¿ Advanced Biotherapy Inc., of San Diego, moved its corporate headquarters to San Diego from Rockville, Md. The company said the relocation is compatible with its new management team, which includes CEO Paul Marangos and Director of Operations and General Counsel Margo Dockendorf.
¿ AVI BioPharma Inc., of Portland, Ore., said two studies indicate that its third-generation Neugene antisense compounds demonstrate stem cell activity. The first study, of a Neugene compound targeted against the TGF-beta gene, showed the compound induced dramatic stem cell multiplication without differentiation. A second study indicated a Neugene compound, targeted against the gene product Evi-1, induced stem cell differentiation without proliferation.
¿ Bayer AG, of Leverkusen, Germany, received FDA clearance for the HER-2/neu serum test for use in follow-up and monitoring applications with metastatic breast cancer patients. The serum HER-2/neu test is the first FDA-cleared blood test for measuring circulating HER-2/neu oncoprotein.
¿ Biogen Inc., of Cambridge, Mass., and NsGene A/S, of Copenhagen, Denmark, said Biogen exercised its option to license the neurodegenerative disease therapeutic Neublastin. Biogen will pay an up-front fee for the license, and, upon commercialization, the companies estimate Biogen will pay NsGene at least $20 million in fees and milestone payments. Biogen and NsGene disclosed the possibility of collaborating on the neurotrophic protein in June. (See BioWorld Today, June 16, 2000.)
¿ BioVisioN GmbH & Co. KG, of Hannover, Germany, and Matrix Science Ltd., of London, agreed to a long-term strategic alliance focused on developing bioinformatics technologies. The companies will combine their technologies in human peptide research and software for protein identification. Financial terms were undisclosed.
¿ Celgene Corp., of Warren, N.J., presented data at the 42nd annual meeting of the American Society of Hematology on the use of Thalomid for treatment of bone marrow disorder myelodysplastic syndromes. Of the 51 evaluable patients in the study, 41 percent exhibited a partial response to thalidomide treatment, and the eight patients who were transfusion dependent became independent of transfusions through treatment. Celgene plans to aggressively pursue a major Phase III program for Thalomid in myelodysplastic syndromes based on the results.
¿ Cell Therapeutics Inc., of San Francisco, said Trisenox, its arsenic trioxide therapeutic, demonstrated high, long-lasting rates of remission in trials of the drug against acute promyelocytic leukemia and chronic myelogenous leukemia. Long-term follow-up data from multicenter pivotal trials indicated Trisenox achieved a 79 percent rate of molecular remission in tested patients with relapsed or refractory acute promyelocytic leukemia. A 34-patient Phase II study of Trisenox for treatment of chronic myelogenous leukemia produced a 75 percent complete remission rate and a partial response in 21 percent of treated patients.
¿ Cytogen Corp., of Princeton, N.J., and Draxis Health Inc., of Mississauga, Ontario, finalized a license, distribution and supply agreement for BrachySeed, Cytogen's prostate cancer therapy. The 10-year agreement calls for Cytogen to market and distribute BrachySeed implants in the U.S. and Draxis to supply radioactive seed to Cytogen for sale in the U.S. through its subsidiary, Draximage. Financial terms were undisclosed
¿ EntreMed Inc., of Rockville, Md., initiated a pilot Phase II trial of 2-methoxyestradiol, an oral small-molecule angiogenesis inhibitor. EntreMed also extended its 1993 sponsored research agreement with Children's Hospital, Boston, to continue discovery research focused on novel antiangiogenic agents.
¿ Exact Sciences Corp., of Washington, D.C., changed its name from Exact Laboratories Inc. The company has filed for an initial public offering expected to bring in about $54.8 million.
¿ Genome Therapeutics Corp., of Waltham, Mass., extended its licensing agreement with Bristol-Myers Squibb Co., of New York, allowing Bristol-Myers to continue using the PathoGenome database for gene target identification. Bristol-Myers will use the database to identify targets for bacterial and fungal infection therapies, as well as to create new anti-infective products to address drug-resistant bacterial infection.
¿ IDEXX Laboratories Inc., of Westbrook, Maine, said its subsidiary, Blue Ridge Pharmaceuticals, received FDA approval to market Acarexx otic suspension for treatment of ear mites in cats and kittens as young as 4 weeks old. IDEXX also is seeking approval for an equine protozoal myeloencephalitis treatment, a nonsteroidal anti-inflammatory compound and a novel, long-acting antibiotic for companion animals.
