Additional Information about P1101
PharmaEssentia Corp. is developing BESREMi® (P1101) a 40K mono-pegylated form of interferon for a MPNs. Currently BESREMi® has completed a Phase II study in Polycythemia Vera and recently a Phase III study, also in Polycythemia Vera.
The primary objective of the study is to compare the efficacy of BESREMi® (P1101) vs. Hydroxyurea in terms of disease response rate in both hydroxyurea-naïve and hydroxyurea-pretreated (but with no resistance or intolerance) patients diagnosed with Polycythemia Vera. Molecular and cytogenetic abnormalities are being also explored during the long term treatment with P1101.
Development of P1101 covering other MPNs is being considered by PharmaEssentia. On the contrary to other pegylated interferons, P1101 can be administered once every two weeks and, for the patients treated for at least one year with P1101, treatment interval can be reduced to once monthly. P1101 is an investigational agent at the moment and cannot be yet prescribed in any country of the world. Expanded access program with P1101 may potentially start late 2016 or early 2017.
This information was provided by PharmaEssentia Corporation.