Two New Therapies for PARKINSON’S DISEASE Are Being Tested
Inhaled Therapy for PARKINSON’S DISEASE
A small pharmaceutical company, Civitas Therapeutics, has announce successful results of a Phase 2b clinical trial for a novel approach to delivery of levodopa that will alleviate “off” time in as little as 10 minutes. The novel technique is called Arcus inhalation technology and uses a proprietary combination of a powdered form of levodopa and an inhaler. 86 subjects took part in the clinical trial and the company is now negotiating with the Food and Drug Administration to introduce a Phase 3 clinical trial. The inhalation method that is the basis for the work of this company can speed up the availability of the medication and give patients more control over periods when oral medications take much longer to become effective. The company is small, only 30 employees at present, but stressed that there is a manufacturing facility near by that will speed the process of bringing the product to patients who need it.
ProSavin Tested for Efficacy and Safety
A report in the English medical journal Lancet gave the results of a trial of a lentiviral vector-based gene therapy. Researchers injected ProSavin bi-laterally directly into the putamens of 15 patients with motor fluctuations and at least a 5-year history of PARKINSON’S DISEASE. Three cohorts were given different doses, low, medium or high and the patients were followed for a year to assess safety, tolerability and efficacy. All subjects resumed their normal drug regimen after the surgery. Researchers were looking for the number and severity of adverse reactions, but also at the improvement in motor scores. There were many adverse reactions, most in the mild to moderate range and usually involved dyskinesias. There were no serious adverse events. However, motor response was significantly improved, tested off medication at 6 months and one year. ProSavin is a lentiviral vector-based gene therapy injected surgically into the striatum and putamen. The therapy is designed to restore dopamine production in patients with PARKINSON’S DISEASE.
Lancet, 2014 Mar 29; 383(9923): 1138-46. doi: 10.1016/S140-6736(13)61939-X. Epub 2014 Jan 10.
Review by Marcia McCall