Date: 2013-12-18
Type of information:
phase: 2-3
Announcement: enrollment of the first patients
Company: Octapharma (Switzerland)
Product: Octagam 5%
Action mechanism:
Disease: relapsing multiple sclerosis
Therapeutic area: Autoimmune diseases - Neurodegenerative diseases
Country: 35 European sites in several countries; including Austria, Bulgaria, Germany, Hungary and Russia
Trial details: The study will recruit 216 patients with early relapsing MS at approximately 35 European sites in several countries; including Austria, Bulgaria, Germany, Hungary and Russia. The patients will be treated for a 24 month period with expected trial completion by the end of 2016. Full study design was presented at the European Charcot Foundation annual meeting in Baveno, Italy from November 28-30 2013.
Latest
news: * On December 18, 2013, Octapharma, a manufacturer of human proteins, has announced the enrolment of the first two patients in its GAM-27 Phase II/III clinical trial for the treatment of relapsing multiple sclerosis (RMS). Through intravenous administration of immunoglobulin (Octagam 5%), the study seeks to support the overall clinical benefit of a lower annualised relapse rate in patients where first-line treatment is not suitable.This randomised, active-controlled phase II/III study aims to confirm preliminary results that suggested it is possible to identify potential responders to treatment with Octagam 5%. Using a combination of functional genomic and protein expression tests, a special assay panel, Heidelberg Assay Panel (HAP), was developed that could potentially stratify patients into predicted responders or non-responders. These laboratory-based tests require just a simple blood sample from the patient.
