Today, April 23, 2002.)

• Serologicals Corp., of Atlanta, said that Celliance Corp., its wholly owned subsidiary, completed the construction and the internal phases of initial product manufacturing and testing at its new Ex-Cyte plant in Lawrence, Kan. The facility demonstrated that it can manufacture Ex-Cyte product that meets all internal quality and performance characteristics as a cell culture supplement for the production of biological products, the company said.

• Siga Technologies Inc., of New York, said its smallpox drug, SIGA-246, entered preclinical development, after it showed protective efficacy in four different murine challenge models. The company has initiated research that will allow primate efficacy and human safety studies to begin later this year. Siga has other biodefense programs, including several targeting pathogens that cause hemorrhagic fevers.

• Sinovac Biotech Ltd., of Beijing, received a new drug certificate from the Chinese State Food and Drug Administration (SFDA) for its split influenza vaccine. The vaccine is the third Sinovac vaccine, along with the hepatitis A vaccine Healive and the combined hepatitis A and B vaccine Bilive, granted a new drug certificate from the SFDA. Sinovac intends to build a larger flu vaccine production facility if it can access the necessary financing.

• V.I. Technologies Inc., of Watertown, Mass., said that its board approved a reverse split of the company's common stock. The board approved a 1-for-10 reverse split. Shares held as of the close of business on March 14 were split and shares began trading on a post-split basis on Tuesday. Vitex shares outstanding after the effect of the reverse split are about 38.2 million shares.

• Viral Genetics Inc., of Azusa, Calif., completed enrollment of 135 patients in its South African Phase III trial of VGV-1 to treat HIV-1. The primary endpoint of the trial is the effect of VGV-1 on viral load. The trial should be complete in the fourth quarter. VGV-1 is extracted from mammalian thymus tissue, processed and administered through intramuscular injections.