• 4SC AG, of Martinsried, Germany, completed its fourth round of financing, raising €6.5 million (US$7.9 million). The KfW Mittelstandsbank and Bayern Kapital participated in the second closing in June. The first closing occurred in December with investments from Deutsche Venture Capital Gesellschaft, 3i, BioM and Mulligan BioCapital. Proceeds will be used for a Phase IIa study in rheumatoid arthritis, as well as further development of its projects in the fields of cancer and inflammatory diseases.

• Alnylam Pharmaceuticals Inc., of Cambridge, Mass., granted Eurogentec SA, of Liege, Belgium, a nonexclusive license to provide research products and services in RNA interference under the Kreutzer-Limmer patent family owned by Alnylam. The patent family covers short interfering RNAs and their use to mediate RNAi in mammalian cells.

• Amarillo Biosciences Inc., of Amarillo, Texas, resolved all clinical and safety issues with the FDA and is ready to initiate a study with a Turkish pharmaceutical company, Nobel Ilac San. Ve Ticaret AS, Amarillo said. The study is expected to begin in October and to be completed within a year. ABI's oral low-dose interferon-alpha will be tested as a treatment for Behcet's disease in 90 Turkish patients.

• Ambion Inc., of Austin, Texas, and Ambion Ltd., of Huntingdon, UK, formed an agreement with the MitoCheck consortium to provide a genome-wide siRNA library targeting every human gene. MitoCheck is a European Union-funded multinational research consortium that will use a genome-wide human siRNA library in experiments designed to answer questions about how cell division is regulated. The consortium will search for human genes that have a role in mitosis.

• Aphton Corp., of Philadelphia, said positive results from a Phase I trial of IGN311 showed the antibody, which targets the Lewis Y tumor-associated antigen, was generally well tolerated with no hematological toxicities. The capacity of the antibody to destroy tumor cells was significantly induced by IGN311 infusions.

• AspenBio Inc., of Castle Rock, Colo., completed and terminated its offering under a private placement of about $3.6 million in securities, the bulk of which closed in May. A total of 4.1 million shares and 4.1 million warrants were issued in the offering to accredited investors. Westminster Securities Corp. acted as the placement agent. Funds will go to working capital, new product development and general corporate purposes.

• Assay Designs Inc., of Ann Arbor, Mich., purchased Stressgen Bioreagents Corp., of Victoria, British Columbia, which recently acquired the reagents business of San Diego-based Stressgen Biotechnologies Corp. in a transaction funded by Ampersand Ventures. The purchase will allow Assay Design to leverage Stressgen's expertise in heat-shock proteins, active kinases and antibodies to develop kits.

• Bioniche Life Sciences Inc., of Belleville, Ontario, said an investigation into its injectable ascorbic acid product, Betac, has shown that the product is free of microbial contamination. It was the subject of a voluntary recall last month after one-third of the product released to the market was found to contain a small amount of visible particulate matter. But the particulate was identified as a calcium oxalate precipitate, which does not present a significant risk to human health, and it was determined that Betac's potency and pH were not affected by the precipitate's presence.

• Biopure Corp., of Cambridge, Mass., said the FDA put on hold the Naval Medical Research Center's (NMRC) investigational new drug application for a clinical trial of Hemopure for out-of-hospital treatment of trauma patients. The agency has requested dosing instructions showing the product can be safely and effectively administered in the ambulance setting in light of concerns about blood pressure effects in patients receiving Hemopure. The FDA also requested the submission of pre-hospital data from the proposed trauma population to demonstrate a reasonable risk-benefit ratio. NMRC designed the RESUS (Restore Effective Survival in Shock) Phase IIb/III study to evaluate Hemopure's ability in reducing morbidity and mortality in severely injured patients experiencing hemorrhagic shock in the out-of-hospital setting.

