Abraxis BioScience Inc., of Los Angeles, has initiated enrollment in its Phase II trial of Coroxane, for the prevention and reduction of restenosis (re-narrowing of arteries) following stenting or angioplasty of the superficial femoral artery (SFA). The study will compare the safety and efficacy of three different Coroxane dosing schedules to primary percutaneous balloon angioplasty with provisional stenting, the standard treatment for stenosis in the SFA. Earlier preclinical and clinical

Evotec AG, of Hamburg, Germany, reported preliminary findings of a three-way crossover study of EVT 101, an oral NR2B subtype selective NMDA receptor antagonist, in 19 healthy young subjects, showing that all treatments were well tolerated. Researchers used functional magnetic resonance imaging techniques to investigate short-term effects of two doses of EVT 101 and placebo. Although there was no evidence of acute improvement in cognitive function - not expected in healthy young subjects - the

Ferring Pharmaceuticals SA, of Saint-Prex, Switzerland, reported Phase III data showing that degarelix, its gonadotropin-releasing hormone blocker, suppressed testosterone within three days in 96 percent of patients. Results from the 12-month trial, which compared monthly administration of degarelix to monthly leuteinizing hormone-releasing hormone agonist leuprorelin, showed that degarelix suppressed serum testosterone and prostate-specific antigen significantly faster. Degarelix also was able

Anacor Pharmaceuticals Inc., of Palo Alto, Calif., reported results from a Phase IIa trial of AN2728, a topical anti-inflammatory psoriasis drug, showing that it met all its primary and secondary endpoints. In 69 percent of patients, the affected area treated with AN2728 scored better at the end of therapy than the area treated with the vehicle ointment, compared to 6 percent of patients in whom the vehicle-treated areas were superior. Those results were statistically significant. No drug

Alexion Pharmaceuticals Inc., of Cheshire, Conn., said it completed enrollment of patients in its single Phase III registration study, known as AEGIS, to evaluate the safety, efficacy and pharmacology of Soliris (eculizumab) as a treatment for Japanese patients with paroxysmal nocturnal hemoglobinuria (PNH), a rare, acquired genetic blood disorder defined by hemolysis, in which patients' red blood cells are destroyed by complement, a component of the body's immune system. The open-label study

BioSante Pharmaceuticals Inc., of Lincolnshire, Ill., started a Phase III trial of LibiGel (transdermal testosterone gel) in female sexual dysfunction, specifically hypoactive sexual desire disorder. It's the second of two studies to be conducted under the company's special protocol assessment with the FDA. The Phase III trial is expected to enroll about 500 surgically menopausal women for a six-month period. The primary endpoints in both studies are an increase in the number of satisfying

Ceragenix Pharmaceuticals Inc., of Denver, said it completed the patient visit phase of its trial of EpiCeram vs. Elidel in treating the symptoms associated with eczema in children between the ages of 2 and 18. While the study had a goal of enrolling at least 50 patients, enrollment was terminated at 36 patients because the rate of enrollment did not anticipate timely completion of the full cohort of patients. Study results are undergoing statistical analysis, and the company expects to receive

Abbott, of Abbott Park, Ill., said the first two-year data for Crohn's disease patients with fistulas showed that more than half of patients receiving Humira (adalimumab) had continued fistula healing. Those data, presented at the European Crohn's and Colitis Organization annual meeting in Lyon, France, were taken from two subanalyses of fistula patients from Abbott's 854-patient, one-year Phase III CHARM trial. Patients were followed through a second year of therapy into a nonplacebo

Avexa Ltd., of Melbourne, Australia, said updated data from its Phase IIb clinical trial of apricitabine (ATC) for HIV showed that 90 percent of patients achieved undetectable viral loads. The 48-week data also showed increased CD4 cell count, which doubled in patients switched from 3TC to ATC. Biolex Therapeutics Inc., of Pittsboro, N.C., and OctoPlus NV, of Leiden, the Netherlands, said results of a Phase I clinical trial of Locteron, a controlled-release interferon alfa in development for

