• Aegera Therapeutics Inc., of Montreal, said data reported at the Federation of Clinical Immunology Societies conference in Boston detailed the induction of apoptosis as a therapeutic intervention to eliminate encepalitogenic T cells. Preclinical findings showed that when symptomatic mice were treated daily with antisense XIAP (X-linked Inhibitor of Apoptosis Protein; AEG35169), there was a dramatic reduction in incidence and degree of clinical scores within five days. AEG35169 is a mouse analogue of Aegera's current clinical candidate, AEG35156, a second-generation antisense oligonucleotide designed to block the cellular synthesis of XIAP.

• Aegis Therapeutics Inc., of San Diego, entered an agreement to license an anti-obesity peptide from Albany Medical College in Albany, N.Y. The company said it would employ its Intravail intranasal peptide delivery technology with the peptide to assess its commercial potential and to seek partnerships with obesity-interested companies. Financial terms were not disclosed.

• Alliance Pharmaceutical Corp., of San Diego, said its PFC Therapeutics LLC subsidiary and Beijing Double-Crane Pharmaceutical Co. Ltd., of Beijing, entered a development, license and supply agreement for Oxygent, an intravascular oxygen therapeutic, in the Peoples' Republic of China. Double-Crane, which will make undisclosed up-front, milestone and royalty payments to Alliance, will conduct clinical trials in China. Alliance will have the right to use any resulting data in other countries. Double-Crane will have the option to manufacture Oxygent in China, after approval, and also will have a right of first refusal to add specific additional countries to the agreement upon further negotiation with Alliance. Specific financial terms were not disclosed.

• Androclus Therapeutics, of San Diego, completed its first institutional financing round to advance its product development programs in rheumatoid arthritis, multiple sclerosis and inflammatory bowel disease. Investors E. de Rothschild Investment Partners and Matignon Technologies led the financing. Michele Ollier, of Rothschild, and Guillaume Connan, of Matignon, were elected to the board.

• Avanir Pharmaceuticals Inc., of San Diego, said Gerald Yakatan resigned as president and CEO, and stepped down from the company's board, after seven years at the helm. He will continue as a consultant for a year to advise Avanir on its new drug application for Neurodex. As the company works to identify a new CEO, its board has asked Chairman Charles Mathews to assist management on day-to-day operational matters.

• Axonyx Inc., of New York, said its board of directors approved the adoption of a shareholders' rights plan to ensure that shareholders realize fair value and equal treatment in the event of an attempted takeover. It was not adopted as a result of any existing or proposed potential takeover threat, the company said.

• Barrier Therapeutics Inc., of Princeton, N.J.; Cardiome Pharma Corp., of Vancouver, British Columbia; Draxis Health Inc., of Mississauga, Ontario; Idenix Pharmaceuticals Inc., of Cambridge, Mass.; and Progenics Pharmaceuticals Inc., of Tarrytown, N.Y., will have their stocks added to the Nasdaq Biotechnology Index, effective May 23.

• Cel-Sci Corp., of Vienna, Va., said scientists, in collaboration the John Hopkins University Department of Pathology, reported animal data showing that pretreatment and early therapy of experimental autoimmune myocarditis with a compound developed by Cel-Sci resulted in reduction in heart enlargement and disease-associated histopathological changes. The compound used to achieve those results was derived from the company's L.E.A.P.S. (Ligand Epitope Antigen Presentation System) platform technology. Data were presented at the Federation of Clinical Immunology Societies annual meeting in Boston.

• Coley Pharmaceutical Group Inc., of Wellesley, Mass., said the waiting period has expired relating to the company's agreement with Pfizer Inc., of New York, triggering a $50 million payment to Coley. The pair entered a global license agreement in March for the development and worldwide commercialization of Coley's ProMune, also called CPG 7909, a Toll-like receptor drug for cancer. (See BioWorld Today, March 25, 2005.)

• CollaGenex Pharmaceuticals Inc., of Newtown, Pa., said it would restructure as a result of the FDA's approval of a generic form of Periostat for sale by IVAX Pharmaceuticals Inc., of Miami, and CorePharma LLC, of Middlesex, N.J. Periostat is sold as 20-mg tablets of doxycycline hyclate and is the only systemic adjunct to scaling and root planning for adult periodontitis. Unless CollaGenex can get an injunction, the firm will cease all sales and marketing activity with respect to Periostat as of Friday, May 20, and will execute plans to reduce its head count by 63 people, including all of its dental sales force. The 34-person dermatology sales force will continue to market Pandel (hydrocortisone probutate cream, 0.1 percent), a prescription corticosteroid, prepare for the launch of Oracea (doxycycline) for rosacea, with Phase III data due in June. CollaGenex also plans to keep developing its dermatology pipeline. A judge's report already has recommended denial of the company's motion to block the generic version.

• Corautus Genetics Inc., of Atlanta, and Boehringer Ingelheim Austria GmbH, of Vienna, Austria, said they have entered a long-term manufacturing agreement to produce vascular endothelial growth factor-2 plasmid DNA for a Phase III trial and future commercial use to treat cardiovascular disease (severe angina) and other indications. A Phase IIb trial is ongoing by Corautus. Boehringer began feasibility and GMP activities several months ago.

