• Cougar Biotechnology Inc., of Los Angeles, said results from an ongoing Phase II trial of CB7630 (abiraterone acetate) in patients with advanced prostate cancer who have failed docetaxel-based chemotherapy show that the drug is well tolerated with only minimal toxicity in the 10 patients treated so far. Four of those patients (40 percent) experienced a confirmed decline in prostate-specific antigen levels of greater than 50 percent, and, of the five evaluable patients with measurable tumor lesions, one (20 percent) experienced a partial radiological response, as measured by RECIST criteria. To date, 44 patients have been enrolled in the trial, which is testing the oral CB7630, administered once-daily, to patients with castration-resistant prostate cancer who have failed treatment with androgen deprivation therapy and first-line docetaxel therapy. Data were presented at the chemotherapy symposium in New York.

• Elite Pharmaceuticals Inc., of Northvale, N.J., reached an agreement with the FDA for a special protocol assessment on a Phase III trial of ELI-216, an abuse-deterrent formulation of oxycodone hydrochloride plus naltrexone hydrochloride. The pivotal trial is expected to enroll about 300 patients with moderate to severe chronic pain due to osteoarthritis of the hip or knee, and the primary objective is to evaluate the product's safety and efficacy compared to placebo. ELI-216 is based on Elite's abuse resistance technology which incorporates an opioid antagonist with an agonist in the same formulation so that, when administered as an intact product, only the agonist will be absorbed in a sustained manner.

• Keryx Biopharmaceuticals Inc., of New York, reported positive Phase II data of perifosine (KRX-0401) in patients with advanced renal-cell carcinoma, which showed that four of 13 evaluable patients (31 percent) had a partial response and an additional four patients (31 percent) achieved long-term stable disease for a 62 percent overall clinical benefit rate. Patients were considered evaluable for response if they had measurable disease and received at least two courses of perifosine, with at least one tumor measurement after initiation of perifosine. That study is ongoing. The company also reported data from a Phase I study testing perifosine in combination with sorafenib (Nexavar, Onyx Pharmaceuticals Inc. and Bayer Healthcare) demonstrating that the combination has been generally well tolerated so far. The Phase I is expected to enroll an additional 20 patients to confirm a maximum tolerated dose. Data from the two studies were presented at the chemotherapy symposium in New York.

• Pharmion Corp., of Boulder, Colo., said interim findings from its Phase II trial of Amrubicin, a third-generation synthetic anthracycline, in second-line chemo-sensitive small-cell lung cancer indicate favorable response rate and survival data in patients with extensive disease who initially responded to first-line platinum-based therapy but progressed at least 90 days after treatment completion. Data from the study, which compares Amrubicin to topotecan, showed that 11 of the 28 patients (39 percent) treated with at least one or more cycles of Amrubicin demonstrated a response, included two complete responses and nine partial responses. In the topotecan arm, two of 14 patients (14 percent) had a response. Results were presented at the chemotherapy symposium in New York.

• Rigel Pharmaceuticals Inc., of South San Francisco, said results of its Phase II study of R788 (gamatinib fosdium), an oral Syk kinase inhibitor, showed that the drug can improve platelet counts in patients with immune thrombocytopenic purpura. The study, started in January, was designed to test R788 in adult ITP patients who failed to respond to available treatments. Results showed that nine of the first 14 patients (64 percent) responded favorably to the drug, with higher stable platelet counts. Of those, six had peak platelet counts of greater than 100,000 platelets/ul of blood. Two patients in the study who previously had failed a range of other treatment and were receiving weekly IV gammaglobulin, maintained platelet counts while on R788 for 20 weeks. The primary side effects were gastrointestinal-related symptoms.

• Seattle Genetics Inc., of Bothell, Wash., started a Phase IIb trial of SGN-33 (lintuzumab), a monoclonal antibody, in combination with a low-dose regimen of cytarabine chemotherapy in patients with acute myeloid leukemia. The 200-patient study is designed to assess whether that combination regimen extends survival compared to cytarabine alone in previously treated patients 60 years of age or older. The primary endpoint is overall survival, while secondary endpoints will include safety and tolerability, pharmacokinetics and hematologic function, including blood counts, transfusion requirements and quality of life.