• Accelrys Inc., of San Diego, formed an agreement with Bayer Healthcare AG, of Leverkusen, Germany, under which Bayer licensed a library of life science modeling software from Accelrys. Those tools will be applied at Bayer's research centers in Germany and the U.S.

• Advanced Viral Research Corp., of Yonkers, N.Y., said it had a successful pre-investigational new drug application meeting with the FDA and expects to submit an application for the injectable use of AVR118 in patients with cancer by the end of this year or early next. A peptide-nucleic acid complex, the biopolymer has immunomodulatory activity and appears to stimulate pro-inflammatory responses and to dampen aberrant autoimmune-type inflammatory responses.

• Adventrx Pharmaceuticals Inc., of San Diego, appointed Evan Levine president and CEO. He replaces Nicholas Virca, who resigned. For the past two years, Levine has served as vice chairman and chief operating officer of Adventrx, which focuses on cancer and antiviral research.

• Alfacell Corp., of Bloomfield, N.J., said it was approved for relisting on the Nasdaq SmallCap Market under "ACEL." The company's common stock began trading on Thursday. The company is conducting pivotal Phase III trials and preparing for a new drug application filing for its lead product, Onconase, to treat malignant mesothelioma.

• Amarillo Biosciences Inc., of Amarillo, Texas, submitted requests to the FDA's Office of Minor Use and Minor Species Animal Drug Development for listing a designated new animal drug for the company's natural human interferon alpha to treat or prevent a number of animal diseases, including foot-and-mouth disease in cattle and swine, rotavirus in sheep and papilloma, or rotavirus in rabbits.

• American Oriental Bioengineering Inc., of Hong Kong, completed its acquisition of the Chinese pharmaceutical company Heilongjiang Songhuajiang Pharmaceutical Ltd. (HSPL). American Oriental entered the agreement in May to purchase HSPL for $7.2 million in cash. It expects the acquisition to add about $10 million to $12 million in revenue in 2005, as well as about $12 million in net assets. American Oriental produces soybean protein peptides for medicinal products and other uses.

• Anadys Pharmaceuticals Inc., of San Diego, entered a three-year drug discovery collaboration with Aphoenix Inc., of Tokyo. Anadys will apply its drug discovery capabilities to discover and advance lead compounds against Aphoenix targets in multiple therapeutic indications. Aphoenix has early stage programs in respiratory and anti-inflammatory diseases. The agreement includes up-front and future research funding, plus potential milestone payments to Anadys, which also will share in potential downstream value through royalty payments.

• ARC Pharmaceuticals Inc., of Vancouver, British Columbia, said findings published in the August 2004 issue of Inflammation Research showed that camptothecin-loaded polymeric films reduced the number, severity and extent of adhesions in the rat cecal sidewall model of surgical adhesion disease. The inflammatory disorder causes dysfunction and pain and is a complication in a high proportion of common surgical procedures.

• Arriva Pharmaceuticals Inc., of Alameda, Calif., appointed Robert Williamson CEO. Williamson previously had been an adviser to the company, and the president and chief operating officer of Eos Biotechnology, which was acquired in April 2003 by Protein Design Labs Inc., of Fremont, Calif. Arriva focuses on major respiratory diseases, and its lead compound is recombinant alpha 1-antitrypsin.

• Berlex Laboratories Inc., of Montville, N.J., said its application for Bonefos (clodronate) was accepted for filing and designated for priority review by the FDA. The company, a U.S. affiliate of Schering AG, of Berlin, is seeking approval for the product as an adjuvant oral treatment for reducing the occurrence of bone metastases in Stage II/III breast cancer patients.

• BioCurex Inc., of Richmond, British Columbia, reported positive detection results for an additional type of cancer using its Recaf-based blood test. The company said 73 samples from colon cancer patients were compared to 352 normal samples. The Recaf test detected 74 percent at 95 percent specificity, and the sensitivity remained better than 71 percent when the specificity was increased to 100 percent.

• Cartagen Molecular Systems Inc., of Seattle, launched a homogenization kit for the extraction of DNA from plant leaf tissue. The kit is designed for plant leaf samples and enables investigators to process a sample yielding a solution containing DNA, ready to be amplified using polymerase chain reaction.

