• Access Pharmaceuticals Inc., of Dallas, entered a research collaboration with an unnamed pharmaceutical company to combine its vitamin B12 oral drug delivery technology with the collaborator's formulations to provide oral drug delivery options for those formulations. Access's vitamin B12 oral drug delivery technology uses a body's receptor-mediated transport system for vitamin B12 to assist in the absorption of drugs in the gut. Financial terms were not disclosed.

• Agencourt Bioscience Corp., of Beverly, Mass., launched an expanded single nucleotide polymorphism (SNP) discovery service for pre-validated sequencing assays of kinases. Agencourt signed a licensing agreement with the Dana-Farber Cancer Institute in Boston for the sequencing assays developed in the laboratories of cancer researchers. Agencourt will offer both pre-validated sequencing assays and a kinase discovery program in which polymorphisms in more than 92 kinases were mapped. Financial terms were not released.

• Avant Immunotherapeutics Inc., of Needham, Mass., said the Walter Reed Army Institute of Research (WRAIR) initiated a Phase I trial to assess the safety and immunogenicity of an HIV vaccine based on Avant's Therapore technology. The trial is designed to evaluate the vaccine at three escalating-dose levels in 18 adult volunteers. The trial, in conjunction with the Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, U.S. Department of Health and Human Resources, is being conducted at the WRAIR Vaccine Clinical Research Center in Rockville, Md.

• Avidex Ltd., of Milton Park, UK, formed a collaboration with Active Biotech AB, of Lund, Sweden, to create targeted immunotherapeutics for cancer. Active Biotech will supply its intellectual property, knowledge and clinical experience on its super-antigen protein, while Avidex will supply its platform of tumor antigen-specific human monoclonal T-cell receptors (mTCRs). The companies will combine the super-antigen with the mTCRs as a new fusion protein. Financial terms were not disclosed.

• Axcan Pharma Inc., of Mont St.-Hilaire, Quebec, received FDA and Canadian regulatory approval to begin Phase III trials of ITAX (itopride hydrochloride) for functional dyspepsia. The company will conduct two studies involving a total of 1,000 patients. Each will assess the efficacy of ITAX 100-mg tablets in treating functional dyspepsia, which also is known as non-ulcer dyspepsia. The primary efficacy endpoint will be an assessment of abdominal symptom relief, while a secondary endpoint will assess changes in the quality of life of patients undergoing ITAX or placebo therapy. Axcan expects to begin the studies next quarter and aims to complete enrollment by the end of the year.

• Biogen Idec Inc., of Cambridge, Mass., said its Executive Vice President Nabil Hanna resigned, following an internal investigation of the company concerning the trading of securities by a third party. Biogen Idec conducted the investigation in response to an informal SEC inquiry regarding the trading. Biogen Idec said it is not a target of the SEC inquiry. William Rastetter and Michael Gilman will assume Hanna's responsibilities.

• Bionomics Ltd., of Adelaide, Australia, said findings published in Human Molecular Genetics point to the identification of a susceptibility gene for a common form of epilepsy, known as generalized epilepsy with febrile seizures. The gene is a subunit of the GABA-A receptor, an ion channel that is the subject of Bionomics' drug discovery program for epilepsy and anxiety. The research was conducted by the company's collaborators at Women's and Children's Hospital, in conjunction with the University of Melbourne and U.S. researchers in Tennessee.

• Bone Care International Inc., of Middleton, Wis., priced its offering of 5 million common shares at $21.75 apiece. The company, which is developing vitamin D hormone therapies to treat kidney disease, cancer and psoriasis, is selling 4.5 million of the shares for net proceeds of about $91 million, and a separate shareholder is selling the other 500,000 shares. Bone Care said it would use proceeds for general corporate purposes. The underwriters, which include Bear, Stearns & Co. Inc. and Citigroup Global Markets Inc. as lead managers and Robert W. Baird & Co., First Albany Capital Inc. and Roth Capital Partners as co-managers, have an overallotment option to purchase up to 750,000 shares from the company.

• Cellectis SA, of Romainville, France, agreed to nonexclusively license patent rights to Murinus GmbH, of Hamburg, Germany, relating to the use of homologous recombination for the specific replacement or insertion of a gene in the mouse genome. Murinus obtained a license for developing and selling, in Europe and the Middle East, genetically modified mice for industry and academia. Financial terms were not disclosed.

