• Adherex Technologies Inc., of Research Triangle Park, N.C., said the FDA cleared its investigational new drug application for Exherin, its lead cadherin antagonist. As a result, this month the company plans to begin a U.S.-based Phase I trial of the tumor vascular-targeting compound. The 20-patient study is designed to evaluate Exherin's safety and drug metabolism, as well as to look at its activity on the tumor and its vasculature.

• Affymetrix Inc., of Santa Clara, Calif., and Perlegen Sciences Inc., of Mountain View, Calif., established a partnership to provide researchers access to custom genotyping services via Perlegen's high-throughput genotyping facility. The services cover projects ranging from a few thousand to 50,000 SNPs, and up to thousands of samples. Affymetrix will market the service and Perlegen will individually genotype customer samples, all on a fee-for-service basis. SNPs to be genotyped can be selected from Perlegen's portfolio of more than 1.5 million previously validated SNP assays, as well as from public sources.

• Alliance Pharmaceutical Corp., of San Diego, said that Nycomed Group, of Roskilde, Denmark, its development partner for Oxygent in the European Union, provided notice that it is terminating the recently reported license agreement. The decision reached by Nycomed was based upon its interpretation of the scientific advice from the European Agency for the Evaluation of Medicinal Products with regard to Oxygent development for European approval. The EMEA advised that blood transfusion is considered an effective treatment of blood loss with a well-documented safety profile and said adverse events such as mismatching and infection are rare. Oxygent is a synthetic PFC emulsion-based oxygen therapeutic. Alliance's stock (OTC BB:ALLP) fell 9 cents Tuesday, or 22.5 percent, to close at 31 cents.

• AltaRex Medical Corp., of Edmonton, Alberta, signed an exclusive distribution agreement for its lead product OvaRex MAb with Dompe International SA, of Lausanne, Switzerland. The covered territory includes Italy, Spain, Portugal, Hungary, Poland, Czech Republic, Switzerland and Austria, as well as other Eastern European countries. The collaboration is structured so that AltaRex remains responsible for product development and registration of OvaRex upon commercialization for the agreed territory. Also, AltaRex will supply OvaRex to Dompe, and will work with Dompe and other collaborators in achieving OvaRex registration in Europe. The agreement, which grants Dompe certain rights of first refusal for additional cancer antibodies in the territory, such as BrevaRex, AR 54, ProstaRex and GivaRex, calls for Dompe to be responsible for product marketing, storage, sales and distribution in the territory.

• Benitec Ltd., of Queensland, Australia, and Promega Corp., of Madison, Wis., granted a worldwide nonexclusive research license to Merck & Co. Inc., of Whitehouse Station, N.J., to practice DNA-directed RNAi (ddRNAi) technology. The commercial research license provides Merck with freedom to use ddRNAi in undertaking research activities throughout its global operations, but does not provide downstream commercial rights for therapeutic development. Financial details were not disclosed.

• CollaGenex Pharmaceuticals Inc., of Newtown, Pa., reported clinically and statistically significant results of a 180-patient trial designed to evaluate the safety and efficacy of Periostat when combined with Atridox and scaling and root planning (SRP), vs. SRP alone. At the end of the six-month study, patients in the Periostat plus Atridox plus SRP group showed a 48 percent mean improvement in clinical attachment level and a 44 percent mean reduction in periodontal pocket depths for pockets of 7 mm or greater at baseline, compared to similar pockets in the patients who had SRP alone. The deep pockets with baseline depths of 7 mm or greater and treated with combination therapy experienced an average reduction in pocket depth of more than 2 mm.

• Commonwealth Biotechnologies Inc., of Richmond, Va., said its common stock has been listed on the Berlin-Bremen Stock exchange without its prior knowledge, consent or authorization. The research and development services company has contacted the exchange and demanded an immediate halt to trading in its common stock.

• Corixa Corp., of Seattle, filed a supplemental biologics license application with the FDA requesting accelerated approval for expanded use of the Bexxar therapeutic regimen (tositumomab and iodine I-131 tositumomab). The company requested approval for expanded use in treating patients with relapsed or refractory low-grade, follicular, or transformed CD20 positive non-Hodgkin's lymphoma, whose disease has relapsed following chemotherapy. The regimen already is indicated for patients with CD20 positive, follicular, non-Hodgkin's lymphoma, with and without transformation, whose disease is refractory to the antibody treatment rituximab and who relapsed following chemotherapy.

