• Agilent Technologies Inc., of Palo Alto, Calif., released new software called ChemStation for its 1100 Series liquid chromatography purification system. The company said its ChemStation software modules provide flexible functionality for preparative liquid chromatography, enabling users to start with a basic solution and add modules for specific needs.

• Amersham Biosciences, the life sciences business of Amersham plc, of London, signed an agreement with the Windber Research Institute in Windber, Pa., to develop a Scierra Solutions Laboratory Workflow System to manage the data generated in its clinical breast cancer project. Windber has been using Amersham's technology for gene expression, sequencing, genotyping and proteomics, but needed to expand its work to include a clinical laboratory workflow system to collect information on patient histories, samples and pathologies. Financial terms were not disclosed.

• Applied Biosystems Group, of Foster City, Calif., launched SNPbrowser Software, its genome-wide human genetic variation map based on single nucleotide polymorphisms, at the American Society of Human Genetics meeting in Los Angeles. The company, a unit of Applera Corp., released a free, downloadable tool for viewing the variations in the context of individual genes, chromosomal regions and the entire human genome. The tool can be downloaded at www.allsnps.com/snpbrowser. Separately, Applied Biosystems launched two kits for forensic testing and other human identification purposes that allow analysts to determine the amount of human DNA or male-specific DNA present in samples at the CODIS (Combined DNA Index System) meeting in Lansdowne, Va.

• Biobase GmbH, of Wolfenbuttel, Germany, launched its Brenda enzyme database. It includes information on 80,000 enzymes, which have been largely extracted by hand, from scientific publications, and the company already has customers in Europe, the U.S., Australia and Japan.

• Biotech Holdings Ltd., of Vancouver, British Columbia, received Mexican regulatory approval to market Sucanon as a treatment for Type II diabetes symptoms. The company said it would finalize an agreement with a Mexican marketing group to introduce Sucanon. Biotech Holdings will produce Sucanon's premix in Vancouver, while tableting will be carried out in Mexico City.

The Biotechnology Industry Organization in Washington issued a statement in support of the FDA's draft guidance on pharmacogenomics. BIO said the agency's proposal to gain an exchange of pharmacogenomic information without stalling the drug development process would usher in "a significant step toward the era of personalized medicine."

• Chiron Corp., of Emeryville, Calif., granted a nonexclusive license to Rigel Pharmaceuticals Inc., of South San Francisco, for the research, development and commercialization of small-molecule therapeutics against certain hepatitis C virus drug targets. Financial terms and other details of the license were not disclosed. Separately, Chiron reported findings at the American Association of Blood Banks meeting in San Diego showing that its Procleix West Nile virus assay has identified 861 blood donations confirmed to be infected with the virus since the investigational use-only assay was implemented at the beginning of the 2003 mosquito season. Since July 1, the company said, more than 80 percent of U.S. blood donations have been screened for West Nile virus using Procleix.

• Cypress Bioscience Inc., of San Diego, filed a shelf registration statement with the SEC to offer up to $60 million worth of common stock. The company said it would use proceeds from any eventual sale for clinical trials, research and development, and general and administrative expenses.

• Dharmacon Inc., of Lafayette, Colo., and Akceli Inc., of Cambridge, Mass., entered a research collaboration to study the use of combining the former's siRNA-mediated gene silencing with the latter's whole-well reverse transfection. The results of the studies conducted using the combined technologies will be used to validate both the efficacy of whole-well siRNA reverse transfection and its use for transfection optimization. Dharmacon's siRNA also will be used to validate Akceli's cancer-related siRNA sequences and cell-based assays. Financial terms were not disclosed.

• Dynavax Technologies Corp., of Berkeley, Calif., gained worldwide, nonexclusive rights to a hepatitis B surface antigen, HBsAg, from Berna Biotech Ltd., of Bern, Switzerland. Dynavax will use the product in its programs for the disease to develop a prophylactic vaccine and therapeutic products that use its immunostimulatory sequence technology. Berna will supply HBsAg to Dynavax and will have the right to elect to commercialize resulting vaccine and therapeutic products on an exclusive basis. Financial terms were not disclosed.

• Enhance Biotech Inc., of New York, said it completed a private equity financing of $2 million through the sale of common stock and warrants. The company will use the funds to accelerate the development of its lead products. The investment will enable Enhance to achieve milestones in its lead development programs over the next three to five months, including completing a Phase IIa trial in premature ejaculation and the beginning of clinical programs for dermatological compounds under development. Enhance will receive an additional $2 million if and when it achieves certain development milestones.

