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

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

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

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

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

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

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

Abbott Laboratories, of Abbott Park, Ill., obtained positive data in its Phase III REVEAL trial of Humira (adalimumab) in moderate to severe psoriasis. The 1,200-patient trial demonstrated the efficacy of Humira both on a short-term and sustained basis. The company plans to include these data, as well as positive findings from a previous Phase III psoriasis study with Humira, in U.S. and European regulatory applications to be submitted in the first half of this year. Humira currently is

Including XL418, Exelixis now has 11 compounds in or ready to enter the clinic, including four compounds in Phase II, and plans to file at least three more INDs this year

Advanced Viral Research Corp., of Yonkers, N.Y., began a Phase II study using a topically applied spray formulation of AVR 118 as a wound healing agent. One cohort of patients will be treated after plastic surgery. The product will be applied to one of their wounds, and their second wounds will serve as an untreated control to determine if AVR 118 can accelerate the time taken for the wound to close and reduce or eliminate subsequent scar formation. A second cohort of patients will be treated

Crucell NV, of Lieden, the Netherlands, said it completed a Phase I study of the alum-adjuvanted formulation of its whole inactivated West Nile vaccine, which was manufactured using its PER.C6 technology. The trial in 47 subjects in Belgium demonstrated safety and tolerability. Cytos Biotechnology AG, of Zurich, Switzerland, said a placebo-controlled Phase IIa trial of the hypertension vaccine CYT006-AngQb showed a reduction in daytime blood pressure. The study was conducted in 72 patients

Addex Pharmaceuticals SA, of Geneva, began a double-blind Phase IIa study in the U.S. of ADX10061 for smoking cessation. Smokers will receive the drug or placebo for seven weeks, with counseling. Endpoints include abstinence measures, nicotine craving and withdrawal, and mood scores. ADX10061 is a selective antagonist of the dopamine D1 receptor. Lexicon Genetics Inc., of The Woodlands, Texas, began a Phase I trial of LX1031, an oral drug candidate for irritable bowel syndrome and other

DOR BioPharma Inc., of Miami, said data from its pivotal Phase III trial showed that orBec (oral beclomethasone dipropionate) demonstrated continued survival benefit when compared to placebo in patients with gastrointestinal graft-vs.-host disease one year after randomization. Overall 18 patients (29 percent) in the orBec group and 28 patients (42 percent) in the placebo group died within one year. Those results were published in an on-line edition of Blood. MediciNova Inc., of San Diego

Allon Therapeutics Inc., of Vancouver, British Columbia, said AL-208 advanced into the randomized portion of its Phase II trial for treating the mild cognitive impairment that can occur following coronary artery bypass graft surgery. The initial portion of the study assessed safety in patients. Now the product's effect on cognitive function will be tested against placebo. The company selected the 300-mg dose, the highest dose studied, for further testing. BioMS Medical Corp., of Edmonton

Bionovo Inc., of Emeryville, Calif., began enrollment in a pharmacokinetics trial to further evaluate its lead drug candidate, MF101, which is designed to treat the symptoms of menopause. The product also is being tested in Phase II trial in 217 postmenopausal women, which began in October. Penwest Pharmaceuticals Co., of Danbury, Conn., began a Phase I study of Nalbuphine ER, a nalbuphine hydrochloride extended-release tablet formulation being developed for pain. The trial will evaluate the

Alexza Pharmaceuticals Inc., of Palo Alto, Calif., completed patient enrollment in its Phase IIa trial of AZ-004 (Staccato loxapine), an inhalation candidate for acute treatment of agitation in schizophrenic patients. The study involved 120 subjects, with the primary aim of assessing the safety and efficacy of a single dose, as determined by the change in the PANSS Excited Component scale. Initial results from the trial are expected in the second quarter. Anesiva Inc., of South San Francisco

Clinic Roundup

An intravenous formulation of Nemonoxacin is set to enter the clinic this spring