• Agennix Inc., of Houston, said Phase II data on talactoferrin alfa in diabetic neuropathic ulcers showed the compound met its primary endpoint - incidence of greater than or equal to 75 percent healing at the end of dosing relative to baseline. Results were presented at the 2005 annual meeting of the American Diabetes Association in San Diego. Patients receiving talactoferrin had double the incidence of 75 percent or greater healing compared to patients receiving placebo gel.

• Amylin Pharmaceuticals Inc., of San Diego, and Indianapolis-based Eli Lilly and Co. said results from a study of Byetta (exenatide) indicated that the injected drug showed sustained improvements in blood sugar control and progressive weight reduction through a year and a half of therapy for people with Type II diabetes failing to achieve acceptable blood sugar control on metformin and/or sulfonylurea. Data, which were presented at the American Diabetes Association annual meeting in San Diego, also show improvements in markers associated with cardiovascular risk factors, including lipids and blood pressure.

• Biogen Idec Inc., of Cambridge, Mass., had Phase II results presented at the 9th International Congress on Malignant Lymphoma in Lugano, Switzerland, showing that Zevalin is effective as a second-line treatment for patients with diffuse large B-cell lymphoma who are not eligible for stem cell transplantation. Overall response rates ranged from 20 percent to 58 percent in the study. The FDA approved Zevalin in 2002 for non-Hodgkin's lymphoma.

• Biopure Corp., of Cambridge, Mass., said that the U.S. Naval Medical Research Center has submitted to the FDA an investigational new drug application to conduct a two-stage clinical trial of the company's oxygen therapeutic, Hemopure, for the out-of-hospital treatment of trauma patients. The NMRC has primary responsibility for designing, seeking FDA acceptance of and directing the trial. The trial is designed as a single-blinded, multicenter, randomized, controlled Phase IIb/III study.

• Duska Therapeutics Inc., of Bala Cynwyd, Pa., said it has entered an agreement with the University of Pennsylvania for preclinical studies of ATPotent to be conducted at Penn's Center for Research on Reproduction and Women's Health. ATPotent, a liquid formulation of adenosine 5'-triphosphate, is begin developed by Duska as a treatment for male infertility in conjunction with intrauterine insemination and in vitro fertilization.

• Entelos Inc., of San Diego, presented data at the 65th annual American Diabetes Association Meeting, describing the results of an analysis on the time-dependent effects of treatment on therapeutic outcomes in the non-obese diabetic (NOD) mouse. Comparison of protocols performed in the NOD mouse model to human protocols for all clinically tested Type I diabetes therapies showed that discrepancies in dosing, formulation and timing could account for the failure of many drugs in human clinical trials. Another presentation described the Type I diabetes PhysioLab platform, a large-scale mathematical model of diabetes pathogenesis and intervention in the NOD mouse model.

• Fournier Pharma, of Paris, and Xytis Pharmaceuticals Ltd., of London, signed an agreement for the development and commercialization of Anatibant (LF16-0687MS) in traumatic brain injury. It originated from Fournier's research. Fournier has granted Xytis an exclusive worldwide license for the development, manufacture and sales of the product containing its bradykinin B2 antagonist Anatibant for traumatic brain injury and, possibly, other indications.

• GeneGo Inc., of St. Joseph, Mich., received a Phase I SBIR grant from the National Institute of General Medical Science of the National Institutes of Health in Bethesda, Md., for development of methodologies intended for reconstruction of functional networks affected in common human diseases. In Phase I, GeneGo will generate and test algorithms enabling comparison of disease-related OMICs data sets of different origin, based on networks topology and contents.

• Genta Inc., of Berkeley Heights, N.J., said data were presented at the International Conference on Malignant Lymphoma in Lugano, Switzerland, on the use of Genasense with rituximab (Rituxan, Genentech Inc.) in patients with relapsed and refractory non-Hodgkin's lymphoma. The trial enrolled 35 patients who had failed a median of two prior chemotherapy regimens with or without rituximab. To date, six patients have achieved a complete response, and nine other patients have achieved a partial response, for an overall response rate of 42 percent.

• Human Genome Sciences Inc., of Rockville, Md., said interim results of an ongoing Phase II trial demonstrate that HGS-ETR1 (mapatumumab) is well tolerated and shows signs of clinical activity in patients with advanced non-Hodgkin's lymphoma. The results were presented at the 9th International Conference on Malignant Lymphoma in Lugano, Switzerland.

• Interleukin Genetics Inc., of Waltham, Mass., said it has appealed the National Association of Securities Dealers' (NASD) determination that the company's common stock is no longer eligible for quotation on the Over-the-Counter Bulletin Board. The company's appeal will be heard on June 16 by a panel authorized by the NASD board of governors. The panel is expected to render a decision within a few days after the hearing. If the company is unable to obtain temporary relief from NASD's requirements, its common stock no longer will be quoted on the OTC BB and will trade on the "Pink Sheets."

