• Ablynx NV, of Ghent, Belgium, entered an oncology collaboration with Genencor International Inc., of Palo Alto, Calif. Ablynx will use its Nanobody platform to discover and develop new drug candidates against tumor targets specified by Genencor. Ablynx will receive research funding and license fees in addition to milestone payments and royalties upon commercialization. Genencor will assume responsibility for the preclinical and clinical development of lead Nanobodies, as well as the commercialization of resulting products.

• Altor Biosciences Corp., of Miramar, Fla., said it was awarded a Phase II Small Business Innovation Research grant to advance its soluble T-cell antigen receptor fusions toward clinical development as cancer therapeutics. The grant of about $1 million over a two-year period was awarded by the National Cancer Institute of the National Institutes of Health in Bethesda, Md.

• Amylin Pharmaceuticals Inc., of San Diego, submitted a complete response to the FDA's second approvable letter for Symlin (pramlintide acetate). The company said the agency is expected to respond to the submission within six months. The FDA's Endocrinologic and Metabolic Drugs Advisory committee voted against approving the drug more than three years ago, but the following fall the agency issued an approvable letter for Symlin if the company would conduct another clinical trial. The second approvable letter was received late last year. (See BioWorld Today, July 27, 2001; Oct. 15, 2001; and Dec. 19, 2003.)

• Antares Pharma Inc., of Exton, Pa., said its stock was approved for listing on the American Stock Exchange. Antares' stock is expected to begin trading under the symbol "AIS" Thursday. Antares is focused on enhancing product performance of established and developing drugs.

• Ariadne Genomics Inc., of Rockville, Md., and GeneGo Inc., of St. Joseph, Mich., formed an alliance for functional analysis of high-throughput experimental data. Ariadne's MedScan TextMiner automated text-processing pipeline will be integrated and co-marketed with MetaCore, GeneGo's analytical platform that includes databases of human biology and chemistry.

• Australian Cancer Technology Ltd., of Sydney, Australia, undertook a secondary listing on the Xetra exchange, the electronic trading system of the Frankfurt Stock Exchange in Germany. AustCancer contracted the Frankfurt-based securities broker dealer firm, Seydler AG Securities and Financial Services, to act as market maker and designated sponsor for the company's shares on Xetra. AustCancer is developing oncology-related projects.

• Avant Immunotherapeutics Inc., of Needham, Mass., said Circulation published results in its Sept. 14, 2004, issue on the TP10 double-blind, placebo-controlled Phase II study in 564 adult patients undergoing cardiac surgery on cardiopulmonary bypass (CPB). TP10 significantly decreased the incidence of mortality and acute myocardial infarction in male patients, but did not show benefit in female patients, causing the study to miss its primary endpoint. Investigators, however, observed that TP10 effectively inhibited complement activation during CPB in both males and females.

• Bionomics Ltd., of Adelaide, Australia, reported a series of initiatives designed to strengthen its presence in the U.S. market. Bionomics has established a collaborative agreement with the School of Medicine at Emory University in Atlanta to study genetic variations associated with severe myoclonic epilepsy of infancy. The company also formed a wholly owned U.S. subsidiary and appointed a U.S. business representative. Bionomics uses its genomic knowledge and technology to develop diagnostics and therapeutics for central nervous system disorders.

• BioTrove Inc., of Woburn, Mass., launched its OpenArray Transcript Analysis system for high-density, quantitative PVR analyses. The OpenArray platform, which enables massively parallel qPCR and nanoliter-scale quantities of reagents and samples, allows researchers to study 9,000 transcripts in about two hours, the company said.

• Corixa Corp., of Seattle, said the FDA accepted its supplemental biologics license application for expanded use of the Bexxar therapeutic regimen. The FDA also granted priority-review status to the BLA, meaning the review should be complete by January 2005. Corixa has requested accelerated approval for the expanded use of Bexxar in treating patients with relapsed or refractory low-grade, follicular or transformed, CD20+ non-Hodgkin's lymphoma whose disease has relapsed following chemotherapy. Bexxar is indicated to treat patients with CD20-positive, follicular NHL, with and without transformation, whose disease is refractory to the antibody rituximab and has relapsed following chemotherapy.

