• Abiogen Pharma, of Pisa, Italy, began a Phase I/II trial using ABIO 05/01 cells for the treatment of peritoneal carcinosis. It will enroll about 18 patients with advanced tumors who have not responded to existing therapies to evaluate ABIO 05/01's safety in humans and to establish safe dose ranges for further studies.

• AlphaVax Inc., of Research Triangle Park, N.C., received a new vaccine development grant from the National Institute of Allergy and Infectious Diseases. The award provides a total of $6.5 million over three years to support the first preclinical development and preparations for clinical development of an influenza vaccine using the AlphaVax replicon vector (ArV) system. Data have shown that an ArV vaccine can protect birds from avian influenza.

• Amarin Corp. plc, of London, said the audit opinion of its accounting firm contained a going concern explanatory paragraph. The company, which is focused on the development of drugs for central nervous system disorders, said the announcement does not represent any change or amendment to its financial statements for the past fiscal year.

• Anadys Pharmaceuticals Inc., of San Diego, and LG Life Sciences Ltd., of Seoul, South Korea, reported positive data from an ongoing Phase II trial of ANA380 (LB80380) in patients with lamivudine-resistant hepatitis B virus infection at the European Association for the Study of the Liver meeting in Paris. Findings showed that oral administration of ANA380 over 12 weeks reduced DNA viral load by an average of 3.9 log10 units, or more than 99.9 percent, in lamivudine-resistant patients receiving 90-mg doses in the study.

• Applied Biosystems Group, of Foster City, Calif., said preliminary results from the first study conducted through its joint research protocol with the Cohort Consortium of the National Cancer Institute, part of the National Institutes of Health in Bethesda, Md., were to be reported at the American Association for Cancer Research meeting in Anaheim, Calif. The presentation is focused on a study of breast and prostate cancer and hormone-related gene variants. The consortium is using the company's TaqMan SNP Genotyping Assays and 7900HT Real-Time PCR Systems to identify inherited gene variants that may contribute to the development of those cancers.

• BioGenex Laboratories Inc., of San Ramon, Calif., launched its Xmatrx application for use in drug research and development. The system is designed for the development of automated slide-based assays created to perform DNA microarray hybridizations, in vitro and in situ PCR, DNA sequencing and to detect SNPs and microdeletions.

• Bioniche Life Sciences Inc., of Belleville, Ontario, reported data from two pilot studies using its sodium hyaluronate product, Cystistat, at last week's joint meeting of the Association of Medical Microbiology and Infectious Disease Canada and the Canadian Association for Clinical Microbiology and Infectious Diseases. Findings from one trial showed that only 14 percent of Cystistat patients had a urinary tract infection during their hospital stay, compared to 77 percent in the usual care group, a statistically significant result. In the other study, 70 percent of women did not have urinary tract infection recurrence at the end of their follow up about a year after treatment.

• Cellegy Pharmaceuticals Inc., of Brisbane, Calif., submitted a written response to an FDA request containing new analyses of data from its Cellegesic Phase III trials. Cellegy said discussions with the FDA have been productive and that the new analyses address the agency's inquiries. The FDA issued a not-approvable letter in December for Cellegesic to treat pain associated with chronic anal fissures. Cellegesic is approved in the UK as Rectogesic. (See BioWorld Today, Dec. 28, 2004.)

• Chiron Corp., of Emeryville, Calif., and XOMA Ltd., of Berkeley, Calif., began a Phase I study of CHIR-12.12, a fully human, antagonist antibody that targets the CD40 antigen, for patients with advanced chronic lymphocytic leukemia. The study is expected to enroll up to 40 patients, and translational medicine will be used to monitor biomarkers in real time. The product is the first to enter clinical testing under an agreement between the companies for cancer antibodies.

• Dharmacon Inc., of Lafayette, Colo., entered an agreement to provide siRNA libraries to Cancer Research UK. The siRNA libraries, which were developed using Dharmacon's SMARTselection and SMARTpool technology platforms, initially include protein kinase genes and associated pathways.

• Genaera Corp., of Plymouth Meeting, Pa., and the Cystic Fibrosis Foundation Therapeutics Inc., of Bethesda, Md., received approval in Ireland to begin a pivotal Phase II trial of Lomucin in cystic fibrosis patients. CFFT is supporting the trial with funding of up to $2.4 million in milestone-driven matching funds through a therapeutics development award. The study will enroll 200 patients in a trial to test the Lomucin oral tablets on pulmonary function and related symptoms.