• Cel-Sci Corp., of Vienna, Va., said its immunotherapy drug Multikine was shown to lower cholesterol in clinical studies involving 120 head and neck cancer patients. The company said that patients treated with Multikine showed no liver toxicity. A meta-analysis of clinical data from the four clinical trials showed the reduction of total cholesterol following treatment to be highly statistically significant (p<0.0001). Multikine consists of naturally occurring cytokines including interleukins, interferons, chemokines and colony-stimulating factors.

• Critical Therapeutics Inc., of Lexington, Mass., licensed a key patent from the University of Florida that provides exclusive composition-of-matter and method-of-use rights to a family of compounds known as cinnamylidene-anabaseines. The compounds target and stimulate the nicotinic alpha-7 cholinergic receptor. The licensed intellectual property comes from U.S. Patent No. 5,977,144.

• Cypress Bioscience Inc., of San Diego, said it expects its partner, Forest Laboratories Inc., of New York, to initiate the second Phase III trial evaluating milnacipran for the treatment of fibromyalgia syndrome during the fourth quarter. Cypress is running the first Phase III trial for milnacipran, which began in October. Milnacipran inhibits the reuptake of both norepinephrine and serotonin.

• Diffusion Pharmaceuticals LLC, of Charlottesville, Va., was awarded a $1 million government grant that the company plans to allocate for studies to advance its lead compound, trans sodium crocetinate (TSC), toward human trials. TSC is being developed for illnesses characterized by hypoxia, including hemorrhagic shock following severe blood loss.

• Ecopia BioSciences Inc., of Montreal, reported that its discovery team identified 12 compounds. Four of the compounds were selected for advancement and fall within Ecopia's selected therapeutic fields, demonstrating anticancer, antibacterial or antifungal activity. The compounds are new chemical entities discovered from microorganisms using the company's Decipher technology.

• Encysive Pharmaceuticals Inc., of Houston, completed enrolling 240 patients in the company's multicenter, pivotal Phase III STRIDE-2 (Sitaxsentan To Relieve Impaired Exercise) trial to evaluate the safety and efficacy of Thelin, or sitaxsentan, in patients with pulmonary arterial hypertension. Enrollment will continue through today in order to accept patients still in screening. Thelin is a small molecule that blocks the action of endothelin, a mediator of blood vessel constriction and growth of smooth muscle in vascular walls.

• eXegenics Inc., of Pittsford, N.Y., completed an agreement to license its QCT drug discovery technology to NLC Pharma Inc., of Israel. eXegenics will receive up to $20 million from royalties, licenses or the sale of QCT technology to third parties that are generated by NLC Pharma. QCT is a rational drug design technology based on quantum chemistry, proprietary computational software and molecular modeling. eXegenics also said it received notice that, in addition to its bid price deficiency, it was no longer in compliance with Nasdaq's independent director and audit committee requirements rule. The company was scheduled for a listing qualifications hearing on Thursday.

• Genelabs Technologies Inc., of Redwood City, Calif., said clinical data on Prestara (prasterone) in systemic lupus erythematosus (SLE) were published in Arthritis & Rheumatism. The objective of the trial was to determine whether Prestara improved or stabilized SLE disease activity and symptoms. It monitored disease activity, organ damage and health-related quality of life. A total of 381 women were enrolled in the trial. Researchers found that a greater percentage of patients receiving Prestara responded at a statistically significant rate to the therapy compared with those receiving placebo. The FDA issued an approvable letter for Prestara in 2002, contigent on the successful completion of an additional clinical trial. The results of that study are expected in the fourth quarter. (See BioWorld Today, Sept. 3, 2002.)

• Genzyme Corp., of Cambridge, Mass., said it completed the Phase IV study of Fabrazyme (agalsidase beta) and performed a preliminary analysis of the results. Completing the study was required by the FDA when it approved Fabrazyme in April 2003 to treat Fabry's disease. In its analysis it found that a large proportion of patients receiving Fabrazyme had high proteinuria. The company made an adjustment to correct the imbalance, then it found that of the 82 patients in the study, those receiving Fabrazyme were 53 percent less likely than placebo patients to experience a clinically significant event. Infusion reactions also occurred at a higher rate in the treatment group and most frequently consisted of fever and chills, but the incidence of serious adverse events was similar among the treatment and placebo groups. Genzyme expects to present detailed results at several scientific meetings next month.

• Global Genomics AB, of Stockholm, Sweden, said findings published in Nucleic Acids Research detail the company's tangerine gene-expression profiling method. Specifically, the paper describes the features of tangerine gene-expression profiling - unbiased whole-genome coverage, automatic combinatorial gene identification and sensitivity down to 7.5 parts per 10 million transcripts - and analyzes performance across multiple experiments.

