• Acceptys Inc., of New York, received additional financing from PNK Holdings Ltd., an undisclosed investment to enable Acceptys to expand its technology platform and push its lead anticancer human antibody candidate, ACY-110, through preclinical development. The company also gained an exclusive license to an immortal, humanized cell line called MFP-2 from Columbia University in New York. Financial terms were not disclosed.

• Agilent Technologies Inc., of Palo Alto, Calif., and Rosetta Biosoftware, a business unit of Rosetta Inpharmatics Inc., a wholly owned subsidiary of Merck & Co. Inc., of Whitehouse Station, N.J., said the Institut Gustave-Roussy selected the company's gene expression solutions for use. The institute is a nonprofit organization dedicated to research and clinical work in oncology. Financial details were not disclosed.

• Athenix Corp., of Research Triangle Park, N.C., formed a collaboration with Mertec LLC, of West Point, Iowa. Athenix develops products using genetic traits from microbes. The companies plan to bring developed traits from Athenix to the market in soybean varieties developed by Mertec. Mertec would market the co-developed soybean varieties. Financial terms were not disclosed. Separately, Athenix acquired a commercial license to certain enabling technologies from Stine Biotechnology, a wholly owned subsidiary of Midwest Oilseeds Inc., of Adel, Iowa. Terms of the agreement were not disclosed.

• BD Biosciences, a San Jose, Calif., unit of Becton, Dickinson and Co., said it licensed RNA interference technology from the Carnegie Institute of Washington and the University of Massachusetts (U.S. Patent No. 6.506,559, issued in January). It said the patent is the first to issue on the use of RNAi in mammalian systems. The company has launched a series of RNAi-based vector systems designed to allow better understanding of the function of particular genes. Terms of the license were not disclosed.

• Biogen Inc., of Cambridge, Mass., said the FDA approved a prefilled syringe for Avonex (Interferon beta-1a), designed to make treatment more convenient for people with multiple sclerosis. Biogen said it expects the syringe to be available in August and replace the currently available form of Avonex. As with the old formulation, the new formulation will be indicated to slow the progression of disability and reduce the frequency of relapses in relapsing forms of MS.

• Bioxel Pharma Inc., of Sainte-Foy, Quebec, said data published in Clinical Cancer Research showed that expression of the P7 antigen is associated with malignant tumors in primary breast cancers, especially those showing recurrent or metastatic disease. The P7 antigen, originally identified by Bioxel in multidrug-resistant ovarian and breast cancer cells, is the protein target of its BCM-17 antibody product. The University of Southern California Cancer Center and School of Medicine, Johns Hopkins Oncology Center and the National Cancer Institute jointly conducted the studies.

• Celsion Corp., of Columbia, Md., said it treated the first patient in its Phase I trial of Thermodox with focused heat in prostate cancer. Thermodox encapsulates doxorubicin in a heat-sensitive liposome. Celsion's Microfocus BPH800 Urethroplasty System provides the heat required to trigger the release of the chemotherapeutic agent.

The Center for the Advancement of Genomics in Rockville, Md., entered an agreement with Duke University Medical Center in Durham, N.C., to create a fully integrated practice of genomic-based prospective medicine. They said they plan to generate predictive and prognostic data on specific diseases that could aid in the earlier detection and better treatment of such illnesses. Initially funded internally by both organizations, both parties plan to eventually seek outside funding through government grants, foundations and philanthropic donations.

• ChromaVision Medical Systems Inc., of San Juan Capistrano, Calif., said that researchers conducting two multicenter clinical trials will use the company's ACIS system to detect rare cancer cells in the bone marrow of breast and lung cancer patients. The ChromaVision system was selected by principal investigators at the Keck School of Medicine at the University of Southern California.

• Corixa Corp., of Seattle, entered an agreement with GlaxoSmithKline plc, of London, which will be responsible for registration, marketing and sales of Bexxar therapy (tositumomab and iodine 131 tositumomab) in Canada. Corixa will manufacture and supply the product to Glaxo, which will pay up-front license fees, a milestone payment upon Canadian regulatory approval, milestone payments based on achievement of certain sales volume and reimbursement targets, payments in connection with product supply, and royalties on all future Canadian sales. Still under FDA review for the treatment of patients with B-cell, follicular, non-Hodgkin's lymphoma, Bexxar therapy will be co-promoted in the U.S. by Corixa and GlaxoSmithKline.

