• Ablynx NV, of Ghent, Belgium, reported final positive results from a Phase I study of ALX-0081, an anti-thrombotic therapeutic, showing that the drug was safe and well tolerated at all doses tested in 40 healthy male volunteers, with no dose-limiting toxicities or serious adverse events. ALX-0081, a Nanobody targeting von Willebrand Factor, is in development to reduce the risk of thrombosis in patients with acute coronary syndrome and thrombotic thrombocytopenic purpura. Ablynx intends to start a multidose study in 2008.

• Auxilium Pharmaceuticals Inc., of Malvern, Pa., said it completed patient enrollment in its second U.S. Phase III pivotal trial, known as CORD I, and its Australian Phase III study, CORD II, of Xiaflex (clostridial collagenase for injection) for the treatment of Dupuytren's contracture, a condition that involves contracture of joints in the hand that impairs patients' ability to straighten and move their fingers due to a thickening and shortening of the normal ligaments of the palm and fingers. All enrolled patients have received their first injection of either Xiaflex or placebo. The primary endpoint of CORD I, a double-blind, randomized, placebo-controlled study, is to determine if Xiaflex can reduce the contracture angle of the primary joint to within 0 to 5 degrees of normal after up to three injections of the drug. Upon completion of the U.S. study, all patients are eligible to be enrolled in a separate open-label extension study in which they will receive active drug if they were initially given placebo or have the opportunity to have other affected joints treated. Data from the double-blind study and the open label extension study will form the basis of 12-month follow-up information to be used in the FDA biologics license application for marketing approval.

• Clinical Data Inc., of Newton, Mass., said it started a long-term safety study ahead of schedule for vilazodone, a treatment for depression that acts both as a selective serotonin reuptake inhibitor (SSRI) and a 5-HT1A partial agonist. The safety study, along with a second pivotal Phase III trial set to begin by March 31, is intended to support a new drug application in 2009. The firm reported in September that the drug in an earlier Phase III study of 410 patients met its primary endpoint of mean change from baseline in the Montgomery-Asberg Depression Rating Scale score compared to placebo (p=.001), and met a key secondary endpoint of the study, defined as mean change from baseline on the Hamilton Depression Rating Scale (p=.022), with a safety profile similar to marketed SSRIs.

• Collegium Pharmaceutical Inc., of Cumberland, R.I., said it received positive feedback from the FDA and plans to move forward with its proposed pivotal Phase III trial of COL 118 for allergic rhinitis. The trial is expected to start in early 2008 and will be designed to show that the combination drug COL 118 is more effective than its components, a short-acting sedating antihistamine and a longer-acting non-sedating antihistamine.

• Dynogen Pharmaceuticals Inc., of Waltham, Mass., said results from its Phase II trial of DDP225, an oral noradrenaline reuptake inhibitor and a weak 5HT3 receptor antagonist, achieved a 71 percent response rate compared with a 25 percent response rate for placebo in relief of pain or discomfort in patients with irritable bowel syndrome with diarrhea (IBS-d). Those results showed a statistically significant (p=0.009) benefit over placebo using an efficacy measure accepted by the FDA as the basis for approval for treatment of IBS-d. The Phase II trial enrolled 87 women at multiple centers in the U.S. and Canada. The company said it is on track to have four Phase III-ready programs within the next two years.

• Endo Pharmaceuticals Inc., of Chadds Ford, Pa., said a planned interim analysis of its ongoing Phase III trial of Rapinyl showed the oral, fast-dissolving fentanyl formulation met its primary endpoint of decreasing pain intensity within 30 minutes (p=0.0004) for patients with breakthrough cancer pain. All secondary endpoints also were met. Endo plans to discontinue enrollment in the double-blind, crossover portion of the trial but will continue the safety portion, as well as a second Phase III trial. The company also will evaluate the possibility of filing a new drug application based on the interim data. Endo licensed North American rights to Rapinyl from Orexo AB, of Uppsala, Sweden.

• GeneNews Ltd., of Toronto, started collecting patient samples for clinical validation studies of its ColonSentry colon cancer diagnostic. The studies are expected to begin in 2008.

• Nutra Pharma Corp., of Boca Raton, Fla., said its drug discovery arm, ReceptoPharm, successfully completed its six-month patient crossover in its Phase IIb/IIIa clinical trial of RPI-78M as a therapy for adrenomyeloneuropathy, a rare inherited metabolic disorder characterized by the loss of the fatty covering on nerve fibers within the brain and the progressive degeneration of the adrenal gland.

• Phosphagenics Ltd., of Melbourne, Australia, reported positive results of its Phase I trial showing that its delivery technology, TPM, delivered pain-relief drug oxycodone through the skin without causing disruption or irritation of any kind. Phosphagenics is developing a sustained-release oxycodone patch for the management of chronic pain. Plans are under way to conduct a pivotal study in the first half of 2008.

• SuperGen Inc., of Dublin, Calif., initiated a Phase Ib trial of MP470 in combination with several standard-of-care chemotherapy regimens. The open-label, dose-escalation study will enroll up to 105 patients. MP470 inhibits mutant forms of the kinases c-KIT, PDGFR and FLT3, while also suppressing c-MET, c-RET and the Rad51 protein.

• Vasogen Inc., of Mississauga, Ontario, said new FDA draft documents may result in the Center for Biologics Evaluation and Research (CBER) assuming the role of lead reviewer for its Celacade System, although the product likely is to continue to be considered a medical device. Vasogen is working with the FDA to finalize a protocol for its ACCLAIM-II trial focusing on NYHA Class II heart failure patients, the subgroup for which the failed Phase III ACCLAIM trial showed some benefit.