• Adolor Corp., of Exton, Pa., reported top-line results of its 519-patient Phase III study, called 14CL306, of Entereg (alvimopan) in postoperative ileus. The primary objective was to evaluate the safety of Entereg 12 mg administered twice a day for seven postoperative days in subjects undergoing total abdominal simple hysterectomy. Entereg was generally well tolerated with 93 percent of patients completing treatment in the alvimopan 12-mg treatment group and 92 percent of patients completing treatment in the placebo group. The most frequently observed adverse events in both groups were nausea, vomiting and constipation. Discontinuations due to adverse events were 4 percent in the treatment group and 5 percent in the placebo group. The company is conducting four Phase III trials with the drug, and the two previous studies, 302 and 313, both hit their primary endpoints. The fourth trial, 308, is ongoing and the company is aiming to submit a new drug application in the first half of 2004. The company's stock (NASDAQ:ADLR) rose 6 cents Thursday to close at $18.51. (See BioWorld Today, April 3, 2003, and Sept. 24, 2003.)

• ARYx Therapeutics Inc., of Santa Clara, Calif., initiated the company's first clinical trial. The Phase 1 study will evaluate the safety and pharmacokinetic profile of ATI-2042 in atrial fibrillation. ATI-2042 is an amiodarone analogue that has been designed to have similar efficacy to amiodarone, but with certain improvements. The ATI-2042 Phase 1 trial will involve up to 42 healthy volunteers.

• Cangene Corp., of Toronto, received funding from the National Institute of Allergy and Infectious Diseases, a unit of the National Institutes of Health in Bethesda, Md., to develop monoclonal antibodies to Burkholderia. Two species of the pathogenic type of bacteria have been identified as Category B bioterrorism agents by the U.S. Centers for Disease Control and Prevention in Atlanta, placing it among the second highest priority agents due to their ease of dissemination, moderate health risks, and need for enhanced diagnostic capacity or disease surveillance. Cangene will partner with Defence R&D Canada and Los Alamos National Laboratory for the project.

• Cedra Corp., of Austin, Texas, said it is teaming with CellzDirect Inc., of Tucson, Ariz., to create a new biotechnology laboratory in Austin. The venture involves the sale of Cedra's in vitro drug metabolism division to CellzDirect. Cedra's bioanalytical and clinical research business will remain intact and will continue to provide services to the health care industry. Since September 2002, CellzDirect has partnered with Cedra to offer hepatocytes and subcellular fractions derived from human and animal livers to scientists who are conducting research in lead optimization, drug metabolism, drug-drug interactions and toxicology.

• Cell Therapeutics Inc., of Seattle, said data reported by Stanford University researchers at the American Society for Therapeutic Radiology and Oncology meeting showed that Trisenox (arsenic trioxide) in combination with radiation in mice increased the benefit of radiation alone in treating glioblastoma. More specifically, in both lab dish and mice, exposing glioblastoma cells to radiation within two hours of receiving a dose of arsenic trioxide amplified the effects of radiation treatment on its own. Separately, Cell Therapeutics and Novuspharma SpA, of Milan, Italy, said they received shareholder approval for their $236 million merger, which they expect to close late this quarter or early in the first quarter of next year. (See BioWorld Today, June 18, 2003.)

• Cerus Corp., of Concord, Calif., initiated a Phase Ib trial of its allogenic cellular immune therapy (ACIT). ACIT is being developed to improve stem cell transplant outcomes in patients with hematologic malignancies, including leukemia and lymphoma. The trial is a multicenter, investigator-sponsored study, which will evaluate three different doses. A maximum of 42 patients with hematologic malignancies will be enrolled. The study is designed to demonstrate the safety of a combination treatment regimen consisting of stem cells and Helinx-treated T-cells in patients with leukemia and lymphoma.

• Cumbre Inc., of Dallas, in collaboration with researchers at the University of Wisconsin-Madison, said findings published in the Oct. 24, 2003, issue of Science describe the identification and characterization of the new CBR703 class of inhibitors. A study author said the privately held company's RNA polymerase inhibitors provide a new tool to study the mechanism of the central enzyme in the process of gene expression.

CV Therapeutics Inc., of Palo Alto, Calif., said the FDA's Cardiovascular and Renal Drugs Advisory Committee will review Ranexa (ranolazine) for the treatment of chronic angina on Dec. 9. The company submitted its new drug application late last year, but two months ago it and the FDA mutually agreed to cancel the advisory meeting as both parties failed to have all documentation and questions surrounding the application prepared for the panel's briefing document. That news dropped CV's stock nearly 21 percent. But Thursday, its stock (NASDAQ:CVTX) gained $4.23, or 23.2 percent, to close at $22.45. (See BioWorld Today, Dec. 31, 2002, and Aug. 5, 2003.)

• Dyax Corp., of Cambridge, Mass., and URRMA Biopharma Inc., of Montreal, entered an agreement to discover and develop fully human monoclonal antibodies to the R7V antigen. Anti-R7V neutralizing antibodies have the potential to control the progression of AIDS, Dyax said. Dyax will use its antibody libraries to identify candidates, and URRMA will evaluate the leads for their ability to neutralize HIV. Both companies will assume joint development of any product candidates that might be identified and will equally share commercialization rights and profits. The companies also have the option to jointly develop URRMA's existing anti-R7V antibody as a therapeutic product candidate. Should the companies proceed with joint development of the URRMA antibody, Dyax would pay URRMA a one-time license fee in return for a 45 percent financial interest in any marketed products.