• Coley Pharmaceutical Group Inc., of Wellesley, Mass., completed enrollment in its Phase II study of its lead TLR Therapeutic, ProMune, in non-small-cell lung cancer. The study goal is to improve the outcome of standard first-line chemotherapeutic regimens (taxane and platinum) for NSCLC by adding ProMune. Seventy-five patients were enrolled. Patients in the trial have advanced Stage IIIb/IV NSCLC and have not received prior chemotherapy. Coley plans to release interim data June 5 at the 2004 annual meeting of the American Society of Clinical Oncology in New Orleans.

• CV Therapeutics Inc., of Palo Alto, Calif., agreed to sell $125 million of 2.75 percent senior subordinated convertible notes due 2012 through a private placement to qualified institutional buyers. The company, which expects to close the transaction on or about May 18, also granted the initial purchasers a 30-day option to purchase up to $25 million of the notes. CV may redeem all or a portion of the notes at any time after May 20, 2009. They will be convertible by holders at any time on or prior to maturity into common shares at an initial conversion rate of about 56.55 shares per $1,000 of notes, representing an initial conversion price of about $17.68 per share. Also, CV said it reached agreements with a limited number of holders of its outstanding 4.75 percent convertible subordinated notes due 2007 in privately negotiated transactions to repurchase about $71.6 million of the notes.

• Cytokinetics Inc., of South San Francisco, said GlaxoSmithKline plc, of London, initiated a Phase I trial of SB-743921, the second small-molecule inhibitor of kinesin spindle protein (KSP) to be advanced into the clinic under a collaboration the firms established in June 2001. The Phase I study will investigate SB-743921 in patients with advanced cancers. SB-743921 is a small-molecule compound designed to modulate cell proliferation and promote cancer cell death by inhibiting KSP, a mitotic kinesin essential for cell proliferation, a process that, when unregulated, results in tumor growth. (See BioWorld Today, June 26, 2001.)

• Debiopharm SA, of Lausanne, Switzerland, signed a license agreement with the Shanghai Institute of Materia Medica in China for the development of ZT-1, a cholinesterase inhibitor for Alzheimer's disease. The institute will supply Debiopharm with predefined amounts of huperzine A, of which ZT-1 is a derivative, with a dual mechanism of action to potentially offer neuroprotective properties on top of its cholinergic effects. Debiopharm has the exclusive license to develop and commercialize ZT-1 worldwide except in China, where the institute retains such rights. Debiopharm, which has conducted about 60 preclinical studies and seven Phase I/II studies on ZT-1, is seeking co-development and commercial partnerships with pharmaceutical companies.

• Evotec OAI AG, of Hamburg, Germany, entered a drug discovery agreement with Guilford Pharmaceuticals Inc., of Baltimore, to identify small-molecule compounds that interact with selected Guilford targets. Evotec will develop assays and screen them in ultra-high-throughput format against multiple Guilford targets. Evotec will receive research fees and could receive milestone payments on the successful preclinical development of the compounds and their approval for clinical development.

• Eyetech Pharmaceuticals Inc., of New York, filed a registration statement with the SEC covering a proposed offering of 4 million shares of stock, plus an additional 600,000 shares of stock to cover overallotments. Eyetech will not sell any of the shares or receive any of the proceeds. All of the shares will be sold by selling stockholders. Merrill Lynch & Co. and Morgan Stanley are joint book-running managers, and Bear, Stearns & Co. Inc. is acting as co-manager. Eyetech is focused on diseases affecting the back of the eye, with Macugen as its most advanced product.

• Gene Logic Inc., of Gaithersburg, Md., provided the Center for Drug Evaluation and Research (CDER) a gene-expression dataset derived from vehicle-treated rat liver samples. The data, which are part of Gene Logic's GeneExpress System, correspond to specific FDA-selected gene fragments that are common to multiple microarray platforms. CDER researchers will mine, evaluate and use portions of the data to compile a list of invariant genes across multiple microarray platforms.

• GenoMed Inc., of St. Louis, said two nonprofit groups that care for wild birds with West Nile virus encephalitis will use its treatment this season. GenoMed's protocol, which uses blood-pressure drugs already carried in drug stores, is based on the theory that brain inflammation and death result from an over-response by the host's immune system to the virus. The treatment suppresses the immune system at an early step in its activation.

