• The Albert B. Sabin Vaccine Institute in Washington said that clinical trials to test the safety of a human hookworm vaccine will begin in the Washington area in a couple of months. No current vaccine is available to prevent hookworm disease. The Human Hookworm Vaccine Initiative is funded by the Bill & Melinda Gates Foundation.

• Amylin Pharmaceuticals Inc., of San Diego, reported the exercise by its underwriters of an overallotment option to purchase 1.2 million shares of common stock associated with its follow-on stock offering, which priced on Jan. 20. Including the overallotment, the offering will total 9.2 million shares at $22 a share, resulting in expected net proceeds of about $190.5 million. Amylin is focused on the development of medicines for patients with diabetes and other metabolic disorders. The company said it plans to use the funds to expand its commercialization capabilities in advance of regulatory action on its two lead product candidates, Symlin and exenatide. Both diabetes drugs are under FDA review. (See BioWorld Today, Jan. 24, 2005.)

• BioSource International Inc., of Camarillo, Calif., commercialized the first multiplex protein microarray able to measure multiple phosphorylated proteins in one sample, the Mercator PhosphoArray. Through collaboration with Whatman Schleicher & Schuell, BioSource produced an assay capable of altering the methods whereby scientists can study protein phosphorylation for the research of disease.

• Cell Therapeutics Inc., of Seattle, said it expects to report results in late March or early April from the Xyotax trial in non-small-cell lung cancer, known as STELLAR 3, now that the required number of deaths for data analysis has been reached. CTI delayed data analysis due to prolonged survival rates. The company also has progressed with STELLAR 2 and STELLAR 4 trials.

• CeMines Inc., of Golden, Colo., announced a joint clinical research project with The Children's Hospital of Denver to target improvements in the diagnosis and monitoring of childhood leukemia. The project is based on CeMines' Molecular FingerPrinting platform. CeMines will sponsor the research, which aims at analyzing messenger RNA anomalies from pediatric leukemia patients and comparing samples with those of healthy children.

• The Coriell Institute for Medical Research in Camden, N.J., and the Technion-Israel Institute of Technology announced a collaborative program aimed at advancing the study of adult and embryonic stem cells. The program will focus on three research areas: comparative studies of the developmental capabilities of stem cells from adults and embryonic sources, altering and directing the development of those cells and strategies for applying the technology to therapeutic purposes. A pledge of $1 million for Coriell trustee Ed Satell will be shared equally between both institutions and will establish the collaboration.

• Cyntellect Inc., of San Diego, secured a new customer for its Cell Xpress service, an undisclosed U.S.-based biotechnology company. The service is built upon Cyntellect's LEAP (Laser Enabled Analysis and Processing) platform, which enables high-throughput, in situ imaging and measurement of protein secretion on an individual cell basis, coupled with laser-based elimination of undesired cells to directly clone cells with the highest protein secretion.

• Cytogen Corp., of Princeton, N.J., said researchers at Johns Hopkins Kimmel Cancer Center in Baltimore will investigate the use of Quadramet (samarium Sm-153 lexidronam) in combination with docetaxel for the treatment of hormone-refractory prostate cancer that has spread to bone. The study will evaluate the clinical benefits of escalating-dose and administration schedules of docetaxel in combination with multiple doses of Quadramet, a product designed to pair the targeting ability of a small molecule, bone-seeking phosphate with the therapeutic potential of radiation.

• Danisco A/S, of Copenhagen, Denmark, signed an agreement to acquire Genencor International Inc., of Palo Alto, Calif. Danisco will acquire all the outstanding shares of Genencor's common stock, other than those held by Danisco, Eastman Chemical Co. or their respective subsidiaries, for $19.25 per share. In connection to the agreement, Danisco also agreed to purchase all outstanding shares of Genencor held by Eastman for $15 per share, and all the outstanding shares of Genencor's preferred stock held by Eastman for $44 million in cash.

• GB Therapeutics Ltd., of Mississauga, Ontario, gained an exclusive license to a Phase III molecule labeled CHF1512 from Chiesi Farmaceutici SpA, of Parma, Italy. The compound is a methyl-ester of levodopa, melevodopa, combined with the decarboxylase inhibitor carbidopa. Its clinical development for Parkinson's disease has been completed in Europe, leading to a registration in Italy. Additional Phase III trials to meet FDA and ICH guidelines targeting motor fluctuations are expected to begin in the first quarter of next year. Financial considerations given to Chiesi include an equity investment in GB Therapeutics.

