Alnylam Pharmaceuticals Inc., of Cambridge, Mass., initiated a Phase I trial of an RNAi treatment for respiratory syncytial virus (RSV) infection, ALN-RSV01, in the U.S. The inhaled treatment will be administered in a nebulized formulation on healthy adults. Two previous Phase I studies tested the drug in an intranasal form. Aspreva Pharmaceuticals Corp., of Victoria, British Columbia, reported data from an 80-patient investigator initiated trial at Duke University Medical Center with The

AVI BioPharma Inc., of Portland, Ore., said results from the second phase of its exploratory study of Neugene antisense compound AVI-4065 in patients with chronic active hepatitis C virus infection showed the drug exhibited favorable safety and tolerability profiles in 12 patients. Consistent with the preliminary results reported in May, the therapeutic threshold required for efficacy was not achieved at the treatment dose used in the study protocol. AVI decided to initiate a protocol

Adherex Technologies Inc., of Research Triangle Park, N.C., initiated a Phase I trial of ADH-1 in combination with chemotherapy in conjunction with the U.S. Oncology Research network. The study, expected to involve up to 55 patients with N-cadherin positive solid tumors, is designed to define the dose-limiting toxicities and maximum tolerated dose of ADH-1 in three separate combinations - with docetaxel, with carboplatin, or with capecitabine. ADH-1 also is being tested as a single agent in two

Avantogen Oncology Inc., of Los Angeles, submitted an investigational new drug application for RP101, a compound for pancreatic cancer. The company plans to start a Phase II, randomized, double-blind, placebo-controlled study in early 2007 to assess RP101 therapy combined with gemcitabine chemotherapy vs. gemcitabine chemotherapy alone in patients with metastatic pancreatic cancer. Survival at six months from randomization will be the primary endpoint. BioCryst Pharmaceuticals Inc., of

Adherex Technologies Inc., of Research Triangle Park, N.C., began a Phase I/II trial of eniluracil combined with 5-fluorouracil (5-FU) in Asian patients with liver cancer. The Phase I dose-escalation part of the study, which is expected to enroll about 25 patients with hepatocellular cancer, is intended to establish dosing safety and the combination's schedule in that patient population. The Phase II part is expected to enroll 25 additional patients to provide initial efficacy information in

Alba Therapeutics Corp., of Baltimore, dosed its first patient in a Phase II trial for the treatment of celiac disease. The study will evaluate AT-1001 in 79 celiac disease subjects during gluten challenge. Bioenvision Inc., of New York, said the latest results from its ongoing European study of Evoltra (clofarabine) in pediatric acute lymphoblastic leukemia patients confirmed that the drug delivers a significant response rate in that population. Data showed a complete response rate of 28

Active Biotech AB, of Lund, Sweden, reported data from an interim analysis of the ongoing TASQ Phase I study showing that daily treatment of 0.5 mg TASQ led to a reduced rate of prostate specific antigen (PSA) in all 10 patients with hormone-refractory prostate cancer. In nine of the 10 patients, that decrease was greater than 50 percent, and four patients showed a decrease serum level of PSA after four months of TASQ treatment. The trial is expected to involve a total of 24 patients. Active

Amgen Inc., of Thousand Oaks, Calif., said results from a post-hoc exploratory analysis of an ongoing Phase II study showed that subjects treated with denosumab subcutaneously, 60 mg twice yearly for up to 24 months, experienced an improvement in bone mineral density, as well as in parameters of hip structural analysis, which estimates geometric properties of bone strength. Denosumab is a fully human monoclonal antibody that targets RANK ligand, a primary mediator of the formation, function and

AlphaVax Inc., of Research Triangle Park, N.C., said an analysis of blinded results from a Phase I trial suggests that a prototype HIV vaccine incorporating the HIV gag gene made using the company's alphavaccine technology induced an antibody response to the HIV gag antigen in 100 percent of the recipients at the highest dose tested and in a majority of the recipients at a 10-fold lower dose. The data were presented last week at the AIDS Vaccine 2006 meeting in Amsterdam, the Netherlands

