• Althea Technologies Inc., of San Diego, received a Phase I Small Business Innovation Research grant from the Innovative Toxicology Models Program of the National Institutes of Health in Bethesda, Md., by way of the National Institute on Deafness and Other Communication Disorders. The grant will be used to develop a low-cost mechanism for translating gene expression-based research in toxicology into validated, high-throughput expression screens for the assessment toxicological and disease mechanistic endpoints.

• Aphton Corp., of Miami, and Daiichi Pure Chemicals Co. Ltd., a unit of Tokyo-based Daiichi Pharmaceutical Group, signed a collaboration and license agreement for the development, manufacturing and commercialization of gastrin-related diagnostic kits. Daiichi will develop diagnostic kits based on assays and monoclonal antibodies developed by Aphton. Daiichi will have exclusive worldwide manufacturing and supply rights and will commercialize the kits by itself or with specialized distributors in Asia. Aphton will have the rights to commercialize the kits by itself or with distributors outside of Asia.

• Australian Cancer Technology Ltd., of Sydney, Australia, said it completed due diligence on its proposed $5 million acquisition of Galenica Pharmaceuticals Inc., of Birmingham, Ala. Galenica's technology includes three families of adjuvants used to stimulate the immune system. Employed as stand-alone therapeutics, or as vaccine components, the compounds are being used in cancer vaccines in two Phase I trials and one Phase I/II study in the U.S. The transaction remains subject to the approval of Australian Cancer shareholders.

• Biopure Corp., of Cambridge, Mass., said its board appointed a new president and CEO, restructured the executive management team and initiated a corporate strategic realignment, reducing its staff by 25 employees. Zafiris Zafirelis took on the role of new president and CEO and a member of the board. The company's new focus is cardiovascular disease, specifically Hemopure as an oxygen therapeutic for applications in cardiac ischemia. It is sponsoring a 45-patient Phase II trial in Europe in patients undergoing coronary angioplasty. Biopure intends to continue in its agreement with the U.S. Naval Medical Research Center to develop Hemopure as an agent for trauma. And it is conducting FDA-requested animal studies of Hemopure to satisfy questions surrounding its biologics license application to market the product in the U.S. for an indication in orthopedic surgery patients. Zafirelis formed an interim operating team, including three new employees, Daniel Burkhoff, Thomas Casey and Mary Ellen Freddo. Current CEO Francis Murphy stepped back to his previous position of chief financial officer. Former Chief Financial Officer Ronald Richards and Chief Medical Officer Douglas Hansell resigned. Biopure also established a medical advisory board, consisting of Howard Cohen, David Holmes, Spencer King, Martin Leon, William O'Neill and Steven Schulman. The company's stock has fallen below $1 for 30 consecutive business days and may lose its listing on Nasdaq, if it does not regain compliance by Dec. 14.

• BioSante Pharmaceuticals Inc., of Lincolnshire, Ill., completed its Phase II trial of LibiGel (transdermal testosterone gel) to treat female sexual dysfunction. The double-blind, placebo-controlled study included 46 patients in the U.S. The company expects data will support moving into a Phase III trial. LibiGel is a gel formulation of bioidentical testosterone designed to be absorbed through the skin after application on the arms, shoulders or abdomen.

• BioSyntech Inc., of Laval, Quebec, said its securities would no longer trade on U.S. equity markets after terminating the registration of its common shares from the Over-the-Counter Bulletin Board. The stock will continue trading in Canada on the Toronto Stock Exchange's Venture Exchange, under the new symbol "BSY." All shares previously trading on the OTC BB automatically will be eligible to trade on the TSX Venture Exchange.