• Cytogen Corp., of Princeton, N.J., said new data on Quadramet demonstrate how its mechanism of action might enhance anticancer activity when used in combination with melphalan and other therapeutic agents. Quadramet is available as a non-opioid alternative for pain relief from metastatic bone disease associated with various cancers. The data were presented at the 36th Congress of the International Society of Pediatric Oncology by Mayo Clinic researchers who are evaluating Quadramet with chemotherapy to treat acute myeloid leukemia. Quadramet consists of a short half-life therapeutic radionuclide (Samarium-153) bound to a small-molecule, bone-seeking phosphonate that selectively concentrates in osteoblastic sites.

The Dana-Farber Cancer Institute in Boston said its scientists published data in the Sept. 21, 2004, issue of Cancer Cell showing their ability to correct a flaw in cancer cells that lets them evade the normal cell-death process, eliminating leukemia cells from mice. The scientists observed 28 mice, which at 5 to 7 weeks of age had developed leukemia. Fourteen were given an antibiotic in their water to turn off the BCL-2 genes, and within three days the treated animals had a decline in leukemia cells and their white blood cell counts became normal within 10 days. There was no such improvement in the untreated mice, whose cancers resisted death because of their active BCL-2 genes; they all died in just more than 100 days of age. By contrast, five of the mice with silenced BCL-2 genes survived for more than 200 days, and one lived more than a year.

• Depomed Inc., of Menlo Park, Calif., said the FDA accepted for review its new drug application for Proquin XR, a once-daily, extended-release formulation of ciprofloxacin. Proquin is the company's second product under review for approval. Earlier this year, authorities accepted for review in the U.S. and Canada regulatory filings for its Type II diabetes treatment, Glumetza. The Proquin NDA is based on pivotal Phase III data on 1,037 patients with uncomplicated urinary tract infections.

• Endo Pharmaceuticals Inc., a wholly owned subsidiary of Endo Pharmaceuticals Holdings Inc., of Chadds Ford, Pa., said it received final FDA approval for the clinical trial protocol relating to oxymorphone immediate-release tablets. The company had submitted the protocol under the agency's special protocol assessment process. Endo also said that with respect to an additional clinical trial of the extended-release tablet version of oxymorphone (oxymorphone ER) the FDA had requested, the agency has asked Endo to clarify some aspects of the data analysis prior to granting final approval of the protocol pursuant to the SPA. The additional request does not affect the already agreed upon design of the oxymorphone ER trial.

• Entropin Inc., of Indio, Calif., said the second phase in the development and selection of the ENT-103 formulation to be used in future clinical trials was completed. The first series of studies evaluated the absorption rate of ENT-103 into and through human skin when used with a variety of prototype formulations. The second series of studies tested those formulations and evaluated different concentrations to further refine the formulation. Skin penetration of ENT-103, expressed as the total amount of radioactivity present in the receptor fluid samples following the 24-hour exposure period, was in excess of 20 percent of the applied dose.

• Evogene Ltd., of Rehovot, Israel, and the Israeli seed company Zeraim Gedera signed a collaboration for the joint development and commercialization of salt-tolerant tomato rootstocks and seed varieties. The companies will jointly develop tomato lines tolerant to high-salinity levels. Zeraim will be responsible for the breeding of the varieties and rootstocks by contributing its existing commercial tomato germplasm.

• Eyetech Pharmaceuticals Inc., of New York, and Pfizer Inc., also of New York, said the European Medicines Agency accepted the filing of their marketing authorization application for Macugen (pegaptanib sodium injection), for neovascular age-related macular degeneration. The companies also completed the filing of a new drug application for Macugen in Canada, where it has been given priority review, and have begun clinical trials with the candidate in Japan.

• Genzyme Corp., of Cambridge, Mass., said it will enhance access to Renagel (sevelamer hydrochloride) for Medicare beneficiaries through the Renagel REACH Program. Medicare beneficiaries will be eligible to receive Renagel for either $5 or $25 per month, depending on income. Renagel helps control serum phosphorus in patients with chronic kidney disease on hemodialysis, the company said.

• Global Genomics AB, of Stockholm, Sweden, entered an agreement with Rheoscience A/S, of Roedovre, Denmark, for the use of tangerine gene-expression profiling to study targets in metabolic diseases. Financial terms were not disclosed.

