Abstract Details

Title Glatiramer Acetate Depot (extended-release) phase IIa study in patients with relapsing remitting multiple sclerosis: safety, tolerability and efficacy (No Evidence of Disease Activity) subpopulation three-years analysis

Topic Multiple Sclerosis

Presentation(s) P9 - Poster Session 9 (12:00 PM-1:00 PM)

Poster/Presentation
Number 9-021

Objective Assess the safety, tolerability and efficacy by NEDA, defined as: no relapses, no 12-week confirmed disability progression, no new T2 lesions and no gadolinium-enhancing lesions on MRI after three years of treatment with GA Depot in the subpopulation of 11 RRMS patients who completed the core study and continued through two years of the study extension.

Background MS is a chronic disease, requiring lifelong therapy. While several DMTs have been approved, improvement of treatment adherence remains an unmet need. GA long-acting injection (GA Depot) consists of extended-release microspheres containing GA, administered intramuscularly once every 28 days. Results of GA Depot phase IIa one-year core study and two years extension period in relapsing remitting MS (RRMS) suggest that GA Depot is safe, tolerable and efficacious.

Design/Methods Eligibility criteria included: age 18-70 years, diagnosis of RRMS and treatment with Copaxone® for ≥12 months prior to enrollment. Patients received GA Depot at doses of 80mg or 40mg in the core study and 40mg in the study extension.

Results AEs mainly included mild injection site reactions. No unexpected AEs were reported. Number of AEs was significantly reduced during the second and third year. No systemic immediate post-injection reactions were detected. Patients received all injections as per protocol. Data analyzed by intention to treat population (mITT) (n=11): Mean EDSS score after two years showed no significant change compared to baseline. One patient had 3 relapses during the three-year study. No MRI activity was noted during that period. Three years NEDA was achieved by 81.8% of the patients (mITT) or 90% of the per protocol population.

Conclusions Encouraging results of the GA Depot three-year study support its safety, tolerability, and efficacy in this cohort. It further supports the assumption of GA Depot’s potential to improve MS treatment by significantly reducing frequency of injections, increasing adherence and providing a therapeutic benefit.

Authors/Disclosures
Shlomo Flechter, MD, F�鶹��ýӳ�� (Outpatient Clinic) PRESENTER	Dr. Flechter has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Dr. Flechter has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Mapi Pharma.
Ariel L. Miller, MD, PhD	Dr. Miller has nothing to disclose.
Laura Popper, MD (Mapi Pharma Ltd.)	Dr. Popper has received personal compensation for serving as an employee of Mapi Pharma.
Nadav Bleich Kimelman	Nadav Bleich Kimelman has nothing to disclose.
Shai Rubnov	Shai Rubnov has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for Mapi pharma.
Uri Danon	Uri Danon has received personal compensation for serving as an employee of Mapi harma.
Ehud Marom	Mr. Marom has received personal compensation for serving as an employee of Mapi Pharma. Mr. Marom has received personal compensation in the range of $500,000-$999,999 for serving as an officer or member of the Board of Directors for Mapi Pharma. Mr. Marom has or had stock in Mapi Pharma.Mr. Marom has received intellectual property interests from a discovery or technology relating to health care.
Ron E. Milo, MD, F�鶹��ýӳ�� (Barzilai Medical Center)	Dr. Milo has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Merck KGaA . Dr. Milo has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Dr. Milo has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. Dr. Milo has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck-Serono. Dr. Milo has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi. Dr. Milo has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Brystol-Myers-Squibb . Dr. Milo has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Medison. Dr. Milo has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Neopharm. Dr. Milo has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Teva. Dr. Milo has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Novartis. Dr. Milo has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Merck. Dr. Milo has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Brystol-Myers-Squibb.
Joab Chapman, MD, PhD (Sheba Medical Center)	Dr. Chapman has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Mapi Pharma. Dr. Chapman has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi Genzyme. Dr. Chapman has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merk Serono. The institution of Dr. Chapman has received research support from Ministry Of Industry.
Alla Shifrin, MD (Rambam Medical Center)	Dr. Shifrin has nothing to disclose.
Ronit Gilad	Ms. Gilad has nothing to disclose.
	No disclosure on file
Dimitrios Karussis, MD, PhD (Hadassah HMO)	Prof. Karussis has nothing to disclose.
Arnon Karni, MD, PhD (Tel Aviv Sourasky medical center)	Prof. Karni has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Neopharm. Prof. Karni has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for BMS. Prof. Karni has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck. Prof. Karni has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. The institution of Prof. Karni has received research support from Medison. The institution of Prof. Karni has received research support from BMS. The institution of Prof. Karni has received research support from Novartis.

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