• Insmed Inc., of Richmond, Va., initiated a Phase I trial of its antitumor agent, recombinant human insulin-like growth factor binding protein-3. The trial is an open-label, dose-escalation study designed to evaluate for the first time in humans, the safety, tolerability and pharmacokinetics of a single intravenous dose of rhIGFBP-3.

• Isotechnika Inc., of Edmonton, Alberta, said interim results of its lead immunosuppressive drug, ISA247, showed there were no ECG changes or QTc signals seen in the treatment group as compared to placebo. At a dose about 11 times higher than the expected maximum dose for the upcoming Phase III psoriasis trials, the interim report noted that there were no changes in cardiac conduction or morphology. The company expects to file later this fall to conduct a Canadian Phase III psoriasis trial.

• Maxygen Inc., of Redwood City, Calif., and Rentschler Biotechnologie GmbH, of Laupheim, Germany, signed an agreement for the scale-up and manufacture of Phase I and Phase II supplies of Maxygen's next-generation granulocyte-cell stimulating factor (G-CSF) molecule. Preclinical data from primate, rat and mouse models suggest the candidate reduces the duration of neutropenia by 25 percent when compared to currently marketed products. The company expects to advance G-CSF into clinical development in the next 18 to 24 months.

• Neurocrine Biosciences Inc., of San Diego, reported positive efficacy and safety results from its Phase III trial of modified-release indiplon 15 mg in 229 elderly patients with chronic insomnia. Efficacy data demonstrated a statistically significant improvement on the primary endpoint of patient-reported total sleep time as compared to placebo (p<0.0001) at all time points during the two-week study. Improvements in secondary patient-reported sleep maintenance endpoints, such as wake after sleep onset, total wake time and number of awakenings after sleep onset, also were statistically significant (p<0.0001) for all parameters and at all time points. The company said it remains on track to submit new drug applications for the immediate- and modified-release formulations beginning next month. The NDAs will include data from Phase I, II and III trials including more than 7,400 patients.

• Norak Biosciences Inc., of Research Triangle Park, N.C., said that F. Hoffmann-La Roche Ltd., of Basel, Switzerland, exercised a second-year option to screen more of its G protein-coupled receptor targets using Norak's Transfluor technology. The option was part of a 2-year-old agreement between the companies. Terms call for Norak to provide its Transfluor cell lines expressing GPCR targets of interest to Roche for use in a primary screen of its compound libraries. Financial terms were not disclosed.

• Oscient Pharmaceuticals Corp., of Waltham, Mass., launched once-daily Factive (gemifloxacin mesylate) tablets, a new oral antibiotic approved by the FDA for the treatment of acute bacterial exacerbations of chronic bronchitis and mild to moderate community-acquired pneumonia.

• Stressgen Biotechnologies Corp., of San Diego, broadened the clinical program for its lead candidate, HspE7, by enrolling patients with internal genital warts in a Phase II trial. Fifteen of the 30 patients in the trial have been enrolled. The primary endpoint of the single-arm pilot study will be complete response at six months measured by complete clearance of baseline internal warts. Patients will be followed for a year and the first data should be available in mid-2005.

• Trimeris Inc., of Durham, N.C., appointed Steven Skolsky CEO and a board member. He succeeds company founder Dani Bolognesi, who will continue as chief scientific officer and was named vice chairman. Skolsky joined Trimeris from GlaxoSmithKline plc, of London, where he was senior vice president of global commercial strategy. Trimeris is developing therapeutic agents for viral disease, in particular HIV.

• Vicuron Pharmaceuticals Inc., of King of Prussia, Pa., completed enrollment in a Phase III trial of anidulafungin for invasive candidiasis/candidemia. The double-blind, randomized trial of more than 250 patients was designed to study the safety and efficacy of a 100-mg daily dose of anidulafungin preceded by an initial 200-mg loading dose of anidulafungin vs. fluconazole. Patients received daily intravenous infusions for 10 to 42 days, and the primary endpoint is global assessment of clinical and microbiological responses at the end of therapy. The company expects to release results in the first quarter.

• Vyrex Corp., of La Jolla, Calif., said it is moving forward with plans to use its antioxidant and prodrug technologies to develop radioprotective agents against nuclear and radiologic terrorism. The first agent, GEN-VYX1-2004, has been synthesized, underwent initial animal toxicity studies and was found to be non-toxic.

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