• Acambis plc, of Cambridge, UK, said a Phase I trial of its investigational vaccine against Clostridium difficile infection demonstrated antibody responses in all subjects receiving vaccine. Four weeks after the first injection of the highest dose, anti-toxin A and anti-toxin B immunoglobulin G levels were at least tenfold higher than those reported in another study of patients who had recovered from natural infection with C. difficile and did not suffer recurrent disease. The randomized, double-blind, placebo-controlled study included a total of 50 healthy adult subjects, 37 of whom received the vaccine.

• Adventrx Pharmaceuticals Inc., of San Diego, said patient recruitment has passed the halfway point in its Phase IIb trial of CoFactor in metastatic colorectal cancer initiated in May 2005. The company plans to start Phase III studies in March to evaluate CoFactor as a first-line treatment of metastatic colorectal cancer and as a third-line treatment for advanced breast cancer. The news was presented at the BIO CEO conference in New York.

• Aegera Therapeutics Inc., of Montreal, initiated its third human clinical study for AEG35156, the company’s therapeutic targeting the X-linked inhibitor of apoptosis protein, a key regulator of apoptosis. The Phase I trial is an open-label study of AEG35156 administered in combination with ara-C and idarubicin in patients with refractory or relapsed acute myeloid leukemia. It is being conducted at the University of Texas M.D. Anderson Cancer Center in Houston, and at Princess Margaret Hospital in Toronto.

• Amicus Therapeutics Inc., of Cranbury, N.J., said AT2101 received orphan drug designation from the FDA. AT2101 is an oral therapy to treat Gaucher’s disease, a lysosomal storage disorder. The therapy acts as a pharmacological chaperone that binds to glucocerebrosidase and is expected to enter clinical studies in the first half of this year.

• Biogen Idec Inc., of Cambridge, Mass., and Elan Corp. plc, of Dublin, Ireland, said the FDA removed the hold on clinical dosing of Tysabri (natalizumab) in multiple sclerosis. The companies expect to begin an open-label, safety extension study in the coming weeks. Tysabri was voluntarily suspended by Biogen and Elan a year ago following reports of three patients diagnosed with progressive multifocal leukoencephalopathy. However, after further analysis confirmed no other instances of the potentially fatal brain disease, the companies submitted a supplemental biologics license application in September. Tysabri has been designated for priority review. (See BioWorld Today, March 1, 2005, and Sept. 28, 2005.)

• Cell Therapeutics Inc., of Seattle, said updated results of a Phase II study of Xyotax in combination with carboplatin among 35 women and 39 men with advanced non-small-cell lung cancer showed that estimated one-year survival of women receiving Xyotax is 36 percent, compared to only 16 percent of men. The results are consistent with data from the STELLAR 3 trial reported in March 2005. Data were presented at the BIO CEO & Investor conference in New York.

• Critical Therapeutics Inc., of Lexington, Mass., enrolled and dosed the first patient in its Phase I/II trial of intravenous zileuton in patients with asthma. The trial is designed to evaluate the I.V. formulation’s safety, tolerability and preliminary efficacy in 60 patients who responded to oral zileuton and had a baseline lung function that’s 40 percent to 80 percent of predicted normal, as measured by forced expiratory volume.

• Genta Inc., of Berkeley Heights, N.J., said Genasense (oblimersen sodium) injection increased the proportion of relapsed or refractory chronic lymphocytic leukemia patients who achieved a complete or nodular partial remission (CR/nPR) from 7 percent in the fludarabine plus cyclophosphamide (Flu/Cy) arm to 17 percent in the Genasense arm (p=0.025). The duration of CR/nPR was significantly longer in patients treated with Genasense compared with those who received Flu/Cy only. The Phase III trial included 241 patients, and the data were presented at the 10th Annual International Congress on Hematologic Malignancies in Whistler, British Columbia.

• GPC Biotech AG, of Martinsried, Germany, said the European Medicine Agency’s Committee for Orphan Medicinal Products recommended granting orphan product designation for the company’s 1D09C3 monoclonal antibody for multiple myeloma. 1D09C3 is in Phase I studies in patients with relapsed or refractory B-cell lymphomas, including Hodgkin’s and non-Hodgkin’s lymphomas, who have failed prior standard therapy.

