• aaiPharma Inc., of Wilmington, N.C., received notification from the Nasdaq Stock Market that due to the company's failure to file its report for the period ended March 31, it is not in compliance with a Nasdaq rule for continued listing of its common stock. At a hearing held last month, aaiPharma requested that its common stock continue to be listed pending the filing of its annual report, as well as its quarterly report, but the request still is pending.

• AEterna Laboratories Inc., of Quebec City, and its wholly owned subsidiary, Zentaris GmbH, announced positive Phase II data on cetrorelix in endometriosis and pre-surgical treatment of uterine myomas. In three Phase II trials in endometriosis, the product showed a highly statistically significant improvement of pain score. The product also demonstrated a significant decrease in endometriosis-related symptoms that was seen within four weeks of starting the therapy and lasted for at least two months following the end of therapy. In the pre-surgical treatment of uterine myomas, the product led to a reduction of myoma and uterine volumes after a one-month treatment period.

• Agennix Inc., of Houston, received a Phase I Small Business Innovative Research grant from the National Institute of Allergy and Infectious Diseases in Bethesda, Md., to further characterize the efficacy of oral recombinant human lactoferrin (rhLF) in a primate model of asthma. RhLF is an anti-inflammatory and immunomodulatory agent that protects against early and late asthmatic responses, as well as allergen-induced delayed hypersensitivity and cellular infiltration in animal models of asthma. A Phase II trial is under way.

• Angiotech Pharmaceuticals Inc., of Vancouver, British Columbia, said its corporate partner, Natick, Mass.-based Boston Scientific Corp., reported nine-month results from a clinical trial assessing the safety and efficacy of a moderate-release formulation paclitaxel-eluting stent in high-risk patients, including long lesions with overlapping stents, small vessels and diabetics. Data show that the moderate-release formulation is as safe and effective as the slow-release formulation. The trial enrolled 448 patients at 44 sites in Europe. The study is using Boston Scientific's Taxus Express coronary stent system.

• Applied Biosystems Group, of Foster City, Calif., released its Mouse Genome Survey Microarray for use with its recently launched Expression Array System. The company said it contains probes representing a complete, annotated and fully curated set of about 32,000 mouse genes from both public databases and Celera Genomics Group, of Rockville, Md. Both companies are subsidiaries of Applera Corp.

• AutoImmune Inc., of Pasadena, Calif., said its securities will be delisted from the Nasdaq SmallCap Market as of the open of business today. The company held a hearing to appeal the exchange's decision to delist its stock, but the Nasdaq panel rejected the appeal. AutoImmune said it is fully compliant with all of the stated requirements. The company focuses on developing a new class of mucosally administered therapies to treat autoimmune and cell-mediated inflammatory diseases and conditions.

• Biogen Idec Inc., of Cambridge, Mass., and Elan Corp. plc, of Dublin, Ireland, submitted a biologics license application to the FDA for Antegren (natalizumab) to treat multiple sclerosis. The submission includes one-year data from two ongoing Phase III trials that the companies said they would complete. In order to protect the two-year studies' integrity they will not disclose the data. The partners first outlined regulatory submission plans earlier this year. (See BioWorld Today, Feb. 19, 2004.)

• Cell Therapeutics Inc., of Seattle, completed enrollment in STELLAR 4, one of three Phase III studies of Xyotax (paclitaxel poliglumex), for non-small-cell lung cancer. The trial, which involves 122 sites in the U.S., Europe and Latin America, is comparing Xyotax at a paclitaxel-equivalent dose of 175 mg/m(2) to gemcitabine (1000mg/m[2]) or vinorelbine (30mg/m[2]) in poor-performance status lung cancer patients. Its primary endpoint is to determine if Xyotax improves survival when compared to single-agent gemcitabine or vinorelbine therapy. Reported trials of gemcitabine or vinorelbine have not demonstrated a survival benefit in such patients, the company said. (See BioWorld Today, Oct. 8, 2002.)

• First Genetic Trust, of Chicago, entered a further research collaboration with GlaxoSmithKline plc, of London, to manage a research study designed to evaluate the relationship between genetic variations and certain adverse drug reactions. The study will help explain how differences in an individual's genetic profile affect susceptibility to a serious adverse reaction across a class of medicines. It might lead to tools and procedures enabling doctors to prescribe more effective medicines.

