Therapy Areas: AIDS & HIV
First Patient Enrolled in CARES10, a Phase 3, Multi-Center Study to Assess a 10 % Intravenous Immunoglobulin in Adults with Primary Immunodeficiency Disease
12 August 2019 - - US-based plasma-derived therapeutic products maker Kedrion Biopharma has initiated the CARES10 (Clinical Assessment of phaRmacokinetics, Efficacy, Safety of a 10% Ig) clinical study, the company said.

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% intravenous immunoglobulin in the treatment of adult patients with primary immunodeficiency diseases.

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 to the US Food and Drug Administration.

According to analysts, the global plasma-derived immunoglobulin market is growing at a compound annual growth rate of approximately 7% per year and is expected to exceed USD 18bn by the end of 2025.

Kedrion Biopharma is one of several companies that supply immunoglobulin therapies to US and Canada patients, and to patients in about 100 other locations around the world.

Primary Immunodeficiency is an umbrella term for a group of more than 350 rare and chronic disorders in which part of the body's immune system is either missing or not functioning properly. PI disorders are not contagious. Rather, they are caused by hereditary or genetic defects. PI can affect anyone, regardless of age or gender. 

Approximately 250,000 people are diagnosed with PI in the United States.

Kedrion Biopharma is an international company that collects and fractionates blood plasma to produce and distribute plasma-derived therapeutic products for use in treating and preventing serious diseases, disorders and conditions such as hemophilia, primary immune system deficiencies and Rh-sensitization.

Kedrion Biopharma Inc., the US subsidiary of Kedrion Biopharma, is headquartered in Fort Lee, New Jersey. Kedrion Biopharma launched US operations in 2011, but the company's international roots stretch back several decades in the production of blood and plasma-derived products.

Kedrion Biopharma places a high value on the welfare of those who benefit from its products, as well as on the people and the communities it serves.
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