KUALA LUMPUR, Dec 4 (Bernama) – Helsinn Group and MEI Pharma, Inc. have announced interim data from a Phase 2 study evaluating pracinostat in combination with azacitadine for the treatment of patients with IPSS-R high/very high-risk of Myelodysplastic Syndrome (MDS).
The data demonstrates a nine per cent discontinuation rate due to adverse events – a substantially lower rate than observed in an earlier study and an encouraging 36 per cent complete response rate among patients receiving at least six cycles of treatment.
According to a statement, these data were presented 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 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 statement added.
Helsinn Group is a Swiss pharmaceutical group which focused on building quality cancer care products while MEI Pharma is an oncology company focused on the clinical development of novel therapies for cancer. More details at www.helsinn.com
-- BERNAMA
-- BERNAMA
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