Clinical Data Inc. began enrolling patients in a pivotal Phase III study of vilazodone, a dual serotonergic compound aimed at treating depression.

The double-blind, placebo-controlled trial is expected to evaluate the safety and efficacy of the drug in about 400 adult patients diagnosed with major depressive disorder. Individual patient data also will be analyzed to discover genetic markers for response to vilazodone to determine a patient population most likely to respond.

The Newton, Mass.-based company anticipates initial study results by the middle of 2007 and said at least one long-term safety study and an additional pivotal study likely will be required before it can submit a new drug application.

Vilazodone is designed to work both as a selective serotonin reuptake inhibitor and as a 5Ht1A partial agonist. It previously has been tested in 15 Phase I trials and five Phase II trials involving a total of 369 healthy subjects and 1,163 patients suffering from depression. In earlier trials with positive controls, the drug failed to demonstrate significant efficacy against placebo, but demonstrated efficacy comparable to that of the positive controls.

Clinical Data gained the right to vilazodone when it acquired New Haven, Conn.-based Genaissance Pharmaceuticals Inc. last June in an all-stock transaction valued at about $56 million. Genaissance previously licensed the drug from Darmstadt, Germany-based Merck KGaA in September 2004. (See BioWorld Today, June 22, 2005.)

Shares of Clinical Data (NASDAQ:CLDA) closed at $20.10 Thursday, up 50 cents.

In other clinic news:

• Aspreva Pharmaceuticals Corp., of Victoria, British Columbia, completed patient enrollment in a Phase III study designed to assess the safety and efficacy of CellCept (mycophenolate mofetil) in association with corticosteroids to achieve remission in patients with active pemphigus vulgaris. The 77-patient study is investigating the drug’s safety and efficacy over a treatment period of 52 weeks, with a primary endpoint encompassing both minimal disease activity defined as no new persistent lesions, with a low steroid dose. Aspreva expects to complete the study in 2007.

• Humanetics Corp., of Minneapolis, said the FDA approved the start of clinical trials for the company’s oral compound, NIC5-15, aimed at combating Alzheimer’s disease. The Phase I and Phase II studies will be conducted by the Humanetics' collaborator, Mount Sinai School of Medicine in New York, and are expected to measure safety, dosing, efficacy and biomarkers for Alzheimers’s disease.

• Pro-Pharmaceuticals Inc., of Newton, Mass., completed patient enrollment in Stage I of its Simon Two-Stage-designed Phase II trial for third- and fourth-line treatment of colorectal cancer patients. In the study, patients with colon cancer that spread despite treatment with approved therapies are receiving Davanta plus 5-FU in monthly cycles for at least two cycles or until their disease progresses. The study is aimed at evaluating the ability of Davanta, a polysaccharide polymer comprising mannose and glactose carbohydrates in a carbosome formation, plus 5-FU to shrink tumors or prevent further growth. Pro-Pharmaceuticals expects to report preliminary results in the second quarter.

• PTC Therapeutics Inc., of South Plainfield, N.J., was granted fast-track designation for development of PTC124 to treat Duchenne’s muscular dystrophy due to a nonsense mutation in the dystrophin gene. The drug previously received orphan drug designation in that indication. PTC124 is in Phase II trials in DMD, as well as in Phase II studies in patients with cystic fibrosis due to a nonsense mutation. Those trials are expected to wrap up in the second half of this year.

• ViroPharma Inc., of Exton, Pa., reported positive preliminary results from a 111-patient Phase II study of maribavir, an oral antiviral drug aimed at inhibiting cytomegalovirus reactivation in transplant patients. Data demonstrated that prophylaxis with maribavir displays strong antiviral activity, as measured by significant reduction in the rate of reactivation of CMV in recipients of allogeneic stem cell transplants. Results also showed that administration of maribavir for up to 12 weeks had a favorable tolerability profile. ViroPharma said it plans to meet with the FDA to reach an agreement on a Phase III program, with the goal of initiating a study in allogeneic stem cell transplant patients around mid-year, followed by an additional Phase III study in solid-organ transplant patients by the end of 2006. Maribavir, from a class of drugs called benzimidazole ribosides, is designed to inhibit viral DNA assembly and also inhibit egress of viral capsids from the nucleus of infected cells. Shares of ViroPharma jumped nearly 9 percent on the results, and the stock (NASDAQ:VPHM) closed at $12.79 Thursday, up $1.10.