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

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

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

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

The move to the clinic triggers a $2 million milestone payment from Paris-based Sanofi-Aventis SA, which licensed the compound as part of a broad collaboration agreement to discovery, develop and commercialize cancer drugs using ImmunoGen's antibody expertise and its Tumor-Activated Prodrug technology

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

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