• Cypress Bioscience Inc., of San Diego, said clinical results with its lead product, milnacipran, appear to demonstrate distinct mechanisms for the agent's effects on pain and mood in patients with fibromyalgia syndrome. The Phase II trial results demonstrate the safety and efficacy of milnacipran in treating patients with FMS. There were 125 patients enrolled in the trial. The results were presented in a poster presentation at the annual New Clinical Drug Evaluation Unit meeting sponsored by the National Institutes of Mental Health in Boca Raton, Fla.

• Dharmacon Inc., of Lafayette, Colo., launched the SARS siArray Gene Set, a library of short interfering RNA duplexes targeted against regions of the coronavirus believed to cause severe acute respiratory syndrome.

• Florida Atlantic University researchers in Boca Raton, Fla., said they successfully tested a drug for human colon cancer in animal models. Results were published in the Proceedings of the National Academy of Sciences. They developed the drug using a gene found on chromosome 21 that normally is associated with Down syndrome. Researchers detected a gene product, called SIM2, in colon, pancreatic and prostate cancers. They designed the drug using a second-generation antisense technology, to inhibit the gene from producing the proteins needed for the tumor to grow.

• Generex Biotechnology Corp., of Toronto, raised $3.2 million, with net proceeds to Generex of $3 million, in a private placement of its unregistered common stock. Generex issued about 2.8 million shares to accredited institutional investors. The investors, who participated in previous financings, also received three-year warrants to purchase shares at $1.71 per share. Generex is focused on the research and development of drug delivery systems and technology.

• Genzyme General, a division of Genzyme Corp., of Cambridge, Mass., said it treated the first patient in a pivotal clinical trial of Myozyme, its recombinant human acid alpha-glucosidase enzyme, for Pompe disease. The trial will include up to 16 infants younger than six months at the time of their first infusion. Genzyme, which in March began enrollment in a Myozyme trial in children between 6 months and 3 years, also was named in a lawsuit filed in Massachusetts Superior Court on behalf on investors that held stock in its biosurgery division who disapprove of the company's decision to eliminate its tracking stock structure. (See BioWorld Today, May 12, 2003.)

• Guava Technologies Inc., of Hayward, Calif., reported a new single-cell test/assay designed to provide biologists with an easy way to obtain a detailed and quantitative profile of each phase of cell division, the company said. Using a minimal number of cells, the Guava Cell Cycle Assay enables researchers to screen drug compounds or explore key pathways controlling cell growth and death.

• Inflazyme Pharmaceuticals Ltd., of Vancouver, British Columbia, said it received shareholder approval to acquire GlycoDesign Inc., of Toronto. Inflazyme said 99.9 percent of GlycoDesign stockholders approved the C$12.8 million (US$ 8.7 million) transaction, in which Inflazyme proposed to issue 22 million shares to acquire GlycoDesign's outstanding stock. (See BioWorld Today, April 10, 2003.)

• Isis Pharmaceuticals Inc., of Carlsbad, Calif., initiated a Phase II trial to assess the benefit of adding ISIS 14803 to standard treatments for hepatitis C virus. In the study, ISIS 14803 will be administered to patients who do not achieve an early response to treatment with pegylated interferon and ribavirin. The company plans to enroll about 30 people with genotype 1, drug-resistant HCV in the open-label, dose-escalation study. ISIS 14803, an antisense inhibitor of HCV viral replication, also is the subject of a Phase II study as a single agent for the treatment of HCV.

The state of Michigan awarded about $30 million of its in-state life sciences corridor funding to advance research efforts in the Great Lakes State. Of the total, the largest single award provided $3.4 million to Wayne State University in Detroit. Another $2 million went into an emergency fund for researchers recently laid off by Pfizer Inc., of New York, following its acquisition of Pharmacia Corp., of Peapack, N.J. Seneca Health Partners, of Birmingham, Ala., received a $1.5 million award to begin a health care venture capital fund.

• Nastech Pharmaceutical Co. Inc., of Bothell, Wash., reported results from a Phase II at-home trial using its intranasal formulation of apomorphine to treat female sexual dysfunction. Initial efficacy results were reported in data from 38 women enrolled in the study. All were premenopausal and were diagnosed with female sexual arousal disorder. Results shows that in women taking 0.5 mg intranasal apomorphine, 23 parameters studied showed a statistically significant improvement from baseline, including sexual relationship satisfaction (p=0.01), overall sexual life satisfaction (p=0.0007), arousal frequency (p=0.003), arousal intensity (p=0.008), maintaining the aroused state (p=0.0001), frequency of adequate lubrication (p=0.0003) and orgasmic frequency (p=0.01). In the primary efficacy endpoint of the study, improvement in satisfaction with sexual activity, 55 percent of women responded in the affirmative.

