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Kedrion Biopharma Announces First Patient Enrolled in CARES10, a Phase 3, Multi-Center Study to Assess a 10 Percent Intravenous Immunoglobulin in Adults with Primary Immunodeficiency Disease

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Tuesday, August 13, 2019
  • CARES10 (Clinical Assessment of phaRmacokinetics, Efficacy, Safety of a 10 percent Ig) is the first study of a clinical candidate called KIG10 by Kedrion Biopharma, a leading specialist in plasma-derived products used in treating rare and serious diseases.
  • With the initiation of CARES10, a phase 3, open-label, prospective, multi-center study to assess the pharmacokinetics, safety, and efficacy of a 10 percent intravenous immunoglobulin in primary immunodeficiency patients in the U.S. and Canada, Kedrion Biopharma expands its long-term strategic focus to include entry into scientific research and development of plasma-derived therapies.
  • CARES10 is expected to yield pivotal data that will be used in a biologics license application (BLA) submission to FDA.
  • Immunoglobulin is a widely accepted and proven treatment available for various immune disorders in a global market expected to exceed $18B by the end of 2025.

FORT LEE, N.J. - 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.

About Primary Immunodeficiency

Primary Immunodeficiency (PI) 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.

About Kedrion Biopharma

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 U.S. 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. Additional information about Kedrion Biopharma can be found at www.kedrion.com and www.kedrion.us.

Contacts
Media:
Forrest McCaleb
Director, Global Communications – U.S.
Kedrion Biopharma

214-557-8030

Sheila Burke
Method Health Communications
484-667-6330
Source: Kedrion Biopharma
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