• Amarillo Biosciences Inc., of Amarillo, Texas, said Taiwan-based CytoPharm Inc., its partner in Taiwan and China, engaged a clinical research organization for a clinical trial in 152 chronic hepatitis C patients. The patients will receive one of three doses of oral human interferon alpha or placebo. The patients must have failed to respond to injectable interferon, or relapsed after initially responding. The trial is expected to start in the fourth quarter. In addition to studies on hepatitis C, CytoPharm plans to test oral interferon in patients with chronic active hepatitis B patients and influenza.

• Cytheris SA, of Paris, said it will start two Phase I/IIa trials of its CYT107 recombinant interleukin in hepatitis C and oncology, with the aim of confirming IL-7's potential in building immune system response. The hepatitis C trial will involve 12 to 18 HCV-infected patients who are nonresponders to standard treatment of PEG-interferon and ribavirin. Those patients will receive CYT107 injected weekly over four weeks in addition to the standard treatment. The oncology trial will target 18 to 30 patients with metastatic melanoma or advanced renal-cell carcinoma and will be designed as a dose-escalation study.

• Discovery Laboratories Inc., of Warrington, Pa., said one-year follow-up results from its SELECT and STAR Phase III trials of Surfaxin were published in Pediatrics. The long-term data from the trials concluded that Surfaxin demonstrated a statistically significant survival advantage in premature infants with respiratory distress syndrome, relative to the existing animal-derived surfactants Survanta and Curosurf, Discovery said. The FDA has issued an approvable letter on Surfaxin for the prevention of RDS in premature infants.

• Kamada Ltd., of Ness Ziona, Israel, and PARI Pharma GmbH, of Munich, Germany, reported positive data from the first of two stages of the Phase I trial of Kamada's alpha-1 antitrypsin liquid drug candidate for inhalation delivered with PARI's eFlow electronic nebulizer. It is being developed for treatment of AAT deficiency. Results showed favorable safety and tolerability profiles. They plan to continue development of aerosolized AAT delivered with an optimized eFlow device.

• LifeCycle Pharma A/S, of Horsholm, Denmark, reported positive Phase I results showing that LCP-Tacro, a once-daily tacrolimus tablet, delivers consistently higher bioavailability of about 50 percent compared to Prograf and reduces peak levels as well as peak/trough fluctuation compared to Prograf. The specialty pharmaceutical company next plans to advance its product into Phase II trials for organ transplantation.

• Medicure Inc., of Winnipeg, Manitoba, said results from its Phase II MEND-CABG trial outlines evidence of MC-1's potential efficacy in reducing ischemic reperfusion injury. Data from a post hoc analysis demonstrated a statistically significant lower incidence of atrial fibrillation in the MC-1 groups compared to placebo between postoperative day four and the end of the trial. Those results were published in the Journal of Thoracic and Cardiovascular Surgery. The 901-patient MEND-CABG trial, which was completed in 2006, demonstrated a 37.2 percent reduction in the composite of cardiovascular death, nonfatal myocardial infarction and nonfatal stroke in patients receiving the 250-mg dose of MC-1 vs. placebo. An ongoing Phase III study, the MEND-CABG II, is ongoing.

• OxiGene Inc., of Waltham, Mass., reached an agreement with the FDA on a special protocol assessment for a Phase II/III pivotal trial of its potential first-in-class vascular-disrupting agent, Zybrestat (combretastatin-A4 phosphate/CA4P), in anaplastic thyroid cancer (ATC). The trial is expected to begin this month. It will be a randomized, controlled study expected to enroll about 180 patients with ATC, two-thirds of whom will receive intravenous Zybrestat plus carboplatin and paclitaxel; the rest will receive carboplatin and paclitaxel alone. The primary endpoint is the overall survival, as determined by a log-rank analysis of Kaplan-Meier survival curves. The design incorporates an interim analysis for efficacy and safety. About 45 clinical trial sites worldwide are expected to participate in the study.

• Peregrine Pharmaceuticals Inc., of Tustin, Calif., reported positive top-line results of its Phase Ib trial of bavituximab in combination with chemotherapy in advanced cancer patients with metastatic disease who had failed prior therapy. Data showed that 50 percent of all evaluable patients receiving bavituximab plus chemotherapy achieved objective tumor response or stable disease, and that 75 percent receiving the combination of bavituximab plus gemcitabine chemotherapy achieved objective tumor response or stable disease. Those results are being further analyzed to support the initiation of Phase II trials in cancer later this year. Bavituximab, a monoclonal antibody designed to target and bind to phosphatidylserine, is in additional trials in solid tumors and as a treatment for hepatitis C infection in patients co-infected with HIV.

• Serenex Inc., of Durham, N.C., initiated a Phase I trial of SNX-5422, a heat-shock protein 90 inhibitor designed as an orally administered small molecule using the company's chemoproteomics technology platform. The dose-escalating study is expected to involve up to 50 patients and will evaluate safety, pharmacokinetics and pharmacodynamics. SNX-5422 is in development for cancer, and has demonstrated in preclinical tumor models efficacy as both a single agent and in combination with other cancer therapies.

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