• Caprion Pharmaceuticals Inc., of Montreal, formed a research collaboration with Boehringer Ingelheim GmbH, of Ingelheim, Germany, to identify biomarkers of metabolic and inflammatory diseases using Caprion's CellCarta proteomics discovery platform. Caprion will identify pharmacodynamic markers in plasma resulting from the administration of different preclinical compounds.

• Critical Therapeutics Inc., of Lexington, Mass., President and CEO Paul Rubin told attendees at a scientific conference in China last week that inflammatory molecules known as leukotrienes, a type of eicosanoid, might play a key role in certain types of severe persistent asthma and other diseases. Rubin was speaking at the 13th International Eicosanoids Conference in Beijing.

• HaptoGuard Inc., of Fort Lee, N.J., reported publication of the first data that demonstrated applicability of a new animal model for drug development based on the haptoglobin gene. Haptoglobin, an antioxidant protein secreted by the liver, scavenges hemoglobin released by red blood cells and inhibits hemoglobin-induced oxidative reactions associated with inflammation. An article on the subject will be published in the July/August 2005 issue of Diabetes/Metabolism Research and Reviews.

• Iconix Pharmaceuticals Inc., of Mountain View, Calif., signed an agreement with Neurocrine Biosciences Inc., of San Diego, to provide the company with chemogenomic analyses on candidate compounds in Neurocrine's drug discovery programs. As part of the agreement, scientists will apply Iconix's DrugMatrix technology to provide a gene expression-based chemogenomic work-up on a minimum of 12 Neurocrine compounds.

• ID Biomedical Corp., of Vancouver, British Columbia, said the FDA's Center for Biologics Evaluation and Research designated its Fluviral influenza virus vaccine a fast-track product. Earlier this year, the flu vaccine was made eligible for accelerated approval and priority review. Also, the company said ongoing expansion and upgrading of its Quebec-based flu vaccine manufacturing facilities is on schedule. The expansion of its primary manufacturing site in Quebec is complete and the validation process has begun, while an upgrade of its Laval facility has begun to allow additional upstream capabilities. Should the injectable flu vaccine receive approval, the company expects to be able to produce about 20 million to 25 million doses for the U.S. market next year and about 40 million doses in 2007.

• Intrac Inc., of New York, and its wholly owned Innovative Drug Delivery Systems subsidiary said a pivotal Phase II/III study of Dyloject (diclofenac sodium injection) met its primary endpoint of superior pain relief over four hours, compared to placebo, and demonstrated therapeutic non-inferiority to Voltarol. In the European study, labeled DFC-001, patients with moderate to severe post-surgical pain given a single intravenous injection of Dyloject showed rapid, sustained and statistically significantly greater pain relief compared to placebo patients. Also, a preliminary analysis did not reveal any unexpected safety signals. Further analyses are ongoing and will be submitted for presentation at an upcoming medical meeting. Dyloject is an injectable non-steroidal anti-inflammatory drug with an active ingredient, diclofenac, which is the same as Voltarol.

• Isotechnika Inc., of Edmonton, Alberta, closed its C$20 million (US$16.6 million) bought-deal financing led by GMP Securities Ltd. and including Canaccord Capital Corp., National Bank Financial Inc. and TD Securities Inc. The underwriters purchased a total of 8.9 million common shares at $2.25 each. Net proceeds will be used to fund the company's Phase IIb kidney transplant trial and Phase III psoriasis trial.

• Large Scale Biology Corp., of Vacaville, Calif., and Planet Biotechnology Inc., of Hayward, Calif., are expanding their biomanufacturing program to extract and purify Planet's lead product, CaroRx, a recombinant plant-made antibody shown in clinical studies to prevent the adhesion to the tooth surface of decay-causing bacteria. Planet's tobacco plants expressing the proprietary CaroRx Protected SIgA will be extracted by LSBC at its Owensboro, Ky., manufacturing facility. CaroRx is approved for sale as a medical device in the European Union.

