• Active Biotech AB, of Lund, Sweden, and Avidex Ltd., of Oxford, UK, reported that the CD80 antagonist, RhuDex, for the treatment of rheumatoid arthritis, entered Phase I trials. RhuDex is an orally administered small molecule initially intended for the indication of rheumatoid arthritis. In April 2002, Active Biotech signed a licensing agreement with Avidex regarding Active's CD80 antagonists. The agreement grants Avidex the exclusive right to further develop and market the CD80 antagonists.

• Applied Biosystems Group, of Foster City, Calif., and Dartmouth Medical School presented data using a preliminary version of Applied Biosystems' TaqMan MicroRNA assays to profile microRNA expression in human brain cancer samples; miRNAs are a recently discovered class of small RNA molecules known to play a gene regulatory role in cell differentiation, developmental biology, cancer and other diseases.

• Astralis Ltd., of Fairfield, N.J., said results of its 120-patient Phase II trial of Psoraxine in the treatment of psoriasis did not demonstrate a statistically significant improvement after six injections in 20 weeks, according to the Psoriasis Area Severity Index, compared to placebo, though the drug was found to be safe. Following analysis of the data, the company said it has identified several factors, including the limited number of injections used and the formulation of the active components of the product, which might have contributed to the Phase II results. Data were presented at the Society of Investigational Dermatology meeting in St. Louis. Astralis' shares dropped by nearly half - losing 30 cents to close at 32 cents - when preliminary 12-week results were released March 14. (See BioWorld Today, March 15, 2005.)

• Coremed Inc., of Chicago, said its inhalable insulin, Alveair, is the focus of a consortium of international diabetes companies. Alveair is based on the company's insulin nanotechnology. Coremed also said its oral insulin (Intesulin) has started its first trial in human subjects, and early data from a limited number of patients have demonstrated positive results.

• Corgentech Inc., of South San Francisco, said its NF-kappaB Decoy candidate demonstrated a decrease in inflammation and swelling in preclinical models of atopic dermatitis. The product, which should enter Phase I/II trials by mid-year, was shown to not only reduce recruitment and proliferation of pro-inflammatory cells, but also to induce apoptosis of cells relating to inflammation. The data were presented at the Society for Investigative Dermatology Meeting in St. Louis.

• Cornerstone BioPharma Inc., of Cary, N.C., and Lupin Ltd., of Mumbai, India, entered a development and licensing agreement in which both companies will collaborate on the clinical development of a drug delivery system for an anti-infective product. Cornerstone would have the rights to sell and market the prescription drug in the U.S. upon FDA approval.

• Curis Inc., of Cambridge, Mass., said a new report has documented the beneficial effects of Hedgehog pathway stimulation for accelerated wound closure in an animal model of diabetes-impaired wound healing. The study was presented at the 66th annual meeting of the Society for Investigative Dermatology held last week in St. Louis.

• Cytomedix Inc., of Rockville, Md., completed the planned enrollment of 72 patients in the ongoing clinical trial to test the safety and effectiveness of its AutoloGel System to treat diabetic foot ulcers. In the trial, patients undergo up to 12 weeks of treatment and healed patients are followed for another 12 weeks. The trial should be completed in the second half of this year.

• Definiens AG, of Munich, Germany, and Cenix BioScience AG, of Dresden, Germany, entered a licensing and co-marketing agreement, formalizing an ongoing relationship. Cenix is providing research services for the life science industry and academic groups, focusing on the combination of high-throughput RNAi with high-content assays in human and rodent cells. For those groups capable of carrying out large-scale studies themselves, Definiens is providing its image analysis software system, Cellenger.

• Duska Therapeutics Inc., of Bala Cynwyd, Pa., said results of a research study to identify a Vagonixen drug candidate demonstrated that the compound A-317491, owned by Abbott Park, Ill.-based Abbott Laboratories, can block the activation of vagal pulmonary sensory nerve terminals by alpha, beta, methylene-ATP, a stable analogue of ATP that is a selective P2X receptor agonist. Vagonixen is Duska's proposed drug for the treatment of chronic obstructive pulmonary disease. Based on the data, Duska has filed a U.S. provisional patent application for the use of A-317491 as a P2X receptor antagonist in the treatment of COPD.

• Dyadic International Inc., of Jupiter, Fla., said Agencourt Bioscience Corp., of Beverly, Mass., completed the genome sequence of Dyadic's C1 fungus. The C1 organism can produce large volumes of enzymes for industrial, textile and agricultural applications. The work will permit Dyadic to mine the information from the fungal host for improved protein products for the pharmaceutical industry, as well as the energy, feed and food, and pulp and paper industries.

• GeneGo Inc., of St. Joseph, Mich., said that Procter & Gamble Pharmaceuticals Inc., a subsidiary of Procter & Gamble Co., of Cincinnati, licensed MetaCore and MetaBase from GeneGo. MetaCore is a manually curated, human database with the ability to work with rat, mouse, fly, yeast and worm orthologues. MetaCore also includes a suite of software tools for analysis in the context of pathways. MetaBase is designed to provide researchers with direct access to MetaCore content and the ability to add their own algorithms and data to the MetaCore schema.

• Genta Inc., of Berkeley Heights, N.J., saw its shares (NASDAQ:GNTA) rise 17.1 percent, or 19 cents, closing at $1.30, following the release of its first-quarter earnings. Genta reported revenues of $18.5 million and a profit of $14 million, or 15 cents per share. First-quarter profit was attributed to accelerated recognition of deferred revenues due to Paris-based Sanofi-Aventis Group's notice of termination of the 2002 Genasense (oblimersen sodium) injection collaboration agreements. As of March 31, Genta had cash, cash equivalents and marketable securities totaling $31.2 million.

