• Histogenics Corp., of Waltham, Mass., reported positive Phase II data for its NeoCart autologous cartilage tissue implant. The study compared NeoCart with microfracture for knee cartilage injury treatment at two years postoperation. NeoCart was associated with statistically significant improvements in knee and general health outcomes scores by six months, at the primary endpoint of 12 months and at two years. The implant is now in Phase III under a special protocol assessment. The data were presented at the American Orthopaedic Society for Sports Medicine annual meeting.

• Ipsen SA, of Paris, said its partner Inspiration Biopharmaceuticals Inc., of Laguna Niguel, Calif., presented results from its clinical development program for OBI-1, an intravenous recombinant porcine factor VIII product. Interim results from the first registration study in the Accur8 program showed OBI-1 stopped the bleeding in all three patients with acquired hemophilia who had experienced severe bleeds not controlled with by-passing agents. A second Phase III study in individuals with congenital hemophilia A who have developed inhibitors against factor VIII is set to begin later this year. The data were presented in a scientific session held in conjunction with the 23rd Congress of the International Society on Thrombosis and Haemostasis.

• Lexicon Pharmaceuticals Inc., of The Woodlands, Texas, completed a Phase I trial of LX1033, an oral small-molecule drug candidate for diarrhea-predominant irritable bowel syndrome. Top-line results showed that LX1033 was well tolerated at all doses and produced a statistically significant reduction in serotonin synthesis compared with placebo, as measured by both plasma and urinary 5-hydroxyindoleacetic acid. LX1033 is designed to act locally in the gastrointestinal tract by reducing the serotonin available for receptor activation, without affecting serotonin levels in the brain.

• Polaris Group, of San Diego, dosed the first patient in a pivotal Phase III trial evaluating ADI-PEG 20 (pegylated arginine deiminase) in patients with hepatocellular carcinoma, or primary liver cancer. The randomized, double-blind, placebo-controlled, global study will enroll more than 600 patients who have failed prior systemic therapy. Subjects will receive weekly intramuscular injections of ADI-PEG 20 until disease progression. The trial is being conducted under a special protocol assessment. (See BioWorld Today, April 1, 2011.)

• RegeneRx Biopharmaceuticals Inc., of Rockville, Md., is ready to begin a Phase II trial in 72 patients with dry eye syndrome. Enrollment will begin on Aug. 13, and preliminary data should be available by October. The double-masked, placebo-controlled trial is testing the safety and efficacy of its RGN-259 against placebo.