• Cadence Pharmaceuticals Inc., of San Diego, completed patient enrollment in its pivotal Phase III study of intravenous acetaminophen in acute pain following gynecologic surgery. A total of 331 subjects were enrolled to receive either I.V. acetaminophen or placebo in the 48-hour period following gynecologic surgery, with the primary endpoint of the trial defined as analgesic efficacy as measured by reduction in pain intensity compared to placebo. Top-line results are expected in early 2008. The trial is part of the company's overall Phase III program, which also includes efficacy trials in acute pain and fever, plus safety and pharmacokinetic studies.

• Karo Bio AB, of Stockholm, Sweden, said it has discontinued development of KB5359, a preclinical stage compound designed as a follow-up to dyslipidemia drug KB2115, following findings in 28-day toxicology studies in rats and dogs. The company said that those findings, however, are considered to be compound-specific and not related to selective thyromimetics as a class of drugs. Karo Bio also provided an update on other programs, including KB2115, which showed statistically significant efficacy on LDL cholesterol, triglycerides and other factors in its first Phase II study. A second Phase II in combination with statins is planned for this fall. The company also expects to begin Phase I testing soon with KB3305, a liver-targeted glucocorticoid antagonist in development for Type II diabetes.

• Memory Pharmaceuticals Corp., of Montvale, N.J., said that dosing was initiated for the first study participant in the single ascending dose study of its Phase I clinical program of R4996/MEM 63908, a partial agonist of the nicotinic alpha-7 receptor. Compounds acting on this receptor could be beneficial in the treatment of Alzheimer's disease, schizophrenia and other psychiatric and neurological disorders. As part of the Phase I clinical program, the firm plans to conduct a food interaction study in healthy adult male volunteers and a randomized, placebo- controlled single dose study in elderly male and female volunteers. The company expects to complete the SAD study in the first quarter of 2008.

• Obecure Ltd., of Ramat Gan, Israel, reported preliminary results from its 281-patient Phase II trial of Histalean (formerly OBE101) in obesity, and said data suggested strong gender and age effects, with greatest efficacy in women 50 or younger. Subjects in the study were randomized into one of four groups to be treated with 16 mg, 32 mg or 48 mg of Histalean or placebo for a 12-week treatment period. Top-line results showed no statistically significant difference among any of the treatment arms vs. placebo; however, a post hoc segmentation analysis of female subjects, age 50 or younger, in the per-protocol cohort demonstrated a substantial difference between the mean weight loss in the high-dose arm compared to the placebo arm. Obecure reported that the effect was even more pronounced when the analysis was limited to non-Hispanic women. At the end of week 12, 12 of the 25 women receiving Histalean at the 48-mg dose lost an average of 2.61 kg (2.91 percent of their weight) vs. 23 women on placebo, who lost 0.4 kg (0.43 percent of their weight). Histalean is comprised of betahistine, an H1 receptor agonist and partial H3 receptor antagonist.

• Opko Health Inc., of Miami, said the first patient was dosed in the Phase III COBALT trial of bevasiranib for the treatment of wet age-related macular degeneration. Patients will get an initial pretreatment with three injections of Lucentis (ranibizumab, Genentech Inc.). The trial will include more than 330 wet AMD patients and will assess whether bevasiranib administered every eight or 12 weeks is safe and has equivalent efficacy in preventing vision loss as Lucentis. The company said bevasiranib is the first therapy based on RNA interference technology to advance to Phase III trials. Opko announced initiation of the trial last month. (See BioWorld Today, July 12, 2007.)

• Transition Therapeutics Inc., of Toronto, and its development partner Elan Corp. plc, of Dublin, said the firms have successfully completed Phase I clinical studies of ELND-005/AZD-103, an investigational product for the treatment of Alzheimer's disease. About 110 study participants have been exposed to ELND-005/AZD-103 in multiple Phase I studies, including single and multiple ascending dosing, pharmacokinetic evaluation of levels in the brain, and CSF and plasma studies. ELND-005/AZD-103 was safe and well-tolerated at all doses and dosing regimens examined, and there were no severe or serious adverse events observed, the companies said.

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