• BioCryst Pharmaceuticals Inc., of Birmingham, Ala., has initiated enrollment in a pivotal trial of its lead oncology drug candidate forodesine HCL in cutaneous T-cell lymphoma (CTCL). The multinational trial will evaluate once daily oral forodesine HCL treatment, and will be conducted under a special protocol assessment agreement with the FDA. The study will evaluate the rate of objective responses of patients with CTCL of Stages Ib through IVa who have disease that is persistent, progressive or recurrent during or after treatment with at least three systemic therapies. The study's primary endpoint is the objective response rate, defined as either complete response or partial cutaneous response that is sustained for at least 28 days.

• Biogen Idec Inc., of Cambridge, Mass., and PDL BioPharma Inc., of Fremont, Calif., said Phase II data showed a significant reduction in new or enlarged gadolinium-enhancing lesions when daclizumab is added to interferon beta therapy in patients with active relapsing multiple sclerosis. The ongoing randomized, double-blind, placebo-controlled study known as the CHOICE trial studies MS patients who continue to have active disease while receiving interferon beta therapy. The study patients given daclizumab 2 mg/kg subcutaneously every two weeks showed a statistically significant 72 percent reduction in the number of new or enlarged gadolinium-enhancing lesions (Gd+) at week 24, compared to patients on interferon beta therapy alone. Patients from the CHOICE study were followed for an additional 48 weeks after the daclizumab treatment period to further assess safety and efficacy. The results were presented at the 23rd Congress of the European Committee for Treatment and Research of Multiple Sclerosis in Prague, Czech Republic.

• Biolex Therapeutics, of Pittsboro, N.C., and OctoPlus, of Leiden, the Netherlands, announced preliminary top-line results from the Phase IIa trial, a 12-week study designed to evaluate a range of four doses of Locteron administered once every two weeks in combination with the antiviral drug ribavirin. In each of the two highest dose cohorts, the combination of Locteron and ribavirin resulted in an early virologic response (EVR) in 100 percent (16/16) of the hepatitis C patients treated. Study results also suggested that patients receiving Locteron experienced less frequent and less severe side effects than those previously reported in clinical trials for competitive products.

• BioXell SpA, of Milan, Italy, said top-line results of a randomized, double-blind, placebo-controlled, parallel group Phase IIb trial with Elocalcitol in benign prostatic hyperplasia (BPH) met the primary endpoint of arresting prostate growth (p<0.0002). The drug also showed effects on urgency, frequency, nocturia and maximum urinary flow rate. Additional data will be presented next week. Elocalcitol, which is derived from BioXell's Vitamin D3 technology platform, is also in Phase IIb trial for overactive bladder and will begin a Phase IIa for male infertility in the fourth quarter.

• Cougar Biotechnology Inc., of Los Angeles, announced positive results from ongoing Phase I and Phase II trials of investigational drug CB7630 (abiraterone acetate) in prostate cancer. Of the 44 evaluable patients from the Phase I/II trial, 27 patients (61 percent) experienced a confirmed decline in prostate specific antigen (PSA) levels of greater than 50 percent and 11 patients (25 percent) experienced PSA declines of greater than 90 percent. Of the 21 evaluable patients with measurable tumor lesions, treatment with CB7630 resulted in partial radiological responses (as measured by the RECIST criteria) in 12 patients (57 percent), with seven patients demonstrating ongoing stable disease and three experiencing regressing bone disease on imaging. Improvement in pain and a reduction in opioid use also was reported. The median time to PSA progression was estimated to be 252 days (8.4 months). In a Phase II trial of CB7630 in 28 patients with advanced prostate cancer who have failed docetaxel-based chemotherapy, CB7630 was well tolerated with only minimal toxicity. Of the 28 patients treated, 14 patients (50 percent) experienced a confirmed decline in PSA levels of greater than 50 percent and five patients (18 percent) experienced PSA declines of greater than 90 percent.

• Novacea Inc., of South San Francisco, started a Phase II trial with AQ4N (banoxantrone) for relapsed or refractory acute lymphoblastic leukemia (ALL). The multicenter, single arm, open-label study will enroll about 56 evaluable patients, with a primary efficacy objective of response rate (confirmed complete response or confirmed complete response without platelet recovery) achieved over three cycles of AQ4N. The secondary efficacy objectives consist of duration of response and overall survival. Safety and tolerability of AQ4N as a monotherapy for patients with ALL, whose disease had either relapsed or was refractory to one or more prior chemotherapy regimens, also will be evaluated.

• Threshold Pharmaceuticals Inc., of Redwood City, Calif., has stopped enrollment in a Phase II clinical trial evaluating glufosfamide in patients with recurrent, sensitive small-cell lung cancer because the drug failed to meet the goal of objective response rate. The trial used a two-stage design to ensure an adequate response rate to justify complete enrollment, and only one confirmed partial response was observed among 21 patients enrolled in the first stage of the trial, indicating that glufosfamide is not effective as a single agent for patients with small-cell lung cancer, the company said.