• Affymetrix Inc., of Santa Clara, Calif., said it would develop a biodefense microarray test to detect bacterial and biological threats such as anthrax and plague. The new test, funded by a $2.1 million grant from the National Institute of Allergy and Infectious Diseases in Bethesda, Md., is expected to offer researchers a single test for biodefense.

• Akorn Inc., of Buffalo Grove, Ill., signed an exclusive binding term sheet by which Hameln Pharmaceuticals GmbH, of Hameln, Germany, will license and supply to Akorn two orphan drugs, Calcium-DTPA and Zinc-DTPA. FDA approved in August, they are indicated for the treatment of radioactive poisoning. Hameln will provide Akorn an exclusive license for five years, with automatic successive two-year extensions. Akorn paid €100,000 to enter the deal, and the companies intend to enter a binding contract by Nov. 30, at which time Akorn will pay a €1.5 million license fee. Akorn will be responsible for marketing and distributing the drugs in the U.S. and Canada, and the companies will share revenues evenly. Hameln will be responsible for manufacturing and Akorn will be responsible for paying any annual FDA-establishment fees and for the cost of any post-approval studies.

• Altachem Pharma Ltd., of Edmonton, Alberta, said results of an animal toxicology study of its lead compound, ACP-SL017 for photodynamic therapy (PDT), showed that all rats injected with the product survived the 14-day period with no apparent toxicity observed. Also, gross necropsy of all the tested animals did not reveal any abnormalities attributed to the ACP-SL017 at all dose levels. The company's PDT technology is based on a non-toxic family of photosensitizing compounds isolated from parasitic fungi on bamboo, and the lead compound has been demonstrated to specifically kill cancer cells upon activation by light.

• Althea Technologies Inc., of San Diego, received a Phase I Small Business Innovation Research grant from the National Cancer Institute to establish gene-expression assays that serve as genetic signatures for the diagnosis of multiple pediatric cancers, including neuroblastoma, rhabdomyosarcoma, non-Hodgkin's lymphoma and Ewing family tumors. The genetic signatures, initially determined at the NCI through the analysis of microarray-based expression data, are being translated and validated to high-throughput assays using Althea's eXpress Profiling technology.

• Benitec Ltd., of St. Lucia, Australia, granted a worldwide nonexclusive license to Panomics Inc., of Redwood City, Calif., to make and sell DNA-directed RNAi-based products. Panomics specializes in tools for decoding the proteome, including arrays for global analysis of transcriptional regulation and cell signaling.

• Biopharmacopae Design International Inc., of Quebec City, said preclinical data reported at the AACR International Conference Frontiers in Cancer Prevention Research in Seattle demonstrated that a combination of two of its purified plant fractions might be an effective means of inhibiting primary cancer tumor growth and metastasis. The company specializes in the discovery of new therapeutic molecules from natural plant extracts.

• Cambrex Corp., of East Rutherford, N.J., said its wholly owned subsidiary, Cambrex France SARL, paid about $6 million in cash to acquire Genolife SA, of Saint Beauzire, France. Genolife specializes in microbial-detection testing for the pharmaceutical, agricultural, food and cosmetic industries. Cambrex will use Genolife's technology internally for in-process testing of its media, biologics and cell-therapy production to cut product costs and cycle times.

• Corcept Therapeutics Inc., of Menlo Park, Calif., began its second pivotal Phase III trial to evaluate Corlux (mifepristone) for the treatment of the psychotic features of psychotic major depression (PMD). The company, which last month began enrolling patients in its first pivotal study, expects to have initial results from both trials in the first half of 2006. The second study, known as Corcept 06, will enroll about 440 patients at 30 U.S. sites. Its primary endpoint is the proportion of patients with at least a 50 percent improvement in the Brief Psychiatric Rating Scale Positive Symptom Subscale at both day seven and day 56. As with the other study, called Corcept 07, treatment with antipsychotic medications or electroconvulsive therapy will not be allowed. Corlux is a fast-track product for PMD; the company reached a special protocol assessment agreement with the FDA two months ago to begin the pivotal program. (See BioWorld Today, Aug. 31, 2004.)

• GenoMed Inc., of St. Louis, said the National Institute of Allergy and Infectious Disease, a unit of the National Institutes of Health in Bethesda, Md., has expressed interest in testing GenoMed's approach to the flu using an animal model. The company is testing the use of a class of blood pressure medications in viral diseases, including the flu, and met last week with government officials to discuss the potential broad-spectrum viral antidote and further testing of the approach against viral diseases. GenoMed said the meeting resulted in an expansion of a contract it signed with the institute in December.

