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Largest Ever CIDP Clinical Study Completed

Tuesday, March 7, 2017   (0 Comments)
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KING OF PRUSSIA, Pa., March 1, 2017 /PRNewswire/ -- Global biotherapeutics leader CSL Behring announced today that it has completed the largest ever Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) trial, known as PATH (Polyneuropathy And Treatment with Hizentra┬«).  The Phase III clinical trial was designed to demonstrate the efficacy, safety and tolerability of two different doses of CSL Behring's subcutaneous immunoglobulin (SCIG), Hizentra┬« (Immune Globulin Subcutaneous [Human]), compared with placebo, in the maintenance treatment of CIDP patients previously treated with intravenous immunoglobulin (IVIG).

Hizentra, the no. 1 prescribed immunoglobulin therapy in treating primary immunodeficiencies (PI), the most prescribed SCIG worldwide, and the only 20% SCIG designed with the natural stabilizer L-proline, was self-administered by patients.  Throughout the study, subjects were allowed to use dose volumes up to 50 mL/site and infusion rates of up to 35 mL/hour, to provide them with greater flexibility and autonomy to infuse when and where they choose.   A long-term open label extension study is ongoing and is expected to be completed in 2017.

"Patients living with CIDP experience different symptoms with varying severities.  We value organizations like CSL Behring whose ongoing neurology research continues to look at bringing new options for patients, caregivers and physicians to choose the individualized treatment that's right for each patient," said Lisa Butler, Executive Director, GBS/CIDP Foundation International.

 "The PATH trial, our second major neurology study, drives us towards unlocking the promise of immunoglobulins for treatment of neurological conditions and demonstrates our commitment in this important medical specialty," says Andrew Cuthbertson, Chief Scientific Officer and R&D Director. "We look forward to sharing the results of the PATH trial with colleagues at key neurology congresses this year."

Investigators and patients in over 10 countries participated during the last five years to bring this groundbreaking prospective, multicenter, randomized, double-blind, placebo-controlled clinical trial to completion. A trial of this scale will contribute greatly to our understanding of these patients.

CIDP is a rare disorder of the peripheral nerves (those outside the brain and spinal cord). The condition is immune-mediated and the effects can worsen over time. The protective covering of the nerves is damaged, which may cause numbness or tingling, muscle weakness, fatigue and other symptoms. CIDP can occur at any age and is more common in men than in women. If left untreated, approximately 30 percent of CIDP patients will progress to wheelchair dependence.

For more information about the PATH study, visit http://www.clinicaltrials.gov and search with identifier: NCT01545076.

 

View source article via PR Newswire here.


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