• Esperion Therapeutics Inc., of Ann Arbor, Mich., lost share value on rumors that later this week, an undisclosed medical journal would unveil poor data on its cardiovascular drug candidate, ETC-216. The company has not publicly commented on the rumor. Its stock (NASDAQ:ESPR) dropped $6.21 Monday, or 26 percent, to close at $17.66.

• GenSci Regeneration Sciences Inc., of Vancouver, British Columbia, changed its name to SMC Ventures Inc. after emerging from bankruptcy and completing the sale of substantially all of its assets by IsoTis SA, of Lausanne, Switzerland. GenSci's common shares were delisted from the Toronto Stock Exchange at the close of trading Oct. 30, while SMC's class A common shares were listed on the NEX Board of the TSX Venture Exchange under the symbol "SMV.H" on Oct. 31. Also as a result of the closed transaction, GenSci made an initial $2.5 million payment to Osteotech Inc., of Eatontown, N.J., as part of a total $7.5 million due Osteotech in connection with a settlement of claims that GenSci infringed Osteotech's Grafton DBM patents. (See BioWorld Today, June 4, 2003.)

• Hybrigenics SA, of Paris, entered an agreement with Group de Recherche Servier, also of Paris, to begin a pair of drug discovery collaborations and license arrangements related to cancer drugs. Servier will provide research funding for two years to Hybrigenics, as well as milestone payments and royalties on any resulting products. Servier will have exclusive worldwide rights to develop and market drugs against the selected targets, as well as an option for other therapeutic indications and a users' license to Hybrigenics' PIMRider software. More specific financial terms were not disclosed. The agreement marks the renewal of a drug target discovery collaboration that began in early 2001. (See BioWorld Today, Feb. 9, 2001.)

• Ingenuity Systems Inc., of Mountain View, Calif., licensed its Pathways Analysis technology to the Stanford Genome Technology Center at Stanford University in Palo Alto, Calif. The web-delivered application is designed to allow biologists to discover, visualize and explore therapeutically relevant networks significant to their experimental results. The parties also are collaborating on the development of new functionality to further extend the application's capabilities and systems biology.

• Linden Bioscience, a division of Linden Technologies Inc., of Woburn, Mass., launched its Expression Snapshot mRNA Archiving Kit, which it designed for researchers performing gene expression analysis studies with RNA samples requiring amplification and that are difficult to obtain or expensive to produce. Expression Snapshot provides an archival dsDNA representation of the original RNA sample that may be stored and retranscribed repeatedly over several months.

• Merck KGaA, of Darmstadt, Germany, said its Australian pharmaceuticals subsidiary, Alphapharm Pty. Ltd., filed for marketing approval in that country for Erbitux (cetuximab) to treat metastatic colorectal cancer. Alphapharm, which is seeking approval of the drug as a monotherapy and in combination with irinotecan, could receive authorization by the end of next year. The drug is under FDA review following U.S. submission by ImClone Systems Inc., of New York, and Bristol-Myers Squibb Co., also of New York. (See BioWorld Today, Oct. 14, 2003.)

The National Institutes of Health in Bethesda, Md., said it would provide $51 million over five years through its newly established Rare Diseases Clinical Research Network. It will consist of seven research centers, as well as a data and technology coordinating center. Separately, the NIH said data published in the online edition of Nature Medicine showed that nitrite can improve blood flow by opening blood vessels. The findings showed that when hemoglobin releases its oxygen in regions of the body with low oxygen or high metabolism, it then can convert nitrite into nitric oxide, which is known to dilate blood vessels.

• OraSure Technologies Inc., of Bethlehem, Pa., said the underwriters of its recent public offering partially exercised their overallotment option to purchase an additional 311,000 shares as part of the 5 million-share sale. With the exercise, the offering will have resulted in total proceeds of about $45.2 million to OraSure, which develops oral fluid specimen collection devices and tests, as well as other diagnostic products.

• Oxigene Inc., of Waltham, Mass., said its investigational antitumor compound will be tested in a clinical trial of newly diagnosed cancer patients whose disease has not yet metastasized. Oxigene's Combretastatin A4 Prodrug will be studied in combination with the chemotherapy drugs doxorubicin/cisplatin and radiation in patients with newly diagnosed anaplastic carcinoma of the thyroid. About 33 patients are expected to be recruited for the trial.

