First patient in a phase 3b clinical trial investigating Bethlemi (lopeg interferon alfa-2b-njft) for the treatment of adults with myeloproliferative neoplasms, polycythemia vera, and a type of blood cancer that causes excessive bone marrow reddening Blood cells administered in the study.
The ECLIPSE PV trial will evaluate an accelerated dosing schedule for Besremi and compare it to currently approved doses for this patient population. The primary goal of this trial is the proportion of patients achieving a complete hematologic response. This indicates that the blood cells have been in the normal range (red blood cell count less than 45%) for at least 3 months. The duration of the trial he is 24 weeks.
The researchers will also investigate the cancer-fighting ability, safety and tolerability of two regimens of Beslemi.
About 100 patients with polycythemia vera will participate in the trial. They were given either the accelerated dose (starting at 250 mcg, increasing to 350 mcg at week 2, and targeting 500 mcg at week 4) or the currently approved dose (50 or 100 mcg). randomly assigned to receive. To the press release issued by PharmaEssentia USA.
“Our goal with this study is to provide evidence of the potential enhanced benefits of administering Bethlemi to patients through this rapid dosing schedule, and to demonstrate the utility of the therapy for managing this chronic cancer.” Raymond Urbanski, director of U.S. clinical development and medical affairs for PharmaEssentia USA, said in a press release: “This study demonstrates Bethlemi’s ability to meet the needs of PV patients. I believe it will give us more insight into the possibilities.”
Patients may consult with their healthcare provider regarding the possibility of participating in clinical trials that are currently recruiting participants.
To be eligible, patients must be at least 18 years of age, diagnosed with polycythemia vera between 2008 and 2016 according to World Health Organization criteria, have good liver function and prespecified blood levels. , must be able to consent to the study. Patients who cannot receive interferon-alpha, who have discontinued interferon-alpha, or who have hypersensitivity to interferon-alpha are excluded. Patients must also not have a history of major organ transplantation, be pregnant or breastfeeding, or have any illnesses that might conflict with the study.
Besremi will be approved for use in patients with polycythemia vera in November 2021, based on the results of a clinical trial showing that 61% of patients treated with this drug over 7.5 years experienced a complete hematologic response. Approved by
In a March 2022 interview with CURE®, Dr. Naveen Pemmaraju, associate professor of leukemia at MD Anderson Cancer Center, said the approval of Besremi was “one of the most important developments” in the treatment of polycythemia vera. said it is.
“This therapy represents an important addition to the therapeutic arm of PV in the United States, and clinical data support its use in a wide range of patients, regardless of treatment history.” Icahn Medicine, Mount Sinai, New York It took place at a university, the press release said. “This new study addresses important therapeutic and clinical questions as to whether treatments utilizing accelerated dosing lead to more rapid hematologic and molecular responses, suggesting potential disease-modifying activity and long-term efficacy.” shows excellent disease control.”
The researchers expect the ECLIPSE PV study to be completed in December 2025.
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