Kedrion Biopharma, an international specialist in the manufacture and distribution of plasma-derived therapeutic products used in treating rare and serious diseases, today announced initiation of the CARES10 (Clinical Assessment of phaRmacokinetics, Efficacy, Safety of a 10% Ig) clinical study.
CARES10 is a United States/Canada-based open-label, prospective, multi-center phase 3 clinical study to assess efficacy, safety and pharmacokinetics of a 10 percent intravenous immunoglobulin in the treatment of adult patients with primary immunodeficiency diseases (PI). CARES10 may also enroll a limited number of pediatric patients in order to gather preliminary data in that population.
The first patient enrolled in CARES10 is under the care of Elena Perez, M.D., at Allergy Associates of the Palm Beaches, one of the 16 sites in the study. To date, 20 patients are enrolled in CARES10. Enrollment will continue until January 2020, with the goal of reaching a total of approximately 50 patients. The study is scheduled to be completed by mid-2021. A subsequent goal will be to submit a biologics license application (BLA) to the U.S. Food and Drug Administration.
“Kedrion is leveraging decades of scientific leadership in primary immunodeficiency to advance research in intravenous immune globulin as replacement therapy for primary immunodeficiency in humans. Drawing from our rich heritage, Kedrion is well equipped to sustainably support the unmet medical needs in this particular field,” said Paolo Marcucci, Kedrion Biopharma Chairman and Chief Executive Officer.
“We continually strive to put patients first and bring treatments to those living with primary immunodeficiency diseases around the world,” said Alessandro Gringeri, Kedrion Biopharma Chief Medical Research Officer. “I am particularly excited to be part of Kedrion, a long-term support to the primary immunodeficiency community.”
According to analysts, the global plasma-derived immunoglobulin market is growing at a compound annual growth rate of approximately 7 percent per year and is expected to exceed $18B by the end of 2025. Kedrion Biopharma is one of several companies that supply immunoglobulin therapies to U.S. and Canada patients, and to patients in about 100 other locations around the world.