¿ 3-Dimensional Pharmaceuticals Inc. (3DP), of Exton, Pa., formed a collaboration with Cyprotex Ltd., of Manchester, UK, for the use of Cyprotex¿s computerized methods for the prediction of human pharmacokinetics. The collaboration will focus on the application of Cyprotex¿s ADME (absorption, distribution, metabolism and excretion) prediction methods along with 3DP¿s Discover Works small-molecule drug discovery process to improve preclinical drug optimization. Terms were not disclosed.

¿ Adolor Corp., of Exton, Pa., said it dosed the first group of normal volunteers in a Phase I trial of ADL 10-0116, an orally available peripherally restricted kappa opioid receptor agonist designed to relieve inflammatory pain. ADL 10-0116 is the second in a series of kappa agonists that Adolor is evaluating.

¿ Biogen Inc., of Cambridge, Mass., said a study in the Journal of Biological Chemistry published by its scientists showed for the first time that kidney fibrosis, the hallmark of most types of progressive kidney disease, is characterized by elevated levels of macrophage genes. The research also identified previously overlooked inflammatory events in the kidney that may lead directly to renal failure, and suggested possible new strategies for treating chronic inflammatory and fibrotic diseases by targeting the expression of the alpha-1 integrin protein. Biogen has an active program in fibrosis.

¿ BioMarin Pharmaceutical Inc., of Novato, Calif., said that recombinant human N-acetylgalactosamine 4-sulfatase (rhASB), an investigational enzyme replacement therapy for the treatment of mucopolysaccharidosis (MPS) VI, was well tolerated at both dose levels by the six patients evaluated in the company¿s Phase I trial. The company reported no drug-related serious adverse events and that rhASB reduced levels of urinary glycosaminoglycans in all six patients. BioMarin said it plans to initiate a Phase II trial in the first quarter of 2002.

¿ Cell Genesys Inc., of Foster City, Calif., said that preclinical studies of CV890, an oncolytic virus engineered to target and destroy liver cancer cells, demonstrated significant synergistic antitumor activity in a mouse model when used in combination with doxorubicin, an agent commonly used in the treatment of liver cancer. Data published in the September issue of Cancer Research reported that human liver tumors in mice could be completely eliminated following a single intravenous injection of CV890 combined with doxorubicin. At the end of the 10-week study, all of the mice treated with a single administration of CV890 and doxorubicin combination therapy had at least a 95 percent reduction in liver tumor burden, with about 50 percent experiencing complete elimination of tumors.

¿ Cell Pathways Inc., of Horsham, Pa., reported the completion of a Phase I safety study of Aptosyn (exisulind) and weekly Taxotere (docetaxel) treatment in patients with a variety of solid tumors. The company said data suggest that the combination therapy was well tolerated. Based on the initial results of this study, the company is planning a Phase II trial in patients with advanced non-small-cell lung cancer. The Phase II study is an open-label trial evaluating daily Aptosyn and six weekly treatments of Taxotere.

¿ Connetics Corp., of Palo Alto, Calif., said it entered a product licensing agreement with Mipharm SpA, of Milan, Italy. The agreement grants Mipharm commercial rights in Italy for Connetics¿ OLUX topical treatment for moderate to severe scalp dermatoses; permethrin foam for the treatment of scabies; and Hexifoam, a hand disinfectant. Connetics will receive up-front licensing fees, milestone payments and royalties on future product sales. Connetics retains rights for the rest of Europe.

¿ GeneLogic Inc., of Gaithersburg, Md., said UCB Research, a division of UCB Pharma, of Brussels, Belgium, subscribed to the BioExpress Module of GeneLogic¿s GeneExpress suite and is the first commercial subscriber to Genesis, the GeneExpress Enterprise System software product. UCB also purchased an exclusive license to additional asthma and allergy-related gene targets and associated gene expression data stemming from the companies¿ research collaboration, which started in September 1999.

