• Celgene Corp., of Summit, N.J., said preliminary results from a trial testing Revlimid (lenalidomide) in combination with low-dose dexmethasone (Decadron) in patients with newly diagnosed multiple myeloma suggests survival advantage in patients receiving that treatment regimen, as compared to those receiving Revlimid plus the higher, standard-dose of dexamethasone. Those results were reported by the Eastern Cooperative Oncology Group's Data Monitoring Committee.

• Cerimon Pharmaceuticals Inc., of South San Francisco, started enrolling patients in a Phase IIb study of basiliximab (Simulect), a monoclonal antibody designed to block the IL-2 receptor, in ulcerative colitis. The ARREST UC-1 (Achieve Remission & Reduce or Eliminate Steroid Therapy in Ulcerative Colitis) trial is expected to enroll 135 patients to evaluate safety, efficacy and pharmacokinetics of a three-dose induction regimen of basiliximab in patients with moderate to severe disease who are not responding to a standard course of oral corticosteroids. Cerimon licensed rights to the drug in February 2006 from Basel, Switzerland-based Novartis Pharma AG, which continues to market the product as Simulect in transplantation indications.

• Crucell NV, of Leiden, the Netherlands, said its rabies monoclonal antibody product began a Phase I study in India. The trial will test the compound in 44 healthy volunteers in a dose-escalation format as well as in combinations with rabies vaccines. The antibody, aimed at post-exposure prophylaxis, was designed using the company's MAbstract and PER.C6 technologies. Crucell previously began a Phase I study in the U.S.

• Icagen Inc., of Research Triangle Park, N.C., is stopping the Phase III ASSERT trial of senicapoc (formerly ICA-17043) for the treatment of sickle cell disease in adults. The move followed a recommendation from a data monitoring committee that the trial be terminated because of the low probability of achieving a reduction in crisis rate, the primary endpoint. The company said it would analyze final data when available and consider future options for development of senicapoc, an ion channel modular being developed with the McNeil Pediatrics Division of McNeil-PPC Inc., a subsidiary of Johnson & Johnson, of New Brunswick, N.J. Icagen's stock had fallen 73.6 percent to $1.12 in August on news that monitors recommended the company stop treating half the patients in the ASSERT study, focusing instead only on those receiving concurrent hydroxyurea, an antineoplastic drug used in hematological malignancies. Icagen raised $22 million in a private placement of units at $1.42 each in January. Its stock (NASDAQ:ICGN) fell 45 cents Wednesday, or 24.4 percent, to close at $1.39. (See BioWorld Today, Jan. 30, 2007, and Aug. 7, 2006.)

• Innocoll Inc., of Ashburn, Va., said the FDA approved its investigational new drug application to conduct a Phase II trial of its long-acting CollaRx bupivacaine implant product for the management of post-operative pain in patients undergoing abdominal hysterectomy. The implant is a biodegradable and fully resorbable collagen sponge containing the anesthetic bupivacaine, formulated with Innocoll's CollaRx technology. The three-armed trial will compare the analgesic effect of the bupivacaine implant vs. a placebo implant and the current standard of care.

• Novagali Pharma SA, of Evry, France, disclosed positive results from a Phase III trial of Phase III study of Vekacia in children suffering from the orphan disease vernal keratoconjunctivitis. Data showed that both symptoms and signs of disease improved in patients taking Vekacia, a topical cyclosporine A cationic emulsion. VKC is a severe form of chronic allergic conjunctivitis. Novagali said it plans to file in mid-2007 an application seeking approval in Europe.

• Eurand International SpA, of Milan, Italy, disclosed positive data from two Phase III trials of Zentase (formerly EUR-1008) for treating exocrine pancreatic insufficiency, a deficiency of digestive enzymes normally produced by the pancreas. The trials met all primary and secondary endpoints, which were designed to determine whether the drug could alleviate serious malabsorption associated with EPI in both pediatric and older patients. Zentase is a porcine-derived pancreatic enzyme replacement therapy. Eurand said it intends to file for FDA approval of the product this quarter.

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