• Advanced Biotherapy Inc., of Woodland Hills, Calif., completed a pilot study using antibodies to interferon-gamma in the treatment of patients suffering from herpes simplex virus Type 1. The study was held at the Department of Skin and Venereal Diseases at Russia State Medical University in Moscow. Patients treated topically with antibodies to interferon-gamma noted rapid reduction of burning and pain around the lesions.

• Althea Technologies Inc., of San Diego, said that through a collaborative agreement with Expression Analysis Inc., of Durham, N.C., the companies developed a streamlined approach for the identification and application of genomic biomarkers. EA and Althea will offer a Signature Discovery Service for gene-expression analysis.

• Applied Biosystems Group, of Foster City, Calif., introduced the Applied Biosystems 7900HT Fast Real-Time PCR System, the first fast real-time PCR system offered in a traditional 96-well format. The system reduces real-time PCR thermal cycling times up to fourfold compared to standard real-time PCR systems, it said.

• Berlex Inc., of Montville, N.J., a U.S. affiliate of Schering AG, said an eight-year follow-up study presented at the 20th Congress of the European Committee for Treatment and Research in Multiple Sclerosis in Vienna, Austria, showed that the benefits observed in patients treated with interferon beta-1b (Betaseron) continued many years after the completion of the clinical study. The placebo-treated group, when changed to interferon beta 1-b, showed a similar, sustained benefit. Berlex also presented the study design of a 16-year long-term follow-up study of the therapy.

• ChemBridge Corp., of San Diego, and the University of Hong Kong reported that a team of researchers used chemical genetics methods to screen a ChemBridge library of more than 50,000 compounds to identify small molecules that stop the spread of the severe acute respiratory coronavirus. The team found a number of compounds that inhibited the spread of the disease, ChemBridge said. The group is working on identifying the mechanisms by which those compounds work.

• Corautus Genetics Inc., of Atlanta, said that effective at the opening of trading Wednesday, shares of the company's common stock will trade on the Nasdaq Stock Market under the symbol "VEGF." Corautus is a clinical-stage biopharmaceutical company focused on the development of gene-transfer therapy products for the treatment of cardiovascular and peripheral vascular diseases.

• Cryo-Cell International Inc., of Clearwater, Fla., said its affiliate, Saneron CCEL Therapeutics Inc., in collaboration with its research affiliates, recently published promising results using cord blood stem cells in conjunction with stroke in animal models. In the October issue of the American Heart Association journal Stroke, an article co-published by the Medical College of Georgia in Augusta and the University of South Florida in Tampa describes that stem cells taken from umbilical cord blood, and then given intravenously with a drug known to temporarily breach the brain's protective barrier, can reduce stroke size and damage, among other findings.

• CV Therapeutics Inc., of Palo Alto, Calif., began enrollment in the Merlin TIMI-36 study of Ranexa, which is being conducted under the FDA's special protocol assessment process, and if successful, could support approval of Ranexa as first-line therapy for patients suffering from chronic angina. The study also could result in approval for acute coronary syndromes and for long-term prevention of ACS, the company said.

• Entropin Inc., of Indio, Calif., said that an analysis by a topical formulation expert of percutaneous studies performed at Dow Pharmaceutical Sciences supports the continued development of ENT-103 as a topical product. Previous study results by Dow were reviewed by Joel Zatz, professor of pharmaceutics at Rutgers University. ENT-103 is planned for use as an analgesic.

• Genetic Technologies Ltd., of Melbourne, Australia, granted a licensed to Genzyme Corp., of Cambridge, Mass., for human-testing applications, as part of a new collaboration. Genzyme will pay GTL a signing fee and an annual fee for the life of certain non-coding patents. The rights apply nonexclusively in the U.S., Europe and Japan. GTL retains all rights in the Asia-Pacific region. Financial terms were not disclosed.

• GNI Ltd., of Tokyo, entered a research and development collaboration with Toyama Chemical Co. Ltd., of Tokyo, for use of its gene regulatory network technology platform in Toyama's drug development efforts. GNI will also offer its gene-expression data and discovery sciences.

• Hemispherx Biopharma Inc., of Philadelphia, said clinical data were presented on its pivotal, randomized, double-blind Phase III trial of Ampligen vs. placebo in chronic fatigue syndrome at the 7th International Conference for CFS in Madison, Wis. In the intent-to-treat analysis, patients receiving Ampligen improved exercise treadmill performance at 19.3 percent vs. 4.1 percent in the placebo group (p=0.037). Data from the trial were first disclosed in May. (See BioWorld Today, May 4, 2004.)

• Lifeline Cell Technology LLC, of Los Angeles, signed an agreement to exclusively license from Advanced Cell Technology, of Worcester, Mass., certain embryonic stem cell technology to produce retinal cells for therapeutic research use. Previous studies have shown that retinal cells have potential in blinding diseases, including macular degeneration and retinitis pigmentosa. Privately held Lifeline is focused on culturing and producing cells to treat and study diabetes, liver and retinal diseases, while Advanced Cell focuses on the field of regenerative medicine.

