• 4SC AG, of Martinsried, Germany, said it successfully concluded Phase I studies of SC12267, its small-molecule candidate for autoimmune diseases such as rheumatoid arthritis and multiple sclerosis. The trials determined a safe and well-tolerated dose, and there were no relevant side effects after 14 days of once-daily dosing. The company also noted that SC12267 demonstrated a positive pharmacokinetic profile suitable for a once-daily schedule.

• Adherex Technologies Inc., of Research Triangle Park, N.C., said Health Canada granted regulatory clearance for the company's Phase II trial of ADH-1, an antitumor compound known as Exherin. The trial, expected to enroll up to 60 patients and involve up to three cancer centers in Canada, will investigate repeated doses of ADH-1 in an every-three-week dosing schedule in patients whose tumors express the molecular target N-cadherin. Adherex said the goals of the Phase II program are to determine the optimal dose and dosing schedule, estimate the level of antitumor activity and identify the tumor types most suitable for Phase III trials.

• Affymetrix Inc., of Santa Clara, Calif., reported in an online issue of Science that it completed a high-resolution scan of structure and function for about 30 percent of the human genome sequence. Researchers used high-density GeneChip microarrays to study every fifth base of 10 human chromosomes. They found that thousands of regions of the genome are transcribed into overlapping RNA sequences and those sequences are separated by regions in which RNA is transcribed more scarcely.

• Altachem Pharma Ltd., of Edmonton, Alberta, said it entered an agreement to issue $1 million principal amount of 8 percent convertible debentures with a one-year maturity to two arm's length parties. The debentures could be converted in whole or in part by the holder at any time into common shares at 45 cents per share and could be redeemed at any time by the corporation. Altachem said proceeds will be used to begin trials of its SonoLight-based technology.

• BioMS Medical Corp., of Edmonton, Alberta, raised C$41.4 million (US$34 million) in an offering of 11.5 million units at C$3.60 per unit. The gross proceeds include C$5.4 million raised from the exercise of the overallotment option. Each unit consists of one common share and a four-year share purchase warrant, which allows the holder to acquire an additional share at $5 per share. Fraser Mackenzie Ltd. led the financing, which included investments from Pacific International Securities Inc. and Dlouhy Merchant Group Inc. The proceeds will allow the company to conduct its multinational pivotal Phase II/III trial for MBP8298, its lead multiple sclerosis drug. BioMS also intends to initiate a Phase I trial later this year for HYC750 to treat the side effects of cancer therapy.

• Cara Therapeutics Inc., of Tarrytown, N.Y., initiated dosing in a Phase I trial for CR665, its candidate for the treatment of post-operative pain. The single-dose protocol is scheduled to be completed in the second quarter. Conducted in the UK, the study will evaluate the safety, tolerability and pharmacokinetic profile of CR665 in a double-blinded, placebo-controlled, ascending single intravenous dose trial in healthy volunteers.

• Cenix BioScience GmbH, of Dresden, Germany, announced the publication of its genome-wide RNAi screen for cell division genes in C. elegans as a full article in the March 24, 2005, issue of Nature. The study represents the culmination of a research effort, originally initiated as an academic pilot project in 1998 that focused on one of the six chromosomes of C. elegans, and became the founding project of Cenix when the company was founded in 2000.

• Chiron Corp., of Emeryville, Calif., said it awarded $400,000 to four organizations for five projects to address public health issues in the U.S. and abroad. Recipients are the CDC Foundation in Atlanta, to fund an immunization program at Rabio-Balkhi Women's Hospital in Kabul, Afghanistan; a second grant to the CDC Foundation for its International Emerging Infectious Diseases fellowship program; Every Child by Two in Washington for an outreach campaign to all U.S. Department of Agriculture Women, Infant and Children staff agencies for new vaccine recommendations; the Immunization Action Coalition in St. Paul, Minn., to provide funding to distribute a guide to adult vaccination to immunization leaders; and the National Foundation for Infectious Diseases in Bethesda, Md., to support its Traveling Professorship in Rural Areas program for educational outreach about infectious diseases, such as influenza. The grants were provided by the Chiron Foundation.

