User Settings
Article10.1182/blood.v122.21.4046.4046

Efficacy and Safety Of AOP2014/P1101, a Novel, Investigational Mono-Pegylated Proline-Interferon Alpha-2b, In Patients With Polycythemia Vera (PV): Update On 51 Patients From The Ongoing Phase I/II Peginvera Study

Heinz Gisslinger,Veronika Buxhofer‐Ausch,Josef Thaler,Ernst Schloegl,Guenther Gastl,Dominik Wolf‎+12 more-2013-11-15-Blood
9

TL;DRAbstract

Abstract Background AOP2014/P1101 is a novel, investigational mono-pegylated proline-interferon alpha-2b. In contrast to other pegylated IFNs, AOP2014/P1101 consists of one predominant isoform. AOP2014/P1101 has Orphan Drug Designation in EU and USA for treatment of patients with PV. Study design Long term efficacy and safety data are being collected in the follow-up extension stage of the study (collecting the data of both Phase I and Phase II portions of the study), after the maximum tolerated dose (MTD) of AOP2014, administered subcutaneously every 14 days, has been defined earlier. Patients with confirmed PV diagnosis, age ≥18 years, both naïve and cytoreduction pre-treated were eligible. After establishing the MTD, an extended cohort of 25 additional patients has been planned to be recruited. Complete hematological response (CR) is defined by Hct<45%, platelet count≤400*109/L, WBC count≤10 *109/L, normal spleen size by sonography, and absence of thromboembolic events. Partial r

Chat with Paper

AI Agents for this Paper

Abstract Background AOP2014/P1101 is a novel, investigational mono-pegylated proline-interferon alpha-2b. In contrast to other pegylated IFNs, AOP2014/P1101 consists of one predominant isoform. AOP2014/P1101 has Orphan Drug Designation in EU and USA for treatment of patients with PV. Study design Long term efficacy and safety data are being collected in the follow-up extension stage of the study (collecting the data of both Phase I and Phase II portions of the study), after the maximum tolerated dose (MTD) of AOP2014, administered subcutaneously every 14 days, has been defined earlier. Patients with confirmed PV diagnosis, age ≥18 years, both naïve and cytoreduction pre-treated were eligible. After establishing the MTD, an extended cohort of 25 additional patients has been planned to be recruited. Complete hematological response (CR) is defined by Hct<45%, platelet count≤400*109/L, WBC count≤10 *109/L, normal spleen size by sonography, and absence of thromboembolic events. Partial r

Keywords

MedicinePhlebotomyInternal medicinePolycythemia veraGastroenterologyPegylated interferonCohortPhases of clinical research

Chat

Click to start Chat