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Abstract Details

Glatiramer Acetate Depot (extended-release) phase IIa study in patients with primary progressive multiple sclerosis: safety and efficacy snapshot
Multiple Sclerosis
P8 - Poster Session 8 (8:00 AM-9:00 AM)
9-014
To assess the safety and efficacy of GA Depot treatment (for up to 19 months) in seven primary progressive MS (PPMS) subjects.
PPMS is characterized by worsening neurologic function (accumulation of disability) from the onset of symptoms, without early relapses or remissions. GA long-acting injection (GA Depot) consists of extended-release microspheres containing GA, administered intramuscularly (IM) once every 28 days. Results of GA Depot phase IIa for three years 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.
Eligibility criteria included: age 18-65 years, subjects diagnosed with PPMS with signs of disease progression (rate of ≥ 1 point increase / year in EDSS score) in the year prior to screening, EDSS score at baseline ≥2.0 and ≤ 6.5. Patients are receiving GA Depot IM at dose of 40 mg every 28 days. 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.

AEs mainly included mild injection site reactions. No unexpected AEs were reported.  EDSS score remained stable for all patients and no 12 weeks confirmed disability progression (CDP) was detected. Mean 9HPT and T25FW scores remain stable or slightly improved. MRI analysis (n=5) revealed one new, one active T2 and one new and active T1 lesions for the same patient. Gd-enhancing lesions were noted in two patients.

These interim results suggest a possible safe and effective therapy with GA Depot for patients with PPMS which encourage us to continue this on-going investigation.
Authors/Disclosures
Shlomo Flechter, MD, FÂ鶹´«Ã½Ó³»­ (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.
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.
No disclosure on file
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, FÂ鶹´«Ã½Ó³»­ (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 Dr. Vaknin-Dembinsky has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Medison Pharma. Dr. Vaknin-Dembinsky has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for neopharm group. Dr. Vaknin-Dembinsky has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for medisone . Dr. Vaknin-Dembinsky has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for alexion.
Mark Hellman Mark Hellman 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.