• Gilead Sciences Inc., of Foster City, Calif., said its partner, F. Hoffmann-La Roche Inc., of Nutley, N.J., filed a supplemental new drug application seeking an extension of the prophylaxis indication for Tamiflu (oseltamivir phosphate) to include children ages 1 through 12. The drug is indicated for the prophylaxis of influenza in adult patients and adolescents 13 years and older, as well as for the treatment of uncomplicated acute illness due to influenza Type A or Type B infection in patients 1 year and older who have been symptomatic for no more than two days. The application was based on results from a subset of pediatric patients in a clinical study, which showed that the protective efficacy of Tamiflu was the same in children aged 1 to 12 as the whole population.

• Inncardio Inc., of New York, a company founded by Bioaccelerate Holdings Inc., formed an agreement with Sigmoid Biotechnologies Ltd., of Dublin, Ireland, for the co-development and licensure of two formulations of established drugs. Once approved, the drugs could achieve combined peak annual sales of more than $1 billion. Terms were not disclosed.

• Insmed Inc., of Richmond, Va., said the U.S. District Court for the Northern District of California granted the company's motion to dismiss the amended complaint filed by Tercica Inc. and Genentech Inc., both of South San Francisco, alleging patent infringement against Insmed relating to the U.S. commercialization of SomatoKine for growth hormone-insensitivity syndrome, which Tercica claimed infringed its patents. The court granted Tercica and Genentech leave to file another amended complaint within 30 days.

• Inyx Inc., of New York, received from Kos Pharmaceuticals Inc., of Cranbury, N.J., a 10-year contractual relationship to produce Kos' Azmacort inhalation aerosol product line. The contract should generate about $10 million in annual revenues to Inyx. Kos acquired Azmacort from Aventis Pharmaceuticals Inc. (now Paris-based Sanofi-Aventis Group) in March 2004. The product is used in the maintenance treatment of asthma.

• Isis Pharmaceuticals Inc., of Carlsbad, Calif., said its Ibis division was granted two new contracts totaling $1.5 million from the Department of Homeland Security's Science and Technology Directorate for the development of a new microbial forensics application of the company's TIGER (Triangulation Identification for Genetic Evaluation of Risks) biosensor system. The awards also will support further enhancement of the Microbial Rosetta Stone database to include additional genetic information on infectious agents.

• JPT Peptide Technologies GmbH, of Berlin, said it formed an agreement with Antibodies by Design, a division of MorphoSys AG, of Martinsried, Germany. The deal is to co-market the rapid generation of monoclonal antibodies by Antibodies by Design and the complementary peptide-based services and products from JPT. Each partner will offer the services of the other to its worldwide customers, save for Japan. JPT is a wholly owned subsidiary of Jerini AG, of Berlin.

• Lorus Therapeutics Inc., of Toronto, closed the third and final tranche of a C$15 million (US$12 million) private placement of convertible secured debentures. The proceeds will be used to finance the cancer company's development, commercialization and ongoing operations. The C$5 million debenture is convertible at the holder's option at any time prior to maturity into common shares at a conversion price of C$1 per share, and the conversion price represents a 41 percent premium to the Toronto Stock Exchange closing price on April 14.

• Morphotek Inc., of Exton, Pa., entered a multiyear research collaboration agreement with Thousand Oaks, Calif.-based Amgen Inc. to apply Morphotek's Morphodoma technology to Amgen's cell lines to generate high-titer antibody-producing cell lines for scaleable manufacturing. Under the terms of the nonexclusive agreement, Morphotek will receive funding to support research efforts to optimize Amgen cell lines. Morphotek also will receive research fees and milestone payments upon the successful achievement of program goals and the advancement of product candidates through clinical development. Further details were not disclosed.

• Nanogen Inc., of San Diego, entered a supply and license agreement with DeCode Genetics Inc., of Reykjavik, Iceland, to provide a new genomics assay for single nucleotide polymorphism discovery, validation and screening. The assay incorporates a range of Nanogen's products, including the Eclipse Dark Quencher, new DNA linker technology, modified bases and fluorescent dyes. It allows rapid SNP analysis on a large number of patient samples.

