• Alfacell Corp., of Somerset, N.J., reported that Onconase substantially decreases reactive oxygen intermediates (ROI) in normal cell types and tumor cell lines, and that the antioxidant effect might be important to the drug s cytotoxic effect on cancer cells. In vitro research demonstrated that treatment of cells in cultures with Onconase reduced intracellular oxidative stress by suppressing ROI generation and promoting their degradation. Data also indicated that the drug has a propensity to reverse the generation of ROI from asbestos exposure in mesothelial cells. Those results were published in the International Journal of Oncology. Alfacell currently is conducting a Phase IIIb trial of Onconase in patients with unresectable malignant mesothelioma.

• Biogen Idec Inc., of Cambridge, Mass., and Elan Corp. plc, of Dublin, Ireland, said the National Institute for Health and Clinical Excellence in the UK issued final guidance recommending the use of Tysabri (natalizumab) in people with highly active relapsing remitting multiple sclerosis. The companies said that following a positive NICE decision, there is a legal requirement for funding to be put in place to cover treatment within three months of the recommendation. In addition, clinicians are required to take the NICE guidance into account when reaching decisions about appropriate care for patients.

• BioMarin Pharmaceutical Inc., of Novato, Calif., licensed intellectual property from the University of California in San Francisco covering compounds that modulate the cystic fibrosis transmembrane conductance regulator (CFTR) protein. The compounds target the misfolding and activation of abnormal CFTR protein that underlie cystic fibrosis. BioMarin expects to conduct additional animal testing and optimization with the lead compounds prior to filing an investigational new drug application in 2009. Terms were not disclosed.

• Cell Therapeutics Inc., of Seattle, said its wholly owned subsidiary Systems Medicine LLC entered a Cooperative Research and Development Agreement (CRADA) with the National Institutes of Health's National Cancer Institute. The five-year CRADA will focus on human monoclonal antibodies, peptides and small molecules targeting a ligand that activates insulin-like growth factor receptor type I (IGF-IR). Systems Medicine retains an option to all resulting products. Cell Therapeutics acquired Systems Medicine last month. (See BioWorld Today, July 26, 2007.)

• Ceragenix Pharmaceuticals Inc., of Denver, said it is still in discussions with potential marketing partners for EpiCeram, its FDA-approved, nonsteroidal cream for dry skin and dermatitis. The company said it missed previously expected deadlines for signing a partner due to management and corporate changes within some potential partners that delayed or eliminated the possibility of completing a deal. Ceragenix still intends to close a deal in time to launch the product in the first half of 2008.

• Draxis Health Inc., of Mississauga, Ontario, said its DraxImage radiopharmaceutical business unit signed a research agreement with Med Discovery SA, of Geneva. The research will use DraxImage's radiopharmaceutical expertise to radiolabel Med Discovery's targeted protein therapeutics for cancer. Terms were not disclosed.

• Generex Biotechnology Corp., of Worcester, Mass., said its wholly owned immunotherapy subsidiary, Antigen Express Inc., entered an agreement with the University of Rochester as part of its efforts to develop a vaccine against avian influenza. The collaboration involves the peptide vaccine technology of Antigen Express and participation by John Treanor, a professor of medicine and of microbiology and immunology. Terms of the deal were not disclosed. In addition to an avian flu vaccine, the company also is conducting clinical trials of another peptide aimed at stimulating an immune response to a tumor-associated protein in breast cancer patients. That program is in Phase II development.

• Hana Biosciences, of South San Francisco, received fast-track designation from the FDA for Marqibo (vincristine sulfate injection, Optisome) in the treatment of relapsed or refractory adult patients with Philadelphia chromosome negative acute lymphoblastic leukemia (ALL). Hana is conducting a Phase II trial in that indication and is planning a Phase III trial in elderly, newly diagnosed ALL patients. Marqibo is an Optisomal formulation of vincristine, a microtubule inhibitor approved to treat hematologic malignancies. Shares of Hana (NASDAQ:HNAB) rose 32 cents, or 24 percent, to close at $1.68 on Wednesday.

• Janssen LP, of Titusville, N.J., received FDA approval for Risperdal (risperidone) as the first treatment on the U.S. market for schizophrenia in adolescents ages 13-17. The drug also was approved for the short-term treatment of manic or mixed episodes of bipolar I disorder in pediatric patients ages 10-17. Regulators said the approval does not include Risperdal Consta, a long-acting injectable form of the drug.

• Lexicon Pharmaceuticals Inc., of The Woodlands, Texas, said it discovered and optimized a series of orally administered, peripherally acting small-molecule inhibitors of the key enzyme responsible for producing serotonin in the gastrointestinal tract, tryptophan hydroxylase 1 (TPH1). In preclinical studies with the molecules, including LX1031, Lexicon confirmed that serotonin levels could be predictably reduced in the intestine without affecting levels of the neurotransmitter in the brain. The data were presented at the American Chemical Society meeting in Boston.

• Neurocrine Biosciences Inc., of San Diego, said the FDA accepted its resubmitted new drug application for indiplon 5-mg and 10-mg capsules for the treatment of insomnia, and set a PDUFA action date of Dec. 12. Neurocrine resubmitted the NDA in June, following receipt of an approvable letter last year. (See BioWorld Today, June 14, 2007.)

• Operon Biotechnologies, of Huntsville, Ala., and DNA2.0 Inc., of Menlo Park, Calif., formed a partnership to combine Operon's oligonucleotide production platform with DNA2.0's gene synthesis process. Under the deal, Operon will co-market DNA2.0's gene synthesis services, while serving as the primary source of oligos for the synthetic genes. Financial terms were not disclosed.

• Oxis International Inc., of Foster City, Calif., said it received a $500,000 up-front payment and a $500,000 investment from Synvista Therapeutics Inc. (formerly Alteon Inc.) according to the companies' previously announced license agreement for BXT-51072 (ALT 2074). Oxis also may receive milestone payments and royalties. Synvista gets exclusive worldwide rights to ALT-2074, a small-molecule organoselenium mimic of glutathione peroxidase, as well as all related organoselenium compounds in Oxis' library. Synvista is testing ALT-2074 in a Phase II trial aimed at reducing myocardial injury in diabetic patients undergoing angioplasty. (See BioWorld Today, April 10, 2007.)

• SemBioSys Genetics Inc., of Calgary, Alberta, updated a release issued July 12, which said it had achieved commercial levels of apolipoprotein AI (native Apo AI) and apolipoprotein AI (Milano) accumulation in safflower seed lines. SemBioSys confirmed in multiple assays that it has developed commercial levels of Apo AI Milano in safflower seed lines. Based on further evaluation of existing data, however, the company said it must clarify that, to date, it had not proved it has achieved commercial levels of native Apo AI accumulation in safflower.

• Viropro International Inc., of Montreal, said a delegation from Intas Biopharmaceuticals Ltd., of Ahmedabad, India, completed a site visit following the companies' memorandum of understanding in May for production of an undisclosed protein therapeutic. An initial sum of $50,000 has been sent to Viropro as a down payment toward the first milestone payment upon signing the agreement, and both firms are expected to finalize the deal by Sept. 7. Further terms were not disclosed.

• Vivalis, of Nantes, France, licensed intellectual property and technology from North Carolina State University for producing undifferentiated avian cell cultures using avian primordial germ cells. The deal is Vivalis' third with the university. Terms were not disclosed.