• AEterna Zentaris Inc., of Quebec City, said its partner Spectrum Pharmaceuticals, of Irvine, Calif., presented an abstract outlining detailed Phase II results for AEterna Zentaris' fourth-generation luteinizing hormone-releasing hormone antagonist, ozarelix, in benign prostatic hyperplasia (BPH). Results indicated that ozarelix was well tolerated and demonstrated statistically significant as well as clinically meaningful efficacy in the treatment of lower urinary tract symptoms secondary to BPH. Results also showed no statistically significant impact on quality of life or erectile function. Ozarelix is a fourth-generation luteinizing hormone-releasing hormone antagonist administered as a depot formulation for the treatment of benign and malign hormone-dependent diseases. It is in Phase IIb clinical trials for both BPH and prostate cancer. The abstract was presented at the American Urological Association Annual Meeting in Anaheim, Calif.

• Bioniche Life Sciences Inc., of Belleville, Ontario, presented data at the American Urological Association Annual Meeting in Anaheim, Calif., on the direct anticancer activity of its Mycobacterial Cell Wall-DNA Complex technology (MCC). The study determined the anticancer activity of MCC and bacillus Calmette-Guerin (BCG) against bladder cancer cell lines derived from low- and high-grade bladder cancer using treatment times typical of optimal residence in the bladder following intravesical administration (three hours). The data showed that the activity of MCC against all human bladder cancer cell lines studied was comparable, and that a treatment time of three hours was sufficient for the expression of anticancer activity. In contrast, BCG, an immunotherapeutic containing live mycobacteria that is currently used as a treatment for non-muscle-invasive bladder cancer, had variable activity against the human bladder cancer cell lines studied and, in contrast to MCC, required prolonged treatment times (48-144 hours) for the expression of anticancer activity.

• HUYA Bioscience International LLC, of San Diego, and Chipscreen Biosciences Ltd., of Shenzhen, China, said a Phase I clinical trial has been initiated in China with Chidamide (CS055)/HBI-8000, an investigational cancer compound. HUYA holds exclusive worldwide rights to the compound outside of China, while Chipscreen maintains rights in China. The Phase I clinical trial is designed to assess the safety, tolerability and pharmacokinetics of the compound. HUYA will assist Chipscreen with development of Chidamide in China. HUYA also plans to file an investigational new drug application and begin clinical trials with HBI-8000 in the U.S. and Europe. Chidamide/HBI-8000 is an orally bioavailable histone deacetylase inhibitor derived from the benzamide class.

• MGI Pharma, of Bloomington, Minn., said its Aquavan (fospropofol disodium) Injection in patients undergoing colonoscopy achieved its primary endpoint in a pivotal Phase III trial. The randomized, double-blind, multicenter study compared dosing regimens of 6.5 mg/kg and 2.0 mg/kg for achieving moderate sedation in patients undergoing colonoscopy. The results showed that 87 percent of patients who received an initial bolus dose of Aquavan 6.5 mg/kg achieved sedation success, defined by three consecutive Modified Observer's Assessment of Alertness/Sedation (MOAA/S) scores of greater than or equal to 4, plus completion of the procedure without the need for alternative sedative medications and manual or mechanical airway assistance. In comparison, 26 percent of patients who received Aquavan 2.0 mg/kg achieved sedation success (less than 0.001), while 69 percent who received midazolam 0.02 mg/kg achieved sedation success. Additional endpoints measured physician and patient satisfaction at the end of the procedure, and both were higher for the 6.5 mg/kg dosing. The data were presented at the Digestive Disease Week conference in Washington.

• Morphotek Inc., of Exton, Pa., has received approval of protocol by the Paul-Ehrlich-Institute, Germany's regulatory authority charged with biologics development oversight, for clinical trial Phase II site selections for MORAb-003, a humanized monoclonal antibody that targets the folate receptor alpha, a target overexpressed in more than 90 percent of ovarian cancers and a number of other solid tumors. The study will investigate the efficacy of MORAb-003 in women who are in their first relapse of ovarian cancer. Morphotek has enlisted 15 clinical sites in the U.S. to conduct its Phase II study of MORAb-003.

