Octapharma AG, one of the largest global manufacturers of human proteins, today 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.
A subgroup of patients with RMS experience disabling side effects with current first-line treatments, which can result in an inability to comply with their treatment protocol, or do not benefit from this treatment. By identifying predicted responders it is believed that the known and favourable tolerability profile of Octagam 5% could improve the quality of life for this group of patients. The GAM-27 Steering Committee (Prof. Thomas Berger, Clinical Department of Neurology, Medical University Innsbruck, Austria; Prof. Irina Elovaara, Medical School, Department of Neurology, University of Tampere, Finland; Prof. Hans-Peter Hartung, Neurological Clinic, Heinrich-Heine-Universität, Düsseldorf, Germany) welcomed the enrolment of the first 2 patients into the trial in Bulgaria and anticipates further enrolment in the other participating countries.