• Immunicon Corp., of Huntingdon Valley, Pa., filed a universal shelf registration statement with the SEC to permit the offer, sale and issuance of up to $75 million of its common stock, preferred stock, debt securities, warrants, depositary shares, stock purchase contracts and stock purchase units.

• Inhibitex Inc., of Atlanta, reported top-line findings from its Phase II trial of Aurexis for the adjunctive treatment of Staphylococcus aureus bloodstream infections in combination with antibiotics, compared to antibiotic treatment alone. The company said favorable results were observed in the primary composite endpoint of mortality, relapse rate and infection-related complications, and in a number of secondary endpoints, including the progression in the severity of sepsis and days in the intensive care unit.

• InSite Vision Inc., of Alameda, Calif., entered definitive agreements for a $9 million private financing of common stock and warrants for common stock. The company is selling about 16.4 million newly issued shares of common stock at 55 cents per share, and has issued warrants to purchase about 4.9 million shares at about 63 cents per share. New York-based Paramount BioCapital Inc. is serving as the placement agent. Proceeds will be used for continued development and completion of Phase III pivotal trials with AzaSite to treat bacterial conjunctivitis.

• Lipid Sciences Inc., of Pleasanton, Calif., said data acquisition from its primate study is complete. The company said the study, conducted at the Wake Forest Baptist Medical Center, was designed to demonstrate the safety and effectiveness of Lipid Sciences' HDL Therapy in treating cardiovascular disease. The African green monkeys were evaluated with intravascular ultrasound to establish a baseline at the beginning of the study, with a second ultrasound conducted after 12 weekly infusions of plasma delipidated by the company's product. The infusions appear to have been well tolerated, and it is anticipated that the analysis of all data resulting from the study will be completed by mid-year.

• Novavax Inc., of Malvern, Pa., restructured its relationship with Cardinal Health Inc., of Dublin, Ohio, so that Novavax will manufacture Estrasorb and Cardinal Health will be responsible for the fill-finish operation that prepares the product in patient packaging. The new facility and packaging agreement will reduce Novavax's manufacturing costs. Estrasorb is a topical emulsion for estrogen therapy.

• PharmaStem Therapeutics Inc., of Wayne, Pa., said the U.S. Patent Office has confirmed patent claims on two of its patents, Nos. 6,461,645 and 6,569,427, stating that the prior art cited by third parties did not raise a new question of patentability. PharmaStem is the successor of Biocyte Corp., and develops umbilical cord blood preservation and its therapeutic use.

• Pro-Pharmaceuticals Inc., of Newton, Mass., dosed a colorectal cancer patient in a Phase II trial of intravenous Davanat in combination with 5-fluorouracil at Medical Oncology & Hematology PC in Waterbury, Conn. The trial is being conducted in metastatic colorectal cancer patients who have disease progression after receiving standard chemotherapeutic regimens. A total of seven medical centers will take part in the trial, which is expected to enroll up to 38 patients.

• Scottish Medicines Consortium, of High Wycombe, UK, announced that Amias (candesartan cilexetil), an angiotensin-receptor blocker, used in the treatment of essential hypertension, has been accepted for use in Scotland in patients with chronic heart failure and left ventricular systolic dysfunction as add-on therapy to an angiotensin-converting enzyme inhibitor (ACEi) or for those unable to tolerate an ACEi. The consortium reported that the use of Amias results in longer lives for patients and requires fewer hospitalizations.

• SkyePharma plc, of London, said the FDA approved Triglide, its formulation of fenofibrate. The approval will trigger a $15 million milestone payment from its partner Alpharetta, Ga.-based First Horizon Pharmaceutical Corp. SkyePharma granted First Horizon exclusive U.S. marketing and distribution rights for a cardiovascular product, and stands to receive up to $50 million in milestone payments, $30 million of which are sales based. In addition, SkyePharma will receive 25 percent of First Horizon's net sales. Fenofibrate is an oral treatment for lipid disorders, such as elevated cholesterol and triglycerides, but is insoluble in water. SkyePharma said its formulation, Triglide, has a comparable absorption under fed and fasting conditions and, therefore, allows patients to take the drug at any time.

• Southern Research Institute, of Birmingham, Ala., entered a joint collaborative research program with Kenilworth, N.J.-based Schering-Plough Corp. to discover compounds for treating infectious diseases. Building on leads generated from Southern Research's compound repository, scientists from both companies will work as a drug discovery team in a lead expansion and optimization program. Southern Research will share in intellectual property and receive milestone payments.

• Stratagene Corp., of La Jolla, Calif., has filed suit against Third Wave Technologies Inc., of Madison, Wis., for infringement of Stratagene's patents covering its FullVelocity technology for the quantitative detection of nucleic acids. The company said FullVelocity is a high-speed reagent system for quantitative PCR and QRT-PCR.

• V.I. Technologies Inc., of Watertown, Mass., said that its president, John Barr, will resign from the company following a transition period expected to last until the end of July 2005. Prior to closing the merger with Panacos Pharmaceuticals Inc., of Gaithersburg, Md., on March 11, Barr was president and CEO of V.I. Technologies. (See BioWorld Today, March 11, 2005.)

• Viragen Inc., of Plantation, Fla., and Cancer Research Technology Ltd., of London, announced a license agreement that provides Viragen with worldwide, exclusive rights to commercialize the anti-CD55 antibody, which is in preclinical development in cancer. Viragen recently reported that the anti-CD55 antibody, known as VG102, was able to enhance the action of Rituxan (rituximab, Genentech Inc. and Biogen Idec Inc.), resulting in the significant increase in the destruction of cancer cells in vitro, indicating the potential of the agent to be used effectively in combination with other therapies. Financial terms were not disclosed.