• Life Science Angels Inc., of Palo Alto, Calif., closed on its first three investments and met its mid-year funding goal, investing a total of $1 million. The companies given early stage capital were California-based Athenagen Inc. and Pegasus Biologics Inc. and Seattle-based Uptake Medical Corp.

• Maas BiolAB LLC, of Albuquerque, N.M., and the Walter Reed Army Institute of Research, of the U.S. Army Medical Research and Material Command in Silver Spring, Md., signed a Cooperative Research and Development Agreement to develop cyclosporin neuroprotection in indications relevant to military casualties and homeland security. Under the terms of the CRADA, the pair will further collaborate to develop the Maas-patented cyclosporin neuroprotection formula NeuroSTAT in models of military traumatic brain injury and nerve-gas poisoning.

• Medicure Inc., of Winnipeg, Manitoba, completed enrollment in the MEND-CABG trial, which is evaluating Medicure's lead cardioprotective product, MC-1, in patients undergoing coronary artery bypass graft surgery. The Phase II component of the Phase II/III trial enrolled 900 patients.

• Novogen, of Stamford, Conn., said results of a Phase II trial of its wound-healing compound, Glucoprime, in venous stasis ulcers showed the product promoted the rate at which wounds healed. The overall mean level of healing over the 12 weeks was 10 percent for the placebo group, 59 percent for the low-dose Glucoprime arm and 55 percent for the high-dose Glucoprime arm. The trial was conducted in Australia by Novogen's subsidiary, Glycotex Inc., which holds the rights to the glucan technology.

• Transkaryotic Therapies Inc., of Cambridge, Mass., issued an open letter to stockholders, urging them to vote in favor of the proposed transaction with Shire Pharmaceuticals Group plc, of Basingstoke, UK. In April, TKT and Shire entered an agreement under which Shire has agreed to pay $37 in cash for each share of TKT common stock, or about $1.6 billion in aggregate value. The TKT stockholder vote will be held at a special meeting on July 27. (See BioWorld Today, April 22, 2005.)

• U3 Pharma AG, of Martinsried, Germany, appointed Joanna Horobin CEO. Horobin joins U3 Pharma from MPM Capital, of San Francisco, where she was entrepreneur-in-residence. Prior to MPM Capital, she was chief operating officer at CombinatoRx, of Boston.

• Velcura Therapeutics Inc., of Ann Arbor, Mich., received a $1.3 million Phase II Small Business Innovation Research grant from the National Institute on Aging for proteomics-based drug discovery in human osteoblasts. Velcura received a $224,000 Phase I SBIR grant in 2003 for the regulation of the human osteoblast proteome that supported a study of protein expression patterns in human bone formation. The Phase II grant seeks to develop the initial observations to discover new drugs that stimulate bone formation.

• VistaGen Therapeutics Inc., of Burlingame, Calif., won a $197,000 grant from the National Institute of Drug Abuse, a division of the National Institutes of Health. The Phase I Small Business Innovation Research grant is the third for AV-101, the company's lead drug candidate, and will allow VistaGen to complete preclinical efficacy studies for the compound as a potential first-in-class therapeutic for treating pain caused by nerve damage associated with diabetes, viral infections, injuries and cancer. VistaGen is focused on small-molecule and protein therapeutics for nervous system disorders and metabolic diseases using embryonic stem cell technologies.

• Xenomics Inc., of New York, finalized a research and development agreement with the Lazzaro Spallanzani Institute, Italy's National Institute for Infectious Diseases. The parties have created an entity called SpaXen in a joint venture to research Xenomics' diagnostic technology for the detection of infectious disease. The new agreement defines terms of the relationship among Xenomics, Spallanzani and SpaXen, including licensing Xenomics' technology, and running royalties from sales by the various entities.

• Xsira Pharmaceuticals Inc., of Research Triangle Park, N.C., said the FDA declared effective its investigational new drug application for intravenous adenosine. The company, which plans to develop the product as an intra-operative infusion to reduce post-operation pain, expects to begin a multicenter Phase II study this fall.

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