Advanced Magnetics Inc., of Cambridge, Mass., completed enrollment in two of four multicenter Phase III studies of ferumoxytol as an intravenous iron replacement therapeutic for the treatment of anemia in chronic kidney disease patients, whether or not on dialysis. Arpida Ltd., of Basel, Switzerland, completed patient enrollment in ASSIST-1, the first of two Phase III trials with its lead investigational antibiotic iclaprim, in patients with complicated skin and skin-structure infections. The

ACE BioSciences A/S, of Odense, Denmark, began Phase I trials of its lead product, ACE393, a vaccine for travelers' diarrhea caused by Campylobacter infection. The study will test the product's safety, tolerability and immunogenicity in up to 72 healthy subjects. In the first stage, subjects will receive a single intramuscular injection of the vaccine in escalating doses, starting at 25 mcg, rising to 100 mcg and finally 250 mcg. In the second stage, additional subjects will receive two

Addex Pharmaceuticals SA, of Geneva, started a Phase II trial of ADX10059 as an acute migraine treatment, after Phase I data indicated good tolerability across a broad dose range. Two additional Phase II studies are set to begin in acute anticipatory anxiety and for the prevention of acid reflux in patients with gastroesophageal reflux disease. ADX10059 is a selective, negative allosteric modulator of the metabotropic glutamate receptor 5, which is implicated in anxiety, migraine and other

Allos Therapeutics Inc., of Westminster, Colo., completed patient enrollment in its pivotal Phase III ENRICH study of Efaproxyn (efaproxiral) in women with brain metastases originating from breast cancer. ENRICH (Enhancing Whole-Brain Radiation Therapy In Patients with Breast Cancer and Hypoxic Brain Metastases) is designed to evaluate whole-brain radiation therapy with supplemental oxygen with or without Efaproxyn. A total of 360 patients were enrolled at 126 participating centers in the U.S

Cell Therapeutics Inc., of Seattle, said data from a Phase I study of weekly Xyotax given in combination with radiation for patients with esophageal or gastric cancer were published in the August edition of the American Journal of Clinical Oncology. Twenty-one patients were treated to evaluate the safety of the regimen and to determine the maximum tolerated dose of Xyotax in combination with 50.4 Gy of concurrent radiation. Of the 12 patients with loco-regional disease in whom tumor responses

GenVec Inc., of Gaithersburg, Md., said the first human therapeutic clinical trial involving the company's adenoviral-vector technology used in an HIV vaccine candidate will be conducted by the Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health in Bethesda, Md. The randomized, placebo-controlled study will measure safety and immunogenicity in 15 HIV-positive patients. MethylGene Inc., of Montreal, enrolled the first patient in a

Athenagen Inc., of South San Francisco, began testing ATG003 for age-related macular degeneration in a Phase I trial. A topical formulation of mecamylamine, ATG003 has shown efficacy in animal models and is a possible alternative to current therapies for AMD, which require frequent needle injections directly in the eye. The study represents the first human study of an eye drop antiangiogenic therapy for AMD, with a Phase II efficacy study expected to follow early next year. Introgen

Ambrilia Biopharma Inc., of Montreal, reported findings from a Phase Ia study of its HIV protease inhibitor, PPL-100, showing that the drug is safe and well tolerated with a favorable pharmacokinetic profile. Results also indicated that the drug has a long elimination half-life. Data were reported at the XVI International AIDS Conference in Toronto. Argos Therapeutics Inc., of Durham, N.C., initiated dosing in a Phase I/II trial of AGS-003, a personalized immunotherapy for advanced kidney

Ceragenix Pharmaceuticals Inc., of Denver, began enrolling patients in a trial to assess EpiCeram compared to Cutivate, a mid-strength steroid, in patients with moderate to severe atopic dermatitis. The company expects to have results in the fourth quarter. The study will consist of 90 children between the ages of 6 months and 18 years, with half receiving treatment with EpiCeram and the other half receiving the steroid for a four-week period. Ceragenix received 510(k) clearance in April from

CuraGen Corp., of Branford, Conn., and TopoTarget A/S, of Copenhagen, Denmark, started a Phase I trial evaluating the administration of oral PXD101, a small-molecule histone deacetylase inhibitor, in patients with advanced solid tumors. The open-label, multicenter trial is designed to establish the maximum tolerated dose for oral PXD101 administered once or twice daily. Patients in the U.S. and Europe will be treated with oral PXD101 in a dose-escalation regimen and may continue to receive up