• AIKO Biotechnology Inc., of Portland, Maine, completed the first Phase I trial of AIKO-150, demonstrating that the compound's mechanism of action as a neutral antagonist, exhibiting potency for relief of opioid-induced gastrointestinal slowing while being less potent for precipitating opioid withdrawal. The study tested four increasing doses of drug administered to methadone-dependent subjects. The company anticipates a second exploratory Phase I trial in the near future.

• Alkermes Inc., of Cambridge, Mass., has begun a Phase I study of ALKS 37, an orally active, peripherally-restricted opioid antagonist with potential to block the opioid agonist effects on gastrointestinal motility. The randomized, double-blind, placebo-controlled study will assess the safety, tolerability and pharmacokinetic effects of a single oral administration of five doses of ALKS 37 in approximately 40 healthy volunteers.

• Arena Pharmaceuticals Inc., of San Diego, reported data from the pivotal BLOSSOM Phase III study of lorcaserin showing highly significant improvements or favorable trends compared to placebo in multiple secondary endpoints, including body composition, cardiovascular risk factors and quality of life. Those findings, presented at the Obesity Society meeting in Washington, add to the top-line data presented earlier this year, which showed a significant weight loss in patients receiving one year of treatment with lorcaserin. (See BioWorld Today, Sept. 21, 2009.)

• ImmunoCellular Therapeutics Ltd., of Los Angeles, announced additional data from its Phase I trial evaluating ICT-107, its dendritic-cell based cancer vaccine for the treatment of glioblastoma multiforme. With 80 percent of newly diagnosed patients (13 of the 16) still alive at a median time of 20 months, it is too early to determine the median overall survival time, the company said. Historically, only 26.5 percent patients survive two years with standard of care, it said.

• Intercept Pharmaceuticals Inc., of New York, reported positive results from a 165-patient, placebo controlled, double-blind Phase II trial of INT-747 in patients with primary biliary cirrhosis (PBC). The study evaluated the effects of adding one of three doses of INT-747 or placebo to ursodeoxycholic acid therapy in patients who did not respond adequately to UDCA therapy alone. All three doses of INT-747 added to UDCA produced a statistically highly significant reduction in alkaline phosphatase levels, the primary endpoint at the end of the 12-week treatment period. The company said it will request an end of Phase II meeting with the FDA to review the results and plans for a Phase III program.

• Logical Therapeutics Inc., of Waltham, Mass., reported positive results of a Phase I/II trial evaluating the gastrointestinal safety of its investigational drug LT-NS001, the first of a new class of bioactivated prodrugs being developed for the chronic treatment of arthritic conditions. Subjects receiving LT-NS001 experienced a 78 percent reduction in the rate of gastric ulcers, and fewer gastric and duodenal erosions, when compared with subjects receiving Naprosyn (naproxen).

• Nektar Therapeutics Inc., of San Carlos, Calif., said data from a Phase II study demonstrated that oral NKTR-118 improved lower gastrointestinal dysfunction by increasing the frequency of bowel movements in patients with opioid-induced constipation, while simultaneously preserving opioid-mediated analgesia. Data were presented at the American College of Gastroenterology meeting in San Diego. NKTR-118, an oral, peripherally acting opioid antagonist, is partnered with London-based AstraZeneca plc.

• NeoPharm Inc., of Lake Bluff, Ill., submitted a Phase II protocol to the FDA for the study of liposome entrapped docetaxel, a liposomal delivery system of docetaxel, the active ingredient of Taxotere, for locally advanced or metastatic pancreatic cancer patients. NeoPharm anticipates enrolling 40 patients in the Phase II trial at three to four locations in the U.S. and Europe

• Orexigen Therapeutics Inc., of San Diego, reported results from new intent-to-treat analyses from its COR-I and COR-II Phase III trials of Contrave (naltrexone SR/bupropion SR), which showed that about 25 percent to 33 percent of patients lost 10 percent or more of their body weight and 12 percent to 16 percent lost at least 15 percent. Obese patients on Contrave also demonstrated significant improvements in markers of cardiometabolic risk, including waist circumference, HDL and triglycerides. Data were presented at the Obesity Society meeting in Washington. Top-line data from COR-I and COR-II were reported in July. (See BioWorld Today, July 21, 2009.)

• PolyMedix Inc., of Radnor, Pa., completed a second successful clinical study of its anticoagulant reversing agent, PMX-60056. The Phase Ib trial was a pilot proof-of-concept study conducted in the U.S. under an investigational new drug application. Results showed PMX-60056 completely reversed the anticoagulant effects of heparin and normalized blood clotting time in human subjects in less than 10 minutes. No serious adverse events occurred.

• ZymoGenetics Inc., of Seattle, has begun a Phase II trial of PEG-Interferon lambda (IL-29) and ribavirin in treatment-naïve patients with chronic hepatitis C virus (HCV) infection (the "EMERGE" study), triggering a $70 million milestone payment to ZymoGenetics from Bristol-Myers Squibb Co., of New York. The EMERGE study is an international, randomized multicenter trial of approximately 50 patients in the first, open label portion that will explore a wide range of doses to be tested in the second part of the study. The second part is designed to enroll approximately 500 patients. Weekly subcutaneous doses of PEG-Interferon lambda will be administered for up to 48 weeks. The study will assess the safety and antiviral efficacy of PEG-Interferon lambda compared to Pegasys. All patients will also receive daily ribavirin. The primary endpoint is the proportion of patients who achieve undetectable levels of HCV RNA after 12 weeks of therapy.