• Peregrine Pharmaceuticals Inc., of Tustin, Calif., said researchers at the University of Texas Southwestern Medical Center at Dallas received a $1.68 million grant from the National Institute of Allergy and Infectious Diseases, a unit of the National Institutes of Health in Bethesda, Md. Their research uses Peregrine's anti-aminophospholipid antibodies as a potential treatment for Lassa fever. The investigative efforts center on developing drugs that direct immune responses to the inside-out components of the viral membrane, exploiting the fact that many viruses coat themselves with an outer membrane where some of the lipids are inside-out.

• Presutti Laboratories Inc., of Arlington Heights, Ill., submitted to the FDA a new drug application for tinidazole, a second-generation therapy for trichomoniasis, giardiasis, intestinal amebiasis and amebic liver abscess. The company said the 5-nitroimidazole compound has both anti-anaerobic and anti-protozoal properties. The FDA designated tinidazole as an orphan drug for giardiasis.

• Repligen Corp., of Waltham, Mass., began a clinical trial in healthy volunteers to assess the safety, tolerability and pharmacokinetic profile of subcutaneously injected RG1068 (synthetic human secretin), which already is in two Phase III trials for autism. The company said the study is designed to establish a subcutaneous secretin dose that will be comparable to blood levels, which can be achieved when administered intravenously. Repligen also said it plans to begin a Phase II trial of the drug in schizophrenia later this year.

• Stressgen Biotechnologies Corp., of Victoria, British Columbia, reported interim Phase II data at the Society of Ear, Nose and Throat Advances in Children meeting in New Orleans, showing that HspE7 therapy increased the first post-treatment interval 78.6 percent over the pretreatment interval, a statistically significant change (p<0.01), in treating recurrent respiratory papillomatosis. With 50 percent of the study population completing the follow-up period, the median of all post-treatment intersurgical intervals compared to pretreatment increased to 95.9 days (compared to 83.1 days previously reported and 55.3 days at baseline), also a statistically significant increase (p=0.03). The data follow on findings reported about two months ago. (See BioWorld Today, Sept. 17, 2003.)

• Synthetic Blood International Inc., of Costa Mesa, Calif., began a Phase I trial of Oxycyte, its perfluorocarbon-based blood substitute, which involves 27 patients. The company said it expects Oxycyte might be useful in treating stroke, heart attack and cancer patients and for use as a blood substitute and in organ preservation.

• The Immune Response Corp., of Carlsbad, Calif., initiated a preclinical program with IR103, a vaccine candidate for the prevention and treatment of HIV. The program is based on results obtained from proof-of-concept studies with IR103. IR103 combines Amplivax, an adjuvant being developed by Hybridon Inc., of Cambridge, Mass., to enhance the immune response to a vaccine antigen, with the HIV-1 Immunogen technology employed in Remune, Immune Response's immune-based therapeutic vaccine being evaluated in Phase II trials in the treatment of HIV-infected individuals.

• TransForm Pharmaceuticals Inc., of Lexington, Mass., said it discovered 16 previously unreported salt forms of setraline, the active molecule found in Zoloft (Pfizer Inc.), three of which it said appear to be less prone to polymorphism than the currently marketed drug. The company, which uses high-throughput technologies to optimize drug forms, also said it discovered a new crystalline form of the salt marketed in Zoloft.

• Transgene SA, of Strasbourg, France, entered an agreement with the French AIDS Research Agency (ANRS) and the French Institute for Health and Medical Research (INSERM) in which it will make constructs consisting of modified vaccinia ankara vectors carrying AIDS virus epitopes from Gag, Nef and Pol genes, and will manufacture the preclinical lots. INSERM, which owns the intellectual property of the Nef protein fragments, will conduct the immunological preclinical testing together with ANRS, which will make payments to Transgene. Its stock (NASDAQ:TRGNY) gained 37 cents Monday, or 15.5 percent, to close at $2.76.

• Xcellsyz Ltd., of Newcastle-upon-Tyne, UK, secured a $125,892 DTI Grant for research and development. The grant will be used to help test the feasibility of Xcellsyz's human cell-based approach to drug discovery through further development of the company's lead compound series XD4000. The XD4000 family of compounds has been shown to act on three therapeutically relevant kinases: glycogen synthase kinase 3, rho-kinase II and p70s6 kinase.

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