• Crucell NV, of Leiden, the Netherlands, said GlaxoSmithKline plc, of London, renewed its PER.C6 technology license agreement. The pharmaceutical firm has a nonexclusive, worldwide license to use the technology for research and clinical development of viral-vectored biopharmaceutical products, with an option for a commercial license. Crucell will receive up-front and annual payments. Further financial details were not disclosed.

• Encysive Pharmaceuticals Inc., of Houston, confirmed that enrollment in the Stride-2 trial is expected to be complete in the third quarter. Enrollment is close to three-quarters complete in the 240-patient study. The company expects to provide its next update when Stride-2 has been fully enrolled. Stride-2 is a Phase III, randomized, double-blind, placebo-controlled safety and efficacy study of Thelin treatment with an open-label bosentan arm in patients with pulmonary arterial hypertension.

• Forbes Medi Tech Inc., of Vancouver, British Columbia, outlined plans for a U.S.-based Phase II study of its lead compound, FM-VP4, to focus on identifying the magnitude of the reduction in LDL-cholesterol produced by the product. FM-VP4 demonstrated efficacy and safety in a European Phase II study completed in the first quarter, and the upcoming safety and efficacy study will include three parallel groups made of 50 patients in each, vs. the 25 per group recruited for the European trial. Its efficacy endpoint will measure the anticipated reduction of LDL cholesterol by 15 percent or greater. Forbes said it would begin the trial in the second quarter of next year, and finish it in the first quarter of 2006.

• Forest Laboratories Inc., of New York, entered an agreement for the U.S. and Canadian development and marketing of desmoteplase, a product from Paion GmbH, of Aachen, Germany. The blood clot-dissolving agent is under development in the U.S. and Europe for acute ischemic stroke. Phase II results showed that the compound has the potential to treat patients up to nine hours after the onset of stroke symptoms. Forest made an undisclosed up-front payment to Paion, which also is entitled to milestone payments and royalties. Forest will fund all continuing clinical development activities for the U.S. and Canadian markets, where it is responsible for regulatory and sales and marketing activities. Forest also will have development and marketing rights to other indications in the territories. Paion retains commercial rights in Europe, Japan and the rest of the world.

• Gene Logic Inc., of Gaithersburg, Md., said the June 2004 issue of Cell Cycle detailed data on Gene Logic's Match/X Algorithm. The Match/X Algorithm is a gene-expression pattern-matching tool used to identify relationships between genes that might share common biological functions and is embedded in Gene Logic's Ascenta System, an intuitive gene-expression knowledgebase.

• GenoMed Inc., of St. Louis, said it applied for listing on the American Stock Exchange. The company, which is working to develop treatments to eliminate the threat of West Nile virus, said it expects a response in six to eight weeks.

• Inimex Pharmaceuticals Inc., of Vancouver, British Columbia, reported the first closing of a Series A financing for C$6 million (US$4.5 million) led by a syndicate of venture capital funds. Proceeds of the financing will support the lead optimization and preclinical development of the first drug based on Inimex's innate immunity platform.

• IntraBiotics Pharmaceuticals Inc., of Palo Alto, Calif., was named the subject of a class-action lawsuit. The complaint charges the company and several of its officers with failing to disclose and misrepresenting several adverse facts concerning iseganan. Safety issues related to the drug caused IntraBiotics to halt its late-stage program, causing the company's share value to fall by more than two-thirds.

• Isotechnika Inc., of Edmonton, Alberta, completed the single ascending-dose trial for the company's lead immunosuppressive drug candidate, ISA247. The trial was conducted in healthy volunteers using the trans-ISA247 formulation to assess the appropriate dosage of the enhanced composition of the drug. The data confirmed that the trans formulation of ISA247 is about 1.5 times more potent than the original mixture and up to five times more potent than cyclosporine.

• Merck KGaA, of Darmstadt, Germany, selected Chemical Diversity Labs Inc., of San Diego, as its preferred provider of screening libraries of lead-like small compounds through 2006. A steering committee with representatives from both companies will determine compounds to be synthesized by Chemical Diversity for early screening at Merck. Promising hits will then be further optimized and placed into Merck's discovery pipeline. Financial terms were not disclosed, though the agreement also includes an option to extend beyond 2006.

• Miravant Medical Technologies Inc., of Santa Barbara, Calif., entered a collaboration agreement and a securities purchase agreement with Guidant Corp., of Indianapolis. Guidant agreed to provide up to $7 million capital in support of Miravant's PhotoPoint cardiovascular programs, including an up-front payment of $3 million and additional staged investments based on the achievement of certain milestones through Phase I trials. The development programs include regional treatments for atherosclerosis and atherosclerotic vulnerable plaque.

