Barzilai University Medical Center

Author Of 2 Presentations

Clinical Trials Late Breaking Abstracts

LB1227 - Glatiramer Acetate Depot (extended-release) phase IIa study in patients with Primary Progressive Multiple Sclerosis: safety and efficacy snapshot (ID 2106)

Abstract

Background

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.

Objectives

To assess the safety and efficacy snapshot data of GA Depot treatment (for up to 112 weeks) in the eleven primary progressive MS (PPMS) subjects enrolled out of the 24 planned.

Methods

Eligibility criteria included: age 18-65 years, subjects diagnosed with PPMS with signs of rapid disease progression (rate of ≥ 1 point increase / year on EDSS score) in the year prior to screening, EDSS score of ≥2.0 and ≤ 6.5 at baseline. Patients are receiving GA Depot IM at a 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.

Results

AEs were mainly 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 findings in three out of the 11 patients’ population.

Conclusions

These interim snapshot data suggest that GA Depot is possibly 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.

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Clinical Trials Late Breaking Abstracts

LB1228 - Glatiramer Acetate Depot (Extended-Release) Phase IIa Study in Patients with RRMS: Safety, Tolerability and Efficacy Four-Years Analysis (ID 2107)

Abstract

Background

Multiple sclerosis is a chronic disease, requiring lifelong therapy. While several DMTs have been approved, improvement of treatment adherence remains an unmet need. Glatiramer acetate (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 three years extension period in relapsing remitting MS (RRMS) suggest that GA Depot is safe, tolerable and efficacious.

Objectives

Assess the safety, tolerability and efficacy by NEDA-3, 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 10 RRMS patients who completed the core study and continued through three years of the study extension.

Methods

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

Results

Adverse events (AEs) mainly included mild injection site reactions. No unexpected AEs were reported. The number of AEs was significantly reduced during the extension study compared to the core study, and during the fourth extension year compared to the first two years of the study. No systemic immediate post-injection reactions were detected. Patients received all injections as per protocol. Data analyzed by intention to treat population (mITT) (n=10): Mean EDSS score after four years showed no change compared to baseline. No Relapses or MRI activity was noted during that period. Four years NEDA-3 was achieved by 90% of the per protocol population.

Conclusions

Encouraging results of the GA Depot four-year study support its long-term safety, tolerability, and efficacy in this study 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.

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