Actelion Ltd., of Allschwil, Switzerland, said the European Commission granted marketing authorization for Tracleer tablets for pulmonary arterial hypertension. The authorization is valid for all 15 EU member states and also will be recognized by Norway and Iceland. By June 15, patients in Germany and the United Kingdom will be the first to have access to the treatment. Actelion expects to introduce Tracleer, an orally active endothelin receptor antagonist, in most other European Union markets by the end of the year.

AVI BioPharma Inc., of Portland, Ore., completed two preclinical studies indicating the concept of using its antisense as a new form of antibiotic may have therapeutic relevance. Data from the studies will be presented in sessions at the annual meeting of the American Society of Microbiology in Salt Lake City. One paper is "Isolation and Partial Characterization of a Calicivirus from a Cat with Hepatitis and Hemorrhagic Enteritis." Identification of the lethal virus is important because it can be transferred from companion animals to humans. The other paper is titled "Antisense Phosphorodiamidate Morpholino Oligonucleotide Transport and Inhibition of Gene Expression in E. coli."

Biogen Inc., of Cambridge, Mass., said the European Regulatory Agency for pharmaceuticals approved Avonex, its drug for patients at high risk of developing clinically definite multiple sclerosis after a patient has one multiple sclerosis attack, making it the only MS treatment approved for earlier use. The standard practice of MS diagnosis and treatment previously involved diagnosis only after patients experienced two separate attacks or demyelinating events. The approval is based on data from Biogen's long-term clinical study known as CHAMPS (controlled high-risk subjects Avonex multiple sclerosis prevention study).

Cell Therapeutics Inc., of Seattle, presented preliminary results from five Xyotax clinical trials at an investor meeting Monday. The results suggest Xyotax (polyglutamate paclitaxel, or CT-2103), as an alternative to marketed taxanes, may provide superior clinical benefit, including easier administration and a better disease control rate and safety profile. One example is from a Phase I study in combination with cisplatin in which six of 21 patients demonstrated platinum/taxane-resistant ovarian cancer, and after treatment with Xyotax and cisplatin, all six showed disease control. Xyotax is a first-in-class drug that links paclitaxel, the active ingredient in Taxol, to a biodegradable polyglutamate polymer.

Cephalon Inc., of West Chester, Pa., funded a study at the Sleep Disorders Center at Thomas Jefferson University in Philadelphia demonstrating that Modafinil was effective in reducing fatigue and sleepiness in patients with major depressive disorder. Of 136 patients randomized, 118, or 87 percent, completed the study. Of those, 82 percent were fatigued and half were sleepy. Modafinil rapidly improved fatigue and daytime wakefulness, with significantly greater mean scores from baseline than placebo in Fatigue Severity Scale scores at week two (p<0.05) and Epworth Sleepiness Scale scores at week one (p<0.01), investigators said. Modafinil was well tolerated in combination with a variety of antidepressants.

Dynavax Technologies Corp., of Berkeley, Calif., initiated a Phase I study of its inhaled ISS (immunostimulatory DNA sequence) for asthma. The trial will test pharmacokinetics and biological activity and be used as the basis for selecting an appropriate dose for Phase II study. The randomized, placebo-controlled study will evaluate three dosages of ISS-1018 administered via nebulizer to 54 healthy male volunteers.

Human Genome Sciences Inc., of Rockville, Md., and Cambridge Antibody Technology plc, of Melbourn, UK, said that HGS exercised an option to enter an exclusive development partnership on a human monoclonal antibody to Trail Receptor-2. Trail-R2 MAb is an agonistic antibody designed to specifically recognize the Trail Receptor-2 protein, found on the surface of a number of solid and hematopoietic tumors. Trail receptor-2 is a member of the tumor necrosis factor family of receptors.

Idun Pharmaceuticals Inc., of San Francisco, presented results from its Phase I trial of IDN-6556 showing that it was safe and well tolerated in a study involving 76 normal adults and patients with mild liver impairment. Statistically significant and clinically relevant improvements in liver enzymes were seen in the patients with mild liver impairment and stable hepatitis C infection. Idun plans to study IDN-6556 in larger Phase II trials in patients with HCV infection and acute alcoholic hepatitis. Idun said IDN-6556 is the first broad-spectrum caspase inhibitor to be studied in humans and acts to preserve the structure and function of cells under stress. The results were presented at the Digestive Disease Week 2002 conference in San Francisco.

Matritech Inc., of Newton, Mass., and Bruker Daltonics Inc., of Billerica, Mass., partnered to develop an automated mass spectrometer system that would allow clinical laboratories to perform Matritech's proteomics-based cancer tests, including blood tests for breast and prostate cancer. The companies will optimize Bruker's mass spectrometers to perform Matritech's cancer screening tests.

Morewood Molecular Sciences Inc., of Pittsburgh, received a Phase I Small Business Innovation Research grant from the National Institutes of Health in Bethesda, Md., to support development of its high-throughput enzyme-assaying technology. Morewood plans to create a caspace chip to model apoptotic pathways in cells subjected to various chemical agents.

NaPro BioTherapeutics Inc., of Boulder, Colo., received an $8 million milestone payment from its marketing and development partner, Abbott Laboratories, of Abbott Park, Ill. The payment was due upon first commercial sale of NaPro's paclitaxel by Abbott in the United States. The companies entered a partnership valued at $125 million in 1999 to develop and commercialize at least one formulation of paclitaxel for cancer in the United States and Canada. (See BioWorld Today, July 27, 1999.)

Novacea Inc., of South San Francisco, formerly known as D-Novo Therapeutics, said it is making progress with its lead compound, DN-101, a formulation of calcitriol for the treatment of androgen-independent prostate cancer. Novacea is planning a randomized, double-blind clinical trial of DN-101 in the third quarter of 2002.

Onyx Pharmaceuticals Inc., of Richmond, Calif., said a paper describing its new virus, ONYX-411, was published online in the May 2002 issue of Cancer Cell. The paper is titled "Selectively Replicating Adenoviruses Targeting Deregulated E2F Activity are Potent, Systemic Anti-Tumor Agents." ONYX-411 was engineered to target cancer cells that have lost control of the regulatory pathway known as Rb, but not healthy cells that maintain a properly controlled Rb pathway.

Orchid BioSciences Inc., of Princeton, N.J., said that its diagnostics business launched the LifeMatch platform in the United States for human leukocyte antigen genotyping and antibody detection. The system runs on the Luminex xMAP platform using reagents developed by Orchid researchers. It includes instrumentation, reagents and software developed for integrated performance, providing laboratories with the components to test more than 350 samples in a single shift. LifeMatch uses a sequence-specific oligonucleotide probe technique that uses fluorescent-labeled beads to simultaneously detect multicolored beads in suspension.

Valentis Inc., of Burlingame, Calif., granted a nonexclusive license to Medigene AG, of Martinsried, Germany, for Valentis' GeneSwitch gene regulation technology for research purposes. The agreement involves an up-front payment and annual maintenance fees. Valentis said the GeneSwitch system allows researchers to control the level and duration of selected genes in transgenic animals and cell cultures, aiding in the identification and characterization of a gene's function.

Zygogen LLC, of Atlanta, and Aventis Pharma SA, of Frankfurt, Germany, launched a pilot project to develop a zebrafish model for thrombosis. The collaboration will combine Zygogen's Z-Tag technology and Aventis' expertise in thrombosis drug discovery to create a new disease model that can be used for identifying and validating new targets, as well as compound screening. Z-Tag zebrafish provide an opportunity to visualize in real-time platelet aggregation and adhesion in a living vertebrate organism.