Octapharma enrolls first patients in GAM-27 Phase II/III clinical trial for relapsing multiple sclerosis

Dec 18 2013

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.

"Funding this study is part of our on-going long-term commitment to supporting advances in MS therapies," commented Dr Wolfgang Frenzel, International Medical Director at Octapharma. "This extensive trial is a critical step in confirming the ability to identify the subset of patients for whom treatment with Octagam 5% has the potential to change the course of the disease and offer an improvement in their quality of life."

"The potential for this HAP test to accurately identify the estimated 20-30% of these patients with relapsing multiple sclerosis who should benefit from Octagam 5% treatment, could provide a significant step towards personalised therapies for this patient group," said Stefan Meuer, Professor of Immunology at the Department of Immunology at the Ruprecht Karls-University in Heidelberg, in whose group the HAP test had been developed.

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.