• Adolor Corp., of Exton, Pa., said the FDA extended the Prescription Drug User Fee Act target action date from April 25 to July 25 for the completion of its review of the new drug application for Entereg (alvimopan) capsules for the management of postoperative ileus. In January, the FDA requested that the company provide information from London-based GlaxoSmithKline plc's European Phase III study of alvimopan in postoperative ileus, and the company indicated its goal was to deliver the information in a time frame that would allow for a PDUFA date extension. The final component of the requested information, the study report from GSK, was submitted to the FDA earlier this month.

• Advanced Viral Research Corp., of Yonkers, N.Y., added the Jacobi Medical Center in New York as a new site for its Phase II trial of AVR118. The study will examine the safety, tolerability and efficacy of AVR118 in patients with advanced cancer who are suffering from symptoms such as weight loss, fatigue and loss of appetite.

• Anthera Pharmaceuticals Inc., of San Francisco, completed its Series A preferred financing and is moving forward under a leadership team that includes Paul Truex as president and CEO. Truex previously served as director, president and CEO of Alameda, Calif.-based Peninsula Pharmaceuticals Inc., which this week was acquired by Johnson & Johnson unit Ortho-McNeil Pharmaceutical Inc. in a $245 million deal. Anthera will focus on in-licensing clinical candidates for the treatment of respiratory and inflammatory diseases and has identified four clinical-stage products with the potential to address a variety of those diseases. Joining Truex at the new company are board members, including Chairman Lowell Sears, of Sears Capital Management; Dennis Lanfear, of Lanfear Capital Advisors LLC; and Christopher Henney, of Biomira Inc. (See BioWorld Today, April 20, 2005.)

• Ariad Pharmaceuticals Inc., of Cambridge, Mass., said its mTOR inhibitor, AP23573, was designated a fast-track product by the FDA for the treatment of soft-tissue and bone sarcomas. The FDA's decision was based, in part, on review of both Phase I and Phase II trials of AP23573 conducted by Ariad in refractory sarcoma patients. Ariad said it will pursue treatment of soft-tissue and bone sarcomas as the initial registration path for AP23573.

• Biomira Inc., of Edmonton, Alberta, and Merck KGaA, of Darmstadt, Germany, started a Phase II, single-arm, open-label study of BLP25 liposome vaccine (L-BLP25). The trial will assess the safety of the formulation of L-BLP25 that the companies expect to use in the upcoming Phase III study. Enrollment of the 20-patient trial involving men and women with non-small-cell lung cancer is expected to be completed in the third quarter, with initial results expected before the end of the year.

• Genmab A/S, of Copenhagen, Denmark, reached an agreement with the FDA under the special protocol assessment process for its pivotal study of HuMax-CD4 (zanolimumab) to treat cutaneous T-cell lymphoma. The study will be carried out under FDA fast-track designation and include patients with the most common form of CTCL, mycosis fungoides, who are refractory to or intolerant to Targretin (Ligand Pharmaceuticals Inc.) and one other standard therapy. The first stage of the trial will be open label and designed to characterize in humans the new antibody material, compared to that used in previous studies, while the second stage of the trial will be blinded and will include 70 patients randomized to either 8 mg/kg or 14 mg/kg of HuMax-CD4 once weekly for 12 weeks. The primary endpoint will be the complete and partial response rate during treatment and an eight week follow-up period.

• GenoMed Inc., of St. Louis, constructed a Healthchip that might serve as an early warning system for the top six common cancers - breast, colon, lung, ovarian, pancreatic and prostate. The Healthchip is made up of many single nucleotide polymorphisms, and, in internal testing, correctly identified the type of cancer in 85 percent of the cases.

• Insmed Inc., of Richmond, Va., initiated a Phase II trial examining the therapeutic benefit of treating HIV-associated lipodystrophy with SomatoKine, the company's once-daily, IGF-I therapy. The Phase II trial is an open-label study. To qualify for inclusion in the study, patients must be between 18 and 65 years of age, have confirmed HIV-1 infection, fat accumulation and evidence of insulin resistance. The primary goal of the study is to determine the effects of SomatoKine on visceral fat and insulin sensitivity. SomatoKine is a drug product of insulin-like growth factor-1 and its principal binding protein, IGFBP-3.

