• Access Pharmaceuticals Inc., of Dallas, said that its product for the treatment of canker sores, Aphthasol, received marketing approval in 10 European Union countries following completion of the mutual recognition procedure. Aphthasol also is approved for marketing in the U.S.

• AmpliMed Inc., of Tucson, Ariz., began enrollment in a Phase I/II trial that will study its lead candidate, Amplimexon, in combination with gemcitabine as a treatment for patients with previously untreated advanced pancreatic adenocarcinoma. The study will determine the maximum tolerated doses of Amplimexon, as well as its toxicity.

• Biogen Idec Inc., of Cambridge, Mass., is the subject of a class-action lawsuit filed in the U.S. District Court for the District of Massachusetts on behalf of all securities purchasers of Biogen Idec between Feb. 18 and Feb. 25 inclusive. The complaint charges Biogen, William Rastetter and James Mullen with violations of the Securities Exchange Act of 1934. More specifically, the complaint alleges that the company failed to disclose and misrepresented the material adverse facts that were known to defendants or recklessly disregarded by them. Earlier this week, the company pulled its multiple sclerosis drug, Tysabri, from the market. (See BioWorld Today, March 1, 2005.)

• Cellegy Pharmaceuticals Inc., of South San Francisco, achieved 50 percent enrollment in the Savvy (C31G vaginal gel) Phase III HIV prevention trial, reporting that more than 1,500 women have enrolled since March 2004. Cellegy's Biosyn subsidiary is conducting two Phase III HIV prevention trials in Africa to study Savvy in comparison to placebo for a 12-month period. The primary endpoint is a 50 percent reduction in the rate of HIV transmission.

• Chemokine Therapeutics Corp., of Vancouver, British Columbia, completed enrollment of study subjects and the administration of its investigational immune recovery drug CTCE-0214 as part of a Phase I trial. The study's primary objective is to determine safety, as well as the pharmacodynamic and pharmacokinetic profiles of the drug. Results are expected next quarter. CTCE-0214 is a small peptide agonist of stromal cell-derived factor-1.

• Corixa Corp., of Seattle, announced a joint collaboration with Lorantis Ltd., of Cambridge, UK, to continue the development of a therapeutic hepatitis B vaccine, containing Corixa's RC-529 adjuvant, as well as Lorantis' CV-1831 hepatitis B core antigen, previously owned by San Diego-based Apovia Inc. Lorantis will assume many of Apovia's development responsibilities. Corixa will take the lead for regulatory application and clinical trials, while Lorantis will handle preclinical studies and supply the core antigen. Both will share equally in all costs and potential revenues.

• First Horizon Pharmaceutical Corp., of Alpharetta, Ga., entered an agreement to acquire U.S. rights to the Type II diabetes medication Fortamet (metformin hydrochloride) and the cholesterol medication Altoprev (lovastatin) from Fort Lauderdale, Fla.-based Andrx Corp. First Horizon will pay Andrx $50 million at closing and up to $35 million when Andrx achieves and maintains certain defined manufacturing service levels. Andrx also is entitled to royalties on net sales of both products.

• Geneva Bioinformatics (GeneBio) SA, of Geneva, announced a joint venture with London-based Current Science Group to form a company called Current BioData Ltd., which will focus on the further development, promotion and distribution of ProXenter, a web-based information resource platform focused on specific groups of proteins for drug discovery.

• Genzyme Corp., of Cambridge, Mass., said that the European Commission approved the company's marketing application for a therapeutic indication for Thyrogen (thyrotropin alfa for injection), when used in combination with radioiodine. The new label permits the product's use in the European Union for the ablation of remnant thyroid tissue, a procedure that patients commonly undergo when being treated for thyroid cancer. Genzyme also is seeking to add the ablation indication to the product's U.S. label and expects regulatory action on the submission in the second half of the year.

• Helix BioMedix Inc., of Bothell, Wash., said it closed on the final round of a private equity financing, in which it raised an aggregate of $2.5 million in gross proceeds, including the $2.2 million announced Feb. 28. The company issued a total of about 1.7 million shares of common stock and warrants to purchase 125,000 shares to accredited investors. Helix said proceeds will be used for working capital and to further the development of anti-infective peptides.

