• The American Technion Society in New York said a new cancer treatment has been shown to eliminate or shrink tumors in 100 mice. The treatment causes antiviral T cells to recognize tumors as virus-infected cells, and thus attack them. The Technion-Israel Institute of Technology study is published in the June 15, 2004, Proceedings of the National Academy of Sciences.

• Aria Biosystems Corp., of Menlo Park, Calif., secured $5.5 million in its first venture capital round co-led by Alloy Ventures and Latterell Venture Partners. Agilent Ventures and Versant Ventures also participated. The financing allows Aria to complete development of its first product and advance its next two products. Aria's analytical tools are designed using optical fiber-based sensors that are self-calibrating and capable of measuring molecular binding kinetics and concentrations in real-time. Craig Taylor, of Alloy Ventures; James Woody, of Latterell; and Deborah Neff, president and CEO of South San Francisco-based Predicant Biosciences Inc. joined Aria's board.

• Ariad Pharmaceuticals Inc., of Cambridge, Mass., expects to begin enrollment of patients with relapsed or refractory hematologic cancers in a multicenter Phase II trial of AP23573 as a single agent by the end of the month. AP23573 will be studied further as a single agent in patients with specific solid tumors in a series of Phase II trials, the first of which is expected to be initiated during the third quarter. In parallel with Phase II trials, a series of Phase Ib trials is planned in selected cancers aimed at further evaluating AP23573 as a single agent and in combination with chemotherapeutic agents and other molecularly targeted drugs. The first such trial is planned by the end of the month.

• Axon Instruments Inc., of Union City, Calif., reported the release of its Axoporator 800A single-cell electroporator. The Axoporator 800A electroporator is designed to make single-cell electroporation practical with high transfection and cell-survival rates.

• BioSante Pharmaceuticals Inc., of Lincolnshire, Ill., reported positive preclinical results at the Controlled Release Society meeting in Honolulu, showing that its calcium phosphate (CAP) delivery system for long-acting insulin might extend the duration of action far beyond that of injecting insulin alone. Specifically, a subcutaneously injected formulation of CAP, polyethylene glycol and insulin (CAPI), prolonged the absorption of insulin and substantially lowered blood-glucose levels compared to insulin solution alone, and the glucose-lowering effect of CAPI was more dramatic in the diabetic mouse model. CAPI extended the hypoglycemic effect of insulin to at least eight hours, compared to two to four hours for insulin alone.

• CoTherix Inc., of South San Francisco, began a Phase II trial of Ventavis (iloprost inhalation solution) in combination with Tracleer (bosentan, from Actelion Ltd.) in patients with pulmonary arterial hypertension. Labeled the STEP study (Iloprost Inhalation Solution Safety and Pilot Efficacy Trial in Combination with Bosentan for Evaluation in Pulmonary Arterial Hypertension), it is designed to evaluate the combination of a prostacyclin analogue (Ventavis) with the endothelin receptor antagonist (Tracleer) in 60 patients.

• Crucell NV, of Leiden, the Netherlands, and DSM Biologics, of Groningen, the Netherlands, signed a PER.C6 research license agreement with Chiron Corp., of Emeryville, Calif. The license allows Chiron to research and preclinically develop its portfolio of recombinant monoclonal antibody products using Crucell's PER.C6 technology. Crucell and DSM Biologics will receive an up-front payment and annual maintenance fees. Further financial details were not disclosed.

• Dharmacon Inc., of Lafayette, Colo., reported an expansion of its siArray small interfering RNA library offering. The company now has 17 siRNA gene family libraries and subsets. Dharmacon also introduced a whole human-genome library containing more than 100,000 gene-silencing reagents targeting more than 22,000 unique human genes listed in the NCBI RefSeq database.

• Discovery Laboratories Inc., of Doylestown, Pa., said the FDA accepted its new drug application filing for Surfaxin in respiratory distress syndrome in premature infants. The FDA granted a standard review designation and has established a target date of Feb. 13 for completion of the review. The application was filed in April. (See BioWorld Today, April 15, 2004.)

• GTx Inc., of Memphis, Tenn., entered a collaboration with diaDexus Inc., of South San Francisco. GTx will provide clinical samples from its completed Phase IIb trial that evaluated Acapodene (toremifene citrate) tablets for reduction in the incidence of prostate cancer in men with high-grade prostatic intraepithelial neoplasia (PIN). Acapodene is a nonsteroidal selective estrogen receptor modulator that appears to block estrogen's unwanted effects on the prostate. DiaDexus will evaluate any resulting information from the collaboration to develop a commercial assay or test from blood or urine to detect high-grade PIN or prostate cancer.