• GenVec Inc., of Gaithersburg, Md., entered a formal collaboration with the National Cancer Institute in Bethesda, Md., by signing a Cooperative Research and Development Agreement. GenVec will provide the institute with clinical supplies of its TNFerade product candidate for the study. Through the use of the institute's imaging and proteomic capabilities, information regarding TNFerade's mechanism of action and distribution is expected to be gained. In addition to the trial, the institute will work with GenVec to test mutually agreed upon second-generation TNF product candidates that target tumors when given systemically or regionally.

• IBC Pharmaceuticals Inc., a majority owned subsidiary of Immunomedics Inc., of Morris Plains, N.J., entered a research collaboration with Schering AG, of Berlin, involving bispecific antibody, pretargeting technologies being developed by IBC for cancer therapy. The joint research will involve the evaluation and potential development of a new cancer therapeutic involving a Schering antibody and IBC's bispecific antibody technology. Both companies will share potential products resulting from the research, though specific financial and business terms were not disclosed.

• IsoTis SA, of Lausanne, Switzerland, issued about 27.5 million new shares to pay for shares of GenSci OrthoBiologics and certain related assets that IsoTis will acquire from GenSci Regeneration Sciences Inc., of Toronto, in the context of its merger with GenSci OrthoBiologics. At the same time, GenSci President and CEO Douglass Watson resigned to pursue other opportunities. (See BioWorld Today, June 4, 2003.)

• Northwest Biotherapeutics Inc., of Bothell, Wash., said preclinical data published in the Oct. 10, 2003, issue of Journal of Translational Biology describe a method for the activation of dendritic cells to be used in cancer immunotherapy, which ensures stimulating the correct type of immune response believed to be critical in immune-based therapies, an underpinning of the company's DCVax-Direct approach to cancer immunotherapy. DCVax-Direct, which uses activated dendritic cells for direct injection into the tumor, is primarily intended to be used with standard treatment in advanced cancer cases for which often no other treatment options are available and where life expectancy is limited. Northwest said it would begin clinical trials next year.

• Ortec International Inc., of New York, entered an agreement with Teva Medical Ltd., a wholly owned subsidiary of Teva Pharmaceutical Industries Ltd., of Jerusalem, which obtained a license to promote and sell Ortec's tissue-engineered wound healing product, OrCel, in Israel for chronic wounds and other dermatological applications. The agreement, which has an initial term of 10 years, provides for marketing and sales commitments on behalf of OrCel and requires Teva to seek regulatory approval and reimbursement of OrCel in Israel. Financial terms were not disclosed. Ortec's stock (OTCBB:ORTN) gained 45 cents Thursday, or 22.5 percent, to close at $2.45.

• Paradigm Therapeutics Ltd., of Cambridge, UK, in collaboration with the reproductive endocrine unit of Massachusetts General Hospital in Boston, said findings published in the Oct. 23, 2003, issue of New England Journal of Medicine point to their identification and validation of a cell-surface receptor, GPR54, required for regulation of sex hormone secretion. Gene mutations that disrupt the normal function of the receptor cause a lack of production of hormones from the pituitary gland, and have been shown to result in failure to reach sexual maturation in both mice and humans.

• Pharmos Corp., of Iselin, N.J., said that Nasdaq Europe approved its request to delist its shares from that market, effective Nov. 6. The request to delist was prompted by the decision by Nasdaq Europe shareholders at an extraordinary shareholders' meeting on June 26 to close the markets operated by Nasdaq Europe. Pharmos will maintain its listing on the U.S.-based Nasdaq SmallCap exchange.

• QLT Inc., of Vancouver, British Columbia, upped its full-year fiscal guidance as a result of improved sales of Visudyne, which generated about $90 million in third-quarter sales for the period ended Sept. 30. The company moved its Visudyne sales guidance from $335 million to $350 million up to $350 million to $355 million, or top-line growth over 2002 of 22 percent to 24 percent. At the same time, QLT increased its 2003 earnings-per-share guidance to range between 62 cents and 67 cents.

• Schering-Plough Corp., of Kenilworth, N.J., received European approval of Remicade (infliximab) for maintenance dosing for sustaining clinical response in fistulizing Crohn's disease patients who have responded to initial infliximab therapy. The company, which markets the product in Europe, said no other anti-TNF therapy has demonstrated proven activity in the treatment of Crohn's disease. Remicade was developed by Centocor Inc., of Malvern, Pa., a unit of Johnson & Johnson.

• SurroMed Inc., of Mountain View, Calif., was awarded a Small Business Innovation Research grant from the National Institutes of Health in Bethesda, Md., to undertake development of a modified version of recombinant human annexin V, a naturally occurring protein, for multiple cardiovascular indications. The company said annexin can prevent thrombosis without increasing hemorrhage.

• TaiGen Biotechnology Co. Ltd., of Taipei, Taiwan, signed an agreement with the Executive Yuan of the Republic of China for the discovery and development of drugs against the coronavirus that causes severe acute respiratory syndrome. TaiGen will receive funding of NT$29.5 million (US$890,000) to support 50 percent of the total cost that TaiGen budgeted for the first year of research. Future funding of the six-year proposal will depend on the progress made, it said.

• The Michael J. Fox Foundation for Parkinson's Research in New York committed $2 million to a research initiative supporting study of the nerve cell networks that are affected in Parkinson's disease. The new initiative has two areas of focus. The first is to better understand the developmental biology of the normal brain's dopamine-regulating circuitry. The second is the creation of alternative cell sources.

• Vivus Inc., of Mountain View, Calif., updated its development plan for Alista, its product for female sexual arousal disorder. The company said it met with the FDA's Urologic and Reproductive Drug Products Division to discuss the product, and, based on guidance, will pursue a Phase III trial. The company is designing a protocol and plans to submit it to the FDA this year. It anticipates starting a trial in the first half of 2004.