• Napo Pharmaceuticals Inc., of South San Francisco, Calif., said its partner Trine Pharmaceuticals Inc., of Newton, Mass., presented data from a Phase IIa study showing that crofelemer for diarrhoea predominant irritable bowel syndrome (d-IBS) was safe and led to significant improvement in pain, and trends toward improvement in adequate relief, stool frequency and urgency. The randomized double-blind placebo-controlled, dose-ranging (placebo, 125 mg, 250 mg and 500 mg bid) study covered a 12-week treatment period in 246 patients with d-IBS. Symptoms were self-reported by the patients, who needed to exhibit active disease during the two-week baseline period. Patients received treatment for 12 weeks followed by a two-week treatment-free period. The results showed the 125 mg bid of crofelemer exhibited a consistent response during each month among most efficacy endpoints in women with d-IBS reaching statistical significance (p<0.05) for pain. Crofelemer had little effect on the stool consistency score, though there was a trend toward reduced stool frequency. Treatment benefits were not apparent in men, although relatively few men enrolled in the trial. The data were presented at the Digestive Disease Week conference in Washington.

• Neurogen Corp., of Branford, Conn., presented data from previous Phase I and Phase IIa clinical studies for NG2-73, its lead compound for treatment of insomnia, showing it rapidly induced sleep in a transient insomnia study. Data showed Latency to Persistent Sleep (LPS) was statistically significantly reduced, compared to placebo, at all doses of NG2-73, and demonstrated a dose-response relationship. The mean times for LPS were 30.8 minutes for placebo, and 17.8, 10.6, 7.8 and 6.6 minutes for the 1, 3, 10 and 20 mg NG2-73 groups, respectively. NG2-73 also had a statistically significant effect on Total Sleep Time and Sleep Efficiency at doses of 3mg and above. All doses had a statistically significant effect on "refreshing sleep," which was subjectively rated by study participants. NG2-73 was generally well tolerated, with adverse events primarily reflecting an extension of the drug's sedative effects, including sedation, somnolence and dizziness. The data were presented at the American Psychiatric Association annual meeting in San Diego. Two Phase IIb clinical studies with NG2-73 in chronic insomnia patients are being conducted.

• Palatin Technologies Inc., of Cranbury, N.J., and King Pharmaceuticals Inc., of Bristol, Tenn., presented data showing that bremelanotide improved both self-esteem and sexual relationship in men with erectile dysfunction in Phase IIB trials at the American Urological Association Annual Meeting in Anaheim, Calif. For the studies, patients were administered the SEAR (Self-Esteem and Relationship) psychological instrument measuring sexual relationship and confidence. Subjects were divided among five dosing groups, including placebo, 5 mg, 7.5 mg, 10 mg, 12.5 mg and 15 mg, and scores were measured from baseline. The largest improvement in SEAR score was the 12.5 mg dose, with a 17.2 improvement after 12 weeks. Bremelanotide is the first in a new class of drugs called melanocortin receptor agonists. Melanocortin receptor agonists work centrally on the area of the brain specific to the pathway that controls sexual function without acting directly on the vascular system. The companies said they plan to meet with the FDA later this year to discuss plans to move into Phase III trials.

• VASTox plc, of Oxford, UK, said initial Phase I studies of its neurodisorder drug programs showed the small-molecule candidates to be safe and also to significantly suppress saliva and sebum production, the causes of two symptoms in Parkinson's disease. Results from the sebum study showed a reduction in sebum production (greasy skin) of 70 percent, and the company said that has led it to investigate this clinical candidate as a potential treatment in the acne market. In the seborrhoea program, recruitment for the next Phase I clinical trial is under way, and the company said it expects to begin the study in mid-2007. In sialorrhoea, a combined Phase I/II clinical trial in patients will begin in the fourth quarter of 2007. Pemphigus Vulgaris is a rare, severe, and chronic autoimmune disease that causes blisters of the skin and mucous membranes.

• Wyeth Pharmaceuticals, of Madison, N.J., presented clinical study results on bifeprunox, an investigational treatment for adults diagnosed with schizophrenia at the 2007 annual meeting of the American Psychiatric Association in San Diego. New analyses of six- month data in stabilized adult patients with schizophrenia from a double-blind, placebo-controlled study demonstrated that bifeprunox maintained stability vs. placebo and displayed a favorable weight and lipid profile comparable with placebo. Analyses of data from one Phase III, six-month, randomized, double-blind, placebo-controlled study showed that compared with placebo, bifeprunox significantly prolonged time to deterioration over six months; bifeprunox patients experienced decreases in body weight and body mass index vs. placebo over six months; and bifeprunox patients showed favorable effects on total cholesterol, triglycerides, very low-density lipoprotein and low-density lipoprotein, comparable with placebo over a six-month period.

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