Alkermes Inc., of Cambridge, Mass., said it completed enrollment in a Phase I/II trial of ALKS 29, an oral compound for the treatment of alcohol dependence. Alkermes is not disclosing the nature of the compound. The multicenter, randomized, double-blind, placebo-controlled trial is designed to assess the safety and efficacy of ALKS 29 in about 150 subjects with alcohol dependence. Alkermes expects to provide top-line results from the study in the first half of 2007. AOP Orphan Pharmaceuticals

Advanced Magnetics Inc., of Cambridge, Mass., said a data monitoring committee overseeing the ferumoxytol Phase III intravenous iron replacement therapy program met for the final time and identified no safety concerns. The DMC recommended continuation of the ferumoxytol Phase III studies with no modifications. At the meeting, the DMC reviewed safety data from 1,610 subjects enrolled in the Phase III program. The therapy is being tested in chronic kidney disease patients. AlphaRx Inc., of

Pharmaxis Ltd., of Sydney, Australia, said a Phase II trial of Bronchitol in children with cystic fibrosis closed its enrollment phase after entering 25 subjects, fewer than the 42 originally expected. The number was revised following a review of the trial and because of a shortage of volunteers at the two UK sites. Children in the trial are completing three months of treatment with each of three different therapies - Bronchitol alone, both Bronchitol and Pulmozyme (domase alfa, Genentech Inc

Acambis plc, of Cambridge, UK, said that ChimeriVax-JE, its single-dose vaccine against Japanese encephalitis, met and exceeded the primary immunogenicity endpoint in a pivotal Phase III trial. The study enrolled 820 adult subjects who were randomized to receive either ChimeriVax-JE or JE-VAX, the licensed three-dose JE vaccine, to compare the immunogenicity 30 days after immunization. Acambis' vaccine met the primary non-inferiority endpoint of seroconversion rates based on neutralizing

Human Genome Sciences Inc., of Rockville, Md., initiated dosing in ACHIEVE 2/3, a Phase III trial of Albuferon (albinterferon alfa-2b) in combination with ribavirin in treatment-na ve patients with chronic hepatitis C virus genotypes 2 and 3. ACHIEVE is the second of two pivotal trials of Albuferon, and HGS aims to file global marketing applications for the product in 2009. The product is being developed in partnership with Basel, Switzerland-based Novartis AG. In separate news, HGS reported

BioMS Medical Corp., of Edmonton, Alberta, began the open-label, follow-on portion to its MAESTRO-01 pivotal Phase II/III trial of MBP8298 for secondary progressive multiple sclerosis. Eligible patients who successfully completed the blinded, placebo-controlled MAESTRO-01 trial, which has completed enrollment of 550 patients, may choose to receive MBP8298 on an unblinded basis in MAESTRO-02, regardless of whether they were previously on placebo or drug. It primarily will evaluate the drug's

Algeta ASA, of Oslo, Norway, announced positive results from a Phase II trial of its lead product, Alpharadin, in patients with late-stage hormone-refractory prostate cancer. In a double-blind placebo-controlled clinical trial involving 64 patients, those treated with at least two injections of the compound, a novel radiotherapy based on radium-223, survived on median nearly 25 weeks (53 percent) longer than those receiving placebo (71 weeks compared to 46.4 weeks). At the time of the 18-month

Antisoma plc, of London, presented positive interim findings from its ongoing Phase II trial of AS1404 in hormone-refractory prostate cancer. Men receiving AS1404 plus standard docetaxel chemotherapy had a substantially higher PSA response rate than men receiving chemotherapy alone. As previously reported, among the first 64 of 74 patients, PSA response rates were 57 percent with the AS1404-docetaxel combination versus 35 percent with docetaxel alone. Addition of AS1404 to chemotherapy also

AspenBio Pharma Inc., of Castle Rock, Colo., said results from ongoing research and clinical studies show that its human appendicitis blood test appears able to identify patients with appendicitis at a very high sensitivity level of 94 percent to 97 percent, compared to significantly lower diagnostic success rates for CT scans. Three studies have been conducted during the past 30 months, with one 400-patient study still ongoing. AspenBio anticipates a regulatory filing with the FDA later this