• Connetics Corp., of Palo Alto, Calif., began a Phase III program for Primolux (formerly OLUX-EF) a topical steroid formulated with 0.05 percent clobetasol propionate in the company's VersaFoam-EF emulsion foam delivery vehicle. The clinical program will consist of two Phase III trials focusing on atopic dermatitis and psoriasis. Connetics anticipates submitting a new drug application to the FDA by the end of the year.

• EntreMed Inc., of Rockville, Md., entered an exclusive worldwide license agreement with Summit, N.J.-based Celgene Corp. for the development and commercialization of Celgene's small-molecule tubulin inhibitor compounds for the treatment of cancer. Under the terms of the agreement, Celgene will receive an up-front licensing fee and additional milestone payments upon successful completion of certain clinical, regulatory and sales milestones. EntreMed said it will assume responsibility for preclinical and clinical development of the tubulin inhibitors, compounds designed to bind to tubulin and cause apoptosis by disrupting microtubules.

• ESA Biosciences Inc., of Chelmsford, Mass., was awarded a Roadmap Initiative grant from the National Institutes of Health to accelerate ongoing work in metabolomics research. The company will extend and integrate electrochemical and mass spectrometric technologies to facilitate metabolomics studies. Metabolomics is the study of an organism's low-molecular-weight molecules or metabolites.

• Guilford Pharmaceuticals Inc., of Baltimore, voluntarily suspended enrollment in a Phase III study of Aquavan in order to review dosing levels of the drug. Aquavan injection in patients undergoing elective colonoscopy procedures met its primary efficacy endpoint, demonstrating a sedation success rate of 96 percent with a median time to sedation of 2 minutes and a median time to full recovery from the end of the procedure of 11 minutes. Patients who received Aquavan experienced deeper levels of sedation for longer sustained periods than patients who received midazolam, but they also had a higher level of adverse events. The company plans to seek a lower dose that is more ideal for procedural sedation and has a better chance of getting approval from the FDA. Guilford had planned on filing a new drug application in the first half of 2006, but that likely will be delayed. The company gained full rights to Aquavan in December through its acquisition of Lawrence, Kan.-based ProQuest Pharmaceuticals Inc. The company's stock (NASDAQ:GLFD) fell 33.7 percent Thursday, or $1.19, to close at $2.34. (See BioWorld Today, Dec. 3, 2004.)

• Helsinn Healthcare SA, of Lugano, Switzerland, and CSC Pharmaceuticals Inc., of Vienna, Austria, signed an agreement granting CSC the exclusive license and distribution rights for Aloxi (palonosetron hydrochloride) in Austria and other Central and Eastern European countries. Aloxi, a long-acting anti-emetic belonging to a second generation of serotonin (5:HT3) antagonists, is marketed in the U.S. The drug received approval in Europe in December for the prevention of acute nausea and vomiting associated with emetogenic cancer chemotherapy. Financial terms of the deal were not disclosed.

• Icoria Inc., of Research Triangle Park, N.C., will receive $6.75 million in cash, installment and milestone payments, plus additional consideration, from Monsanto Co., of St. Louis, in exchange for selected agricultural genomics assets. Icoria intends to focus more on health care by using proceeds to fund a biomarker-enabled drug and diagnostics discovery program focused on diabetes, obesity and other metabolic disorders. Specifically, it will leverage its capabilities in metabolomics, gene expression, tissue analytics software and computational know-how to focus on biomarker-enabled drug discovery. Icoria already has received $4.75 million in cash, with the remaining $2 million due in January. Icoria, which ended last year with 188 employees, expects to have fewer than 120 by the end of this quarter. In addition to the nearly 60 employees expected to join Monsanto, Icoria recently reduced staff at its Pittsburgh office.

