• Molecular Insight Pharmaceuticals Inc., of Cambridge, Mass., disclosed results of a study designed to develop and validate its Zemiva Normals reference database using gender-based and cardiac ischemia risk stratification parameters. Results indicated that the database accurately differentiated normal from abnormal metabolic heart activity in patients dosed with Zemiva. The database is designed to enable interpreting physicians to rapidly and quantitatively assess a patient's cardiac image against normal images. Zemiva (iodofiltic acid I 123 or BMIPP) is a molecular imaging pharmaceutical in development for the diagnosis of cardiac ischemia. Data were presented in a poster presentation at the annual meeting of the American Society of Nuclear Cardiology in San Diego.

• OSI Pharmaceuticals Inc., of Melville, N.Y., presented data from more than 58 studies with Tarceva (erlotinib), approved for non-small-cell lung cancer, at the 12th World Congress on Lung Cancer in Seoul, Korea. The studies reinforced the role that Tarceva may have across a broad range of patients with NSCLC, including its investigational use as a first-line treatment and at a higher dose in current smokers, the company said. One study suggested that a higher dose of Tarceva may improve drug exposure for lung cancer patients who continue to smoke, and data will be submitted to the FDA for consideration in the label.

• Protox Therapeutics Inc., of Vancouver, British Columbia, presented interim data from the recently completed Phase I study testing PRX302 in patients with locally recurrent prostate cancer following radiation failure. Results offered at at the American Urological Association South Central Section meeting in Colorado Springs, Colo., showed the drug is safe and well tolerated, with encouraging signs of therapeutic activity, the company said. PRX302 is rationally designed to kill prostate cancer and hyperplastic cells that overproduce the enzyme prostate specific antigen.

• Spectrum Pharmaceuticals Inc., of Irvine, Calif., began enrolling patients into its second and final pivotal Phase III trial of EOquin (apaziquone for intravesical instillation) for noninvasive bladder cancer. The primary endpoint is the difference in the rate of tumor recurrence after two years. The double-blind, placebo-controlled, randomized, 562-patient trial was reviewed under a special protocol assessment with the FDA, as was the first pivotal Phase III trial, which was initiated in May. (See BioWorld Today, March 14, 2007.)

• ThromboGenics NV, of Leuven, Belgium, and BioInvent International AB, of Lund, Sweden, completed enrollment and initial follow-up of all 56 patients in a randomized, placebo-controlled, dose-escalation Phase I trial of TB-402 for venous thromboembolic disorders. Initial data showed TB-402, an antibody that binds Factor VIII, was well tolerated and met its efficacy endpoints. Final data are anticipated in late 2007, and a Phase II trial is planned for the first half of 2008.