• Hovione, of Loures, Portugal, and CyDex Inc., of Lenexa, Kan., formed an alliance to develop and commercialize improved formulations of drugs that are off-patent or soon will be off-patent. The collaboration will use CyDex's Captisol technology to develop formulations offering advantages such as improved bioavailability, dissolution and stability. The companies will develop Captisol-enabled formulations of six drugs initially. Hovione is a fine chemicals company that specializes in the process development and manufacture of active pharmaceutical ingredients and regulated intermediates.

• Iconix Pharmaceuticals Inc., of Mountain View, Calif., said it formed an agreement with Taisho Pharmaceutical Co. Ltd., of Tokyo, to perform a preliminary chemogenomics profiling and analytical study for a compound in Taisho's drug discovery pipeline. Taisho will apply Iconix's DrugMatrix platform to enhance drug candidate selection and optimization. Iconix will use biomarkers of drug pathology and mechanisms from its Drug Signature library to profile select leads from Taisho's various compounds. Financial terms were not disclosed.

• InSite Vision Inc., of Alameda, Calif., completed a $16.5 million private placement with the receipt of net proceeds from the $14.6 million final tranche. Stockholder approval for the financing, a precondition to its completion, was reported at InSite's annual meeting of stockholders on June 1. InSite obtained the first tranche of the private placement on March 26. (See BioWorld Today, June 3, 2004).

• Intradigm Corp., of Rockville, Md., said results published in this month's issue of Antiviral Therapy pointed to its achievement of prophylactic and therapeutic effects of siRNA inhibitors of severe acute respiratory syndrome coronavirus in nonhuman primate cells. The findings showed that siRNA duplexes are specific inhibitors of SARS-CoV, protecting cells from both viral infection and replication, and revealed SARS genome sequences sensitive to RNAi. The study was conducted in collaboration with Hong Kong University, Sun Yat-Sen University, Guangzhou Institute of Respiratory Diseases, Top Genomics Ltd., of Guangzhou, China, and Qiagen Sciences Inc., of Germantown, Md.

• MedImmune Inc., of Gaithersburg, Md., said the exclusive U.S. distributor of FluMist (influenza virus vaccine live, intranasal) for the upcoming flu season will be Henry Schein Inc., of Melville, N.Y. MedImmune, which has exclusive rights to manufacture and market the vaccine, will oversee all sales and marketing activities with special emphasis on pediatricians and pharmacies. In addition to selling FluMist, Henry Schein will respond to customer product inquiries, process returns and promote the product through marketing initiatives to primary-care physicians. MedImmune added that it halved FluMist's price from last season, and it will sell for $23.50 per returnable dose. Two months ago, the company lost its marketing agreement with Wyeth, of Madison, N.J. (See BioWorld Today, April 28, 2004.)

• Ondine Biopharma Corp., of Vancouver, British Columbia, said it would raise C$15 million (US$10.9 million) in gross proceeds after entering an agreement for the private placement of up to about 6.7 million common shares at C$2.25 apiece. The company also granted a 2.2 million-share overallotment option to a syndicate of agents co-led by McFarlane Gordon Inc. and Canaccord Capital (Europe) Ltd., and also including Haywood Securities Inc. Ondine said it would use net proceeds for product development, clinical trials and commercialization plans for its topical, non-antibiotic treatments for bacterial, fungal and viral infections using photodynamic disinfection technology. The transaction is expected to close on or about June 28.

• Ovation Pharmaceuticals Inc., of Deerfield, Ill., expanded its product portfolio with the acquisition of a central nervous system product, Buronil (melperone hydrochloride), from H. Lundbeck A/S, of Copenhagen, Denmark. Financial terms were not disclosed. Ovation assumes all of Lundbeck's responsibilities for Buronil in Europe, where Lundbeck markets the drug to treat schizophrenia and other central nervous system conditions in 12 countries. Ovation will assess the opportunity to seek approval for Buronil in other European countries, as well as in the U.S.

• ProMetic Life Sciences Inc., of Montreal, said its joint venture with the American Red Cross, Pathogen Removal and Diagnostic Technology Inc., demonstrated that its ligand technology can selectively bind and remove families of viruses from blood and blood products. PRDT's pathogen-reduction products are designed to assist blood transfusion services in maintaining the safety of blood and blood-derived products by targeting prions and viruses.

• SciClone Pharmaceuticals Inc., of San Mateo, Calif., said an animal model study evaluating Zadaxin in combination with carmustine (BCNU) to treat glioblastoma multiforme showed the treatment led to significantly lower tumor burdens and increased cure rates as compared to treatment with BCNU alone. The results were presented at the 11th annual International Symposium on Pediatric Neuro-Oncology conference in Boston. The data suggest the addition of thymosin alpha-1 (Zadaxin) could enhance the effectiveness of BCNU-mediated eradication of glioblastoma.

