Dynavax Technologies Corp., of Berkeley, Calif., started a Phase I dose-escalation trial with its TLR9 agonist in combination with a standard chemotherapeutic regimen for metastatic colorectal cancer. The enrollment target of the trial is 15 patients, all of whom will have been previously treated for colorectal cancer but had a recurrence of the disease. The trial, which will be conducted at three centers in the U.S., is designed to identify the optimum dose and to yield safety and tolerability

4SC AG, of Martinsried, Germany, started a Phase IIa study with SC12267 for rheumatoid arthritis. The 120-patient study will take place at 12 centers in Germany, Poland and Serbia. The application process for Serbia and Poland still is under authority review. SC12267 is a new type of small-molecular active agent from the class of disease-modifying anti-rheumatic drugs, and works as a selective inhibitor in the biosynthesis of pyrimidine, which inhibits the proliferation of fast proliferating

Arpida Ltd., of Basel, Switzerland, reported positive results from its first Phase III trial of iclaprim, showing that the primary efficacy endpoint of statistical noninferiority compared to Zyvox (linezolid, Pfizer Inc.) in the clinical cure rate at the test-of-cure visit in patients with skin and skin structure infections. Data from the ASSIST-1 study showed that the overall clinical cure rates for the intent-to-treat population of 497 patients were 85.5 percent and 91.9 percent iclaprim and

Alnylam Pharmaceuticals Inc., of Cambridge, Mass., initiated a human experimental infection study with respiratory syncytial virus designed to establish a safe and reliable RSV infection of the upper respiratory tract in adult volunteers. Upon determination of the optimal level of RSV inoculum, the company plans to begin a subsequent clinical protocol to test the antiviral activity of ALN-RSV01, an RNAi therapeutic. About 40 subjects are expected to be enrolled in the study. Alnylam also is

Biothera, of Eagan, Minn., initiated a Phase I/II trial of Imprime PGG in combination with G-CSF for mobilization of bone marrow stem cells into the peripheral blood in normal human subjects. The study's objective is to determine whether that combination is better than G-CSF alone for enhancing stem cell mobilization. Biothera anticipates completing the enrollment of 56 subjects by the end of the year. Dyax Corp., of Cambridge, Mass., completed the double-blind portion of its pivotal Phase

Aegerion Pharmaceuticals Inc., of Bridgewater, N.J., said interim results from an ongoing Phase II trial of its cholesterol management compound, AEGR-733, in combination with Zetia (ezetimibe, Schering-Plough Corp.), show that patients receiving both achieved an LDL reduction of 35 percent after four weeks. Patients treated with Zetia alone achieved a 20 percent reduction. As a monotherapy, AEGR 733 was found to reduce mean LDL-C 19 percent and 28 percent in patients who received the 5-mg dose

Advanced Viral Research Corp., of Yonkers, N.Y., filed an amendment with the FDA to its existing investigational new drug application to expand the use of its product, AVR118, to include topical and intralesional therapy, which could be used in treating dermatologic conditions. AVR118 is a cytoprotective agent in development for cachexia-related disorders and has shown topical wound healing properties in animal models. Dyax Corp., of Cambridge, Mass., said findings from its 77-patient EDEMA2

Allos Therapeutics Inc., of Westminster, Colo., said Phase II data reported at the American Society for Therapeutic Radiology and Oncology meeting in Philadelphia showed that Efaproxyn (efaproxiral) produced superior survival in patients with unresectable non-small-cell lung cancer receiving sequential chemoradiotherapy compared to those with similar characteristics in another trial, the Radiation Therapy Oncology Group (RTOG) 94-10 study. Specifically, median survival of Efaproxyn patients was

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

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

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

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

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