Alfacell Corp., of Bloomfield, N.J., reported Phase IIIa data showing that patients with unresectable malignant mesothelioma treated with Onconase (ranpirnase) had greater median survival times than those treated with doxorubicin, as measured by the prognostic scoring systems of both the Cancer and Leukemia Group B and European Organization for Research and Treatment of Cancer. Findings were presented at the 8th International Mesothelioma Interest Group conference in Chicago. Onconase, which

AM-Pharma BV, of Bunnik, the Netherlands, disclosed positive results from a pilot study in sepsis with its patented alkaline phosphatase drug. The study assessed the safety of a single treatment with 200 U alkaline phosphatase I.V./kg in patients suffering from severe sepsis. Efficacy parameters were recorded as secondary variables. Thirty-six patients admitted to intensive care units with the diagnosis of severe sepsis were included in the study, and the treatment proved well tolerated

Accentia Biopharmaceuticals Inc., of Tampa, Fla., said a new study has shown that the administration of a BiovaxID formulation given to patients with relapsed follicular non-Hodgkin's lymphoma following chemotherapy, with or without concomitant Rituxan (rituximab, Genentech Inc. and Biogen Idec Inc.), can induce complete long-lasting remissions. In the study, 80 percent of patients achieved an immune response to the BiovaxID formulation, and among those responders, the median time of complete

AVI BioPharma, of Portland, Ore., announced a multicenter, double-blind, randomized, placebo-controlled study of AVI-5126, a new generation of the Neugene antisense drug, for coronary vascular disease. AVI-5126 silences a gene known as c-myc, involved in cardiovascular restenosis. The study will evaluate the therapeutic benefit of exposing a saphenous vein to AVI-5126 before connecting it to the coronary artery circulation of patients undergoing coronary artery bypass grafts. Initial patient

Antisoma plc, of London, reported positive data from its Phase II trial of AS1404 in ovarian cancer, with investigators' assessments showing a response rate of 75 percent for those receiving the company's drug plus chemotherapy, compared with 63 percent for patients receiving chemotherapy alone. Those findings were presented at the International Gynecological Cancer Society meeting in Santa Monica, Calif. Phase II studies of AS1404 are ongoing in ovarian and prostate cancers, with further data

AVAX Technologies Inc., of Philadelphia, reached a special protocol assessment agreement with the FDA to begin a pivotal Phase III trial of M-Vax, its AC Vaccine technology for metastatic melanoma. The double-blind registration study will enroll up to 387 patients with Stage IV melanoma and assign them in a 2:1 ratio to M-Vax or placebo. The M-Vax arm will consist of an initial dose of M-Vax (autologous DNP-modified tumor cells) followed by cyclophosphamide and then six weekly doses of M-Vax

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

Ceregene Inc., of San Diego, said the gene therapy CERE-120 for Parkinson's disease was well tolerated and appeared to reduce symptoms by approximately 40 percent (p<0.001), as measured by the Unified Parkinson's Disease Rating Scale motor "off" score, in an open-label Phase I study in 12 patients with advanced disease. Initial results of the study were presented by William Marks, principal investigator of the study and associate professor of neurology at the University of California San

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

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

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

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

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