• Cardiome Pharma Corp., of Vancouver, British Columbia, reported additional results, including QT data, from a Phase I study of RES1235 in the prevention of recurrence of atrial fibrillation. The drug was found to be well tolerated with repeat oral dosing, and dose-proportional increases in plasma levels were seen with steady state plasma levels reached within three to four days. Data also showed that QT interval, a measure of the time required for depolarization and repolarization of the heart for each heartbeat, was not changed significantly when measured at maximal plasma levels following seven days of treatment with RSD1235. A Phase IIa pilot study involving about 180 patients is ongoing, with results expected by the end of the year.
• Critical Therapeutics Inc., of Lexington, Mass., posted a net loss for the first quarter of $16.7 million, or 49 cents per share, based on about 34.1 million weighted average shares outstanding, compared to a net loss of $9.1 million, or 38 cents per share, for the same period in 2005, based on about 23.9 million weighted average shares outstanding. The company said it has identified $15 million to $20 million in cost reductions that will be made this year, through lower spending on research and development and consolidating or eliminating 15 sales territories, which will drop the number of sales reps from 80 to 65.
• Incitive Ltd., of Perth, Australia, made its debut on the Australian Stock Exchange, trading at A25 cents (US19 cents), which is 25 percent above its A20-cent initial public offering, which raised $3 million in late April. The company is focused on inflammation and autoimmune diseases.
• MIV Therapeutics Inc., of Vancouver, British Columbia, established an official U.S. headquarters with the opening of a new corporate office in Atlanta. The office will be dedicated to reinforcing business and research opportunities and relationships in the U.S., and follows the appointment of Mark Landy, medical device analyst, as the president of the firm.
• Prana Biotechnology Ltd., of Melbourne, Australia, received an independent report of its Phase I trials of PBT2 in Alzheimer's disease showing that the drug appeared to be safe and well tolerated at doses to 800 mg, was absorbed, achieved blood levels and is primary metabolized to PBT2-glucuronide. The trial program evaluated PBT2 in single and multiple oral doses in 55 male volunteers, ages 18 to 45, and in 32 male and female volunteers, ages 45 to 75. Prana said plans are under way for a Phase II trial.
• Vivus Inc., of Mountain View, Calif., reported positive results from a pivotal Phase III trial of Evamist, its estradiol-metered dose transdermal spray to treat vasomotor symptoms associated with menopause. Data from the 12-week, 457-patient study demonstrated that the most effective Evamist dose showed a statistically significant decrease (78 percent) in the number of hot flashes, from 10.7 hot flashes per day at baseline to 2.3 hot flashes after treatment. A statistically significant reduction in the frequency and severity of moderate to severe hot flashes was seen for all three doses evaluated, and the product was well tolerated. Vivus expects to file a new drug application in the second half of 2006.