• Immunomedics Inc., of Morris Plains, N.J., said data reported at the American College of Rheumatology meeting in San Antonio showed that all 14 patients in its Phase II study of epratuzumab in systemic lupus erythematosus showed symptomatic improvement 24 hours after the last treatment. Also, nine of the 14 had lowered their global BILAG scores by 50 percent or more 24 hours post-therapy. Separately, the company said it plans to study the safety and efficacy of epratuzumab in registration trials in systemic lupus erythematosus. Following its report of a successful meeting with FDA, in which Phase II data were reviewed and the design of registration trials was presented, Immunomedics plans to file the agreed-upon protocols and to begin enrolling patients into such trials in the near future.

• InKine Pharmaceutical Co. Inc., of Blue Bell, Pa., entered an agreement with an undisclosed third party that will fund its settlement of damages and costs incurred in connection with a class-action lawsuit related to the denial of certain claimed preemptive rights. In addition, the company entered and filed with the Court of Common Pleas in Philadelphia County a settlement agreement with the class of InKine shareholders in the suit. InKine and its insurance carriers are not expected to bear any costs in connection with the settlement arrangement, which remains subject to a number of conditions, including final court approval.

• Insmed Inc., of Richmond, Va., said it would begin clinical development of a small-molecule tyrosine kinase inhibitor in collaboration with the University of California at San Francisco's school of medicine. Insmed and UCSF will initiate a dose-escalating study primarily designed to define the maximum tolerated dose of INSM-18 in patients with relapsed prostate cancer. INSM-18 has demonstrated selective inhibition of the insulin-like growth factor-1 receptor.

• Introgen Therapeutics Inc., of Austin, Texas, said preclinical data reported at the AACR International Conference on Frontiers in Cancer Prevention Research in Seattle demonstrated the promise of INGN 225 as a cancer vaccine. Findings showed that up to 85 percent of mice were protected from developing tumors after first being vaccinated with their own dendritic cells or with INGN 225, and then after 24 days following injection with cancer cells. INGN 225 also was assessed for its effect on existing tumors and demonstrated a significant reduction in tumor growth compared to controls. Also, activation of the immune system to recognize high levels of p53 expressed in cancer cells did not result in damage to normal tissue.

• KBI BioPharma Inc., of Durham, N.C., said it would receive $500,000 under a Phase II Small Business Innovation Research grant from the National Science Foundation to support ongoing development work applying KBI's Centrifugal Bioreactor technology to biopharmaceutical production. The technology applies fluidized bed methodology to allow cells producing recombinant therapeutic and vaccine products to be immobilized at high densities without the use of membranes or other solid support or retention devices.

• Kinexus Bioinformatics Corp., of Vancouver, British Columbia, launched its sixth Kinetworks Phospho-Site Screening Service, KPSS 6.0. The screen, developed in collaboration with Stressgen Bioreagents in Victoria, British Columbia, was designed to detect the presence and relative quantities of 34 critical protein phosphorylation sites in humans and diverse animal model systems.

• Kosan Biosciences Inc., of Hayward, Calif., said the FDA named its cancer compound 17-allylamino-17demethoxy-geldanamycin (17-AAG), an analogue of the polyketide geldanamycin, an orphan drug for the treatment of multiple myeloma. A Phase I trial of the company's formulation of 17-AAG, KOS-953, is investigating the drug as monotherapy in the disease.

• Li-Cor Biosciences Inc., of Lincoln, Neb., said researchers at the University of Washington are using its Odyssey Infrared Imaging System to determine basal expression patterns and co-localization of CB1 and D2 receptors in a normal mouse brain to monitor changes in G protein-coupled receptor levels. They said global imaging of the entire brain slice permitted identification of receptor expression, and also allowed for discrimination of the laminar expression pattern of CB1 receptors in the cortex and both CB1 and D2 receptors in the hippocampus and cerebellum. As a result, they concluded that the approach required less primary antibody, shorter incubation times and provided an extended window for analysis relative to standard immunohistochemical staining approaches.

