A Single-arm, Multicenter Study to Assess the Efficacy, Safety, and Tolerability of P1101 in Adults With ET

Active:	Yes
Cancer Type:	Hematopoietic Malignancies Leukemia Unknown Primary	NCT ID:	NCT05482971
Trial Phases:	Phase II	Protocol IDs:	EXCEED ET / A22-301 (primary) NCI-2023-00605
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	PharmaEssentia
NCI Full Details:	http://clinicaltrials.gov/show/NCT05482971

Summary

A Single-arm, Multicenter Study to Assess the Efficacy, Safety, and Tolerability of
Ropeginterferon alfa-2b-njft (P1101) in Adult Patients with Essential Thrombocythemia

Objectives

PharmaEssentia is developing a pegylated (PEG) IFN-a product, P1101, for the treatment of
Essential Thrombocythemia (ET) as lack of disease modifying therapies in essential ET
constitutes a serious issue in modern hematology.

Ropeginterferon alfa-2b-njft (P1101) may represent an effective, well-tolerated treatment
with the ability to provide a deeper response and superior control of important blood
parameters with the potential to alter the course of the disease and prevent progression to
post-ET myelofibrosis (MF) and/or secondary acute myeloid leukemia (sAML). Ropeginterferon
alfa-2b-njft (P1101) is currently being evaluated in comparison to ANA in the ongoing global
Phase 3 clinical study, SURPASS ET.

Enrolled patients will receive P1101 over 13 months followed by an extension period.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

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