• Immunicon Corp., of Huntingdon Valley, Pa., said underwriters of its recent initial public offering of 6 million shares exercised in full their overallotment option to purchase 900,000 shares from Immunicon at the IPO price of $8 per share, less an underwriting discount of 56 cents per share. The proceeds to Immunicon, after deducting underwriting discounts, from the exercise of the overallotment option will be about $6.7 million, increasing the total net proceeds from the equity offering to about $49.6 million. (See BioWorld Today, April 19, 2004.)

• InKine Pharmaceutical Co. Inc., of Blue Bell, Pa., completed enrollment in a Phase II trial of its next-generation sodium phosphate tablet, INKP-102. The study included about 210 adult patients undergoing colonoscopy, and compared six dosing regimens of the new formulation against Visicol tablets. Results are expected in the third quarter. InKine plans to launch a Phase III study of the new formulation later this year.

• Insmed Inc., of Richmond, Va., said the Department of Defense granted a group of leading oncologists $10 million to support therapeutic individualization for breast cancer treatment. Insmed's rhIGFBP-3 has been selected as one of the candidate therapies for study. Brian Leyland-Jones of McGill University will serve as lead investigator for the trials. The consortium of physicians is called the Breast Cancer Center of Excellence.

• InterMune Inc., of Brisbane, Calif., initiated a Phase II trial of Infergen (interferon alfacon-1) in combination with Actimmune (interferon gamma-1b) for the treatment of patients chronically infected with hepatitis C virus who have failed to respond to therapy with pegylated interferon-alpha-2 plus ribavirin. The trial will enroll up to 80 patients in three sequential groups. The primary objective is to evaluate the safety and tolerability of the combination regimen with or without ribavirin and the potential for Actimmune to replace ribavirin as an adjunct to Infergen in treating nonresponders. Secondary objectives are to determine the highest well-tolerated dosing regimen, assess virologic response at the end of treatment and sustained virologic response 24 weeks after completing therapy. Infergen is a bio-optimized type 1 interferon-alpha indicated for treatment of adult patients with chronic HCV infections with compensated liver disease and is dosed three times a week. InterMune markets Actimmune for chronic granulomatous disease and severe malignant osteopetrosis.

• Introgen Therapeutics Inc., of Austin, Texas, said data appearing in the current issue of Molecular Therapy describe the mechanism by which expression of the mda-7 gene, the active component of INGN 241, inhibits invasion and migration of human lung cancer cells. Introgen is developing INGN 241, which is in Phase II trials for metastatic melanoma and just completed Phase I/II trials in multiple solid-tumor indications. In the studies, the impact of INGN 241 protein on the migration and invasion of human lung cancer cells was examined in two cultured cell lines and in animals implanted with human lung tumors. The studies demonstrated that expression of MDA-7 protein resulted in a decrease in cancer cell migration, compared with controls.

• La Jolla Pharmaceutical Co., of San Diego, said recent findings about antibody-mediated thrombosis, also known as antiphospholipid syndrome, were published in the Proceedings of the National Academy of Sciences and Clinica Chimica Acta. The company's early clinical drug candidate, LJP 1082, is the first candidate designed to target the underlying cause of antibody-mediated thrombosis. The first article highlighted beta 2-glycoprotein I, a blood protein involved in coagulation that is a target of the antibodies involved in APS. Data showed that beta 2-glycoprotein I can inhibit blood clotting. The second article showed how researchers used commercial assays to demonstrate that the antibodies to cariolipin and beta 2-glycoprotein I in patients with APS are highly specific for domain 1 of beta 2-glycoprotein I.

• Lynx Therapeutics Inc., of Hayward, Calif., entered an agreement with the National Cancer Institute to deploy Massively Parallel Signature Sequencing (MPSS) for the characterization of genomic changes in cancer. Lynx will receive payments for the DNA sequencing services. It also signed agreements with the National Institute of Environmental and Health Sciences and the Howard Hughes Medical Institute, and extended existing agreements with the Ludwig Institute for Cancer Research and the National Institute on Aging, for MPSS gene-expression services. The company also announced the acceptance for publication of two peer-reviewed manuscripts in scientific journals that describe the first application of its MPSS technology in a sequenced plant genome. The manuscripts will appear in the June and August issues of Plant Physiology and Genome Research, respectively.