• Genaera Corp., of Plymouth Meeting, Pa., said a study demonstrated a relationship between its mucoregulator target, the human calcium-activated chloride channel, and mucus overproduction. It suggests that blocking mCLCA3 and its human counterpart, hCLCA1, can decrease the mucus hypersecretion and airway inflammation in a model of acute respiratory infection. A second study demonstrated the potential use of anti-inflammatory aminosterols in preventing and treating asthma.

• Genencor International Inc., of Palo Alto, Calif., said in vivo data published in the current issue of the Journal of Immunology demonstrated that a new variant of recombinant interferon-beta reduces the immunological response to the protein. Using the company's I-mune assay and platform, scientists generated a variant of interferon-beta by changing an amino acid at a single position in the immunodominant CD4+ T-cell epitope region of the protein. The immunodominant epitope in the parent protein had been shown in a previously published report to be critical for immunologic responses in both humans and Balb/c mice.

• GlobeImmune Inc., of Aurora, Colo., said its investigational new drug application for the GI-4000 product series became effective, clearing the way for the company to start a Phase I trial. The GI-4000 series is a new class of targeted immunotherapy products developed to treat a number of cancers that targets the Ras protein. The series consists of three products, GI-4014, GI-4015 and GI-4016, directed to five specific mutations in the Ras protein. The Phase I study will evaluate the series in 15 to 25 patients with Stage III or IV colorectal, pancreatic or non-small-cell lung cancer.

• Immunetrics Inc., of Pittsburgh, said the Pittsburgh Life Sciences Greenhouse invested $100,000 in pre-seed funds to Immunetrics through its affiliate, the Pittsburgh Biomedical Development Corp. Immunetrics has developed software that bridges the gap between the drug development processes of preclinical testing and human clinical trials. The company's core technology, a software modeling system that targets inflammatory diseases, is exclusively licensed from the University of Pittsburgh.

• Juvaris BioTherapeutics Inc., of Pleasanton, Calif., entered an exclusive license agreement with Colorado State University to develop therapeutic vaccines using an approach of pattern-recognition receptor ligands complexed to lipids. The technology will enable specific immune responses using the ligands to activate an array of Toll-like receptors present on specialized cells of the immune system. Colorado State will receive licensing fees from Juvaris and be eligible for future royalties on product sales. Juvaris will be responsible for the development, manufacturing and commercialization of products.

• LigoCyte Pharmaceuticals Inc., of Bozeman, Mont., executed an exclusive option from Baylor College of Medicine for a license to technologies related to norovirus vaccines and therapeutics. Noroviruses are associated with worldwide outbreaks of acute gastroenteritis, said the company, which with support from the Department of Defense is developing products to combat norovirus infections. Baylor researchers cloned the Norwalk virus genome in 1990 and eventually conducted a Phase I study of an oral Norwalk vaccine. Financial terms were not disclosed.

• MedImmune Inc., of Gaithersburg, Md., said findings reported at the Conference on Vaccine Research in Arlington, Va., showed that FluMist vaccinations in school children resulted in a significant reduction in school absenteeism, lost workdays for parents and influenza-related costs within families. The conference was sponsored by the National Foundation for Infectious Diseases.

• Myogen Inc., of Denver, said detailed Phase II results reported at the American Thoracic Society's international conference in Orlando, Fla., showed that the use of ambrisentan in patients with pulmonary arterial hypertension demonstrated a statistically significant increase in the primary efficacy endpoint, mean six-minute walk distances, in all dose groups evaluated. Findings from the study, called AMB-220, were previously disclosed. Based on preliminary analysis of data for the 34 patients who have reached week 48, the effect of ambrisentan on exercise capacity appears to be durable, based on a sustained increase in six-minute walk distances and improved scores in the Borg dyspnea index, the company said.

