• Acorda Therapeutics Inc., of Hawthorne, N.Y., said it will design and conduct an additional Phase III trial of Fampridine-SR in people with multiple sclerosis. The company expects to discuss with the FDA a study of the same or shorter duration as its MS-F203 study with a single criterion for efficacy, a consistent response on the timed 25-foot walk.

• Ambrilia Biopharma Inc., of Montreal, said the Phase I repeat-dose study with PPL-100, the company's lead protease inhibitor to treat HIV and AIDS, demonstrated a good safety profile, and only mild adverse events were observed in the treatment groups. No moderate or severe cardiovascular and hepatic adverse effects were observed and no clinically significant abnormalities were observed in laboratory safety tests.

• Cell Therapeutics Inc., of Seattle, said it agreed with its Data Safety Monitoring Board to close the PGT305 PIONEER lung cancer trial and take patients off both treatment arms. The decision was made due to the company's plans to submit a new protocol to the FDA and in light of the aberrantly low rate of deaths in the control group. Cell Therapeutics plans to submit the new protocol by the end of the year. It will focus exclusively on women with normal estrogen levels, the subset in which Xyotax has demonstrated the greatest survival advantage in the STELLAR trials.

• Cougar Biotechnology Inc., of Los Angeles, said Phase I data presented at the American Association for Cancer Research Innovations in Prostate Cancer Research conference in San Francisco showed that the prostate cancer drug candidate CB7630 (abiraterone acetate) was well tolerated at doses as high as 2,000 mg per day with minimal toxicity. Of the 13 patients evaluable for antitumor activity, nine experienced a confirmed decline in prostate specific antigen levels of greater than 50 percent and six patients experienced PSA declines of greater than 90 percent

• Genta Inc., of Berkeley Heights, N.J., said a randomized Phase III trial of chemotherapy with or without Genasense (oblimersen sodium) injection conducted in older, previously untreated patients with acute myelogenous leukemia failed to meet its primary endpoint of overall survival. Further analyses of the data will be submitted for presentation at a scientific meeting. The study was sponsored by the National Cancer Institute under a cooperative research and development agreement.

• GTx Inc., of Memphis, Tenn., said ostarine, a first-in-class selective androgen receptor modulator (SARM), met its primary endpoint in a Phase II trial, but the company plans to start a Phase IIb trial by next summer to further confirm efficacy in cancer cachexia patients. GTx also announced the termination of its 2004 andarine agreement with Ortho Biotech Products LP, a subsidiary of New Brunswick, N.J.-based Johnson & Johnson. GTx now has full ownership and control of its SARM portfolio, freeing it to pursue any indication for ostarine without the concern that andarine could become a competitor. The Phase II double-blind, randomized, placebo-controlled ostarine trial was conducted in 120 subjects in the UK and Germany. Without a prescribed diet or exercise regimen, all subjects treated with ostarine had a dose-dependent increase in total lean body mass, with the 3-mg cohort achieving an increase of 1.3 kg compared to baseline and 1.4 kg compared to placebo (p<0.001) after three months of treatment. Treatment also resulted in a dose-dependent improvement in functional performance, with the 3-mg cohort achieving a clinically significant improvement in both speed (p=0.006) and power (p=0.005). Ostarine continued to demonstrate a favorable safety profile, with no serious adverse events reported.

• Neuro-Hitech Inc., of New York, said it decided to expand the enrollment level for its Phase II trial on the efficacy of Huperzine A, a second-generation acetylcholinesterase inhibitor, for people with mild to moderate Alzheimer's disease. The trial will be expanded by 30 to 60 participants, an increase of up to 40 percent from the original number. The company also has earmarked an additional $2 million in funding for the study.

• NicOx SA, of Sophia-Antipolis, France, said top-line results demonstrated a differentiated and favorable 24-hour blood pressure profile for naproxcinod, compared to naproxen, in hypertensive subjects after two weeks. The trial results showed a 2 mmHg difference in both the average systolic and diastolic blood pressure in favor of naproxcinod, in terms of the mean change from baseline as measured by ambulatory blood pressure monitoring (ABPM). The difference did not reach statistical significance for systolic blood pressure, the primary endpoint, but statistical significance was achieved for diastolic blood pressure, a secondary endpoint.