• Genentech Inc., of South San Francisco, reported positive preliminary results from its Phase III study of Avastin (bevacizumab) plus the FOLFOX4 chemotherapy regimen (oxaliplatin/5-FU/leucovorin), compared to FOLFOX4 alone in second-line metastatic colorectal cancer. The company said the trial achieved its primary endpoint of improving overall survival, with patients receiving Avastin as part of their treatment showing a 26 percent reduction in the risk of death, compared to those who received FOLFOX4 alone, and showing a 17 percent improvement in survival rate (12.5 months). Avastin has been approved as a first-line treatment of metastatic colorectal cancer in combination with intravenous 5-FU-based chemotherapy. In other news, a study testing Avastin plus Erbitux and the chemotherapy agent irinotecan compared to Avastin plus Erbitux alone in patients with refractory colorectal cancer showed that the combination of the two drugs along with the irinotecan regimen resulted in median time to progression of 8.5 months, as compared to 6.5 months with Avastin and Erbitux alone.

• GMP Companies Inc., of Ft. Lauderdale, Fla., said its subsidiary, GMP Genetics Inc., licensed patent rights for its Conversion Technology and Conversion Analysis processes to Mayo Medical Laboratories, the reference laboratory for the Rochester, Minn.-based Mayo Clinic. Using a routine blood sample, Mayo will use the technology to separate paired chromosomes into single chromosomes, analyze them individually using genetic probes and identify gene sequences for gene-based testing.

• Icoria Inc., of Research Triangle Park, N.C., signed a Cooperative Research and Development Agreement with the U.S. Army Edgewood Chemical Biological Center to identify and validate metabolomic biomarkers associated with exposure to low-level chemical warfare agents. The company will use gene expression and metabolic profiling through mass spectrometry with its data analysis and pathway informatics tools to study the blood and selected organs of rats exposed to low levels of VX gas to identify biomarkers. Contingent on future funding, both parties could conduct additional studies and work to develop a prototype blood-based field assay. The agreement runs through October. On Thursday, Icoria's stock (NASDAQ:ICOR) gained 5 cents to close at 57 cents.

• InfleXion Therapeutics LLC, of Little Rock, Ark., received a $3 million grant to conduct clinical trials for the first antibody treatment for addiction to the drug phencyclidine, or PCP. The business development grant from the National Institutes of Health's National Institute of Drug Abuse will provide funding for five years to obtain FDA approval and begin trials on a protein-based therapy designed to blunt the effects of PCP.

• Manhattan Pharmaceuticals Inc., of New York, said that the FDA accepted its investigational new drug application for the initiation of the clinical trials required for FDA approval of Propofol lingual spray. Propofol LS is being jointly developed with Novadel Pharma Inc. as a fast-acting, quick-recovery sedative for use during diagnostics and therapeutic processes.

• Nabi Biopharmaceuticals Inc., of Boca Raton, Fla., said that its StaphVAX (Staphylococcus aureus polysaccharide conjugate vaccine) marketing authorization was accepted for review by the European Medicines Evaluation Agency. The company submitted its MAA filing with the EMEA using the centralized procedure to request marketing approval for StaphVAX for the prevention of S. aureus bacteremia in patients with end-stage renal disease on hemodialysis for up to 40 weeks.

• OSI Pharmaceuticals Inc., of Melville, N.Y.; South San Francisco-based Genentech Inc.; and Roche Holding Ltd., of Basel, Switzerland, said a Phase III study of Tarceva (erlotinib) plus gemcitabine chemotherapy in patients with locally advanced or metastatic pancreatic cancer met its primary endpoint by demonstrating a 23.5 percent improvement in overall survival when compared to patients receiving gemcitabine plus a placebo. Data were presented at the American Society of Clinical Oncology's Gastrointestinal Cancers Symposium in Hollywood, Fla. Twenty-four percent of patients receiving Tarceva plus gemcitabine were alive after one year, compared to 17 percent of patients receiving gemcitabine plus a placebo. Median survival for was 6.4 months with Tarceva compared to 5.9 months with the placebo group.