• Enzo Biochem Inc., of New York, said scientists from Hadassah Hebrew University Medical Center and Enzo Therapeutics, a wholly owned subsidiary, presented a paper on a Phase IIb study of the drug Alequel in Crohn's disease, which demonstrated that clinical remission rates observed during the trial were 58 percent for patients receiving Alequel compared to 29 percent for patients on placebo. A clinical response was seen in 67 percent of the participants receiving the drug compared to 29 percent with placebo, and of the patients taking Alequel 43 percent experienced an improvement in their overall quality of life. The company is presenting those results at the Digestive Disease Week Conference in Chicago.

• GeneGo, Inc., of St. Joseph, Mich., said the Translational Genomics Research Institute has licensed MetaCore, GeneGo's platform for mining high-throughput experimental data in the context of the human and mammalian "interactome" (system of protein-to-protein interaction networks) and common diseases. MetaCore is designed to process genome-scale data files including microarrays and SAGE gene expression, proteomics and metabolomics.

• Hemispherx Biopharma Inc., of Philadelphia, initiated clinical trials as part of an accelerated evaluation of the experimental biotherapeutic Alferon LDO (low dose oral interferon alfa-n3 [human leukocyte derived]) as a potential new experimental therapy for avian flu and other lethal viral diseases that have high acute death rates. Clinical trials in human volunteers are designed to determine whether Alferon N, delivered in a new, experimental oral drug delivery format, can resuscitate the broad-spectrum antiviral and immunostimulatory genes. Those human genes are shut down by acute lethal viral infections such as avian flu and smallpox.

• Indevus Pharmaceuticals Inc., of Lexington, Mass., said it agreed to consent to the acquisition by Saturn Pharmaceuticals Inc., of the rights to market Sanctura from Odyssey Pharmaceuticals Inc., of Florham Park, N.J., a subsidiary of Pliva dd. Under the terms of the amendment and consent, certain provisions of Indevus' license, commercialization and supply agreement, originally with Odyssey, were amended. Sanctura is indicated overactive bladder with symptoms of urge urinary incontinence, urgency and urinary frequency. Saturn Pharmaceuticals is a privately held pharmaceutical company recently formed by two private equity firms, New Enterprise Associates and Domain Associates.

• InterMune Inc., of Brisbane, Calif., said findings from a study evaluating the use of daily Infergen (interferon alfacon-1) in combination with ribavirin in patients with hepatitis C showed that, of patients who failed to show at least a 2log drop in viral load after 12 weeks of first-line therapy with PEG interferon alpha-2b and ribavirin, about 37 percent achieved a sustained virologic response when re-treated with Infergen plus ribavirin. Results of a monotherapy study comparing Infergen in daily vs. three-times-per-week dosing indicated that 20 percent (33 of 168) of patients taking daily Infergen achieved a sustained virologic response compared to 11 percent (19 of 167) for patients receiving 48 weeks of TIW monotherapy and 12 percent (20 of 171) for those receiving TIW monotherapy for 72 weeks. The findings were presented at the Digestive Disease Week meeting in Chicago. InterMune also presented preclinical data on two selective small-molecule inhibitors, which demonstrated specificity and tolerability against the hepatitis C NS3/4 protease.

• Invitrogen Corp., of Carlsbad, Calif., signed a definitive agreement to acquire privately held immunological assay manufacturer Caltag Laboratories, of Burlingame, Calif., in a cash transaction totaling $20 million. Caltag makes and markets antibodies and reagents for biotechnology and pharmaceuticals companies, private and university hospitals, and research laboratories. The transaction is expected to close by the end of the second quarter.

• MedImmune Inc., of Gaithersburg, Md., said data from a Phase I/II study demonstrated that Numax, a humanized monoclonal antibody, appeared to be safe and well tolerated, with an acceptable pharmacokinetic profile, in infants at high risk of respiratory synctial virus disease. MedImmune is developing Numax as a potential improvement to Synagis (palivizumab), which it introduced to the market in 1998. The company presented the information at the annual meeting of the Pediatric Academic Societies in Washington. Also at the meeting, the company presented data from several studies that provide evidence that its live, attenuated intranasal influenza vaccines, including the marketed FluMist (influenza vaccine live, intranasal) and the investigational CAIV-T (cold adapted influenza vaccine, trivalent) might provide broad protection against influenza.

• Peregrine Pharmaceuticals Inc., of Tustin, Calif., said that a research article was published in the May 15, 2005, issue of Cancer Research. It showed that 3G4 (a murine equivalent of the company's Tarvacin monoclonal antibody) in combination with docetaxel resulted in a 93 percent inhibition of human breast cancer growth in mouse models. The researchers found that docetaxel increased the exposure of the 3G4 target on tumor blood vessels but not healthy tissue.

• Sucampo Pharmaceuticals Inc., of Bethesda, Md., said it received a $20 million milestone payment from Osaka, Japan-based Takeda Pharmaceutical Co. Ltd. for initiating a Phase III trial of lubiprostone to treat patients with constipation-predominant irritable bowel syndrome. Lubiprostone is a class of functional fatty acid that produces chloride channel-opening activity.

• Vyteris Holdings Inc., of Fair Lawn, N.J., the parent corporation of Vyteris Inc., said the SEC has declared effective its registration statement covering nearly 13 million shares of its common stock, which consist of 7.8 million outstanding shares and 5.1 million shares covered by outstanding warrants. Vyteris Holding develops and manufactures products based on its Actyve transdermal drug delivery technology.