• Access Pharmaceuticals Inc., of Dallas, said it could reap $2.5 million in licensing fees, milestone payments and royalties over the next 15 to 18 months from agreements for Zindaclin. To date, Access has received about $750,000 representing licensing payments and royalties on product sales. Access said marketing approval in France triggered a milestone payment under a license agreement for European marketing rights with Fujisawa Pharmaceutical Co. Ltd., of Osaka, Japan. Expected launches in France and Germany in the first half of this year would result in milestone payments to Access, while the company said Zindaclin registration activities have begun in numerous other markets.

• AtheroGenics Inc., of Atlanta, said the FDA confirmed that its ARISE Phase III trial protocol is sufficient to support a new drug application for AGI-1067, with an indication for secondary prevention in patients with coronary artery disease. The trial will be conducted in 160 U.S., Canadian and South African cardiac centers to evaluate AGI-1067's impact on outcomes such as death due to coronary disease, myocardial infarction, stroke, coronary revascularization and unstable angina in coronary heart disease patients. The study is designed to assess the incremental benefits of AGI-1067 to standards of care, meaning all 4,000 patients in the trial, including those on placebo, also will receive additional heart disease medications. ARISE will follow its patients for an average of 18 months or until a minimum of 1,160 primary events have occurred. The company began the trial in January. (See BioWorld Today, Jan. 15, 2003.)

• AVI BioPharma Inc., of Portland, Ore., presented data showing that AVI's Neugene antisense technology can be used to decrease metabolism of paclitaxel, reduce its clearance in the liver and thereby increase bioavailability using smaller doses of the drug. The data was presented at the 42nd annual meeting of the Society of Toxicology in Salt Lake City. The study demonstrated that AVI-4557 is an inhibitor of the rat liver enzyme CYP3A2 when paclitaxel is used as a test drug, the company said.

• BioCurex Inc., of Rancho Santo Margarita, Calif., said its board unanimously voted to submit to its shareholders a proposal to forward split all outstanding shares of its common stock at an exchange ratio of 3-to-1. The company also said it would increase its authorized capital from 150 million to 450 million shares. The board said BioCurex's research and development plans remain on target.

• BioPhage Pharma Inc., of Montreal, said two discoveries by Ghislain Opdenakker, a member of the scientific board of Biophage, have been accepted for publication. BioPhage said the new data demonstrate that interferon-beta and insulin are readily degraded by the matrix metalloproteinase 9 (MMP-9), the target enzyme for Biophage's REGA-3G12 antibody. The MMP-9-induced degradation leads to a decrease of the biological effect of the proteins, the company said.

• Curis Inc., of Cambridge, Mass., said the current issue of Nature reports that a significant subset of small-cell lung cancers requires activation of the Hedgehog pathway to maintain their malignant growth. According to the study conducted at Johns Hopkins University School of Medicine in Baltimore, cyclopamine, a specific inhibitor of the Hedgehog pathway, can block growth of the small-cell lung tumors in a model of the disease. Cyclopamine was originally isolated from an extract of a plant found in the western U.S.

• D-Pharm Ltd., of Rehovot, Israel, received results from two independent studies that demonstrate the effect of DP-109 on amyloid beta deposition in both in vitro and in vivo models of Alzheimer's disease, the company said. DP-109 is the second compound to emerge from D-Pharma's Membrane Active Chelator drug discovery program as a lead candidate for combating neurodegenerative disease, it said.

• Dyax Corp., of Cambridge, Mass., completed patient treatment in its European Phase II open-label study to evaluate its lead compound, DX-88, for the treatment of acute attacks of hereditary angioedema or acquired angioedema. Dyax said it met its primary endpoint: relief of angioedema symptoms within four hours of treatment. The initial reports from the nine-patient exploratory study demonstrate the rapid resolution of angioedema symptoms in all treated patients across the dose groups.

• Genomic Solutions Inc., of Ann Arbor, Mich., a wholly owned subsidiary of Harvard Bioscience Inc., completed the acquisition of the assets of Genomic Instrumentation Services Inc., doing business as GeneMachines. The purchase price was about $8.1 million in cash plus the assumption of certain specified liabilities. GeneMachines designs, develops and manufactures and distributes high-throughput instrumentation for DNA and protein microarray production, nucleic acid sample preparation and DNA synthesis.

• Hemosol Inc., of Toronto, said it would suspend enrollment prior to continuing its cardiac trial (HLK 213/304) based on a recommendation by its data safety monitoring board. The company has elected to review safety data from the trial, which involves the use of Hemolink (hemoglobin raffimer), an oxygen therapeutic designed to improve oxygen delivery via the circulatory system, in patients undergoing cardiac bypass grafting surgery. As a precaution, Hemosol also voluntarily suspended enrollment in its Phase II study of Hemolink in orthopedic surgery patients (HLK 210). Hemosol, which lost $54.8 million for the year ended Dec. 31, reported $17.6 million in cash and cash equivalents on that date. The company said it is in discussions with investors and potential partners to access resources that would fund anticipated operating and capital expenditures during the latter half of this year and beyond.