• Human Genome Sciences Inc., of Rockville, Md., completed patient enrollment and initial dosing in a Phase II trial of HGS-ETR1 (mapatumumab) in advanced non-Hodgkin's lymphoma. The trial will evaluate the product, an agonistic human monoclonal antibody to TRAIL receptor-1, in patients with relapsed or refractory forms of the disease. The company said patients are receiving up to six cycles of treatment in the absence of disease progression, with HGS-ETR1 administered as an intravenous infusion once every 21 days. Objectives of the study are to evaluate disease activity and tumor response, and to determine plasma concentrations of HGS-ETR1 for use in a population pharmacokinetic analysis.

• Hybridon Inc., of Cambridge, Mass., presented preclinical data that show an immune modulatory oligonucleotide agonist of Toll-like receptor 9 enhanced the antitumor activity of a monoclonal antibody against the EGF receptor (cetuximab) and the cytotoxic agent irinotecan in mouse models.

• LifeSpan BioSciences Inc., of Seattle, said it entered an agreement with New York-based Pfizer Inc. to develop an automated pathology system for rapid and accurate evaluation of tissue specimens in preclinical studies. Financial terms were not disclosed.

• Lynx Therapeutics Inc., of Hayward, Calif., said that the company's board approved a 1-for-2 reverse stock split, following approval by stockholders on March 1 at the company's 2004 annual meeting. Lynx's stock began trading on Nasdaq on a post-split basis Thursday under the temporary trading symbol "LYNXD" and will trade under that symbol for about 20 trading days.

• Merrimack Pharmaceuticals Inc., of Cambridge, Mass., initiated a Phase II study of its immunomodulator MM-093 in patients with rheumatoid arthritis. The goal of the study is to examine the safety and efficacy of the product in 240 patients, who will receive once-weekly subcutaneous injections of MM-093 or placebo for 24 weeks. Patients also will be evaluated for changes in their signs and symptoms using the ACR criteria for rheumatoid arthritis. MM-093 is a recombinant version of human alpha-fetoprotein.

• Metabolex Inc., of Hayward, Calif., reported positive early clinical trial results for MBX-2044, an investigational oral insulin sensitizer for Type II diabetes. MBX-2044 is designed to eliminate the dose-limiting side effects of the marketed sensitizers. Data from the Phase I dose-escalating study showed that the drug was well tolerated in healthy volunteers.

• Proacta Inc., of San Diego, reported that its wholly owned subsidiary in New Zealand has been awarded about $3.5 million by the New Zealand Trade and Enterprise and TechNZ. The grant will allow Proacta to add an additional drug development candidate to its therapeutic pipeline. NZTE granted Proacta about $2.2 million over three years from the Australia New Zealand Biotechnology Partnership Fund. The grant supports Proacta's ongoing operations in both New Zealand and Australia recognizing the contribution of its Australian investor, GBS Ventures in Melbourne, Monash University and the Peter MacCallum Cancer Research Institute.

• Salix Pharmaceuticals Ltd., of Raleigh, N.C., entered a co-promotion agreement with Altana Pharma U.S., a subsidiary of Konstanz, Germany-based Altana AG's pharmaceutical division, to promote Xifaxan (rifaximin) tablets to treat noninvasive E. coli strains. Altana will use one of its sales forces to promote the product to the primary-care physician market. Further details were not disclosed.

• Senomyx Inc., of La Jolla, Calif., was notified by the Flavor and Extract Manufacturers Association that its savory enhancers S807 and S336 were determined to be generally recognized as safe under the provisions of the FDA-administered Federal Food, Drug and Cosmetic Act. The enhancers are intended to provide for the reduction or elimination of monosodium glutamate and to augment the flavor of naturally occurring glutamate.

• SuperGen Inc., of Dublin, Calif., dosed the first patient in a Phase II trial studying Orathecin capsules and gemcitabine as a first-line combination therapy for advanced pancreatic cancer patients who have not undergone chemotherapy. Orathecin is an orally active camptothecin.

• Xenova Group plc, of Slough, UK, reported preliminary 12-month findings from the second Phase I trial of TA-NIC, the company's therapeutic vaccine being developed for the treatment of nicotine addiction. A total of 60 subjects who smoked between 10 and 75 cigarettes a day were recruited and divided into three cohorts. The data showed that 12-month self-reported quit rates were substantially greater among those receiving TA-NIC than those receiving placebo.