• Lilly ICOS LLC, a joint venture between Eli Lilly and Co., of Indianapolis, and ICOS Corp., of Bothell, Wash., said an analysis of data from 11 clinical studies, reported at the International Society for Sexual and Impotence Research meeting in Buenos Aires, Argentina, showed that 82 percent of men with erectile dysfunction and benign prostatic hyperplasia had improved erectile function when treated with Cialis (tadalafil) 20 mg. Of men receiving Cialis 10 mg, 76 percent reported improved erections. In the placebo group, 35 percent reported improved erections. According to the analysis, 48 percent of Cialis-treated men with BPH attained an erectile function domain score in the normal range of the International Index of Erectile Function at the end of treatment, compared to 11.3 percent on placebo. Cialis was well tolerated.

• Medical Discoveries Inc., of Twin Falls, Idaho, completed a private placement consisting of convertible preferred stock and warrants, generating gross proceeds of $1.2 million. The company is pursuing a commercialization strategy for its anti-infective therapeutic compound, MDI-P.

• Nobex Corp., of Research Triangle Park, N.C., and Biocon Ltd., of Bangalore, India, entered an agreement for the global co-development of an oral insulin product for diabetes. The deal calls for Nobex to combine its peptide oral delivery and process technology with the peptide production capabilities of Biocon. The companies expect to have meaningful clinical data and progress toward manufacturing within two years. Financial terms were not disclosed.

• Norak Biosciences Inc., of Research Triangle Park, N.C., signed a research agreement to investigate the use of its Transfluor technology with a new class of receptors of interest to Curis Inc., of Cambridge, Mass. Specifically, the agreement calls for Norak to use its GPCR drug discovery technology, related intellectual property and scientific know-how to develop Transfluor cell lines expressing Curis' receptors. Financial terms were not disclosed.

• Rigel Pharmaceuticals Inc., of South San Francisco, said preclinical data reported at the American College of Rheumatology meeting in San Antonio suggest that R406 demonstrated a statistically significant reduction in arthritis severity. Data stem from a 28-day study of the compound, an inhibitor of syk kinase, which was tested in a rat collagen-induced arthritis model. Researchers saw a dose-related reduction in arthritis severity, which was evident within seven days of therapy and continued to improve throughout the study. Data concluded that R406 significantly reduced the severity of established collagen-induced arthritis.

• Sirna Therapeutics Inc., of Boulder, Colo., said it would move forward with the development of an RNAi-based treatment for Huntington's disease. Early next year, Sirna expects to select investigational compounds for preclinical development based on the work of its collaborators at the University of Iowa. Findings from the school, published in the August issue of Nature Medicine, demonstrated that a siRNA efficiently inhibited gene expression in an animal model of a disease mimicking spinocerebellar ataxia 1, a member of a class of inherited human neurodegenerative diseases that includes Huntington's. In related news, Sirna said it entered a deal with the Huntington's Disease Society of America.

• St. Jude Children's Research Hospital in Memphis, Tenn., and The Johns Hopkins Kimmel Cancer Center in Baltimore said their investigators published findings in this month's issue of Immunity detailing their discovery that the Lag-3 gene acts as a brake to prevent immune system responses from running out of control. Specifically, they showed that the gene permits regulatory T cells to act as brakes on the immune system, a finding that could lead to new strategies for improving the efficacy of cancer vaccines or preventing autoimmune diseases.

• VaxGen Inc., of Brisbane, Calif., began a Phase I/II trial to test the safety and immune response of its attenuated smallpox vaccine candidate LC16m8. About 150 volunteers will be randomized at a 4:1 ratio and screened for safety risk factors before enrollment. VaxGen's development objectives are to meet the U.S. government's stated interest in acquiring an emergency stockpile of attenuated smallpox vaccine and to license the product for commercial sales.

• VioQuest Pharmaceuticals Inc., of Monmouth Junction, N.J., said its subsidiary, Chiral Quest Inc., entered a ligand technology relationship with Pfizer Inc., of New York. The technology is being used by the pharmaceutical firm for the process development and manufacture of new therapeutic compounds, covering a range of Chiral Quest's catalysts and ligands. Financial terms were not disclosed.

• Weill Cornell Medical College said its researchers published findings in the Oct. 18, 2004, online early edition of the Proceedings of the National Academy of Sciences detailing their discovery that a protein called synaptotagmin I plays a key role in synapse transmissions. It appears to have a double function, working both in the delivery of messenger neurotransmitters at the surface of brain cells, as well as in picking up and recycling emptied neurotransmitters after the delivery.

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