• Cepheid Inc., of Sunnyvale, Calif., and Applera Corp., of Foster City, Calif., through its Applied Biosystems Group and Celera Diagnostics, 50/50 joint venture between Applied Biosystems and Applera's Celera Genomics Group, entered a patent license agreement relating to real-time thermal cycler instruments for research, diagnostics and other applications. Cepheid was granted a nonexclusive worldwide license to make, use and sell its SmartCycler and GeneXpert real-time polymerase chain reaction thermal cyclers, under Applera's Real-Time Apparatus Patent Rights. Separately, Applied Biosystems said the German District Court in Dusseldorf issued injunctions against Bio-Rad Laboratories Inc., MJ Research Inc. and Biozym, MJ Research's distributor in Germany.

• Cytogen Corp., of Princeton, N.J., said a federal appeals court upheld part of a district court decision in a patent-infringement suit filed by Immunomedics Inc., of Morris Plains, N.J. The ruling determined that the district court correctly construed that Cytogen's Prostascint was not an intracellular marker substance, affirming the district court's grant of summary judgment of no literal infringement. But regarding infringement under the doctrine of equivalents, the appeals court disagreed with the district court's conclusion that there was no issue of material fact. It reversed the district court's grant of summary judgment on that point and remanded for further proceedings on the issue.

• Fulcrum Pharmaceuticals Inc., of Las Vegas, concluded its first institutional round of financing, raising $8 million, including a direct investment by Fujisawa Investments for Entrepreneurship and Fujisawa Investments for Entrepreneurship II. The financing was over-subscribed, it said. Fulcrum applies computational chemistry, structural biology and thermodynamics to achieve accelerated design and development of drug products.

• ILEX Oncology Inc., of San Antonio, met the enrollment target of 284 patients for its randomized Phase III trial to evaluate Campath (alemtuzumab) vs. chlorambucil as front-line therapy in previously untreated patients with progressive, B-cell, chronic lymphocytic leukemia. An interim safety update showed that the safety profiles of Campath and chlorambucil were comparable, and an independent data safety monitoring board recommended the trial continue.

• InNexus Biotechnology Inc., of Vancouver, British Columbia, said laboratory results demonstrated that its SuperAntibody Technology platform could increase the ability to induce apoptosis of cancer cells compared to an original, parental antibody. The findings stem from work on the first antibody under evaluation through the company's September agreement with Corixa Corp., of Seattle. The collaboration is focused on enhancing the antitumor activity of selected antibody leads that are in development by Corixa, and, based on the initial results, InNexus plans to engage partners for clinical development. The company also intends to prepare some of its own antibodies for preclinical evaluation, it said.

• Inotek Pharmaceuticals Corp., of Beverly, Mass., said the FDA designated its INO-1001 compound a fast-track drug for the treatment of patients with ST-elevated myocardial infarction undergoing primary percutaneous coronary intervention. The news follows the agency's approval of a multicenter Phase II study of INO-1001 in that indication. The product, an inhibitor of the nuclear cell death enzyme poly (ADP-ribose) polymerase, already is being fast tracked for the prevention of complications in patients undergoing thoracoabdominal aortic aneurysm repair surgery. A Phase II trial in that indication is expected to begin next quarter, as is the ST-elevated myocardial infarction study.

• IQ Corp., of Groningen, the Netherlands, said its two anthrax therapy products were selected for evaluation by the Centers for Disease Control and Prevention in Atlanta. The first of the fully human monoclonal antibodies to be evaluated is Anthraxumab, an antibody directed against PA, the non-toxic but essential component of the anthrax toxin. The second antibody recognizes LF, the deadly component of the anthrax toxin.

• Medarex Inc., of Princeton, N.J., initiated a multidose Phase II trial of MDX-070, a fully human antibody to prostate-specific membrane antigen, in patients with hormone-refractory prostate cancer. The trial is expected to enroll up to 30 patients with prostate cancer. Patients will be assessed for tumor response based on objective tumor response and decrease in prostate-specific antigen serum levels. MDX-070 targets PSMA, a cell-surface marker preferentially expressed on malignant prostate tissues and also on blood vessels in other tumors.