¿ Ligand Pharmaceuticals Inc., of San Diego, said results of a clinical trial of Ontak (denileukin diftitox) in combination with steroids showed a doubling of overall response rate in refractory cutaneous T-cell lymphoma. The rate of response increased from 30 percent to 60 percent. A second study indicated a combination therapy using cytokines and other bioactive agents could have potential in augmenting response to anti-CD25 therapies like Ontak.
¿ Medarex Inc., of La Jolla, Calif., unveiled a unique crossbred mouse developed with Kirin Brewery Co. Ltd., of Japan, at IBC's Antibody Engineering Conference. The mouse is the combination of Medarex's HuMAb Mouse and the Kirin-developed TC mouse. Medarex said the mouse system retains the capacity to produce all human antibody isotypes and exhibits a robust immune response previously unseen in a human antibody-producing mouse system.
¿ Molecular Simulations Inc., of Princeton, N.J., and subsidiary Pharmacopeia Inc. said they will launch a new high-throughput crystallography consortium, an international research project intended to accelerate drug research by developing and validating rapid methods for X-ray structure determination in structural biology. Five members have been named to the consortium already, including Abbott Laboratories Inc., of Abbott Park, Ill.; Cytoclonal Pharmaceuticals Inc., of Dallas; Emerald Biostructures Inc., of Bainbridge Island, Wash; Exelixis Inc., of South San Francisco; and Genencor International Inc., of Palo Alto, Calif.
¿ Neurochem Inc., of Saint-Laurent, Canada, achieved a milestone in the advancement of its anti-amyloid drug candidate for treatment of Alzheimer's disease with the completion of a proof-of-concept study, triggering a number of undisclosed milestone payments from collaborator H. Lundbeck A/S. The study completion also triggers a $2.5 million equity investment in Neurochem by Lundbeck.
¿ Oncology Sciences Corp., of Austin, Texas, entered a collaboration with Tulane University and Colorado State University focused on 2-mehtoxyestradiol and other angiogenesis inhibitors. The research will focus on the effects of hormones, primarily the 2-mehtoxyestradiol-precursor estrogen, and their relation to cancer.
¿ Organogenesis Inc., of Canton, Mass., initiated a stock buyback program calling for the repurchase of up to 500,000 shares on the open market. Organogenesis focuses on tissue engineering and markets Apligraf, a cellular, bi-layered skin substitute approved for treatment of venous leg ulcers and diabetic foot ulcers.
¿ Oxford Glycosciences plc, of Oxford, UK, said qualified shareholders applied to subscribe to up to #32 million (US$46 million) worth of ordinary shares, about 21 percent of the open offer, assuming a #150 million offering size by the Dec. 5 deadline. Oxford plans to list on the Nasdaq Exchange following the international offering, which is expected to be completed today.
¿ SuperGen Inc., of San Ramon, Calif., said its anticancer agent decitibine logged a 100 percent response rate in a 36-week, 6-patient Phase I/II safety and efficacy study in refractory sickle cell anemia. Average fetal hemoglobin levels increased from 3 percent to 14 percent after six cycles of treatment, and there were no reports of any sickle cell episodes or toxicity.
¿ United Therapeutics Inc., of Silver Springs, Md., initiated a stock buyback program that could encompass up to 3 million shares. United Therapeutics, which focuses its drug discovery efforts on cardiovascular, inflammatory and infectious disease, currently has about 20 million shares outstanding.
¿ Viragen Inc., of Plantation, Fla., entered a collaborative project with The Roslin Institute, of Edinburgh, Scotland, designed to enable biotech and pharmaceutical companies to produce drugs, including anticancer monoclonal antibodies, inside the eggs of specially developed chickens. The Roslin Institute said transgenic avian MAb production technology promises faster, cheaper and virtually unlimited production due to the chicken's prolific egg-laying capacity.
¿ Vysis Inc., of Downers Grove, Ill., entered a collaboration with Herceptin marketer F. Hoffman-LaRoche Ltd., of Basel, Switzerland, to allow for use of Vysis' Path Vysion HER-2 breast cancer test kit outside the U.S. Financial terms were undisclosed.