• LION bioscience AG, of Heidelberg, Germany, plans to sell its bioinformatics business. The management and supervisory board will conduct a structured tender. LION said that in the last few weeks, several companies expressed an interest in its bioinformatics business. A potential and alternative management buyout has been deferred for the time that the public tender is being put into place.

• MerLion Pharmaceuticals Ltd., of Singapore, reported a three-year drug discovery and development collaboration with Sankyo Co. Ltd., of Tokyo. Sankyo will provide selected high-throughput screens and additional assays to MerLion, which will provide access to its sample collection and apply its screening and natural products chemistry skills to the isolation of new chemical leads.

• Myogen Inc., of Denver, completed patient enrollment in DAR-201, the company's Phase IIb trial of darusentan in patients with resistant systolic hypertension. The primary objective of the randomized, double-blind, placebo-controlled trial is to determine if darusentan is effective in reducing systolic blood pressure in patients with resistant systolic hypertension. Patients were eligible for enrollment if they had a systolic blood pressure greater or equal to 140 mmHg despite treatment with full doses of three antihypertension medications, one of which was a diuretic.

• Neoprobe Corp., of Dublin, Ohio, completed an option agreement with the University of California at San Diego to expand the field of use for its compound developed by UCSD researchers. The expanded field will allow Lymphoseek to be developed as an optical or ultrasound agent. Neoprobe is completing clinical studies and regulatory registration process for Lymphoseek as a lymphatic tissue-tracing agent.

• Novacea Inc., of South San Francisco, said that patient enrollment began in the company's Phase I/II open-label dose-escalation study of banoxantrone, also known as AQ4N, a tissue-targeting cytotoxic prodrug. The planned study will test banoxantrone in up to 55 patients with B-cell neoplasms. The primary objectives of the study are to establish the maximum tolerated dose of banoxantrone, determine the agent's pharmacokinetic profile and evaluate its safety and tolerability. The study also will evaluate evidence of antitumor activity as measured by overall response rate.

• PharmaDesign Inc., of Tokyo, signed an agreement with Novartis AG, of Basel, Switzerland, to license PharmaGPEP, a G protein-coupled receptor ligand library designed and produced by PDI. PharmaGPEP is a synthetic peptide library designed with PDI's bioinformatics technologies. Financial and other terms were not disclosed.

• PharmaStem Therapeutics Inc., of Wayne, Pa., entered an agreement under which the University of Texas M.D. Anderson Cancer Center obtained a license to its patent portfolio for the storage and use of umbilical cord blood. PharmaStem is the successor to Biocyte Corp., and focuses on the development of umbilical cord blood preservation and its therapeutic use.

• Protein Design Labs Inc., of Fremont, Calif., and Orphan Therapeutics LLC, of Lebanon, N.J., said the FDA granted fast-track status to the development of terlipressin for the treatment of patients with Type I hepatorenal syndrome. PDL's wholly owned subsidiary, ESP Pharma Inc., acquired exclusive marketing, sales and distribution rights for terlipressin, a synthetic 12-amino-acid peptide, in the U.S. and Canada, while Orphan Therapeutics holds the U.S. investigational new drug application for terlipressin and is conducting a Phase III trial in the U.S. and Europe.

• Senomyx Inc., of La Jolla, Calif., announced an agreement for a three-year extension of the collaborative research phase under its initial discovery and development agreement with Nestle SA. The agreement is focused on the discovery and commercialization of flavors and flavor enhancers in the dehydrated and culinary food and frozen food fields. Senomyx stands to receive up to $6.6 million in discovery and development funding.

• Transgenomic Inc., of Omaha, Neb., agreed to provide additional quantities of modified nucleic acid building-block compounds to Geron Corp., of Menlo Park, Calif., under the terms of a new addendum to an existing master supply agreement. The compounds will be used in the synthesis of Geron's cancer drug GRN163L. GRN163L is a thio-phosphoramidate oligonucleotide, a class of synthetic nucleic acid.

• Transkaryotic Therapies Inc., of Cambridge, Mass., said the last patient completed treatment in its open-label Phase I/II trial evaluating GA-GCB, an enzyme-replacement therapy, in Gaucher's disease. The company expects to report top-line results in the second half of 2005. TKT also said it expects to receive results of a Phase III study evaluating Dynepo as a treatment for anemia associated with cancer chemotherapy that previously was completed by Sanofi-Aventis Group, of Paris. TKT previously expected to report top-line results from that study in the first half of 2005; however, the company now expects to report results in June or in the third quarter.