• MicroIslet Inc., of San Diego, formed a collaboration with the University of California at Davis in the area of islet-cell transplantation therapies for treatment of insulin-dependent diabetes. MicroIslet and the California National Primate Research Center at UC Davis plan to conduct non-human primate studies using MicroIslet's technologies for preparation and encapsulation of pig islets. MicroIslet will provide financial support and technical assistance to UC Davis, which will contribute transplantation expertise and access to its primate facilities. MicroIslet has the right to license discoveries made through the collaboration.

• NexMed Inc., of Robbinsville, N.J., raised about $8.3 million from a private placement of its securities to 16 institutional and accredited investors, including SDS Capital and Penfield Partners. UBS Securities LLC acted as a placement agent and adviser. NexMed sold 5.5 million shares of its common stock at $1.50 per share. The investors also received five-year warrants to purchase about 1.9 million shares of common stock, exercisable beginning six months after closing, at an exercise price of $2 per share. The company intends to use proceeds for general corporate purposes and for its product development programs based on the NexACT technology.

• ProdiGene Inc., of College Station, Texas, demonstrated a boost in lactogenic immunity among swine administered a plant-based oral vaccine candidate targeted against transmissible gastroenteritis virus. The company's plant technology platform is based on transgenic corn engineered to produce recombinant proteins in the seed. Vaccine antigens produced with the technology are delivered as edible products using ProdiGene's oral vaccine platform.

• Pro-Pharmaceuticals Inc., of Newton, Mass., reported positive interim Phase I results of its lead compound Davanat alone and in combination with 5-FU (Davanat-1) in refractory solid-tumor patients. In its sixth and final cohort, the study is expected to evaluate a total of 32 patients. Both Davanat and Davanat-1 were well tolerated in patients without any drug-related serious adverse events. Pro-Pharmaceuticals submitted earlier this year a clinical protocol to the FDA for a Phase II trial of Davanat-1 in refractory colorectal cancer patients.

• RegeneRx Biopharmaceuticals Inc., of Bethesda, Md., said its partner, Sigma-Tau Group, of Rome, is planning to conduct a Phase II trial in Europe in the fourth quarter to test Thymosin beta 4 (TB4) for the treatment of patients with venous stasis ulcers. The trial will be in addition to RegeneRx's planned Phase II trials for the treatment of chronic pressure ulcers, epidermolysis bullosa and other chronic dermal indications. In January, RegeneRx exclusively licensed certain rights to TB4 to a wholly owned subsidiary within Sigma-Tau for the treatment of internal and external wound healing in Europe and other relevant countries.

• Rinat Neuroscience Corp., of Palo Alto, Calif., initiated a Phase I safety testing of its lead therapeutic, RI 624. Rinat discovered and is developing RI 624, a humanized monoclonal antibody that inhibits nerve growth factor (NGF), for the treatment of both acute and chronic pain. Researchers have observed that NGF has profound direct and indirect stimulatory effects on the primary sensory neurons that mediate pain, the company said.

• Sepracor Inc., of Marlborough, Mass., said the SEC declared effective its registration statement relating to the resale of an aggregate principal amount of $750 million of zero percent convertible senior subordinated notes and any shares of common stock issuable upon conversion of the notes. The company completed the sale in December. The initial purchasers resold the notes to qualified institutional buyers. Sepracor will not receive any proceeds from the sale of the notes or of common stock issuable upon conversion of the notes.

• Targeted Genetics Corp., of Seattle, said an independent data monitoring committee met for its scheduled interim analysis of a Phase IIb trial of the company's product tgAAVCF to treat cystic fibrosis. The committee recommended continuation of the study as planned based on an analysis of whether or not the study could show a statistically significant positive impact on lung-function measurements in patients treated with tgAAVCF compared to placebo. A total of 100 patients are being evaluated in the trial.

• VizX Labs LLC, of Seattle, and IBM Healthcare and Life Sciences reported on the existence of the VWR In Silico Program, a bundling of technologies designed for research in life science laboratories. Beginning in June, VWR will promote the offering, which includes IBM computers, VizX Labs' GeneSifter software system and other products.

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