• ICOS Corp., of Bothell, Wash., said a Phase II study of IC485 failed to meet its primary endpoint of improving lung function in chronic obstructive pulmonary disease. The study, which enrolled 258 patients, evaluated the inhibitor of phosphodiesterase 4 (PDE4) at three doses compared to placebo. The company did not provide specific data, but instead noted that detailed results would be presented at an upcoming scientific meeting. ICOS said that it would shift its focus to preclinical-stage PDE4 inhibitors and said it believes PDE4 inhibitors could prove beneficial in treating inflammatory disorders.

• Performance Plants Inc., of Kingston, Ontario, raised C$1.5 million (US$1.2 million) as part of a financing round to support commercialization of its Value Enhanced/Stress Tolerance Technology (VEST) products. VEST technologies rely on metabolic engineering to regulate a plant's own genes, thereby enhancing crop productivity and value. Investors included Golden Opportunities Fund, Dynex Capital Partners and Venture Link Funds.

• Protein Design Labs Inc., of Fremont, Calif., completed its previously announced acquisition of ESP Pharma Holding Co. Inc., of Edison, N.J. Under the terms of the agreement, all shares of ESP Pharma common stock and preferred stock were exchanged for 9.9 million shares of PDL common stock and $325 million in cash. Through the acquisition, PDL also purchased certain product rights and assets relating to Retavase, a product from Malvern, Pa.-based Centocor Inc., a unit of Johnson & Johnson. ESP Pharma had paid $110 million to Centocor for the rights to manufacture, develop, market and distribute Retavase (reteplase) in the U.S. and Canada, with additional milestone payments of up to $45 million if certain conditions relating to the ongoing trials and manufacturing arrangements are satisfied. (See BioWorld Today, Jan. 26, 2005.)

• Theratechnologies Inc., of Montreal, reported good safety results from a Phase I trial of TH0318, a glucagon-like peptide-1 analogue, in healthy volunteers. The study included 36 men who were divided into six cohorts. Overall, the safety profile of the treated population was similar to placebo and, at all doses, there were no cases of nausea. At the higher doses tested, decreased blood glucose levels were noted.

• TorreyPines Therapeutics Inc., of San Diego, said its researchers, along with researchers from the MassGeneral Institute for Neurodegenerative Disorders, have identified a gene variant that might increase the risk of late-onset Alzheimer's disease. The company said data indicated that specific changes in the gene, which encodes a protein called ubiquilin-1, appeared to be associated with an increased incidence of the disease in two large study samples. Findings were reported in the March 3, 2005, issue of the New England Journal of Medicine.

• The University of Connecticut at Storrs said its researchers have generated a stable line of embryonic stem cells from cloned cattle embryos that can make unlimited copies of themselves and can morph into cells for nearly all bovine body tissues and organs. The school said the research might offer a tool for scientists studying the use of those cells to treat disease as it suggests that cattle stem cell lines might serve as a better model than those from other species for insight into human cell-based therapies.

• Viventia Biotech Inc., of Toronto, raised C$4.6 million (US$3.8 million) in an interim financing. The company said its board ratified two interim bridge loans, totaling C$2 million, from Chairman Leslie Dan, and approved an additional bridge loan of C$2.6 million from Dan to fund ongoing operations. All of the loans are unsecured, have an interest rate of 4.5 percent per year and are payable on demand. Viventia develops cancer drugs called Armed Antibodies, and its lead product, Proxinium, is in clinical development for head and neck cancer and bladder cancer.

• Xcyte Therapies Inc., of Seattle, said it reduced its work force by 24 percent and has decided to focus its resources on its planned Phase II/III trial of Xcellerated T Cells in chronic lymphocytic leukemia and on initiating a Phase I/II trial in patients with HIV later this year. The company intends to complete its ongoing trials in patients with multiple myeloma and non-Hodgkin's lymphoma, but it will not initiate additional trials in those indications at this time. The Phase II/III study has been delayed while the company works out the design of the trial with the FDA. The reduction of Xcyte's work force to 81 employees will cost about $300,000 in termination benefits. (See BioWorld Today, Feb. 4, 2005.)