• Amylin Pharmaceuticals Inc., of San Diego, said data from a 16-week, Phase II obesity study of pramlintide (AC137), a synthetic analogue of human amylin, showed a statistically significant, progressive weight loss of 3.6 percent compared to placebo, with no evidence of a plateau effect. Subgroup analysis indicated that weight reduction with pramlintide vs. placebo was most pronounced in subjects with obesity class 1 (BMI of 30 to 35 kg/m2) who experience an average weight loss of 5 percent at 16 weeks. The results were presented at the European Congress in Obesity in Athens, Greece.

• Applied Biosystems Group, of San Antonio, and its joint venture partner MDS Sciex, a division of Toronto-based MDS Inc., introduced MarkerView Software, a new package for metabolomics and biomarker profiling analysis. The software simplifies the analysis of large data sets.

• BioDelivery Sciences International Inc., of Morrisville, N.C., closed an additional $2.5 million secured convertible debt financing from Laurus Master Fund Ltd. in New York. The financing follows a $2.5 million funding from Laurus in February. The company said proceeds will be used to support its research, development and commercialization opportunities, including the BEMA Fentanyl formulation in Phase III development and the Bioral Amphotericin B and BEMA Long-Acting Analgesic formulations ready to begin clinical evaluation, as well as for general working capital purposes.

• Bioenvision Inc., of New York, said results from clinical trials of clofarabine in adult AML, involving patients who were unsuitable for intensive chemotherapy, showed an overall response of 67 percent with the drug. Five of the 11 patients (45 percent) with abnormal cytogenetics achieved a complete response with clofarabine, and for patients with normal cytogenetic profiles, the complete response rate was 73 percent. The median duration of remission in patients responding to clofarabine is 9.5-plus months. The data were presented at the 10th European Hematology Association meeting in Stockholm, Sweden.

• BioInvent International AB, of Lund, Sweden, entered a license agreement with Cambridge, UK-based Cambridge Antibody Technology Group plc. Under the agreement, BioInvent and its partners receive rights to use CAT's antibody phage-display patent estate to develop products from BioInvent's n-CoDeR antibody libraries, and BioInvent also agrees to withdraw its opposition to CAT's patents filed at the European Patent Office in Munich. CAT will receive an initial license fee and future payments depending on the number of therapeutic antibodies resulting from the agreement. CAT is entitled to milestone payments and royalties on sales.

• Bioniche Life Sciences Inc., of Belleville, Ontario, presented data from a study demonstrating the immunomodulatory activity of its mycobacterial cell wall-DNA complex (MCC) in dogs. The presentation evaluated the capacity of MCC to induce the synthesis of cytokines and chemokines from mononuclear cells in vitro and following its administration to dogs. MCC is a non-viable cell wall composition prepared from saprophytic microorganism Mycobacterium phlei. MCC acts as an immune stimulant and as a cell cycle arresting/proliferation-inhibiting and apoptosis-inducing agent for cancer cells.

• Biovail Corp., of Toronto, and Depomed Inc., of Menlo Park, Calif., received FDA approval for Glumetza, a once-daily, extended-release formulation of metformin hydrochloride to treat Type II diabetes. The companies received an approvable letter in March, and responded to it in April addressing the finalization of one manufacturing specification. The drug may offer potential advantages such as less frequent dosing and proven effectiveness in combination with other diabetes drugs. (See BioWorld Today, March 2, 2005.)

• Diversa Corp., of San Diego, and Clemson University in Clemson, S.C., said they are collaborating to assess opportunities to leverage existing Diversa enzymes that have the potential to enhance human nutrition. The parties will initially focus on evaluating the ability of protein supplements in food to improve stamina and alertness and reduce fatigue.

• Introgen Therapeutics Inc., of Austin, Texas, said the European Patent Office upheld its opposition to a patent licensed to Schering-Plough Corp., of Kenilworth, N.J., claiming therapeutic applications of the p53 gene, the active component of Introgen's Advexin molecular therapy. Claims to Schering-Plough's patent, directed both to diagnosis of p53 gene mutations and to therapeutic application, were revoked by the EPO's Technical Appeals Board. Introgen said it marks the last of three patent revocations needed before commercializing Advexin therapy in Europe.

• Kosan Biosciences Inc., of Hayward, Calif., said preliminary data of KOS-953, its formulation of the Hsp90 inhibitor 17-AAG, showed early signs of anticancer activity and tolerability when administered as a single agent in a Phase I trial involving heavily pretreated patients with relapsed refractory multiple myeloma. Data from a Phase Ib combination trial of KOS-953 administered with bortezomib (Velcade, Millennium Pharmaceuticals Inc.) also showed signs against myeloma activity in bortezomib-na ve and refractory patients. The results were presented at the 10th European Hematology Association meeting in Stockholm, Sweden.

• Oxford BioMedica plc, of Oxford, UK, in collaboration with Plantation, Fla.-based Viragen Inc. and the Roslin Institute, produced a potentially therapeutic protein selectively in the whites of eggs laid by a transgenic hen. As a result, Viragen's stock (AMEX:VRA) rose 33.9 percent, or 19 cents Friday, to close at 75 cents. The technology is expected to offer a low-cost manufacturing alternative for the production of many protein drugs. The protein was successfully expressed using Oxford BioMedica's LentiVector gene delivery system in Viragen's avian system, and is a novel structure of a Viragen antibody designed to treat malignant melanoma. Separately, Oxford BioMedica presented encouraging Innurex preclinical efficacy data at the Annual Meeting of the American Society of Gene Therapy in St. Louis. The data show that Innurex is able to induce nerve repair in spinal cord injuries and restore both sensory and motor functions in a placebo-controlled preclinical model.

• PharmaFrontiers Corp., of The Woodlands, Texas, said interim results of Tovaxin in two Phase I/II multiple sclerosis studies indicated that it was safe and well tolerated, and that patients showed positive responses. The interim analysis demonstrated that Tovaxin, a trivalent formulation of attenuated myelin-peptide reactive T cells (MRTCs), reduced peripheral blood MRTC levels in concert with improvements in disability scores using the Kurtzke Expanded Disability Status Scale, as well as neurological assessments on the Multiple Sclerosis 29-point Impact Scale.

• Quintiles Transnational Corp., of Research Triangle Park, N.C., said that Quintiles Laboratories Asia amended its existing agreement with Peking Union Medical College Hospital to enhance central laboratory services in China. The amended agreement enhances services for customers by allowing Quintiles central laboratory facilities in China to operate under the same standardized processes, controls and reporting mechanisms as other QLAB facilities.

• Targeted Genetics Corp., of Seattle, said its academic collaborators will present results of preclinical studies designed to evaluate adeno-associated virus vectors in the treatment of inflammatory disease and periodontal disease and to assess cellular vectors that impact the efficiency of AAV-mediated gene delivery. The data will be presented in four abstracts at the 8th annual meeting of the American Society of Gene Therapy in St. Louis.

• TranXenoGen Inc., of Shrewsbury, Mass., said the party with whom it had agreed to sell its building has given notice of withdrawal from the transaction. The board is seeking clarification on the withdrawal and is looking for a new buyer. In July 2004, TranXenoGen reduced its work force from 14 people to three and decided to license and sell its technology due to challenges with fund-raising and partnering efforts. The company is focused on developing new methods for manufacturing therapeutic proteins and a portfolio of products.