• NeoPharm Inc., of Lake Forest, Ill., said updated Phase I trial data for cintredekin besudotox (IL13-PE38QQR) in brain cancer patients demonstrated cytotoxicity against malignant glioma cells expressing the interleukin-13 receptor, and that convection-enhanced delivery of the drug has shown evidence of having a selective antitumor effect in the tumor-infiltrated white matter of the brain. Those data were presented at the 73rd annual meeting of the American Association of Neurological Surgeons in New Orleans. NeoPharm said results of the Phase I study were used to design the ongoing pivotal Phase III PRECISE trial, which is designed to determine whether cintredekin besudotox provides a statistically significant difference in survival outcomes for patients with GBM compared to current treatments.

• OSI Pharmaceuticals Inc., of Melville, N.Y., completed a stock exchange resulting in the acquisition of all minority interest shares of the company's UK subsidiary Prosidion Ltd. OSI issued 84,940 new shares in exchange for 286,200 shares, or 2.7 percent of Prosidion shares. OSI plans to continue to operate its diabetes and obesity effort in its Oxford, UK, facility as Prosidion.

• Palatin Technologies Inc., of Cranbury, N.J., and King Pharmaceuticals, of Bristol, Tenn., said the April issue of Urology published data on the co-administration of low doses of intranasal PT-141, a melanocortin receptor agonist, and sildenafil to men with erectile dysfunction. Co-administration therapy resulted in a significantly enhanced duration and quality of erectile activity, compared to Viagra monotherapy, as measured by RigiScan and by patient self-assessment scores. The therapy did not result in new side effects or in an increase in frequency or severity of side effects compared to monotherapy.

• Protein Design Labs Inc., of Fremont, Calif., reported positive Phase II results showing that ularitide met its primary endpoints by significantly reducing pulmonary capillary wedge pressure (p<0.05) and improving dyspnea score (p<0.05) in all three dose groups compared to placebo. Those doses included 7.5, 15, or 30 ng/kg/min given intravenously as a 24-hour infusion. The study, called SIRIUS II, tested the natriuretic peptide in patients with decompensated congestive heart failure. Primary adverse events were dose-dependent decreases in blood pressure compared to placebo. The company said it would continue to test the drug in that indication.

• Protein Polymer Technologies Inc., of San Diego, announced the final closing of about $3.6 million in a private placement of common stock and warrants, yielding total gross proceeds of approximately $7.75 million. Of the committed capital, about $1.2 million represents the conversion of short-term promissory notes previously issued by the company. Net proceeds are expected to fund research and clinical programs, and for general corporate purposes, including potential acquisitions.

• RegeneRx Biopharmaceuticals Inc., of Bethesda, Md., said a Wayne State University professor and the Kresge Eye Institute in Detroit have shown for the first time that thymosin beta 4 modulates MMP-9, an enzyme associated with persistent inflammation and corneal wounds, which might delay or retard corneal wound healing. RegeneRx is developing TB4 as a platform technology to treat acute and chronic wounds and for a variety of human diseases.

• Sequenom Inc., of San Diego, developed iPLEX, a new multiplexing application for the MassArray system, which it presented to the attendees of the Human Genome Organization's 10th Human Genome Meeting in Kyoto, Japan. iPLEX allows for high-level multiplexing even with small or limited SNP sets, resulting in a reduced cost per genotype. Sequenom believes its MassArray technology can close the gap between genetic discovery and clinical research.

• Synthetic Blood International Inc., of Costa Mesa, Calif., began patient enrollment in a Phase II trial of Oxycyte to prevent tissue hypoxia in hip revision surgery. The product, the company's perfluorocarbon blood substitute and therapeutic oxygen carrier, is being tested in the 60-patient study and is expected to be the subject of additional Phase II trials later this year.

• Washington University School of Medicine in St. Louis reported that newborn mice and dogs with hemophilia A were restored to normal health through gene therapy, using a technique that introduced into the animals' cells a gene that makes clotting Factor VIII, a protein missing due to a genetic defect. The treatment did not prompt an immune response and researchers reported that the blood of the mice and dogs has maintained a normal clotting level since they were treated more than a year ago. The study will be published in the April 26, 2005, issue of the Proceedings of the National Academy of Sciences.