• Aastrom Biosciences Inc., of Ann Arbor, Mich., expanded a U.S. Phase I/II trial of its adult stem cell-based Tissue Repair Cells in the treatment of severe long bone non-union fractures to include a fourth site, Lutheran Medical Center in Brooklyn, N.Y.

• Acacia Research Corp., of Newport Beach, Calif., said its CombiMatrix group moved KM-668 into preclinical development and animal testing. The KM family of compounds is part of CombiMatrix's new internal program to develop therapeutics for exposure to terror threats. KM-668 is designed to treat exposure to radiological weapons.

• Adenosine Therapeutics LLC, of Charlottesville, Va., received a $139,176 Phase I Small Business Innovation Research grant from the National Institutes of Health's Department of Health and Human Services for the development and testing of A2A compounds to treat Parkinson's disease. The company said it anticipates identifying one or more clinical candidates and advancing at least one compound into clinical trials. The project will be conducted in partnership with Jiang-Fan Chen at the Boston University School of Medicine.

• Advanced Biotherapy Inc., of Woodland Hills, Calif., said a newly discovered strain of HIV highlights the need for new therapies that control the infection by augmenting immune system responses. While HIV's usual course of progression to the development of AIDS can take upwards of 10 years, the new strain progressed to AIDS in only three months after HIV diagnosis. In a Phase I trial, researchers are studying the inhibition of tumor necrosis factor-alpha in HIV patients who have received prior antiretroviral treatment with standard therapy but failed to respond.

• Agencourt Bioscience Corp., of Beverly, Mass., and Dyadic International Inc., of Jupiter, Fla., signed an agreement for Agencourt to conduct all sequencing phases for the genome of Dyadic's fungus, Chrysosporium lucknowense (Cl), including construction of multiple libraries, high-throughput sequencing, assembly and finishing. Dyadic said it will use the information with its Cl Host Technology, the basis for Dyadic's Cl Screening System and Expression System, as well as manufacturing gene products in large-scale fermenters. Financial terms of the agreement were not disclosed.

• Athenix Corp., of Research Triangle Park, N.C., and the Iowa Corn Promotion Board reported a research cooperation designed to explore opportunities of applying innovative technologies to corn and provide information regarding potential future benefits to the industry. Financial terms of the agreement were not disclosed.

• Atrium Biotechnologies Inc., of Quebec City, a 61 percent-owned subsidiary of AEterna Zentaris Inc., filed for an initial public offering in Canada. The offering consists of a treasury issue by Atrium and a secondary offering by SGF Soquia Inc., a subsidiary of Societe generale de financement du Quebec. Atrium develops, manufactures and markets products for the cosmetics, pharmaceutical, chemical and nutritional industries.

• Biogen Idec Inc., of Cambridge, Mass., and Elan Corp. plc, of Dublin, Ireland, said data on Tysabri (natalizumab) from the Phase III AFFIRM monotherapy trial showed the drug achieved the two-year primary endpoint of slowing the progression of disability in patients with relapsing forms of multiple sclerosis. Tysabri treatment led to a 42 percent reduction in the risk of disability progression relative to placebo, and a 67 percent reduction in the rate of clinical relapses over two years. Tysabri was approved by the FDA for MS in November. (See BioWorld Today, Nov. 29, 2004.)

• Cangene Corp., of Toronto, said an analysis of interim data from its WinRho SDF trial in dengue hemorrhagic fever showed the product hit its primary endpoint, producing increased platelet counts in patients by 20,000 at 48 hours after dosing. Cangene said the results suggest that WinRho might be an effective treatment for infectious diseases that cause low platelet counts, and the company intends to assess the product in other disease areas, including influenza, malaria and HIV.

• Cell Therapeutics Inc., of Seattle, said it expects results from its pivotal trial of Xyotax (paclitaxel poliglumex) in non-small-cell lung cancer in early March. The STELLAR 3 Phase III trial was designed to study Xyotax in combination with carboplatin vs. paclitaxel with carboplatin as a potential front-line treatment of poor-performance status patients.

• Celsion Corp., of Columbia, Md., treated the first patient in its Phase I trial of ThermoDox combined with radio frequency ablation in liver cancer. ThermoDox is a temperature-sensitive liposomal encapsulation of doxorubicin, designed to allow concentrated delivery of the drug to the tumor target. Celsion said the Phase I trial is expected to determine safe dosage levels and a pharmacokinetic profile of the product in the treatment of liver lesions.

• Cyberonics Inc., of Houston, said the first patient was enrolled in its E20 Phase IV epilepsy study of patients with less-chronic and less-resistant medically refractory partial onset seizures. The E20 study is an open-label trial comparing adjunctive vagus nerve stimulation therapy plus standard-of-care treatment to just standard-of-care treatment over a one-year period. The study will enroll up to 360 patients

• Duska Therapeutics Inc., of Bala Cynwyd, Pa., reported on the status of certain of its drug development activities. The company selected 20 principal investigators and clinical sites for ATPace, its liquid formulation of adenosine 5 triphosphate that is being developed as a diagnostic test for identification of an abnormally slow heart rate as the cause of syncope. Enrollment of patients is expected to begin in 30 to 60 days. Also, in January, Duska received the results of a preliminary study performed by a U.S. infertility clinic of ATPotent, which it said showed that ATP significantly enhanced the rate of acrosome reaction in human sperm.