• Memory Pharmaceuticals Corp., of Montvale, N.J., completed dosing in its Phase I study of MEM 3454, a partial agonist of the nicotinic alpha-7 receptor, in healthy volunteers. Top-line results should be available in the second quarter. The single-center study consisted of four segments: a double-blind, placebo-controlled study to evaluate the safety, tolerability and pharmacokinetics of single ascending doses of MEM 3454, which involved 56 healthy young male volunteers; a standard food interaction study with 12 volunteers; a single ascending dose study with 15 elderly volunteers; and a multiple ascending dose study, which involved 48 healthy young male and female volunteers.

• OSI Pharmaceuticals Inc., of Melville, N.Y., initiated a Phase I study of PSN010, a glucokinase activator designed to rapidly lower blood glucose levels by increasing glucose uptake in the liver and increasing insulin secretion from the pancreas. The trial is expected to enroll up to 80 healthy volunteers, and the company plans to use results from the first study to design a Phase II proof-of-concept trial in diabetic patients.

• Panacos Pharmaceuticals Inc., of Watertown, Mass., said a drug interaction trial evaluating the co-administration of its PA-457 with the approved HIV drug atazanavir met its primary endpoint, showing that PA-457 had no detectable effect on atazanavir-induced hyperbilirubinemia. Results also indicated that neither drug affected the plasma levels of the other. PA-457 is a maturation inhibitor that targets a step in the HIV virus life cycle, and has shown activity against a broad range of HIV, including strains that are resistant to existing drug classes.

• Peregrine Pharmaceuticals Inc., of Tustin, Calif., completed planned patient enrollment and dosing in its initial Phase I trial for Tarvacin Anti-Viral in chronic hepatitis C virus infection. The single dose ascending trial was conducted in patients with chronic HCV who have either failed or no longer respond to standard-of-care treatment. Top-line safety data will be presented later this month at the Viral Hepatitis in Drug Discovery and Development Meeting in Boston.

• Prestwick Pharmaceuticals Inc., of Washington, said data showed that Xenazine (tetrabenazine), a selective and reversible dopamine depletor designed to inhibit vesicular monoamine transporter 2, improved clinical outcomes and reduced symptoms of chorea associated with Huntington’s disease. The results were published in Neurology. A new drug application for Xenazine, which received orphan drug designation, is under review by the FDA.

• Progenics Pharmaceuticals Inc., of Tarrytown, N.Y., reported positive top-line results from the second pivotal Phase III trial of methylnaltrexone (MNTX) in opioid-induced constipation in patients with advanced medical illness. Data from the 133-patient study showed that subcutaneous administration of MNTX induced laxation within four hours in 51.2 percent of patients at more than three times the rate of placebo (15.5 percent), on average over a two-week period. All primary and secondary endpoints were met, and results confirmed data from the first Phase III study reported in March 2005. Progenics and partner Wyeth Pharmaceuticals, a division of Madison, Wis.-based Wyeth, plan to submit a new drug application for MNTX. The companies signed a potential $416 million development and commercialization agreement in December. (See BioWorld Today, March 11, 2005, and Dec. 27, 2005.)

• Rexahn Pharmaceuticals Inc., of Rockville, Md., is initiating a Phase II program with RX-0201, a signal inhibitor designed to block the production of Akt to treat cancer, following Phase I results to date that indicate a limited side effect profile. Rexahn has received orphan drug designations for RX-0202 in stomach, ovarian, pancreatic, brain and kidney cancers.

• Scil Technology GmbH, of Martinsried, Germany, enrolled the first patient in a Phase II trial of MD05, developed for bone regeneration in dental implantology and for bone defects in severe periodontal disease. Results from the study are expected later this year. MD05 consists of the recombinant growth and differentiation factor, rhGDF-5, combined with a fully synthetic inorganic carrier, beta-tricalcium phosphate.

• TolerRx Inc., of Cambridge, Mass., received orphan drug designation for its lead product, TRX4, for new-onset Type I diabetes mellitus, which would guarantee up to seven years of marketing exclusivity upon approval. TRX4 is a monoclonal antibody designed to bind to the CD3 receptor and block the function of autoreactive T-effector cells that cause autoimmune disease.

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