• Guilford Pharmaceuticals Inc., of Baltimore, began a Phase III study to assess the safety and overall efficacy of Aquavan injection vs. midazolam HCl for sedation in patients undergoing colonoscopy procedures. Its primary endpoint is success of sedation, defined as three consecutive Modified Observer's Assessment of Alertness/Sedation scores less than or equal to 4, and completing the procedure without using alternative sedative medications and without requiring manual or mechanical ventilation. Secondary endpoints include duration of sedation, time to recovery and being fully alert following the procedure, and patients and physicians ratings of the procedure. The randomized, open-label, blinded-evaluator trial, which will enroll up to 267 patients, is the first of several Phase III studies the company expects as part of its Aquavan development program. Guilford outlined its broad program plans earlier this year. (See BioWorld Today, May 11, 2004.)

• Human Genome Sciences Inc., of Rockville, Md., said Argeris Karabelas will become chairman following the planned Oct. 17 retirement of William A. Haseltine, current chairman and CEO. The company also said that Craig Rosen was promoted to president and chief operating officer, effective immediately. The company focuses on gene-based protein and antibody drugs.

• Iconix Pharmaceuticals Inc., of Mountain View, Calif., formed an agreement with Roderick Jensen, acting director of the Biotechnology Center and Laboratory for Functional Genomics at the Brigham and Women's Hospital/Harvard Medical School in Boston, to study and validate gene-expression patterns in patients with neurological diseases. Jensen's laboratory has devised a high-throughput validation strategy that uses gene-expression platforms to assay tissue samples in disease and drug studies.

• Icoria Inc., of Research Triangle park, N.C., said its Paradigm Array Labs service unit has developed a gene-expression-profiling quality system compliant with applicable Good Laboratory Practice requirements. It plans to implement Good Manufacturing Practice compliance in the coming months, which would enable it to expand its services into preclinical settings.

• InNexus Biotechnology Inc., of Vancouver, British Columbia, agreed to acquire specific antibodies to treat coronary heart disease and chronic viral diseases from ImmPheron Inc., of Lexington, Ky. The antibodies are in the late preclinical stage and have demonstrated efficacy in animal models of human disease. The companies plan to jointly develop a SuperAntibody version of an antibody with the ability to reduce plaque formation that causes narrowing of the arteries and the occurrence of coronary heart disease. InNexus also is acquiring further rights to the monoclonal antibody 1F7, targeted to treat chronic viral diseases. Terms of the agreement include the issuance to ImmPheron of 500,000 common shares of InNexus, a $50,000 payment, a 3 percent royalty on net sales of product developed and a 10 percent share in consideration received by InNexus from third-party licensees of SuperAntibody versions of the antibodies.

• Integrated BioPharma Inc., of Hillside, N.J., said its wholly owned subsidiary, NuCycle Therapy Inc., entered a research and development agreement with the U.S. Navy to carry out a Phase I trial of a plant-derived oral anthrax vaccine designed to boost immune responses in vaccinated individuals. The project's goal is to create a vaccine to protect civilian and military personnel from anthrax, as well as to improve procedures for vaccinating large populations.

• Isis Pharmaceuticals Inc., of Carlsbad, Calif., said that Indianapolis-based Eli Lilly and Co. licensed LY2275796, a second-generation antisense cancer drug candidate that targets eukaryotic initiation factor-4E. The protein is involved in the translation of key growth and survival factors that drive tumor progression, angiogenesis and metastases. The companies discovered the compound through their alliance begun in June 2002. Isis will receive a $750,000 payment from Lilly for the license. Lilly will fund the continued development of the product and will pay milestones and royalties.

• Medicure Inc., of Winnipeg, Manitoba, developed an intravenous formulation of the company's lead drug, MC-1, after completion of a Phase I trial to assess its safety and tolerability in healthy volunteers. The new product presentation, which complements the existing oral dosage form, broadens MC-1's use as a cardioprotective agent in the management of cardiovascular emergencies, Medicure said.

• Onyx Pharmaceuticals Inc., of Richmond, Calif., said it would receive a $500,000 milestone payment after its collaborator, Pfizer Inc., of New York, began Phase I trials of a cancer compound discovered as part of the collaboration. Pfizer is managing and funding all clinical development and commercialization activities for the compound, labeled PD332991. In exchange, Onyx will receive a high single-digit royalty if it is commercialized, and also stands to receive milestone payments associated with the achievement of certain clinical and regulatory events.

