• Acambis plc, of Cambridge, UK, initiated a Phase I trial of its universal influenza vaccine candidate, ACAM-FLU-A. The vaccine is designed to target all A strains of the influenza virus. The randomized, double-blind, placebo-controlled study in the U.S. is investigating safety, tolerability and its ability to generate an immune response. The trial in up to 80 healthy subjects ages 18 to 40 also will assess two adjuvants to determine whether they improve the effect of the vaccine on the immune system. The recombinant vaccine uses a hepatitis B core protein to present M2e, the extracellular domain of the influenza ion channel protein M2, to the immune system.

• BioCryst Pharmaceuticals Inc., of Birmingham, Ala., initiated a Phase II trial in hospitalized patients using an intravenous formulation of peramivir, its lead influenza neuraminidase inhibitor. The study, to enroll patients during the upcoming flu seasons, will compare the drug's safety and efficacy to orally administered oseltamivir (Tamiflu) in patients who require hospitalization due to acute influenza. BioCryst also is conducting a separate Phase II trial using an intramuscular formulation of peramivir in individuals with influenza in the outpatient setting. Peramivir is being developed under a four-year, $102.6 million Department of Health and Human Services contract, which was awarded to BioCryst in January. (See BioWorld Today, Jan. 5, 2007.)

• BioMS Medical Corp., of Edmonton, Alberta, said an independent data safety monitoring board for the company's Phase II MINDSET-01 trial of MBP8298 in patients with relapsing-remitting multiple sclerosis completed a safety analysis and recommended that the trial continue as per the protocol. Further reviews by the DSMB are expected to occur over the course of the trial. The 15-month study is fully enrolled with about 215 patients, and its objectives are to demonstrate safety and efficacy of MBP8298 vs. placebo as measured by relapse rate, MRI activity and disease progression.

• EntreMed Inc., of Rockville, Md., started a Canadian Phase I study of MKC-1 in leukemia patients following clearance of a clinical trial application by Health Canada. MKC-1, an oral, cell-cycle inhibitor, demonstrated in preclinical studies an ability to inhibit growth of primary cells derived from acute and chronic myelogenous leukemia and also was shown to inhibit P13-kinase and mTOR pathways by inducing a dose-dependent reduction in the levels of the activated forms of the oncogenic kinases Akt and p70S6K. The drug is in two Phase II studies in breast cancer and non-small-cell lung cancer in the U.S., and additional studies in ovarian and pancreatic cancers are planned for later in the year.

• Icagen Inc., of Research Triangle Park, N.C., filed an investigational new drug application for ICA-105665, a small-molecule compound for epilepsy. An activator of subtypes of KCNQ ion channels, the drug demonstrated in preclinical studies efficacy in treating partial seizures, generalized seizures and treatment-resistant seizures. Icagen intends to develop ICA-105665 as a chronic therapy, and upon acceptance of the IND, will start a Phase I study in the third quarter in healthy male volunteers.

• Protalex Inc., of New Hope, Pa., completed dosing in its expanded single-dose Phase I trial in healthy volunteers of PRTX-100, its lead compound for inflammatory disease. The study is designed primarily to increase the safety database for doses of 0.3 mcg/kg and 0.45 mcg/kg of intravenously administered drug. Other objectives of the study were to better characterize the terminal clearance at higher doses, to evaluate a dose of 50 percent higher than that dosed in the initial Phase I study, to evaluate several additional safety biomarkers such as platelet function and to evaluate changes in monocyte and lymphocyte gene expression following PRTX-100 treatment.

• Theregen Inc., of San Francisco, announced a second Phase I trial of its Anginera cell-based cardiovascular heart patch, a study in adult patients suffering from heart disease. Surgeons successfully placed study patches, including Anginera, on the surface of diseased hearts of patients suffering from Stage D heart failure. Each patient also received an implanted left ventricular assist device while waiting for a donated heart. When the study patients later receive a transplanted heart, their removed, diseased heart will be analyzed to determine the effect of Anginera on heart tissue. The Anginera patch contains human fibroblast cells that secrete biochemical factors essential to forming blood vessels and aiding in tissue repair, Theregen said. A Phase I safety study of Anginera as an adjunct therapy in patients undergoing coronary artery bypass graft surgery was initiated in May 2006.