Calistoga Pharmaceuticals Inc., of Seattle, said it has initiated a Phase I clinical trial of CAL-101, an orally available small molecule that inhibits an important intracellular signaling component known as phosphoinositide-3 kinase (PI3K) delta. The trial in healthy volunteers will help define dosing regimens in patients with inflammatory diseases and cancer, the company said. Inovio Biomedical Corp., of San Diego, said that interim data from its first-in-man Phase I clinical trial showed

Cytos Biotechnology AG, of Zurich, Switzerland, announced publication of positive results from a Phase IIa clinical trial with the hypertension vaccine CYT006-AngQb. In the study of hypertensive patients, vaccination with CYT006-AngQb was shown to significantly reduce the mean ambulatory daytime blood pressure by induction of antibodies that bind angiotensin II. Data were published in the March 8, 2008, issue of The Lancet. NovaBay Pharmaceuticals Inc., of Emeryville, Calif., said it has

Akela Pharma Inc., of Montreal, Quebec, has started a Phase I trial for EDACS, its platform technology to prevent abuse of controlled substances. The technology uses extrusion technology to prepare an insoluble matrix containing dispersed drug, which can be shaped into tablets. The open-label, randomized, single-dose, crossover study will investigate the pharmacokinetics and safety of three different extended-release formulations of a well-known opioid product compared to an immediate-release

Biovitrum AB, of Stockholm, Sweden, and Syntonix Pharmaceuticals Inc., of Waltham, Mass., have obtained approval from the FDA to begin a Phase I/IIa study of a intravenous, long-acting, recombinant Factor IXFc for the treatment of hemophilia B. This first-in-human study will evaluate the safety and tolerability of FIXFc and its pharmacokinetic profile (primarily its plasma half-life) after a single injection of six different doses. The study will be performed at two clinics in the U.S

Celsion Corp., of Columbia, Md., said results from a Phase I liver cancer study of ThermoDox in combination with radiofrequency ablation treating patients with primary and metastatic liver cancer showed the dose of 50 mg/m2 is both safe and tolerable for use in a Phase III study. Data were presented at International Hepato-Pancreato-Biliary Association conference in Mumbai, India. Inhibiton Therapeutics Inc., of Centennial, Colo., said testing has shown that its ICA-1 compound demonstrated

7TM Pharma A/S, of Horsholm, Denmark, reported positive results from two clinical studies of obesity drug TM30339, a drug designed to work via the Y4 receptor to mimic a natural satiety signal from the gastrointestinal tract involved in the regulation of food. Results from a Phase Ia study demonstrated that the drug is safe and well tolerated when single doses are administered, resulting in very substantial and persistent plasma levels of the drug. A Phase Ib study in obese patients confirmed

Agennix Inc., of Houston, said final results from its positive Phase II trial of talactoferrin alfa as a monotherapy in non-small-cell lung cancer showed that the drug improved overall patient survival over placebo in patients who had failed previous chemotherapy, meeting the primary endpoint. The trial enrolled 100 patients with Stage IIIb/IV disease to receive treatment in 14-week cycles for up to three cycles or until disease progression. In the 100-patient intent to treat population, median

Cytori Therapeutics Inc., of San Diego, said longer-term follow-up data from an investigator-sponsored Japanese breast reconstruction study showed no significant loss of breast tissue thickness from one month to a mean follow-up of 12 months and a patient satisfaction of 79 percent. The study involved the use of adipose tissue-derived stem and regenerative cells, processed using Cytori's Celution 600 System, to reconstruct breast tissue following partial mastectomy. Data were presented at the

AGI Therapeutics plc, of Dublin, Ireland, reported positive results of a clinical study to assess the pharmacokinetic profile of Rezular (AGI-003), which is in Phase III clinical trials for the treatment of diarrhea-predominant irritable bowel syndrome (IBS-D). Results showed that the gastrointestinally active R-isomer, arverapamil, contained in Rezular can be administered to humans without exposing them to clinically relevant levels of the S-isomer, the form of verapamil which is most potent

Allon Therapeutics Inc., of Vancouver, British Columbia, said it expanded the scope of its ongoing trial of AL-108 by adding Alzheimer's disease patients to the study. The company started dosing healthy subjects last month in the study, which is designed to evaluate the cerebrospinal fluid and plasma pharmacokinetics of AL-108, an intranasally administered compound for Alzheimer's and schizophrenia, and AL-208, designed for intravenous administration to prevent mild cognitive impairment