• Pharmacyclics Inc., of Sunnyvale, Calif., said interim study results of Xcytrin (motexafin gadolinium) injection in combination with Rituxan and Zevalin to treat relapsed and refractory non-Hodgkin's B-cell lymphomas showed evidence that Xcytrin localizes in lymphoma cells, generates reactive oxygen species and induces apoptosis. The study has a target enrollment of 20 patients, and three have been enrolled to date. All three achieved complete tumor remission within one month of starting treatment. The data were presented at the 6th International Symposium on Hodgkin's Lymphoma in Cologne, Germany.

• Pharming Group NV, of Leiden, the Netherlands, said the U.S. Army will evaluate its recombinant human fibrinogen product (rhFIB). The Army will conduct studies using rhFIB to determine its use for various applications. Based on the outcome, Pharming will supply rhFIB to the Army for tissue sealant as well as therapeutic applications. The parties will execute an agreement that will define the extent of the collaboration upon successful evaluation of rhFIB. Pharming is developing protein therapeutics.

• Power3 Medical Products Inc., of The Woodlands, Texas, signed a research agreement with Mercy Women's Center in Oklahoma City related to the identification of protein biomarkers for the early indication of breast cancer in blood serum. Mercy Women's Center will provide the company up to 600 blood serum samples from normal subjects and subjects with various stages of breast cancer.

• Prestwick Pharmaceuticals Inc., of Washington, acquired the rights to commercialize tetrabenazine in Canada under the brand name Nitoman from Cambridge Laboratories, of Newcastle, UK. Tetrabenazine is a dopamine depletor approved in Canada for the treatment of a series of hyperkinetic movement disorders. Tetrabenazine also is approved for use in the UK, a number of European countries and Australia, and it is undergoing Phase III trials in the U.S. Prestwick plans to file a new drug application in the U.S. later in the year.

• Singulex Inc., of Berkeley, Calif., named Philippe Goix president and CEO. Most recently, he had founded and served as chief technical officer at Guava Technologies Inc., of Hayward, Calif. Interim CEO Fred Vogt will continue as chairman of the company, which is developing a molecular-detection system with applications in drug discovery and diagnostics.

• StemCells Inc., of Palo Alto, Calif., said its scientific collaborators would receive up to $1.9 million in grant funding from the National Institutes of Health in Bethesda, Md., focused on the use of the company's human neural stem cells. StemCells was awarded a Small Business Technology Transfer grant for studies in Alzheimer's disease, as well as a multiyear grant to fund studies of the human central nervous system stem cell grafts in the treatment of spinal cord injuries.

• Vertex Pharmaceuticals Inc., of Cambridge, Mass., completed the exchange of about $79.3 million in 5 percent convertible subordinated notes due 2007 for about $79.3 million in newly issued 5.75 percent convertible senior subordinated notes due 2011. The senior subordinated notes were issued through a private offering to qualified institutional buyers. They are convertible into Vertex common stock at $14.94 per share, a 41.6 percent premium to the average closing price of Vertex common stock over a four-day period.

• ViaCell Inc., of Boston, said a federal court in Delaware overturned in its entirety an earlier judgment against the company in a case against PharmaStem Therapeutics Inc., of Wayne, Pa. The court also denied PharmaStem's request for a permanent injunction, and ViaCell will pay no damages to PharmaStem. ViaCell uses a Selective Amplification technology to develop stem cell products based on the isolation, purification and expansion of targeted stem cell populations, and has advanced a cord blood-derived stem cell therapeutic, CB001, into Phase I. The court ruled that cord blood is owned by the family it was collected from and because ViaCell only provides services to assist the family, it does not infringe PharmaStem's patents.

• Ziopharm Inc., of New Haven, Conn., said mouse study data of ZIO-101 showed researchers were able to increase the arsenic dose 30- to 50-fold over that of inorganic arsenic without experiencing any severe side effects. Further testing with ZIO-101 in dogs showed no evidence of heart damage or other toxicity. The findings were presented by The University of Texas M.D. Anderson Cancer Center researchers at the 7th annual meeting of New Trends in the Treatment of Acute Leukemia. The researchers also presented laboratory data that suggest ZIO-101 kills cancer cells more effectively than inorganic arsenic by using different mechanisms.

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