• Isis Pharmaceuticals Inc., of Carlsbad, Calif., said results from 14 preclinical studies demonstrated selective antisense inhibitors of gene targets, directly associated with therapeutic potential in a variety of preclinical models of metabolic diseases, including diabetes, non-alcoholic fatty liver disease and metabolic syndrome. The findings were presented at the American Diabetes Association's 65th scientific sessions in San Diego.

• Lorus Therapeutics Inc., of Toronto, said the FDA has accepted its proposal for a rolling new drug application submission for Virulizin, the company's lead product for pancreatic cancer. In addition to fast-track designation, Virulizin was granted orphan drug status in the U.S. and Europe. Results from a Phase III trial in patients with pancreatic cancer are expected during the second half of the year.

• M.D. Anderson Cancer Center in Houston reported that the colony stimulating factor Leukine (sargramostim, Berlex Inc.) might improve the efficacy of rituximab (Rituxan, Genentech Inc.) in treating the most common form of non-Hodgkin's lymphoma. A study of 39 patients with indolent NHL receiving combination therapy showed that 36 percent experienced a complete response, and the overall response rate was 79 percent. Side effects with the combination treatment were similar to rituximab alone. Those data were presented at the 9th International Conference on Malignant Lymphoma in Lugano, Switzerland.

• MannKind Corp., of Valencia, Calif., reported that its lead product, inhaled Technosphere Insulin, has the potential to mimic in a timely manner the first or early phase insulin response, which is absent in all patients with diabetes. The company said approximating that response would help patients maintain post-meal glucose control better than when insulin is delivered subcutaneously. The results were presented at the American Diabetes Association meeting in San Diego.

• Metabasis Therapeutics Inc., of San Diego, and Tokyo-based Sankyo Co. Ltd.'s drug candidate CS-917 alone was not directly responsible for two serious adverse events of lactic acidosis. Patients with SAEs already had elevated levels of metformin when they entered trials, and those levels rose higher when given CS-917 with metformin, so the two will not be tested together until the specific cause is understood. (See BioWorld Today, March 17, 2005.)

• Millennium Pharmaceuticals Inc., of Cambridge, Mass., said researchers reported Velcade study results at the 9th International Conference of Malignant Lymphoma in Lugano, Switzerland. Phase II data of Velcade with rituximab in indolent lymphomas showed response rates were similar in both arms and the safety profile improved with the weekly schedule. Other data indicated promising response rates and progression-free survival in follicular, marginal zone and mantle-cell lymphomas.

• Momenta Pharmaceuticals Inc., of Cambridge, Mass., said Peter Barrett has been named chairman. Barrett, who helped found Celera Genomics Group, of Rockville, Md., has served as a board member since 2003. Momenta said Alan Crane will remain president and CEO.

• Neurochem Inc., of Laval, Quebec, said its independent safety review board has issued a second recommendation to continue the company's North American Phase III trial of Alzhemed to treat Alzheimer's disease. More than 900 patients have been enrolled to date. The recommendation by the ISRB members was based on the review of safety data from 742 patients who were treated for an average of 12 weeks.

• Nuevolution A/S, of Copenhagen, Denmark, and Biovitrum AB, of Stockholm, Sweden, signed a drug discovery collaboration focused on metabolic diseases. Nuevolution will use its Chemetics drug discovery technology to find new drug leads against a disease target to be provided by Biovitrum. Nuevolution will generate several 100 million membered Chemetics libraries from which high-affinity ligands will be selected. Nuevolution is entitled to certain milestone payments and a share of future product sales resulting from the collaboration.

• OSI Pharmaceuticals Inc., of Melville, N.Y., said data showed that its drug candidates PSN105 and PSN010, both glucokinase activators, modulate the activity of glucokinase, an enzyme that plays a key role in the body's glucose sensor in the liver and pancreas. Those results were presented during the American Diabetes Association's 65th annual scientific meeting in San Diego. The company also presented data from PSN357, a glycogen phosphorylase inhibitor designed to rapidly lower blood glucose levels by preventing glycogen breakdown to glucose in the liver. All three candidates are small-molecule drugs and are set to enter clinical trials later this year.

• Sirna Therapeutics Inc., of Boulder, Colo., entered a sponsored research collaboration with Zheng-Yi Chen at Massachusetts General Hospital in Boston. Sirna will provide Chen and his team with short interfering RNAs and related formulations to evaluate their effectiveness as modulators of the retinoblastoma gene pathway to promote regrowth and differentiation of hair cells that under natural conditions do not grow or divide in adult mammals.

• Theravance Inc., of South San Francisco, said that GlaxoSmithKline plc, of London, has enrolled the first subjects in a Phase I study designed to assess the safety, tolerability and pharmacokinetics of Theravance's inhaled bronchodilator, GSK656398 (formerly known as TD-5742), for the treatment of chronic obstructive pulmonary disease.

• Transkaryotic Therapies Inc., of Cambridge, Mass., said it has received government clearances, with the expiration of required waiting periods, to proceed with the proposed acquisition by Shire Pharmaceuticals Group plc, of Basingstoke, UK. The company has not yet set a date for the stockholder meeting to approve the acquisition. Closing is expected in the third quarter. The companies announced the $1.6 billion merger in April. (See BioWorld Today, April 22, 2005.)