CHELSEA, Mass.--(BUSINESS WIRE)-- Civitas Therapeutics, Inc., a privately-held pharmaceutical company developing transformative therapeutics using the ARCUS(TM) respiratory delivery platform, today announced positive topline results from a Phase 2 clinical trial of CVT-301, an inhaled formulation of levodopa (L-dopa). CVT-301 is being developed as an adjunct therapy to provide rapid and reliable relief from intermittent debilitating motor fluctuations (OFF episodes) that impact a large proportion of Parkinsons disease patients. The study used a randomized, placebo-controlled design to evaluate L-dopa pharmacokinetics and pharmacodynamic effects following administration of CVT-301 to Parkinsons disease patients experiencing motor fluctuations. Administering CVT-301 to patients in the OFF state produced a rapid and durable improvement in motor function. The pharmacokinetic data recapitulated the Phase 1 study results showing CVT-301 provided immediate L-dopa absorption and consistent increases in plasma concentrations in marked contrast to the delayed and variable L-dopa levels seen with Sinemet (oral L-dopa/carbidopa). All doses of CVT-301 were safe and well tolerated with no increase in the frequency or severity of dyskinesias relative to oral. Civitas plans to present the comprehensive data from the study at a future scientific meeting. The unpredictable wearing off of oral L-dopa and the dyskinetic side effects are among the most significant … Continue reading →

Janice Seabrooks, left, helps Tony Greco of West Manchester Township stretch during an exercise class for people who have Parkinson's disease at HealthSouth. Jennifer Harlacher, a senior therapist there, said fear of falling, embarrassment and depression sometimes prevent people from staying active after they've been diagnosed. ( DAILY RECORD/SUNDAY NEWS - KATE PENN) York, PA - While sitting in his wheelchair, Dale McCoy faced his son Craig in the family's Hellam Township living room. "Hands out," Craig McCoy said while demonstrating the movements. "Down to the floor." With wide, concentrated eyes and slow stiff movements, Dale McCoy, 81, extended his arms in front of his body, bent at his waist and lowered his hands to the floor. While still in his wheelchair, he returned his torso to an upright position. Craig McCoy asked his dad to do it again. Dale McCoy has Parkinson's disease, a progressive nervous system disorder that affects movement. The stretching exercise is one of many he does to help retain his mobility. In recent years, experts have started encouraging Parkinson's patients to move more because studies have shown that regular physical activity can improve their quality of life. Jennifer Harlacher, senior therapist for HealthSouth Rehabilitation Hospital … Continue reading →

SAN DIEGO, April 19, 2013 /PRNewswire/ -- Ceregene, Inc. today announced the top-line data from its double-blind, randomized, controlled Phase 2b clinical study of CERE-120 (AAV-neurturin), a gene therapy product designed to deliver the neurotrophic factor neurturin, for Parkinson's disease. The trial did not demonstrate statistically significant efficacy on the primary endpoint (UPDRS-motor off). However, one of the "key secondary endpoints" (Diary-off score), as defined and prespecified in the Statistical Analysis Plan, did produce statistically significant benefit. The trial also provided further evidence for the safety of CERE-120 and the dosing methods employed. A marked placebo effect was observed in this trial in that both the sham-surgery-control patients and the CERE-120 treated patients showed significant improvement following their surgery. Fifty-one (51) patients with moderately advanced Parkinson's disease who could not be satisfactorily controlled with conventional Parkinson's medication were enrolled in the study at 11 leading clinical sites throughout the U.S. Approximately half of the patients received CERE-120 while the other half received sham (placebo) surgery as a control. Patients were monitored for 15-24 months to assess safety and changes in Parkinson's disease symptoms, using multiple endpoints such as the Unified Parkinson's Disease Rating Scale (UPDRS), Daily Diaries that assess motor … Continue reading →