LUGANO, Switzerland and San Diego, USA, December 4 (Bernama-GLOBE NEWSWIRE) -- Helsinn Group, a Swiss pharmaceutical group focused on building quality cancer care products, and MEI Pharma, Inc. (Nasdaq: MEIP), an oncology company focused on the clinical development of novel therapies for cancer, today announced interim data from a Phase 2 study evaluating pracinostat, a histone deacetylase inhibitor, in combination with azacitadine for the treatment of patients with IPSS-R high/very high-risk of Myelodysplastic Syndrome (MDS). The data demonstrate a 9% discontinuation rate due to adverse events, a substantially lower rate than observed in an earlier study, as well as an encouraging 36% complete response rate among patients receiving at least 6 cycles of treatment. These data are being presented today at the 2018 American Society of Hematology (ASH) Annual Meeting.
The ongoing Phase 2 open-label study is evaluating a 45 mg dose of pracinostat in combination with azacitadine in order to improve safety/tolerability and retain patients in study longer than in an earlier Phase 2 study evaluating a 60 mg dose. Prolonged treatment is envisaged to result in a systemic exposure to pracinostat sufficient to achieve the desired treatment effect. The data reported today reinforce results from a planned May 2018 interim analysis meeting a predefined discontinuation threshold and suggest a reduced dose of pracinostat may allow MDS patients to remain on treatment longer and thereby increase the likelihood of a treatment response. If the current Phase 2 open-label study is successful, Helsinn intends to initiate a global registration study.
The ongoing Phase 2 open-label study is evaluating a 45 mg dose of pracinostat in combination with azacitadine in order to improve safety/tolerability and retain patients in study longer than in an earlier Phase 2 study evaluating a 60 mg dose. Prolonged treatment is envisaged to result in a systemic exposure to pracinostat sufficient to achieve the desired treatment effect. The data reported today reinforce results from a planned May 2018 interim analysis meeting a predefined discontinuation threshold and suggest a reduced dose of pracinostat may allow MDS patients to remain on treatment longer and thereby increase the likelihood of a treatment response. If the current Phase 2 open-label study is successful, Helsinn intends to initiate a global registration study.
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