Allon Therapeutics Inc., of Vancouver, has filed an investigational new drug application with the FDA seeking human trials for its AL-108 compound in schizophrenia and related cognitive impairment. The National Institute of Mental Health has agreed to fund Phase II clinical trials for the drug, which will be conducted at seven sites. AL-108 already is being evaluated in a Phase II trial as a treatment for Alzheimer's. The company's AL-208 also is in a Phase II trial for use in preventing and

Auxilium Pharmaceuticals Inc., of Malvern, Pa., presented Phase III data demonstrating that its lead drug candidate, AA4500, reduced joint contracture in both the double-blind and open-label phases of the trial. In the blinded portion of the study, as previously reported, AA4500 injection resulted in a 91 percent success rate in reducing joint contracture to within 5 degrees of normal in patients with Dupuytren's contracture, while no patients in the placebo arm achieved success. In the open

ActivBiotics Inc., of Lexington, Mass., has begun patient enrollment in a Phase II study of an anti-chlamydial antibiotic, rifalazil, on atherosclerotic changes in the carotid artery. The prospective, randomized, double-blind, placebo-controlled multicenter study will treat patients with a history of atherosclerotic disease. They will receive weekly treatments of rifalazil or placebo during a 12-week period and will be followed for 18 months with serial magnetic resonance imaging and ultrasound

Aastrom Biosciences Inc., of Ann Arbor, Mich., said that 90 percent of patients who have completed the 12 months post-treatment follow-up a Phase I/II trial evaluating the use of Tissue Repair Cells in the treatment of severe long bone fractures had multiple bone bridges, evidence of bone regeneration. Twenty of 36 patients in the trial had completed 12-month follow-up. TRCs are a mixture of stem and progenitor cells derived from the patient's bone marrow. ChemGenex Pharmaceuticals Ltd., of

AndroScience Corp., of San Diego, successfully completed an investigational new application filing and intends to begin a Phase I trial this quarter of the acne product ASC-J9, a topical anti-androgen agent. AndroScience also has drug candidates in preclinical testing for alopecia, prostate cancer, benign prostate hyperplasia and other androgen-related disorders. BioLineRx Ltd., of Jerusalem, successfully completed Phase I trials of its lead product, BL-1020, a GABA-enhanced antipsychotic for

Adolor Corp., of Exton, Pa., initiated a Phase I trial with ADL5859, an oral Delta opiod agonist that may be used to treat pain and other conditions. The multi-dose trial will involve twice-daily dosing for seven days in healthy volunteers. Last fall, Adolor suffered a series of setbacks including an approvable letter requesting more safety data for Entereg (alvimopan) in postoperative ileus, two trial failures with Entereg in opioid-induced bowel dysfunction, and the discontinuation of

Argos Therapeutics of Durham, N.C. has began a Phase I/II trial to gauge the immunologic activity and safety of AGS-004 in HIV-infected adults. The study group will be 10 patients with durable viral suppression from highly active antiretroviral therapy. AGS-004 is a personalized RNA-loaded dendritic cell-based immunotherapy designed to stimulate the immune system to target and destroy the patient's unique viral burden. The primary study objective is to evaluate patient-specific anti-viral

Advanced BioHealing Inc., of New York, said it enrolled the first patient in its initial Celaderm pilot study. The primary goal is to evaluate the safety of Celaderm, a next-generation bioengineered tissue product. The study also will assess the potential for Celaderm to accelerate healing of venous leg ulcers compared with optimal standard therapy. The study is designed to enroll 55 patients. Amarillo Biosciences Inc., of Amarillo, Texas, said it began enrolling patients in a Phase II trial

Aida Pharmaceuticals Inc., of Hangzhou, China, announced that the company's researchers have published an article titled "Phase I Clinical Trial of Recombinant Human Apo-2 Ligand (Rh-Apo2L) in Patients with Advanced Cancer," in the Chinese Journal of New Drugs. The article was written by company researchers, scientists and medical professionals from the Department of Medical Oncology of the Cancer Hospital at the Chinese Academy of Medical Sciences and the Peking Union Medical College in

Avigen Inc., of Alameda, Calif., reported positive findings from a Phase IIa safety and tolerability study of AV411 (ibudilast), an oral therapy for neuropathic pain, in normal volunteers. Results also support a twice-daily dosing frequency. The company continues to enroll patients in the study, which is expected to be completed later in 2007. BioCryst Pharmaceuticals Inc., of Birmingham, Ala., said European regulators granted orphan drug status to Fodosine, a transition-state analog