• Avicena Group Inc., of Palo Alto, Calif., reported positive Phase II data from its combination trial involving AL-08, a second-generation drug candidate for amyotrophic lateral sclerosis. The trial's purpose was to determine which drug used in combination with AL-08 would yielded the most favorable results, either minocycline or celecoxib, as measured by neuroprotective capacity. Results showed that patients taking the AL-08/celecoxib showed a smaller mean decline in ALS-Functional Score compared to those taking the AL-08/minocycline combination. Data also demonstrated that AL-08/celecoxib was nonfutile compared to historical controls and merits further evaluation. Those results were presented at the ALS/MND symposium in Toronto.

• Biocept Inc., of San Diego, is initiating a collaborative study with the University of Texas M.D. Anderson Cancer Center to investigate the ability to isolate circulating tumor cells (CTCs) in blood. The study, focusing on ovarian cancer, will use Biocept's CEE (Cell Enrichment and Extraction) technology, which is designed to capture rare cells from a larger heterogeneous cell population. The goals are: to optimize detection and isolation of CTCs in ovarian cancer patients, to quantify the levels of CTCs in patients with primary or recurrent ovarian cancer and to compare gene profiles between CTCs and primary tumor specimens.

• Can-Fite BioPharma Ltd., of Petach Tikva, Israel, submitted an investigational new drug application to start Phase I testing of CF102, its second pipeline drug, aimed at treating liver diseases, including liver cancer, hepatitis virus infections and liver regeneration. Can-Fite anticipates starting the first trial in early 2008.

• EpiCept Corp., of Tarrytown, N.Y., completed patient enrollment in its Phase IIb "Neuracept" trial of EpiCept NP-1 cream, a topical formulation of two FDA-approved drugs - 4 percent amitriptyline and 2 percent ketamine - designed to provide long-term neuropathic pain relief. The four-week, 200-patient trial aims to compare the active ingredients in NP-1 against placebo in patients with diabetic peripheral neuropathy, with a primary endpoint defined as the difference between active and placebo changes in pain intensity from baseline compared to the average over the last seven days of treatment. The company also is evaluating NP-1 in two additional trials: a Phase III study in chemotherapy-induced peripheral neuropathy and a Phase IIb study in peripheral herpetic neuropathy.

• Ferring Pharmaceuticals, of St. Prex, Switzerland, completed the pivotal Phase III study for degarelix, its novel prostate cancer treatment, and the study met the primary objective of reducing levels of testosterone, while the safety profile was in line with previously conducted studies. Degarelix is one of the first drugs in the GnRH-blocker class of treatments for prostate cancer. Ferring intends to submit the compound for approvals in the U.S. and Europe during the first quarter of next year.

• Knopp Neurosciences Inc., of Toronto, reported results of its Phase I study of KNS-760704, an oral, small molecule in development for amyotrophic lateral sclerosis, showing that the drug was safe and well tolerated in single oral doses up to 300 mg when tested in healthy volunteers. Pharmacokinetic results indicated that the drug is rapidly absorbed, with concentrations increasing in proportion to dose, and a high-fat meal appeared to have no effect on the absorption and elimination of KNS-760704. Those data were presented at the ALS/MND symposium in Toronto.

• LifeCycle Pharma A/S, of Horsholm, Denmark, started a Phase II trial with LCP-Tacro, an immunosuppressant to prevent organ rejection in liver transplant recipients. The clinical trial is expected to enroll up to 50 patients in up to 12 centers throughout the U.S. The company expects to report clinical trial results in the first half of 2008. LCP-Tacro is being developed as a once-daily tablet version of tacrolimus, with improved bioavailability and reduced variability in absorption.

• Migenix Inc., of San Diego, reported preliminary four-week interim results from a Phase II viral kinetics study in hepatitis C virus treatment-naive patients which indicated that celgosivir, an oral alpha glucosidase I inhibitor, has no negative effects on the tolerability, pharmacokinetics and viral kinetics when combined with the standard-of-care drugs, pegylated interferon plus ribavirin, as compared to the standard-of-care drugs alone. The drug is the only anti-HCV therapy in clinical development that acts on host-directed glycosylation.

• Pharmacopeia, of Princeton, N.J., reported additional results from its Phase I trial of PS433540, a dual-acting angiotensin and endothelin receptor antagonist, demonstrating that the drug produced statistically significant, dose-dependent increases in plasma-renin activity levels, as well as reductions in systolic and diastolic blood pressure. Pharmacopeia said the observed increase in plasma-renin activity is indicative of the drug's ability to block the angiotensin receptor, a key target for controlling blood pressure in hypertensive patients. Previous data showed the drug to be safe and well tolerated. PS433540 is in an ongoing Phase IIa trial, with results expected in the first half of 2008.

• Phynova Group plc, of Oxford, UK, said preliminary results from the Phase I/II trial of its lead drug candidate PYN17 for treating the symptoms of chronic hepatitis showed that it was well tolerated, with a low level of relatively minor adverse events identical to that seen with placebo. The prospective, double-blind trial consisted of 39 patients, randomized to treatment for one month with either PYN17 or placebo. For the group treated with PYN17, 11 of 26 (42.3 percent) patients reported adverse events of some kind during treatment against 10 of 13 (76.9 percent) in the group receiving placebo. For drug-related adverse events, the incidence was six out of 26 (23.1 percent) on PYN17 compared with three out of 13 (23.1 percent) on placebo.

• Repros Therapeutics Inc., of The Woodlands, Texas, held a Type B meeting with the FDA to review results from the trials of Proellex conducted to date and to discuss the start of Phase III studies. The agency agreed that Proellex, when used as a selective blocker of the progesterone receptor for presurgical treatment for the correction of anemia associated with excessive bleeding due to the presence of uterine fibroids, is acceptable, and regulators suggested the indication would be best considered under a separate investigational new drug application. Repros said it will submit an IND to commence two pivotal Phase III studies for the indication as soon as possible. The FDA also provided a preliminary review for Repros' plans for Phase III pivotal efficacy protocols for the chronic treatment of symptoms associated with uterine fibroids.

• SGX Pharmaceuticals Inc., of San Diego, submitted an investigational new drug application for SGX523, an oral, small-molecule inhibitor of the cMET receptor tyrosine kinase. Phase I testing is expected to start in solid tumor cancer patients in early 2008.

• Titan Pharmaceuticals Inc., of South San Francisco, revealed the early completion of enrollment in its Phase III clinical study of Probuphine in the treatment of opioid dependence. Enrollment was completed about one month ahead of schedule, with results from the study expected to be available by the third quarter of 2008. The randomized, double-blind, placebo-controlled, multicenter study will evaluate the safety and effectiveness of treatment with Probuphine in reducing opioid dependence over 24 weeks of treatment in about 150 patients.

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