¿ Cubist Pharmaceuticals Inc., of Cambridge, Mass., said it completed patient enrollment in the first of two pivotal Phase III trials investigating the safety and efficacy of Cidecin (daptomycin for injection) in the treatment of community-acquired pneumonia requiring hospitalization. The completion of enrollment in this study triggers a $3 million milestone payment from Gilead Sciences Inc., of Foster City, Calif., based on a potential $44 million commercialization agreement entered in January. The first study, which is randomized and double blind, enrolled 729 patients and was conducted predominantly in the Northern Hemisphere. The primary endpoint is clinical efficacy, with the secondary endpoints being bacteriological efficacy and duration of intravenous therapy. Cidecin, dosed at 4 mg/kg once daily, is being compared to Rocephin (ceftriaxone), dosed once daily. The second study is under way using the same protocol as the first and enrolling patients predominantly in the Southern Hemisphere. The company is planning regulatory filings for Cidecin in mid-2002. (See BioWorld Today, Jan. 9. 2001.)

¿ Dendreon Corp., of Seattle, reported the completion of patient enrollment in its first Phase III clinical trial of Provenge, the company¿s therapeutic vaccine for advanced hormone-resistant prostate cancer. Patient enrollment in a second similar Phase III clinical trial is continuing, along with preparations to file a biologics license application with the FDA in 2002 for the approval of Provenge.

¿ Gemini Genomics plc, of Cambridge, UK, said its researchers identified mutations in a gene that may play an important role in the function of human heart muscle. Gemini said that certain abnormalities or variations in the gene, when present, predict an individual¿s susceptibility to congestive heart failure.

¿ Human Genome Sciences Inc., of Rockville, Md., said it received an undisclosed clinical milestone from Glaxo-SmithKline plc, of London, for initiating Phase I trials with a new compound, Lp-PLA2 inhibitor. The compound was discovered by Glaxo investigators using HGS¿s technology.

¿ Keryx Biopharmaceuticals Inc., of Jerusalem and Cambridge, Mass., said the FDA designated its compound, KRX-101 (sulodexide) for the treatment of diabetic nephropathy, as a fast-track product. Nephropathy, a complication of diabetes, results in degradation of kidney function. The company said it is in discussions with the FDA regarding a Phase III trial for the in-licensed product.

¿ Kosan Biosciences Inc., of Hayward, Calif., said it was awarded a Phase I Small Business Innovation Research grant from the National Institute of General Medical Sciences. The company will use the funds to generate a library of novel macrolide polyketide ligands to be screened against G protein-coupled receptors.

¿ Origen Therapeutics Inc., of Burlingame, Calif., said it received two Phase I Small Business Innovation Research grants to support research directed at producing therapeutic proteins in eggs. Each grant provides the company with $100,000 over a six-month period.

¿ MediGene AG, of Munich, Germany, said it expanded a licensing agreement with Children¿s Hospital in Boston covering the herpes simplex virus (HSV)-based amplicon technology. The exclusive worldwide license entitles MediGene to use the HSV amplicon technology for all prophylactic and therapeutic applications in humans as well as for commercial research purposes, with a right to grant sublicenses.

¿ Myriad Genetics Inc., of Salt Lake City, said it discovered a drug target for the treatment of human infection by the hepatitis C virus (HCV), and has initiated high-throughput screening with its ProTrap drug screening technology. The HCV target was discovered using Myriad¿s ProNet proteomics technology to investigate the viral-human protein interactions that allow the virus to replicate after commandeering the human cellular machinery. Myriad said it believes the drug target has not been explored for drug development.

¿ Nabi, of Boca Raton, Fla., said it completed the sale of the majority of its antibody collection business, for $152 million, to CSL Ltd. of Melbourne, Australia. The cash proceeds will help develop its research and development pipeline, as well as be used to acquire or in-license additional biopharmaceutical products. Nabi announced the signing of the agreement June 25.

¿ Origenix Technologies Inc., of Laval, Quebec, said it began a single-center, randomized, double-blind, placebo-controlled Phase I study to evaluate the safety of ORI-1001 in 30 human volunteers. ORI-1001 is a topical gel for the treatment of genital warts caused by human papillomavirus. The investigational new drug application was filed with the FDA.