• NexMed Inc., of Robbinsville, N.J., said final data from a two-year carcinogenicity study in rats showed no evidence of cancer associated with the NexACT skin permeation enhancer. Doses of the NexACT enhancer were up to 833 times the equivalent dose administered to patients enrolled in NexMed's Phase III trial of Alprox-TD. Alprox-TD is a cream treatment for erectile dysfunction that incorporates alprostadil with the NexACT delivery technology.

• Nymox Pharmaceutical Corp., of Maywood, N.J., said data presented at the Manhattan Alzheimer's Disease Conference in New York pointed to the importance of statin drugs in treating the condition. More specifically, data support the underlying mechanism for the potential value of statins in the treatment of Alzheimer's disease.

• Pain Therapeutics Inc., of South San Francisco, said PTI-901, the first of a new class of drugs developed to treat irritable bowel syndrome, significantly improved all the common symptoms associated with IBS. In a 50-patient pilot study, patients of both genders reported a response rate of 76.2 percent at the conclusion of the four-week study. The study also met the secondary endpoints of improving daily abdominal pain, bowel habits and stool consistency. The improvements were observed in patients whose baseline symptoms were either diarrhea or constipation, or both.

• PharmaMar, of Madrid, Spain, a division of the Zeltia Group, entered Phase II trials with Kahalalide F, an antitumor agent derived from the sea slug, Elysia rufescens, in liver carcinoma. The trial will involve five centers and will investigate the efficacy of the product in patients with advanced liver carcinoma. The product is given intravenously.

• Trimeris Inc., of Durham, N.C., and Hoffmann-La Roche Inc., of Nutley, N.J., said the New England Journal of Medicine on Wednesday published results from two pivotal studies of Fuzeon (enfuvirtide), the first in a new class of HIV drugs known as fusion inhibitors. Fuzeon was approved by the FDA in March. The TORO 1 (T-20 vs. Optimized Regimen Only) and TORO 2 were randomized, open-label trials that enrolled about 1,000 HIV-1-infected patients at 112 centers. In TORO 1, 37 percent of patients who were treated with Fuzeon in combination with an optimized background regimen had undetectable blood levels of HIV at 24 weeks, compared to 16 percent who received an optimized background regimen alone (p< 0.0001). Results from TORO 2 were consistent with findings from TORO 1. (See BioWorld Today, March 17, 2003.)

• Valentis Inc., of Burlingame, Calif., said it received a favorable Nasdaq panel determination letter stating that the company evidenced compliance with the current requirements necessary for continued listing on the Nasdaq SmallCap Market. Valentis showed at least $2.5 million in stockholders' equity in its Form 10-Q as of March 31.

• Viragen Inc., of Plantation, Fla., said its subsidiary, Viragen International Inc., received an approval from Mexican regulatory authorities to expand the use of Multiferon. The broadened approval extends the use of the drug to the treatment of patients afflicted with any and all diseases in which patients show an initial response to recombinant alpha interferon followed by treatment failure, probably due to the formation of neutralizing antibodies, Viragen said. Multiferon is approved in Mexico for the treatment of patients with hairy-cell leukemia or chronic myelogenous leukemia who failed or relapsed to recombinant interferon regimens. Multiferon is being marketed primarily for the treatment of hepatitis C and certain cancers, the company said.

• Virogenomics Inc., of Portland, Ore., said a Small Business Technology Transfer grant to study human genes as drug targets for fighting HIV infection was awarded to Virogenomics and scientists at Oregon Health & Science University by the National Institute of Allergy and Infectious Diseases, a division of the National Institutes of Health in Bethesda, Md. The grant provides $99,808 for Virogenomics-sponsored research conducted by OHSU scientists. The grant will be used to identify cellular drug targets through gene expression profiling. The targets will be validated through target-specific gene silencing techniques developed by Virogenomics and OHSU scientists.

• West Pharmaceuticals Services Inc., of Lionville, Pa., and T3 Therapeutics LLC, of Manhassett, N.Y., signed a worldwide agreement for the development and commercialization of an oral sustained-release formulation of liothyronine, used to treat congestive heart failure and hypothyroidism. Liothyronine is a naturally occurring hormone produced by the thyroid gland. Financial terms were not disclosed.

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