• Miravant Medical Technologies Inc., of Santa Barbara, Calif., entered a non-binding letter of intent with a group of existing Miravant investors to provide the company a convertible debt line of credit up to $15 million. Upon execution of definitive agreements, the funds will be available at the company's discretion in increments of up to $1 million per month, with convertible debentures for the principal borrowed amounts and associated warrants for shares of common stock to be issued and priced at the time of each borrowing.

• Neoprobe Corp., of Dublin, Ohio, said it received a formal response from the FDA to a Phase III protocol design proposal for RIGScan CR. The FDA said it would be receptive to a design that would incorporate both near-term disease progression and long-term survival prognostic endpoints. Neoprobe also filed a formal request this week with the FDA to establish an investigational new drug application for Lymphoseek. The company is requesting a meeting with the FDA to review a Phase III protocol and drug production plan. RIGScan CR is a radiolabeled tumor-specific antibody-targeting colorectal cancer drug, and Lymphoseek is a radiolabeled tracing agent that is designed to localize lymphatic tissue in the lymphatic pathway draining from the primary site of malignant tumors.

• Ortec International Inc., of New York, formed a joint venture partnership with Hapto Biotech Inc., of Jerusalem, for the purpose of further developing product leads identified through a research collaboration established in September 2002. The partnership will seek to optimize the combination of peptides found in Hapto's Haptide technology with the properties of Ortec's collagen biomaterial.

• Pacific Biometrics Inc., of Seattle, and UTEK Corp., of Plant City, Fla., signed an agreement that is expected to allow Pacific Biometrics to access technologies from leading universities and federal laboratories. Financial details were not disclosed.

• St. Jude Children's Research Hospital, of Memphis, Tenn., said its investigators found that a protein called Mrp4 blocks the access of the cancer drug topotecan into the brain by transporting the agent back into the bloodstream, thus reducing the ability of the agent to reach tumors. The St. Jude team said that the therapeutic efficacy of drugs targeting central nervous system tumors might be improved by inhibiting the protein. Their findings are published in Molecular and Cellular Biology.

• Teva Pharmaceutical Industries Ltd., of Jerusalem, said data presented at the 20th Congress of the European Committee for Treatment and Research in Multiple Sclerosis held in Vienna, Austria, demonstrated the clinical benefits of Copaxone in relapsing-remitting multiple sclerosis. Results with Copaxone were superior to treatment with interferon-beta therapies on several clinical endpoints, and to no treatment in terms of preventing relapses and slowing disability progression. The company's subsidiary, Teva Neuroscience Inc., also said that MS patients who remained on Copaxone therapy for an average of 10 years showed significantly less progression of disability compared to patients who discontinued therapy. Teva Neuroscience plans to extend the observation period of the trial to 15 years.

• The Pittsburgh Life Sciences Greenhouse said a new company called Biosafe Inc. is leasing laboratory space in the PLSG Incubator. Biosafe has developed an antimicrobial process for multiple applications, including one to protect soldiers and citizens from biological warfare agents.

• Varian Inc., of Palo Alto, Calif., entered a definitive agreement to acquire Magnex Scientific Ltd., of Oxford, UK, for $32 million in cash and assumed net debt. The transaction also includes an opportunity for additional purchase price payments over three years, depending on financial performance. Magnex designs and manufactures magnetic resonance imaging magnets, and it is a supplier of vertical high-resolution nuclear magnetic resonance magnets, superconducting magnets for Fourier Transform mass spectroscopy, and MR microscopy gradients. Varian expects the acquisition to generate external revenues of $15 million to $18 million in the first 12 months. Magnex will operate as a wholly owned subsidiary of Varian. Closing is expected in 30 days.

• VaxInnate Corp., of New Haven, Conn., received a contract from the Department of Health and Human Services for the study of innate immune receptors and adjuvant discovery. Recent evidence shows that fusing a polypeptide ligand specific for a Toll-like receptor to an antigen of interest generates a vaccine that is more potent and selective than the antigen alone. The company also said it signed a lease for a new 20,000-square-foot facility in Cranbury, N.J. Three-quarters of it will be used for laboratory space, quality control and research and development, while the remaining space will be used as administrative offices.

• Yale University in New Haven, Conn., said research identifying an RNA regulatory sequence (or riboswitch) class of bacteria was reported in Science. Functioning as the on-switch in the genetic regulation of three proteins involved in a glycine-processing system, it is the first RNA switch to cooperatively bind to its target - often seen with protein enzymes, not RNA, Yale said. The research, funded by the National Institutes of Health, the National Science Foundation, the Yale Liver Center and the David and Lucille Packard Foundation, has uncovered nine classes to date. Team leader Ronald Breaker, professor in the molecular, cellular and developmental biology department at Yale, is teaming with Harvard and Children's Hospital to examine the use of self-cleaving ribozymes, or enzymes formed from RNA, to control gene expression. (See BioWorld Today, Oct. 4, 2004.)

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