• Cytokinetics Inc., of South San Francisco, said the National Cancer Institute initiated a Phase II trial of ispinesib, a kinesin spindle protein inhibitor, as a second-line treatment for patients with renal-cell cancer. That study will enroll between 18 and 35 patients and will measure response rate as determined by the Response Evaluation Criteria in Solid Tumors (RECIST) as the primary endpoint. The NCI also started a Phase I trial to evaluate ispinesib as a monotherapy in about 30 pediatric patients with relapsed or refractory solid tumors.

• EpiCept Corp., of Tarrytown, N.Y., initiated a Phase I study of EPC2407, a novel small-molecule vascular disruption agent and apoptosis inducer for patients with advanced solid tumors, such as those in the lung, gastrointestinal tract, ovaries and breast, and lymphomas. EPC2407 is the first in a class of microtubulin inhibitors discovered by EpiCept. The compounds cause caspase activation, cell-cycle arrest and apoptic death in cancer cells. The trial is being conducted in two U.S. cancer centers and will administer increasing doses to small groups in about 30 patients. The primary objectives of the study are to determine the safe doses and blood concentrations of the drug. The trial is expected to last one year.

• Gilead Sciences Inc., of Foster City, Calif., said its Phase III AIR-CF2 study of aztreonam lysine for inhalation met its primary endpoint in cystic fibrosis patients who have pulmonary Pseudomonas aeruginosa. Data from the 247-patient trial demonstrated a significant improvement in time to need for inhaled or I.V. antibiotics after a 28-day treatment course of aztreonam lysine compared to placebo, both following a 28-day treatment course of tobramycin inhalation solution. Following an overall study period of 126 days, patients were eligible for enter an open-label follow-up study, which is ongoing.

• Metabolex Inc., of Hayward, Calif., started a Phase IIa proof-of-concept trial of MBX-2044, an oral insulin sensitizer for Type II diabetes. MBX-2044 is the follow-on compound to metaglidasen (MBX-102), a selective PPAR modulator that is in a 400-patient Phase II/III study. Metabolex licensed development and commercialization of both MBX-2044 and metaglidasen in June to Ortho-McNeil Inc., a unit of New Brunswick, N.J.-based Johnson & Johnson. (See BioWorld Today, June 27, 2006.)

• Neurocrine Biosciences Inc., of San Diego, said that through its collaboration with GlaxoSmithKline plc, of London, GSK has started Phase II proof-of-concept trials with a corticotropin releasing factor R1 (CRF1) receptor antagonist compound for social anxiety disorder and in irritable bowel syndrome, resulting in a $8 million milestone payment from GSK. The social anxiety disorder trial is a double-blind, randomized, placebo-controlled, multiple-dose study with more than 200 adults assessing efficacy, safety, tolerability and pharmacokinetics using the Leeds Situational Anxiety Scale and the Social Avoidance and Distress Scale and the Sheehan Disability Scale. The IBS trial is a double-blind, randomized, placebo-controlled study with about 100 patients evaluating efficacy, safety, tolerability and pharmacokinetics. The clinical endpoints reflect change in symptom frequency and severity via validated IBS scales.

• Neurogen Corp., of Branford, Conn., began a Phase II trial of its insomnia agent, NG2-73, in patients with chronic insomnia. As many as 36 patients, up to age 64, are expected to participate in the trial. The study will measure sleep maintenance and onset across a range of doses and formulations. The trial is part of two studies designed to measure sleep maintenance and onset.

• Neurorecovery Inc., of Memphis, Tenn., said its 4-Aminopyridine received orphan drug status for chronic functional motor and sensory deficits resulting from Guillain-Barre syndrome. That designation would ensure seven years of marketing exclusivity in the U.S. upon FDA approval. Neurorecovery's lead product, Ampydin, an immediate-release oral version of 4-Aminopyridine, is moving into a Phase III trial.

• Replidyne Inc., of Louisville, Colo., completed enrollment for a Phase II trial of faropenem medoxomil in pediatric acute otitis media (AOM). The study of more than 300 children will evaluate different treatment doses of the oral liquid antibiotic from the penem subclass of the beta-lactam class of antibiotics for bacteriologic outcomes, as well as compiling pharmacokinetic, safety and clinical outcome data. Results are expected by the end of the first quarter.

• Repros Therapeutics Inc., of The Woodlands, Texas, said interim results of a U.S. Phase III trial of Androxal, an oral drug for testosterone deficiency in men with secondary hypogonadism, suggested that treatment with the drug results in a statistically significant increase in mean testosterone and demonstrated non-inferiority for all parameters compared to Androgel (Solvay Pharmaceuticals Inc.). The double-blind study is comparing 12.5-mg and 25-mg doses to both placebo and open-label Androgel, which is dosed according to physician instructions. Testosterone levels and measures of libido and distress are assessed. To date, 112 patients have completed 12 weeks of treatment. Men treated with 12.5 mg of Androxal showed an increase in mean testosterone of 21 ng/dl (p value<0.0001) over baseline; patients with 25 mg showed an increase of 241 ng/dl (p value<0.0001) over baseline; and men treated with Androgel, at any dose, showed an increase of 167 ng/dl (p value<0.0002) over baseline. Those who received placebo showed no significant change. Men treated with either Androxal or Androgel reported no changes in measures of libido or distress.

• Seattle Genetics Inc., of Bothell, Wash., initiated a Phase II trial of SGN-40 in patients with diffuse large B-cell lymphoma. The single-agent study is expected to enroll up to 40 patients and will assess the antitumor activity, tolerability and pharmacokinetic profile of SGN-40, a humanized monoclonal antibody that targets the CD40 antigen. The drug also is in Phase I trials for relapsed/refractory multiple myeloma and chronic lymphocytic leukemia, and Seattle Genetics anticipates combination studies in non-Hodgkin's lymphoma and multiple myeloma to begin in 2007.

• SIGA Technologies Inc., of New York, received orphan drug designation for SIGA-246, its smallpox drug, which could guarantee seven years of marketing exclusivity in the U.S. upon approval. SIGA-246, which demonstrated 100 percent protection against human smallpox virus in a primate trial, as reported in October, previously received fast-track status. (See BioWorld Today, Oct. 19, 2006.)

• ZymoGenetics Inc., of Seattle, and Serono SA, of Geneva, started a Phase II trial to evaluate atacicept therapy in patients with rheumatoid arthritis. The randomized, double-blind study will investigate the efficacy of atacicept in patients with an inadequate response to prior treatment with TNF inhibitors. The study will enroll 320 patients who have had active rheumatoid arthritis for more than one year and who have had an inadequate response to at least three months of TNF inhibitor therapy. In addition, the trial will measure the safety, tolerability and pharmacologic profile of atacicept. Results of the study are anticipated in mid-2007.

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