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

Advanced Life Sciences Holdings Inc., of Woodridge, Ill., said trial data from its lead candidate, cethromycin, a second-generation ketolide antibiotic, demonstrated safety and efficacy at multiple dose levels in community-acquired pneumonia, acute bacterial exacerbation of chronic bronchitis and anthrax. Results were presented at the 46th Interscience Conference on Antimicrobial Agents and Chemotherapy in San Francisco. Cethromycin is in Phase III studies testing 300 mg QD in community

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

Kalypsys Inc., of San Diego, initiated a Phase Ia study of KD3010, for metabolic diseases and expects to complete it in October. Begun in mid-July, the trial will evaluate the safety, tolerability and pharmacokinetics of KD3010 vs. placebo in healthy volunteers. Kalypsys plans to follow that study with a 28-day safety trial in obese volunteers in early 2007, it said. Pervasis Therapeutics Inc., of Cambridge, Mass., is enrolling patients in two Phase I trials of the company's first product

Astex Therapeutics, of Cambridge, UK, began dosing first patients in a Phase I/IIa trial of its investigational cancer drug, AT9283. Astex discovered AT9283, a potent inhibitor of Aurora kinases, using its innovative fragment-based drug discovery technology, Pyramid. The company's lead product, AT7519, already is in a Phase I trial at sites in the U.S. and the UK. CV Therapeutics Inc., of Palo Alto, Calif., said top-line results from its MERLIN TIMI-36 study of Ranexa (ranolazine) would be

Acadia Pharmaceuticals Inc., of San Diego, provided an update on the timing of its Phase II adjunctive therapy trial with ACP-103 in patients with schizophrenia, saying enrollment is ahead of schedule, which should enable the company to report top-line results for the complete 400-patient clinical trial during the first quarter of 2007, ahead of earlier expectations. The company no longer plans an interim analysis based on the first 200 patients, which had been planned to be conducted by the

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

Antisoma plc, of London, reported the first findings from its ongoing Phase II study of AS1404 in hormone-refractory prostate cancer patients, showing a higher rate of prostate-specific antigen (PSA) responses among men receiving the drug. Preliminary data from 64 patients show a PSA response rate of 57 percent in those getting AS1404 plus docetaxel compared to 35 percent in those receiving docetaxel alone. The proportion of men showing disease progression was nearly halved in the AS1404 arm

AmpliMed Corp., of Tucson, Ariz., said interim results from its ongoing Phase I/II trial of Amplimexon (imexon) in combination with dacarbazine in patients with advanced malignant melanoma show that, of 27 evaluable patients, five have had partial responses and seven have demonstrated stable disease, for an overall 44.4 percent clinical benefit rate. Data were presented at the Congress of Perspectives in Melanoma X and The Third International Melanoma Research Congress in Noordwijk, the

Advancis Pharmaceutical Corp., of Germantown, Md., said the FDA confirmed that the company's successful Phase III trial and other data would be considered adequate for filing a new drug application via the 505(b)(2) regulatory pathway for its once-daily amoxicillin Pulsys product for pharyngitis/tonsillitis. Advancis expects to file the NDA in December or January. Cardiome Pharma Corp., of Vancouver, British Columbia, said top-line results from both the 300-mg and 600-mg dosing groups for its

Acuity Pharmaceuticals Inc., of Philadelphia, disclosed positive data from its Phase II CARE trial for bevasiranib sodium (formerly Cand5), Acuity's lead compound for the treatment of wet age-related macular degeneration. Bevasiranib is a first-in-class small interfering RNA therapeutic designed to silence the genes that produce vascular endothelial growth factor. Though the study included no placebo arm, bevasiranib patients demonstrated stronger measures of visual acuity than predicted by the

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

Active Biotech AB, of Lund, Sweden, and Teva Pharmaceutical Industries Ltd., of Jerusalem, said a Phase IIb study designed to evaluate the safety and efficacy of laquinimod, a once-daily oral agent, in relapsing remitting multiple sclerosis patients, met its primary endpoint. The treatment significantly reduced the rate of inflammatory disease activity and demonstrated a considerable reduction in the number of clinical relapses compared to placebo. The Phase IIb multicenter, randomized, double

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