• Millennium Pharmaceuticals Inc., of Cambridge, Mass. initiated a Phase II trial of Velcade (bortezomib) for injection in combination with rituximab in patients with relapsed or refractory, indolent (follicular and marginal zone), non-Hodgkin's lymphoma. The trials will enroll up to 66 patients with relapsed or refractory, indolent, B-cell lymphoma, including either follicular lymphoma or marginal zone lymphoma. Velcade is approved in the U.S. and Europe for patients with relapsed and refractory multiple myeloma. Velcade also is being studied in solid and hematologic tumors. (See BioWorld Today, May 15, 2003.)

• Neurologix Inc., of Fort Lee, N.J., said findings published in the March 24, 2004, issue of The Journal of Neuroscience demonstrated proof of principle that targeted gene transfer of Neuropeptide Y with local application of recombinant adeno-associated viral vectors inhibited seizures in rats. The company, which said the data provide a potential therapeutic principle for treating drug-resistant partial epilepsies, added that such results support its plan to file an investigational new drug application with the FDA late this year or early next year to begin a Phase I trial of gene therapy for epilepsy.

• Nuevolution A/S, of Copenhagen, Denmark, acquired rights to a portfolio of patents relating to a process of molecular evolution that allows DNA to act as a vehicle to generate potential drug-like molecules. The patents, originating from the Scripps Research Institute in San Diego, relate to the generation and screening of bifunctional molecules. Nuevolution uses its Chemetics technology to generate small-molecule drug leads.

• Nuvelo Inc., of Sunnyvale, Calif., reinitiated and commenced enrollment of a Phase IIa trial of a recombinant nematode anticoagulant protein c2 (rNAPc2) in the treatment of patients with acute coronary syndromes (ACS). After licensing the molecule from Dendreon Corp., of Seattle, in February, Nuvelo took steps to reinitiate the study, also referred to as ANTHEM (Anticoagulation with NAPc2 to Help Eliminate Mace)/TIMI 32. Prior to reinitiation, 77 patients had been enrolled in the trial. An additional 98 patients will be enrolled in this phase for a total of 175 patients in centers across the U.S. and Canada. The study is designed to evaluate Factor VIIa/tissue factor inhibitor, rNAPc2, in patients with non-ST-elevation ACS. The anticoagulant rNAPc2 is a naturally occurring protein that originally was isolated from hookworms and is manufactured as a recombinant protein for clinical use. (See BioWorld Today, Feb. 6, 2004.)

• Research Corp. Technologies, of Tucson, Ariz., said tumor-specific promoters for use in cancer therapies are available for licensing through its Gene eXpression Technologies program. The company originally acquired optimized midkine and c-erbB-2 promoters from Prim'mune KK, of Osaka, Japan, and the Prefecture of Chiba.

• Samaritan Pharmaceuticals Inc., of Las Vegas, said Georgetown University in Washington granted two exclusive worldwide licenses to Samaritan to develop and market Samaritan Research Lab's candidates for the treatment of HIV drug resistance. Samaritan will focus on its lead candidate SP-01A and its preclinical trials. Georgetown granted exclusive rights to develop, manufacture and commercialize the drugs in exchange for royalties and payments if the drugs are partnered or commercialized by Samaritan.

• Viragen Inc., of Plantation, Fla., said the Swedish Medical Products Agency approved extending the shelf-life of Multiferon to 18 months from its previously approved labeling of 12 months. The company also initiated a new sales and marketing compaign for Multiferon in Sweden. Multiferon is a purified, multi-subtype, natural human alpha-interferon derived from human white blood cells and is approved in Sweden for the second-line treatment of diseases in which patients show an initial response to recombinant alpha-interferon, followed by treatment failure.

• Waters Corp., of Milford, Mass., received about $17.4 million as payment of damages from Applera Corp., of Norwalk, Conn., as a result of a judgment in favor of Waters in a patent-infringement case. The suit, originally filed in 1995, dealt with patents that describe designs embodied in differential scanning calorimeter products, instruments for the analysis and characterization of polymers, pharmaceuticals and other materials.

• XCELLentis, a wholly owned subsidiary of Innogenetics, of Ghent, Belgium, said final results of a Phase II trial of LyphoDerm to treat hard-to-heal venous leg ulcers confirmed top-line results announced in March providing new evidence of the treatment's effectiveness. The company began the trial, involving 193 patients, in September 2002. The primary endpoint was the incidence of complete wound closure within 24 weeks. Of the patients receiving LyphoDerm, 38 percent achieved 100 percent wound closure, while 27 percent in the control group did the same. LyphoDerm is a human keratinocyte lysate in a topical formulation.