Abstract Details

Title Glatiramer Acetate Depot (Extended-Release) Phase IIa Study in Patients with Primary Progressive Multiple Sclerosis: Safety and Efficacy Snapshot

Topic Multiple Sclerosis

Presentation(s) P7 - Poster Session 7 (8:00 AM-9:00 AM)

Poster/Presentation
Number 12-001

Objective To assess the safety and efficacy of GA Depot treatment (for up to 144 weeks) in 16 primary progressive MS (PPMS) subjects treated with GA Depot.

Background PPMS is characterized by worsening neurologic function from the onset of symptoms, without early relapses or remissions. GA Depot consists of extended-release microspheres containing GA, administered intramuscularly (IM) once every 28 days. Results of a 5 year GA Depot phase IIa trial in relapsing remitting MS suggest that GA Depot is safe, tolerable and efficacious. The IM administration route together with the slow release formulation may result in a noted effect on PPMS patients as well.

Design/Methods Eligibility criteria included: age 18-65, s PPMS diagnosis with rapid disease progression (rate of ≥ 1 point increase/year on EDSS score) in the year prior to screening, EDSS score of 2.0 - 6.5 at baseline. Safety is assessed by analysis of adverse events, CBC and blood chemistry. Efficacy is assessed by EDSS, 9HPT, T25FW tests, as well as by MRI analysis.

Results 88.2% of the AEs recorded in the study were mild. Most common AEs included injection site reactions and general weakness. No unexpected AEs were reported. Two SAEs were reported (one related and one not related to study drug). EDSS score remained stable for all patients and no 12 weeks confirmed disability progression (CDP) was detected. Mean 9HPT score and T25FW remained stable. MRI analysis (compared to baseline) revealed activity which included T2/FLAIR lesions (new or enlarging) in four patients. Three of these patients had also Gd⁺T1 lesions.

Conclusions

These interim snapshot data suggest that GA Depot is a safe and effective treatment for patients with PPMS, as demonstrated by stable mean EDSS, mean 9HPT and mean T25FW data, which encourage us to continue this on-going investigation.

Authors/Disclosures
Ehud Marom PRESENTER	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 stock in Mapi Pharma. Mr. Marom has received intellectual property interests from a discovery or technology relating to health care.
Shlomo Flechter, MD, FAAN (Outpatient Clinic)	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.
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.
Ron E. Milo, MD, FAAN (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.
Ronit Gilad	Ms. Gilad has nothing to disclose.
Boaz Weller, MD	Boaz Weller has nothing to disclose.
Adi Vaknin-Dembinsky, MD	No disclosure on file
Mark Hellman	Mark Hellman has nothing to disclose.
Alla Shifrin, MD (Rambam Medical Center)	Dr. Shifrin 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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