¿ Peregrine Pharmaceuticals Inc., of Tustin, Calif., signed a development agreement with Medipharm Biotech Co. Ltd., of Shanghai, China, for Peregrine¿s tumor necrosis therapy (TNT). In a contract worth $1.8 million, Peregrine will provide product development and contract manufacturing services to Medipharm, pending Chinese approval. TNT technology is part of Peregrine¿s collateral targeting agent technology portfolio.

¿ PPL Therapeutics plc, of Edinburgh, Scotland, said its second Phase II trial using its transgenically produced Bile Salt Stimulated Lipase (tgBSSL) in cystic fibrosis patients with chronic pancreatic insufficiency produced positive results. The company said that fat absorption in CF patients facilitated by tgBSSL increased relative to the dose of enzyme administered and that the tgBSSL dose response effect was statistically significant (p<0.03). Fat absorption with tgBSSL at the highest dose was statistically better (p<0.04) than no treatment.

¿ Protiva Biotherapeutics Inc., a Vancouver, British Columbia-based spin-off of Inex Pharmaceuticals Corp., signed a C$14.5 million (US$9.3 million) equity financing agreement with venture capitalists and private investors, of which 60 percent is complete. The closing of the second tranche is dependent on the completion of certain milestones. The company is developing drugs based on gene-delivered therapeutic proteins for cancer and inflammatory diseases. Completion of the first tranche of the financing reduced Inex¿s position in Protiva from 75 percent to 40 percent. The financing was structured and led by MDS Capital.

¿ Senomyx Inc., of La Jolla, Calif., withdrew its initial public offering due to market conditions. The company, which discovers and improves proprietary flavor and fragrance molecules, filed for its IPO in February. (See BioWorld Today, Feb. 23, 2001.)

¿ Synthon Chiragenics Corp., of Monmouth Junction, N.J., said it will continue its research and development collaboration with Michigan State University (MSU), of East Lansing, Mich., under a new, four-year expanded partnership deal. Synthon will receive exclusive worldwide rights to biochemistry technology developed by MSU¿s Rawle Hollingsworth. Hollingsworth¿s research will drive the company¿s new drug discovery program. Synthon will provide $1.1 million to support research efforts, plus royalties.

¿ The PSMA Development Co. LLC, a joint venture between Progenics Pharmaceuticals Inc., of Tarrytown, N.Y., and Cytogen Corp., of Princeton, N.J., entered an exclusive worldwide licensing agreement with AlphaVax Human Vaccines Inc., of Research Triangle Park, N.C., for the AlphaVax Replicon Vector system to create a therapeutic prostate cancer vaccine using PSMA¿s prostate-specific cancer antigen. Terms were not disclosed.

¿ Transkaryotic Therapies Inc., of Cambridge, Mass., said at a workshop held in conjunction with the 39th Annual Symposium of the Society for the Study of Inborn Errors of Metabolism, in Prague, Czech Republic, that investigators reported data for Replagal enzyme replacement therapy from the first-ever study of females with Fabry¿s disease. Also, European clinicians presented data relating to long-term safety and efficacy of Replagal. In a 15-patient study it was reported that the pharmacokinetics of Replagal in both males and females were similar, suggesting that delivery of Replagal in women is similar to men.

¿ Valentis Inc., of Burlingame, Calif., said a review of the results of all 80 patients in the Phase IIb trial of its IL-2 Genemedicine product were consistent with the positive results seen in the interim analysis released in June. Valentis previously had reported a positive trend favoring the treatment group receiving the IL-2 Genemedicine product plus chemotherapy compared to the group receiving chemotherapy alone. The study included patients with Stage III and Stage IV carcinoma of the head and neck. Median time to progressive disease was 93 days in chemotherapy patients vs. 129 days for the IL-2 plus chemotherapy group. Additional details of the results will be presented at the Biological Therapy for Cancer meeting Sept. 12-15 in Munich, Germany. The trial was conducted at 14 sites in Germany, the Czech Republic and Russia as part of Valentis¿ collaboration with Roche Holdings Ltd., of Basel, Switzerland.