• Sosei Co. Ltd., of Tokyo, received permission to start a Phase I trial in the UK of SOU-001 in oral formulation for stress urinary incontinence. The trial will evaluate the safety, tolerability and pharmacokinetics of single oral doses of SOU-001 in healthy female volunteers. Sosei acquired exclusive worldwide rights for commercialization of the compound. SOU-001 is from Sosei's drug reprofiling platform.

• Symbollon Pharmaceuticals Inc., of Framingham, Mass., closed the acquisition of certain assets of privately held Mimetix Inc. and other related parties associated with their iodine drug development efforts in women's health care. Symbollon issued 550,000 shares of common stock for the assets, which include patient data from thousands of women with fibrocystic breast condition treated with molecular iodine and the related intellectual property. Symbollon's stock (OTC BB:SYMBA) closed Monday at $1.40, making the acquisition worth about $770,000. The stock rose 46.4 percent on Tuesday, to close at $2.05.

• Taconic Inc., of Germantown, N.Y., said it received an exclusive sublicense to produce and distribute the rasH2 transgenic mouse as part of a collaboration with the Central Institute for Experimental Animals of Japan. The rasH2 Microinjected Mouse carries the human prototype c-Ha-ras oncogene with a human promoter region in addition to the endogenous murine Ha-ras oncogene.

• Tercica Inc., of South San Francisco, paid Genentech Inc., of South San Francisco, $1.3 million for an exclusive license of Genentech's worldwide rights to insulin-like growth factor-1 (IGF-1) combined with insulin-like growth factor-binding protein-3 for all indications, other than diseases and conditions of the central nervous system and, outside of the U.S., diabetes. The rights include patents, patent applications, know-how and other intellectual property relating to IGF-1/IGFBP-3.

• The Immune Response Corp., of Carlsbad, Calif., said Health Canada cleared its first clinical trial investigating IR103 to treat HIV. IR103 combines the company's HIV-1 Immunogen with Amplivax, an immunostimulatory oligonucleotide adjuvant developed by Hybridon Inc., of Cambridge, Mass., and licensed by Immune Response. The Phase I/II single-blind, randomized, controlled trial will begin enrolling volunteers in the next few weeks. The company expects to study IR103 in drug-na ve patients later this year.

• Theratechnologies Inc., of Montreal, said it is presenting six posters at this week's Endocrine Society meeting in New Orleans. The company is disclosing pharmacological results for eight molecules it discovered, including several new long-acting GLP-1 analogues for Type II diabetes. Also, Theratechnologies is presenting new data on its lead product, ThGRF, a growth hormone-releasing factor analogue.

• Transgene SA, of Strasbourg, France, and Merial Ltd., of Lyon, France, formed a collaboration to develop products for animal health indications using Transgene's vector platform. Transgene will provide Merial with research and development support regarding vector-based expression of certain genes selected by Merial. Merial will conduct feasibility studies of different recombinant viruses in veterinary target species, and will have the right to execute an exclusive worldwide license for products originating from the research. The agreement provides for non-material payments to Transgene during the research phase.

• Viragen Inc., of Plantation, Fla., said findings published in the Scandinavian Journal of Infectious Diseases conclude that Multiferon provides an effective therapeutic alternative for difficult-to-treat patients with chronic hepatitis C and hepatitis-associated thrombocytopenia. The article reports on the treatment of a patient with chronic hepatitis C (genotype-1b) and cirrhosis who had failed previous therapies of recombinant alpha-interferon and natural beta interferon. After the patient was switched to Multiferon, thrombocyte and leukocyte counts increased to normal levels, and a sustained complete biochemical and virological response was achieved. The company's stock (AMEX:VRA) fell 15 cents Tuesday, or 10.7 percent, to close at $1.25.

• ViroPharma Inc., of Exton, Pa., is extending the expiration date of its offer to exchange up to about $99.1 million aggregate principal amount of its new 6 percent convertible senior plus cash notes due 2009 for up to all of the $127.9 million aggregate principal amount of its currently outstanding 6 percent convertible subordinated notes. ViroPharma is extending the expiration of the exchange offer to June 21.

• Xanthus Life Sciences, of Cambridge, Mass., initiated Phase I trials of Symadex in patients with advanced solid tumors. Symadex is a next-generation cancer agent designed to have similar or improved efficacy in comparison to the marketed chemotherapeutic, Novantrone, and reduced side effects including cardio-and hemato-toxicities. In the trial, Symadex will be evaluated in a once-weekly infusion cohort and in an additional dosing regimen.

• YM BioSciences Inc., of Mississauga, Ontario, said its European licensee for TheraCIM hR3, Oncoscience AG, of Wedel, Germany, enrolled the first patient in a 47-patient Phase I/II trial in pediatric glioma. TheraCIM hR3 is a humanized monoclonal antibody targeting the epidermal growth factor receptor. The trial will examine the efficacy of TheraCIM hR3 monotherapy in treating recurring, highly malignant brain gliomas in children.

No Comments