• Kos Pharmaceuticals Inc., of Miami, said results of a study published in the March 15, 2003, issue of the American Journal of Cardiology showed that Advicor (niacin extended-release/lovastatin tablets) demonstrated significant efficacy when compared to Lipitor (atorvastatin, from Pfizer Inc.) and Zocor (simvastatin, from Merck and Co. Inc.) in improving the broad spectrum of lipids. Specifically, the drug was six times more effective than Lipitor and 4.5 times more effective than Zocor in increasing HDL2.

• Maxim Pharmaceuticals Inc., of San Diego, was awarded a $750,000 Phase II Small Business Innovation Research grant from the National Cancer Institute in Bethesda, Md. The grant will fund additional testing of MX2167, Maxim's apoptosis-inducing drug candidate for cancer. Maxim acquired its apoptosis platform technology through the acquisition of Cytovia Inc. in a June 2000 stock deal valued at $79 million. (See BioWorld Today, June 7, 2000.)

• MedMira Inc., of Halifax, Nova Scotia, entered an agreement with the Health Minister of the Democratic Republic of the Congo for the purchase of MedMira's rapid diagnostic products. The order is for 1 million MiraWell Triple Test units, which are designed to detect the antibodies to HIV and hepatitis B and C. The purchase agreement follows approvals for MedMira's products from three African nations: the Congo, Chad and Niger.

• Milkhaus Laboratory Inc., of Providence, R.I., reported final results of a Phase IIa trial demonstrating the efficacy of ML-04 for chronic, nonbacterial prostatitis. Relative to the primary endpoint, the chronic prostatitis symptom index, which measures pain, urinary symptoms and quality of life, patients improved in the first four weeks of treatment. By the 12th week they showed an average reduction of more than 11 points from a baseline index value of 24 points.

• NicOx SA, of Sophia Antipolis, France, said its nitric oxide-donating aspirin (NCX 4016) would be studied at the University of Michigan through a $3.3 million grant awarded by the National Cancer Institute, a unit of the National Institutes of Health in Bethesda, Md. The study, designed to assess the pharmacokinetics of NCX 4016 in subjects at risk for colon cancer both at baseline and after six months of continuous oral administration, will recruit 240 subjects. Also, the trial is designed to determine NCX 4016's effect on the number and features of aberrant crypt foci in the colon.

• Novartis AG, of Basel, Switzerland, said results of a study published in the March 13, 2003, issue of the New England Journal of Medicine showed that after 18 months of follow-up, nearly three-quarters of newly diagnosed patients in the chronic phase of chronic myeloid leukemia achieved a complete cytogenetic response when treated with Gleevec. The data also showed Gleevec patients experienced significantly longer delays in disease progression to advanced stages than patients treated with the traditional therapy, interferon and cytosine arabinoside (IFN/Ara-C). The data are from IRIS (international randomized study of interferon vs. STI571), the first head-to-head study comparing Gleevec, taken orally at 400 mg daily, with IFN/Ara-C.

• Pozen Inc., of Chapel Hill, N.C., said the FDA accepted the filing of its new drug application for MT 300 for the acute treatment of migraine. Pozen, which submitted the application before the end of last year, is developing MT 300 as a new, improved product containing dihydroergotamine mesylate in a prefilled syringe. (See BioWorld Today, Dec. 18, 2002.)

• Sicor Inc., of Irvine, Calif., said the FDA issued a tentative approval of an abbreviated new drug application submitted by its wholly owned subsidiary, Gensia Sicor Pharmaceuticals Inc., for fludarabine phosphate for injection, which is indicated for the treatment of B-cell chronic lymphocytic leukemia. Gensia Sicor will use active pharmaceutical ingredients manufactured by Sicor's Italian subsidiary, Sicor SpA.

• Texas Biotechnology Corp., of Houston, and GlaxoSmithKline plc, of London, said the anticoagulant Argatroban was assigned ambulatory payment classification code G9121 by the Centers for Medicare and Medicaid Services. The code will provide Medicare and Medicaid reimbursement for Argatroban use in patients with, or at risk for, heparin-induced thrombocytopenia, undergoing hospital outpatient percutaneous coronary interventions (PCI). Argatroban already is reimbursed for most inpatient PCI procedures.

• The Cleveland Clinic in Cleveland began enrolling patients in a Phase I/II trial in kidney cancer conducted by Genzyme Molecular Oncology, a division of Genzyme General, of Cambridge, Mass. Up to 20 patients with advanced kidney cancer are expected to be treated in the multicenter trial, in which Genzyme will assess the vaccine's safety and seek to measure clinical and immunologic responses.

• Xcellsyz Ltd., of Newcastle-Upon-Tyne, UK, appointed Brad Hoy CEO. Previously, Hoy was senior director of Geron Corp.'s Edinburgh, Scotland-based subsidiary, Geron BioMed Ltd. Xcellsyz focuses on drugs for diabetes and obesity using cell-based technologies.