Contributions
Abstract: P1167
Type: Poster
Abstract Category: Therapy - disease modifying - 26 Immunomodulation/Immunosuppression
Background: Glatiramer acetate (GA) long-acting injection (GA Depot) consists of extended-release microspheres containing GA for IM injection. GA is released from the depot formulation continuously over a 30 days' period. In vivo data, (MOG-EAE model) showed that GA Depot is as effective as CopaxoneÒ. Objective: Assess the safety, tolerability, and efficacy of once-a-month long-acting IM injection of GA Depot in patients with RRMS.
Design and methods: Main eligibility criteria included: age 18-70 years, RRMS diagnosis and treatment with Copaxone® for ≥12 months prior to study enrollment. Patients received GA Depot (80mg or 40mg) every 28 days (IM) for up to 52 weeks.
Results: Six months' data: Twenty-five RRMS patients were enrolled as follows: 80mg dose (n=12) and 40mg dose (n=13). Overall, 72% of study population were female, mean MS duration was 15.5 years and mean EDSS score was 2.4. No unexpected safety issues were recorded with GA Depot. Adverse events (AEs) mainly included mild injection site reactions (ISRs). Statistically significantly fewer ISRs were reported with the 40mg dose than with the 80mg dose. No immediate post-injection reactions, as recorded with CopaxoneÒ, were reported with GA Depot. AEs other than ISRs were mostly mild. Two relapses were recorded during treatment with Copaxone®, within 12 months prior to study enrollment. No relapses occurred during 6 months of treatment with GA Depot. No mean EDSS score changes were recorded. Above 95% of patients showed no changes (no new lesions nor newly enhancing lesions) in 6 months' MRI scans compared to baseline.
Conclusions: GA Depot 6 months' encouraging results, strengthen the original assumption that GA Depot has the potential to improve MS mode of treatment by significantly reducing the frequency of injections and providing a therapeutic benefit. GA Depot 6 months' efficacy, safety and tolerability data prompts the continuation to one phase III pivotal trial. Study Supported by: Mapi Pharma LTD.
Disclosure:
Prof. Ariel Miller participated as the study Coordinating Principal investigator and as a site Principal investigator (PI) in the study funded by Mapi Pharma.
Dr. Shlomo Flechter, Dr. Ron Milo, Prof. Joab Chapman, Dr. Alla Shifrin, Prof. Dimitrios Karussis, Prof. Ronit Gilad and Dr. Arnon Karni participated as Principal investigators in the study funded by Mapi Pharma.
Dr. Chen Hoffmann participated as the central reading MRI facility in the study funded by Mapi Pharma.
Laura Popper, Nadav Bleich Kimelman, Shai Rubnov (co-inventor of GA Depot) and Uri Danon are employed by Mapi Pharma. Ehud Marom is a co-inventor of GA Depot, founder, and the CEO of Mapi Pharma.
Abstract: P1167
Type: Poster
Abstract Category: Therapy - disease modifying - 26 Immunomodulation/Immunosuppression
Background: Glatiramer acetate (GA) long-acting injection (GA Depot) consists of extended-release microspheres containing GA for IM injection. GA is released from the depot formulation continuously over a 30 days' period. In vivo data, (MOG-EAE model) showed that GA Depot is as effective as CopaxoneÒ. Objective: Assess the safety, tolerability, and efficacy of once-a-month long-acting IM injection of GA Depot in patients with RRMS.
Design and methods: Main eligibility criteria included: age 18-70 years, RRMS diagnosis and treatment with Copaxone® for ≥12 months prior to study enrollment. Patients received GA Depot (80mg or 40mg) every 28 days (IM) for up to 52 weeks.
Results: Six months' data: Twenty-five RRMS patients were enrolled as follows: 80mg dose (n=12) and 40mg dose (n=13). Overall, 72% of study population were female, mean MS duration was 15.5 years and mean EDSS score was 2.4. No unexpected safety issues were recorded with GA Depot. Adverse events (AEs) mainly included mild injection site reactions (ISRs). Statistically significantly fewer ISRs were reported with the 40mg dose than with the 80mg dose. No immediate post-injection reactions, as recorded with CopaxoneÒ, were reported with GA Depot. AEs other than ISRs were mostly mild. Two relapses were recorded during treatment with Copaxone®, within 12 months prior to study enrollment. No relapses occurred during 6 months of treatment with GA Depot. No mean EDSS score changes were recorded. Above 95% of patients showed no changes (no new lesions nor newly enhancing lesions) in 6 months' MRI scans compared to baseline.
Conclusions: GA Depot 6 months' encouraging results, strengthen the original assumption that GA Depot has the potential to improve MS mode of treatment by significantly reducing the frequency of injections and providing a therapeutic benefit. GA Depot 6 months' efficacy, safety and tolerability data prompts the continuation to one phase III pivotal trial. Study Supported by: Mapi Pharma LTD.
Disclosure:
Prof. Ariel Miller participated as the study Coordinating Principal investigator and as a site Principal investigator (PI) in the study funded by Mapi Pharma.
Dr. Shlomo Flechter, Dr. Ron Milo, Prof. Joab Chapman, Dr. Alla Shifrin, Prof. Dimitrios Karussis, Prof. Ronit Gilad and Dr. Arnon Karni participated as Principal investigators in the study funded by Mapi Pharma.
Dr. Chen Hoffmann participated as the central reading MRI facility in the study funded by Mapi Pharma.
Laura Popper, Nadav Bleich Kimelman, Shai Rubnov (co-inventor of GA Depot) and Uri Danon are employed by Mapi Pharma. Ehud Marom is a co-inventor of GA Depot, founder, and the CEO of Mapi Pharma.