Advaxis Inc., of North Brunswick, N.J., completed enrolling and dosing the first cohort of patients diagnosed with advanced, recurrent or progressive cervical cancer in its Phase I/II trial of Lovaxin C. Review by an independent safety panel found that this first assessment of a modified Listeria-based live vaccine was safe. Dose escalation is ongoing, and the primary endpoint is to establish a maximum safe dose. Biopure Corp., of Cambridge, Mass., said an independent data and safety

Accentia Biopharmaceuticals Inc., of Tampa, Fla., said it will begin patient enrollment this month for Phase III of SinuNase (intranasal lavage of 0.01% amphotericin B), which has received fast-track status from the FDA, for severe chronic sinusitis refractory to sinus surgery. The trial is to be a 16-week, double-blind comparison with 300 patients randomized between SinuNase and placebo, with the primary endpoint of resolution of key symptoms of chronic sinusitis. Allos Therapeutics Inc., of

Inspire Pharmaceuticals Inc., of Durham, N.C., reported results of a 28-day Phase II study of denufosol inhalation solution in cystic fibrosis patients, ages 5 to 7, showing that both the 20-mg and 60-mg doses of the drug given three times daily were well tolerated, with a safety profile similar to placebo. Data were presented at the 2006 North American Cystic Fibrosis Conference in Denver. Inspire has initiated the first of two planned Phase III trials to evaluate 60 mg of denufosol vs

Ariad Pharmaceuticals Inc., of Cambridge, Mass., reported additional positive efficacy data on AP23573, an mTOR inhibitor, from further analysis of its ongoing Phase II trial in metastatic and/or unresectable bone and soft-tissue sarcomas. Sixty-one patients in the 212-patient trial who had clinical-benefit response with AP23573 - defined as tumor regression or disease stabilization - had a progression-free survival rate at six months of 70 percent, which nearly tripled that of the overall

Cellgate Inc., of Redwood City, Calif., began a Phase II trial of its lead compound, CGC-11047, in metastatic hormone refractory prostate cancer. It will enroll 40 patients who have not yet received prior chemotherapy, and its primary endpoint is efficacy based on prostate specific antigen response. Safety, tolerability and time to progression also will be evaluated. CGC-11047, a polyamine analogue designed to halt cell growth and induce apoptosis, will be administered as a single-agent in once

Array BioPharma Inc., of Boulder, Colo., filed an investigational new drug application for ARRY-797, a selective, orally active inhibitor of p38 MAP kinase. The compound initially will be evaluated in dose-escalation studies in healthy volunteers for safety, exposure and inhibition of mechanism-related biomarkers. Pending positive results, it likely would be tested in patients with inflammatory diseases. Avantogen Oncology Inc., of Los Angeles, said the FDA accepted its investigational new

Adherex Technologies Inc., of Research Triangle Park, N.C., entered an agreement with the International Childhood Liver Tumor Strategy Group, a multidisciplinary group of specialists under the umbrella of the International Society of Pediatric Oncology, to conduct a Phase III trial of Adherex's sodium thiosulfate (STS) to reduce or prevent hearing loss in children associated with platinum-based chemotherapies. The randomized study, which is expected to begin early next year, will enroll about

Dendreon Corp., of Seattle, said data from an exploratory analysis of Phase III studies D9901 and D9902A showed a significant correlation between cumulative CD54 up-regulation and survival for patients treated with Provenge (sipuleucel-T), the company's cellular immunotherapy for men with advanced androgen-dependent prostate cancer. Data were presented at the International Society for Biological Therapy of Cancer annual meeting in Los Angeles. Dendreon has submitted two portions of a rolling

CuraGen Corp., of Branford, Conn., and TopoTarget A/S, of Copenhagen, Denmark, reported encouraging preliminary results from three clinical trials of intravenous PXD101. Phase Ib data showed two partial objective responses in patients with advanced, refractory cancer and stable disease in three other patients lasting greater than 10 cycles of treatment in a study of PXD101 in combination with paclitaxel and carboplatin. Phase II results showed nine patients receiving PXD101 monotherapy achieved

Adenosine Therapeutics LLC, of Charlottesville, Va., initiated a two-part Phase Ib study in humans to evaluate apadenoson (ATL146e), a selective adenosine A2A agonist, as an anti-inflammatory agent. The study is designed to establish the drug's safety, demonstrate anti-inflammatory effectiveness in humans and determine the optimal dose. The results will serve as the foundation for multiple Phase II clinical trials involving acute inflammation. Amylin Pharmaceuticals Inc., of San Diego, said

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

KeyNeurotek AG, of Magdeburg, Germany, initiated a European Phase II trial of KN 38-7271, a cannabinoid receptor agonist, in traumatic brain injury patients. The study is expected to involve more than 100 patients and is designed to demonstrate tolerability and efficacy of the drug. Neurologix Inc., of Ft. Lee, N.J., finished a Phase I trial of its gene therapy for Parkinson's disease, with statistically significant results. The trial confirmed the safety and tolerability in all 12 patients

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

Advanced Life Sciences Holdings Inc., of Woodbridge, Ill., reported data at the Infectious Disease Society of America meeting in Toronto comparing the safety and efficacy of cethromycin at varying doses for the treatment of acute bacterial sinusitis. In one study, the clinical and bacteriological cure rates generally were greater in the 300-mg QD group than in both the 150-mg and 600-mg QD groups. Findings from another study, combined with previous clinical trials for community-acquired

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