• GeoPharma Inc., of Largo, Fla., said its wholly owned subsidiary, Belcher Pharmaceuticals, signed a worldwide marketing agreement with Dechra Pharmaceuticals plc, of Staffordshire, UK, for Belcher's levothyroxine liquid and tablets for animal health applications. Levothyroxine is used to treat hypothyroidism in dogs. Dechra will pay an up-front licensing fee of $500,000 and the companies will share equally in all profits from sales after the deduction of manufacturing and marketing costs. Belcher will produce the levothyroxine products for worldwide markets and transfer them to Dechra at cost of goods. Dechra will pay all worldwide marketing, licensing and registration costs.

• Halozyme Therapeutics Inc., of San Diego, signed a commercial manufacturing agreement with Avid Bioservices Inc., a wholly owned subsidiary of Tustin, Calif.-based Peregrine Pharmaceuticals Inc., to manufacture Halozyme's first recombinant human enzyme. The enzyme is to be used in Halozyme's product candidates, Cumulase and Enhanze SC, designed to offer synthetic alternatives to slaughterhouse-derived enzymes used in the infertility and ophthalmology markets.

• Human Metabolome Technologies Inc., of Yamagata, Japan, reported a collaboration with Mitsubishi Pharma Corp., of Tokyo, on a biomarker study for phospholipidosis. HMT will apply its metabolome technology in the effort.

• Insmed Inc., of Richmond, Va., said a law firm has filed on behalf of the company in defense and in counterclaim to South San Francisco-based Tercica Inc.'s patent-infringement claim. Insmed President and CEO Geoffrey Allan said Insmed has not infringed any valid patent claims and the company will aggressively develop SomatoKine for growth hormone insensitivity syndrome. The company filed a new drug application for the product in January. (See BioWorld Today, Jan. 5, 2005.)

• Medisyn Technologies Inc., of Minneapolis, completed a $1.5 million bridge financing. Proceeds from the transaction will be used to expand current collaborations, advance its own cancer drug through preclinical studies, and attract and retain a CEO by mid-2005, the company said. Medisyn is a drug design and discovery company.

• Monsanto Co., of St. Louis, signed a definitive agreement to acquire Emergent Genetics Inc., of Boulder, Colo., for $300 million. Monsanto intends to finance the purchase with cash and commercial paper. The acquisition will help Monsanto complete a strategic cotton germplasm and traits platform by combining biotechnology and breeding advances.

• PharmaMar SA, of Madrid, Spain, said its second most advanced marine-derived antitumor agent, Aplidin, began Phase II trials in both prostate and bladder cancers. The study will focus on androgen-independent prostate cancer, relapsing or progressing after a previous line of docetaxel-based chemotherapy.

• QLT Inc., of Vancouver, British Columbia, reported the commercial availability in the U.S. of Eligard 45-mg (leuprolide acetate for injectable suspension) six-month formulation, a palliative treatment of advanced prostate cancer. Eligard is a member of a class of drugs known as luteinizing hormone-releasing hormone agonists.

• TheraQuest Biosciences LLC, of Blue Bell, Pa., said the FDA granted orphan drug designation to its TQ-1017, an abuse-deterrent, once-daily, extended-release formulation of tramadol for the treatment of HIV-associated neuropathy. The company said its extended-release version would prevent the drug from being abused for opiate effects.

• Topigen Pharmaceuticals Inc., of Montreal, began dosing in its first human safety study for its inhaled asthma product, ASM8. The dual antisense compound targets multiple mediators and has demonstrated in preclinical studies ability to block two major pathways of the inflammation response, the company said.

• Viragen Inc., of Plantation, Fla., in collaboration with the Roslin Institute in Edinburgh, Scotland, and Oxford Biomedica plc, of Oxford, UK, said an antibody designed to treat malignant melanoma has been detected in the blood of a founder transgenic rooster after the antibody was introduced using a proprietary gene delivery system. The achievement will help to confirm that a humanized antibody can be produced in subsequent generations of chickens and be used as a therapy.

• Vivus Inc., of Mountain View, Calif., completed patient enrollment in its Phase II study of avanafil, a highly selective, orally administered phosphodiesterase type 5 inhibitor, in development for erectile dysfunction. The 298-patient study is designed to evaluate safety and efficacy at different dosage levels, and to help researchers determine dosing for a Phase III trial. Vivus expects to announce trial results later this year. The company reported that previous studies of avanafil demonstrated a rapid onset of action and a half-life of 60 to 90 minutes.

• Xechem International Inc., of New Brunswick, N.J., said it has made significant progress in development efforts for Nicosan/Hemotoxin, its natural product extract for treating sickle cell disease. Xechem obtained an exclusive worldwide license to develop and sell the product from the National Institute for Pharmaceutical Research and Development, of Abuja, Nigeria. Xechem said the product will be launched initially in Nigeria.