• Peregrine Pharmaceuticals Inc., of Tustin, Calif., received clearance from the FDA to move forward with its clinical program for Tarvacin in cancer. The company and the FDA agreed upon the Phase I study protocol following discussions. Patient enrollment can begin pending internal review and approval of the protocol. Peregrine will submit the final revised protocol as agreed upon to the FDA and can initiate the study without waiting for FDA review, the company said. Up to 28 patients with advanced solid tumors that no longer respond to standard cancer treatments will be enrolled.

• PhageTech Inc., of Montreal, changed its name to Targanta Therapeutics Inc. President and CEO Pierre Etienne said the change was made to represent the company's business of discovery and development of targeted antibacterial drugs, including new synthetic antibacterial classes that mimic the use of phages against disease-causing bacteria.

• Pro-Pharmaceuticals Inc., of Newton, Mass., said Phase I data reported at the American Society of Clinical Oncology's Gastrointestinal Cancers Symposium show that Davanat and Davanat/5-FU are well tolerated in patients with advanced solid tumors. Of the 20 patients enrolled through November, 45 percent had stable disease, an equal number had progressive disease and 10 percent had disease that was unmeasurable. The findings also show that a dose-limiting toxicity was not reached when Davanat was administered alone or in combination with 5-FU at the highest dose level, 280 mg/m2, in the sixth and final cohort of Phase l.

• PTC Therapeutics Inc., of South Plainfield, N.J., said the FDA granted orphan drug status to PTC124 for the treatment of Duchenne muscular dystrophy due to a nonsense mutation in the dystrophin gene. PTC124 is a small-molecule drug in Phase I trials.

• Samaritan Pharmaceuticals Inc., of Las Vegas, selected LabConnect to provide central lab testing services for its upcoming monotherapy trial for the orally available SP01A HIV drug. The drug will be administered to HIV-infected patients with evidence of resistance to available antiretroviral therapy.

• Sonus Pharmaceuticals Inc., of Bothell, Wash., said the FDA granted orphan drug designation to its lead oncology candidate, Tocosol Paclitaxel, for the treatment of non-superficial urothelial cancer. Tocosol Paclitaxel is a formulation of paclitaxel. In parallel, Sonus is pursuing initial market entry through a 505(b)(2) new drug application in an indication for which paclitaxel-based products already have been approved, such as breast, ovarian or lung cancers.

• Transport Pharmaceuticals Inc., of Framingham, Mass., granted access to its iontophoretic device/drug combination system to GlaxoSmithKline plc, of London, for the delivery of acyclovir, an approved cold sore treatment. GSK received exclusive rights to market and sell the system in Europe, Australia, Latin America and South Africa, where acyclovir cream is marketed as an over-the-counter product. In exchange, Transport is receiving an up-front license fee, as well as milestone and royalty payments. GSK will provide technical support and contribute to certain costs of upcoming European Phase III trials.

• Trimeris Inc., of Durham, N.C., said data recently presented at HIV DART - Frontiers in Drug Development for Antiretroviral Therapies show that patients who were administered a single Fuzeon (enfuvirtide) dose with a needle-free injection device (Biojector 2000) achieved equivalent drug levels in the blood compared to those who were administered Fuzeon with the standard needle and syringe. Fuzeon is a fusion inhibitor for the treatment of HIV and is designed to block HIV from entering the cell. Trimeris is developing Fuzeon and other peptide fusion inhibitors in collaboration with F. Hoffmann-La Roche Ltd., of Basel, Switzerland.

• ViaCell Inc., of Boston, completed its initial public offering of 7.5 million shares of stock. In addition, the underwriters exercised their overallotment option in full and purchased an additional about 1.1 million shares. All such shares were sold by ViaCell at the IPO price of $7 a share, less underwriting discounts and commissions. ViaCell is focused on enabling the widespread application of human cells as medicine. (See BioWorld Today, Jan. 24, 2005.)

• ViroLogic Inc., of South San Francisco, presented clinical data assessing the ability of the company's eTAG System to accurately predict treatment outcomes for patients with metastatic colorectal cancer. The study demonstrated that the detection of EGF Receptor family dimers as measured by the eTAG assay correlated with disease stability or disease progression in 18 metastatic colorectal cancer patients being treated with erlotinib, or Tarceva.

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