• ActivX Biosciences Inc., of La Jolla, Calif., expanded its collaboration with New York-based Pfizer Inc. to encompass multiple projects ranging from discovery to developmental-stage programs. Under the terms of the agreement, initially signed in June 2003, ActivX will apply its chemical technologies and high-throughput protein analysis to a number of Pfizer programs spanning drug discovery, proteomic filing, compound selectivity and biological activity, and mechanisms of toxicity. ActivX recently was acquired by Tokyo-based Kyorin Pharmaceutical Co. Ltd. to become a wholly owned U.S.-based subsidiary. (See BioWorld Today, Feb. 3, 2005.)

• Australian Cancer Technology, of Sydney, Australia, said results from an extended Phase I/II study evaluating RP101 with chemotherapy demonstrated a doubling of survival in patients with pancreatic cancer. The study involved 13 patients with metastasized pancreatic cancer treated with RP101 and gemcitabine plus cisplatin. For the treatment group, the 50 percent probability of survival was increased to an average of 15 months from a historic average of 7.5 months (p=0.008).

• BioDelivery Sciences International Inc., of Newark, N.J., completed the clinical studies required for its pending new drug application on Emezine, a buccal product for the treatment of nausea and vomiting. BDSI, through its Arius Pharmaceuticals subsidiary, licenses Emezine from a third-party pharmaceutical company.

• ChemGenex Pharmaceuticals Ltd., of Melbourne, Australia, licensed a patented molecule, now called CXS299, from the University of Texas M.D. Anderson Cancer Center in Houston. CXS299 is a platinum IV cancer agent designed to selectively block tumor cells in the G1 phase of the cell cycle, which would make the product less prone to cross-resistance, compared to approved platinum II therapies. The company said it also has properties that might allow physicians to target patients most likely to benefit from therapy. Terms of the licensing deal were not disclosed.

• The Cleveland Clinic in Cleveland was awarded a five-year, $17.2 million grant from the National Institutes of Health in Bethesda, Md., to advance its research in heart attacks. The funding will support the clinic's studies in four areas: the genetics of heart attacks, the genetics of atherosclerosis, the role of proteins in arterial disease and the role of inflammation markers in the formulation of coronary plaques.

• GeneCopoeia Inc., of Germantown, Md., and Deutsches Ressourcenzentrum fur Genomforschung GmbH, of Berlin, entered a partnership to distribute GeneCopoeia's seven sets of 16,000 OmicsLink ORF expression clones in the region of EU member states and Norway, Switzerland and Turkey.

• LION bioscience AG, of Heidelberg, Germany, and Xennex Inc., of Cambridge, Mass., said they will develop wrappers for the human genes' compendium GeneCards, enabling researchers to view GeneCards data within SRS, LION's data-integration platform. LION also entered a collaboration with BioBase GmbH, of Wolfenbuettel, Germany, aimed at integrating BioBase's network content into LION's software products. That will enable scientists to access network and cellular pathway information from LION's SRS technology.

• Meridian Bioscience Inc., of Cincinnati, said its wholly owned subsidiary, Viral Antigens Inc., entered an agreement to provide contract services for Biodefense and Emerging Infections Resources, which was established by the National Institutes of Health's Institute of Allergy and Infectious Diseases.

• Migenix Inc., of Vancouver, British Columbia, said it will have data from two clinical trials of MX-3253 this year in chronic hepatitis C virus infections, and that MX-4509 will complete two early clinical trials this year in Alzheimer's disease and healthy volunteers. The company also intends to start a pivotal Phase III confirmatory study in the middle of this year for MX-226, a candidate to prevent catheter-related infections.

• New River Pharmaceuticals Inc., of Radford, Va., completed enrollment in its pivotal Phase III trial of NRP104, a conditionally bioreversible derivative of d-amphetamine for treating attention deficit hyperactivity disorder in pediatric patients. The 301-patient study will compare NRP104 to placebo in the treatment of children aged 6 to 12. The company said it plans to file a new drug application by the end of the year and anticipates launching the product in 2006.

• Ortec International Inc., of New York, said the FDA completed its review of the company's modified diabetic foot ulcer protocol submitted Jan. 6, and is allowing Ortec to begin a pivotal trial. Ortec said it expects to initiate patient enrollment after receiving premarketing approval for the use of Orcel in the treatment of venous leg ulcers, which is under FDA review. Orcel is a bilayered cellular matrix used to heal chronic and acute wounds.

• ParinGenix Inc., of Tucson, Ariz., received FDA approval for its investigational new drug application for PGX-100. ParinGenix is developing PGX-100 to ameliorate cardiac ischemia-reperfusion injury following myocardial infarction, including both ST-elevated and non-Q-wave myocardial infarctions. The company will begin the first of three Phase I trials in mid-February.

• Pharmaxis Ltd., of Sydney, Australia, received approval to begin a Phase II study in the UK with Bronchitol, a therapeutic for cystic fibrosis. The study, designed to determine the effects of Bronchitol on mucus clearance and lung performance over a three-month period, will compare the effects of twice-daily administration of the product vs. the marketed product pulmozyme. Pharmaxis said 42 patients are to be enrolled, and the study is expected to conclude in 2006.

• Repligen Corp., of Waltham, Mass., amended its 1999 supply agreement with GE Healthcare, of Waukesha, Wis., governing the manufacture of GE Healthcare's recombinant protein A. The amendment extends the term of the agreement through 2010, expands the manufacturing to include an additional GE Healthcare protein and anticipates a mechanism for the manufacturing of future proteins.

• Sequenom Inc., of San Diego, and Iceland Genomics Corp., of Reykjavik, Iceland, entered a research collaboration to analyze Sequenom's panels of genetic markers associated with breast and prostate cancer in Icelandic patient samples. The markers were discovered through a series of genome-wide association studies. Among the markers to be studied are SNPs from the ICAM and NuMA gene regions.

• Sinovac Biotech Ltd., of Beijing, completed the acquisition of an additional 20.6 percent of its Beijing-based operating subsidiary, Sinovac Biotech Co. Ltd., for about $3.3 million. The company's holdings now include almost 72 percent of Sinovac Biotech and 100 percent of the Tangshan Yian R&D and production facility, which was acquired in February.

• Vivus Inc., of Mountain View, Calif., said clinical data from a Phase II study showed treatment with the company's testosterone MDTS, a transdermal testosterone spray, significantly increased the number of satisfactory sexual events in premenopausal women with hypoactive sexual desire disorder. The 28-week, double-blind, randomized, placebo-controlled, dose-ranging study consisted of 261 premenopausal women.

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