• NeoRx Corp., of Seattle, filed an investigational new drug application with the FDA for a Phase II study of STR (Skeletal Targeted Radiotherapy) in patients with breast cancer that has metastasized to the bone. Researchers at MD Anderson Cancer Center in Houston conducted a small investigator-initiated Phase I study of STR in patients with Stage IV breast cancer involving osseous metastases. Six patients were administered STR as a single transplantation. Two of the six patients remain alive, without progression of their disease for more than five years post-transplant.

• NexMed Inc., of Robbinsville, N.J., entered an agreement to provide Schering AG, of Berlin, with exclusive commercialization rights to Alprox-TD in Europe, Russia, the Middle East, South Africa, Australia and New Zealand. NexMed will retain the intellectual property relating to the erectile dysfunction cream treatment, and will manufacture and supply it to Schering. NexMed could receive future milestone payments as well as a share of the revenue through transfer price payments based on the supply of Alprox-TD.

• Novogen Ltd., of Sydney, Australia, began a second clinical trial to evaluate its investigational cardiovascular drug, trans-NV-04. The company called the compound an advanced version of its experimental NV-04 compound. In the study, trans-NV-04 will be tested in subjects who are at risk of cardiovascular disease, but are otherwise healthy. Initially it will evaluate safety and tolerability in a dose-ranging study, followed by a randomized, cross-over, placebo-controlled and double-blinded study.

• Peregrine Pharmaceuticals Inc., of Tustin, Calif., gained a worldwide exclusive license to intellectual property related to anti-phosphatidylserine (anti-PS) antibodies from the University of Texas M. D. Anderson Cancer Center in Houston for use in mammalian therapeutics. Peregrine will pay M.D. Anderson an up-front fee, milestone fees based on the future success of drugs that fall under the licensed intellectual property and a royalty.

• Pharmion Corp., of Boulder, Colo., began its U.S. commercial launch of Vidaza on July 1 with the shipment of initial supplies of the recently approved drug. Vidaza was approved by the FDA in May for myelodysplastic syndrome subtypes, including refractory anemia or refractory anemia with ringed sideroblasts (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia. (See BioWorld Today, May 21, 2004.)

• SIGA Technologies Inc., of New York, appointed Bernard Kasten CEO. Kasten joins SIGA following eight years at Quest Diagnostics where he was vice president of medical affairs of its MedPlus subsidiary. Kasten has been a member of SIGA's board since May 2003. SIGA is applying bacterial genomics in the design and development of products for the prevention and treatment of serious infectious diseases, with an emphasis on products for biological warfare defense.

• Stressgen Biotechnologies Corp., of San Diego, said that after an end-of-Phase II meeting with the FDA for its lead compound, HspE7, it will submit a final pivotal trial protocol for a special protocol assessment. Earlier this year, the company reported that its Phase II trial testing HspE7 in recurrent respiratory papillomatosis patients met its targeted primary endpoint of lengthening the time between surgeries following treatment with HspE7.

• Tapestry Pharmaceuticals Inc., of Boulder, Colo., said it would receive a $3 million cash payment as its share of the proceeds from a paclitaxel litigation settlement. In the agreement, Mayne Pharma (USA) Inc., of Paramus, N.J., settled a patent infringement lawsuit against Mylan Laboratories Inc., of Pittsburgh, regarding stabilized formulations of paclitaxel. Tapestry was formerly known as Napro Biotherapeutics Inc.

• Viragen Inc., of Plantation, Fla., gained exclusive worldwide rights to a LentiVector gene delivery technology from Oxford BioMedica plc, of Oxford, UK. The agreement allows Viragen to use the technology in its collaboration with the Roslin Institute in Edinburgh, Scotland, to develop Avian Transgenic Technology as a platform for manufacturing therapeutic proteins in chicken eggs. In exchange, Oxford received an up-front license fee and annual maintenance payments, and also is entitled to milestone payments and royalties. Further financial details were not disclosed.

• Zonagen Inc., of The Woodlands, Texas, said that Nasdaq approved its application for its stock to trade on the Nasdaq SmallCap Market. Zonagen's stock will transfer from the Nasdaq National Market to the Nasdaq SmallCap Market and begin trading at the open of business on Thursday. Zonagen develops pharmaceutical products that address diseases and conditions associated with the treatment of hormonal and reproductive system disorders.

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