• AlphaRx Inc., of Markham, Ontario, and Proprius Pharmaceuticals Inc., of San Diego, said top-line results from an exploratory Phase II trial of Indaflex 2.5 percent topical indomethacin cream in osteoarthritis of the knee did not meet the primary endpoints. Those were defined as a change from baseline to week six in the global Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score and the subject's global assessment of efficacy - subgroup analysis of patients with moderate to severe pain and more impaired physical function at baseline showed positive trends when treated with Indaflex as compared to placebo or vehicle. The trial enrolled 233 patients. The companies intend to discuss those results with the FDA in preparation of advancing Indaflex into registration trials.

• Cytos Biotechnology AG, of Zurich, Switzerland, reported positive results from a Phase II study of different formulations of CYT003-QbG10, an immunotherapeutic product candidate for allergic diseases. The study included 40 patients suffering from mild to moderate allergic rhinitis due to house dust mite allergy and exploratory efficacy was determined by evaluating the allergic disease status of the patients before and after treatment by the conjunctival provocation test. Both formulations of CYT003-QbG10 were safe and well tolerated and demonstrated a statistically significant increase in the median allergen tolerance against baseline in the two treatment arms which comprised QbG10 (i.e. CYT003-QbG10 monotherapy and CYT005-AllQbG10).

• Pharmaxis Ltd., of Sydney, Australia, said the first patients have been enrolled in a Swiss trial evaluating the ability of Aridol to predict the response to inhaled steroids in patients with chronic obstructive pulmonary disease (COPD). The study is designed to test the hypothesis that COPD patients are more likely to have good clinical responses to inhaled steroids if they have a positive Aridol challenge test. It follows two earlier studies - a pilot study and an Australian Phase II trial - and will follow a larger group of patients diagnosed with COPD and receiving baseline bronchodilator therapy with Spiriva (tiotropium, Boehringer Ingelheim). The trial is expected to conclude in the first half of 2008.

• Point Therapeutics Inc., of Boston, said its board approved an unscheduled interim analysis on the Phase III study of talabostat in combination with pemetrexed (Alimta, Eli Lilly and Co. Inc.) in non-small-cell lung cancer. The study was designed to involve 400 patients who have already failed either one or two prior drug regimens, and to date, about 360 patients have enrolled. The interim analysis will examine about 150 events, defined as either disease progression or death, that already have been recorded and results of that analysis are expected by the end of this month. Talabostat's NSCLC program consists of two randomized, placebo-controlled, double-blind Phase III trials in the second-line and third-line settings, with one trial testing talabostat and pemetrexed vs. placebo and pemetrexed and the second study evaluating talabostat in combination with docetaxel (Taxotere, Sanofi-Aventis). The company has not yet decided whether an interim analysis will be conducted in that second study.

• Synthetic Blood International Inc., of Costa Mesa, Calif., reported positive data from a statistical analysis of its Phase IIa study of Oxycyte in patients with traumatic brain injury. In line with preliminary results announced in December, statistical results confirmed that product met the primary endpoint of increasing patients' oxygen tension levels compared with baseline. Data also showed a decrease in patient glucose and lactate/pyruvate (LP) ratio, consistent with increased glucose metabolism. Patients in the trial were stabilized with either 50 percent or 100 percent oxygen. The company is working to develop a protocol for a Phase IIb trial.

• Telomerase Activation Sciences Inc., of New York, said interim data from a trial of TA-65, a telomerase activator, demonstrated measurable anti-aging benefits in the areas of immune system function, vision, sexual function, skin condition and energy levels. The double-blind, placebo-controlled, 24-week study included 36 male subjects ages 60 to 85. TAS sells TA-65 under an exclusive license from the Geron Corp., of Menlo Park, Calif.

No Comments