• Adherex Technologies Inc., of Research Triangle Park, N.C., said it executed a clinical trial agreement with the National Cancer Institute's Division of Cancer Treatment and Diagnosis for the evaluation of the company's lead compound, ADH-1. The agreement provides for the NCI to sponsor nonclinical and clinical trials of ADH-1 in a variety of administration schedules and tumor types, both as a single agent and in combination with other cancer agents.

• Bioenvision Ltd., of Edinburgh, UK, reported that an overall response was achieved in 92 percent of patients older than 60 with acute myeloid leukemia when they were given a combination of Evoltra (clofarabine) and daunorubucin as a first-line treatment. Results from the 30-patient Phase I/II study were presented at the British Society of Haematology 46th annual scientific meeting in Edinburgh.

• Cerexa Inc., of Alameda, Calif., completed patient enrollment for its multinational Phase II trial of ceftaroline (formerly PPI-0903) in patients with complicated skin and skin structure infections. The 100-patient study was designed to investigate the efficacy and safety of ceftaroline vs. standard therapy. Top-line data are expected in the third quarter.

• Ecopia BioSciences Inc., of Montreal, initiated dosing of the first patient in a Phase I trial of its cancer drug candidate, ECO-4601. The trial is expected to enroll up to 30 patients suffering from one of six types of cancer - glioblastomas, breast, prostate, ovarian, lung and colon - that are refractory to existing chemotherapies.

• Osiris Therapeutics Inc., of Baltimore, completed enrollment in a 53-patient Phase I trial designed to evaluate the safety and preliminary effectiveness of its universal adult stem cell drug candidate, Provacel, in development to treat patients suffering from heart attacks. Provacel is an intravenously administered formulation of adult stem cells designed to help repair damaged tissue. It's being developed as part of a strategic alliance with Natick, Mass.-based Boston Scientific Corp.

• Othera Pharmaceuticals Inc., of Exton, Pa., initiated a Phase II trial by the National Eye Institute of the company's topical eye drop, OT-551, in patients with geographic atrophy, a sign of dry age-related macular degeneration. The 10-patient study will evaluate the product's potential to slow enlargement of the atrophic area in the macula and prevent progression to the vision-threatening advanced stages of AMD over a two-year period.

• Pro-Pharmaceuticals Inc., of Newton, Mass., said preliminary data show an objective partial tumor response from a patient in the first stage of a Simon's two-stage designed Phase II trial for third- and fourth-line treatment of colorectal cancer, according to Response Evaluation Criteria in Solid Tumors (RECIST) guidelines. Patients in the trial received the company's Davanat plus 5-FU in monthly cycles for at least two cycles or until their disease progressed. Based on those results, the company said it will not enroll patients in the second stage, and will begin dosing patients in a European Phase III trial as a second-line treatment of colorectal cancer by the end of this quarter.

• Threshold Pharmaceuticals Inc., of Redwood City, Calif., completed enrollment in its Phase III trial evaluating TH-070 in patients with benign prostatic hyperplasia. The trial involves 500 patients and is testing the efficacy of TH-070 compared to placebo as measured by the International Prostate Symptom Score. Results from that trial, as well as a 200-patient Phase II trial, are expected to be available beginning in the fourth quarter.

• Vertex Pharmaceuticals Inc., of Cambridge, Mass., initiated a Phase II development program for VX-680, triggering a $10 million milestone payment from partner Whitehouse Station, N.J.-based Merck & Co. Inc. The companies signed a global development and commercialization deal in 2004 for VX-680, a drug candidate targeting Aurora kinase. One Phase II trial is an extension of an earlier Phase I study in patients with advanced colorectal cancer, and a second Phase II study is expected to begin this year in patients with advanced lung cancer. (See BioWorld Today, June, 23, 2004.)