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Elto Pharma Receives Notice of Allowance in Australia for Patent Covering Eltoprazine in the Treatment of Parkinson's Levodopa-induced Dyskinesia
Elto Pharma Receives Notice of Allowance in Australia for Patent Covering Eltoprazine in the Treatment of Parkinson's Levodopa-induced Dyskinesia.
About this update from Amarantus Bioscience Holdings, Inc.
[{"type":"text","content":"\n\n SAN FRANCISCO, March 08, 2018 (GLOBE NEWSWIRE) -- via OTC PR WIRE--Elto Pharma, Inc., a specialty pharmaceutical, clinical-stage wholly-owned subsidiary of Amarantus Bioscience Holdings, Inc. (OTCPK:AMBS), advancing Eltoprazine into a Phase 2b trial for the treatment of the orphan indication Parkinson's disease levodopa-induced dyskinesia (PD-LID), today announced that it has received a notice of allowance from the Australian Patent Office for a patent application entitled \"Treatment of Motor and Movement Disorder Side Effects Associated With Parkinson's Disease Treatments\" which protects use of Eltoprazine for the treatment of PD-LID, including the use of Eltoprazine in combination with other relevant Parkinson's therapeutics. Upon issuance, the allowed patent will extend exclusivity for the use of Eltoprazine in Australia for the treatment of PD-LID into 2032. Eltoprazine received orphan drug designation from the US FDA for PD-LID in February 2016.\n An IND for Eltoprazine was opened with the neurology division of the US FDA in May 2015 that allowed the Company to initiate a multi-center, randomized, placebo-controlled crossover design Phase 2b trial of Eltoprazine in the treatment of PD-LID in the United States and Europe that was put on recruitment hold in September 2015. The European portion of the trial was closed in 2016. The Company is currently preparing to redesign its Phase 2b PD-LID trial into a Phase 3-enabling parallel design clinical trial as a result of the recent approval of Gocovri from Adamas Pharmaceuticals for the treatment of PD-LID. Elto Pharma is in the process of recruiting seasoned management to lead Elto Pharma going forward. Clinical data for Eltoprazine in PD-LID The Eltoprazine study in 22 subjects with long standing PD-LID was a randomized, four-way crossover design in which patients received a single dose of placebo and eltoprazine, at 2.5, 5 and 7.5 mg, in combination with a challenge dose of levodopa (1.5 times usual dose), on four different days, separated by an interval of a week. Data from the study demonstrated that eltoprazine significantly reduced peak dose dyskinesia at both the 5 (p<0.05) and 7.5 mg (p<0.05) doses using the Combined Dyskinesia Rating Scale. The 5 mg dose also showed a significant anti-dyskinetic effect on other measures of dyskinesia, including the Rush dysk...