• Nanobac Life Sciences Inc., of Tampa, Fla., said an article in the recent issue of the American Journal of Physiology - Heart and Circulatory Physiology highlighted a method for isolating, culturing and staining nanobacteria that was reproduced by an independent team led by the Mayo Clinic in Rochester, Minn. The experiments used an antibody 8D10, developed and manufactured by Nanobac, confirming that the nanobacteria can be visualized in and cultured from human calcified arteries and heart valves. The experiments also provided evidence that nanobacteria contain DNA.

• Progenics Pharmaceuticals Inc., of Tarrytown, N.Y., said it completed Phase I trials of two different oral formulations of methylnaltrexone (MNTX). Preliminary analysis of data from 61 healthy volunteers who received MNTX at three dose levels indicated that the drug was well tolerated and exhibited predictable pharmacokinetics. The company has selected an oral formulation and dose levels to test in Phase II trials later this year in chronic pain patients with opioid-induced constipation.

• Serono SA, of Geneva, said its board authorized the repurchase of up to CHF750 million (US$591 million) worth of bearer shares through a share buyback program expected to start next month. Lasting a maximum of five years, the shares will be purchased on the open market via a second trading line and subsequently cancelled. The authorization applies only to the bearer shares traded on the virt-x, which is a pan-European blue-chip exchange, and excludes the American depository shares traded on the New York Stock Exchange. It is subject to the approval of the Swiss Takeover Board and the Swiss Stock Exchange.

• SuperArray Bioscience Corp., of Frederick, Md., launched its RT(2) Real-Time Gene Expression Assay Kits for every gene in the human, mouse and rat genomes. The company said the assays are intended for genome-wide disease characterization, pathway elucidation, functional studies, and in the basic research of human disease, as well as for independent verification of DNA microarray data.

• Vertex Pharmaceuticals Inc., of Cambridge, Mass., reported plans to begin a Phase IIb study of merimepodib in hepatitis C virus patients who are nonresponders to prior treatment with pegylated interferon (peg-IFN) and ribavirin. The U.S.-based trial will enroll about 315 patients who will receive merimepodib or placebo in combination with Pegasys (peginterferon alfa-2a) and Copegus (ribavirin), two products from F. Hoffmann-La Roche Ltd., of Basel Switzerland. Roche agreed to provide them to Vertex for use in the study, in exchange for shared data and analysis at predetermined intervals during the trial. Vertex owns merimepodib's worldwide development and commercialization rights.

• ViroPharma Inc., of Exton, Pa., updated its intranasal pleconaril program, to which Schering-Plough Corp., of Kenilworth, N.J., has an option to enter a license agreement. If Schering-Plough exercises the option with ViroPharma, Schering-Plough would assume responsibility for all future development and commercialization of intranasal pleconaril for treating the common cold in the U.S. and Canada.

• Wilex AG, of Munich, Germany, and Fox Chase Cancer Center in Philadelphia began a Phase I trial of WX-UK1 to target tumor-cell invasion, metastasis and primary tumor growth. It marks the first of two clinical trials of the company's compound at Fox Chase, funded by a $3.9 million grant from the Department of Defense to study the compound's potential as a breast cancer therapeutic. In animal models, Wilex said the non-cytotoxic small molecule blocks tumor-cell invasion, metastasis and primary tumor growth by inhibiting the urokinase Plasminogen Activator system.

• Xanthus Life Sciences Inc., of Cambridge, Mass., initiated a Phase I/II study of Xanafide (amonafide) in patients with metastatic prostate cancer. The study aims to validate the safety and efficacy of Xanafide. It is designed as an open-label, multicenter trial in about 40 subjects with hormone-refractory metastatic prostate cancer who have had no or one prior course of chemotherapy. Intravenous infusions will be administered weekly three weeks out of four for about five months.

• Zengen Inc., of Woodland Hills, Calif., said Phase I/II data for its molecule CZEN-002 to treat vulvovaginal candidiasis showed evidence of efficacy. The 20 patients that participated in the open-label, non-randomized study demonstrated 88.2 percent and 87.5 percent efficacy of the drug as determined by potassium hydroxide tests and mycological cultures, respectively. CZEN-002 is a non-azole antifungal synthetic octapeptide. The company plans to begin a Phase IIb dose-ranging study in Europe and Canada later this year.