CHARLOTTE, N.C., March 26, 2012 /PRNewswire/ -- CSL Behring has announced that the first patient has been enrolled in the PATH study, an international clinical trial designed to evaluate the efficacy, safety, and tolerability of two different doses of subcutaneous immunoglobulin (SCIg), compared with placebo, in maintenance treatment of chronic inflammatory demyelinating polyneuropathy (CIDP).
In PATH (Polyneuropathy And Treatment with Hizentra), patients stabilized on intravenous immunoglobulin (IVIg) will be randomized to receive weekly infusions of 1 of 2 Hizentra® doses (0.2 or 0.4 g/kg body weight) or placebo for 24 weeks. The study will measure the proportion of patients who experience a relapse in their CIDP over a period of 52 weeks. For more information, see www.clinicaltrials.gov.
"As a leader in developing SCIg therapy, CSL Behring continues to explore new opportunities to provide greater flexibility and control to patients who require long-term immunoglobulin therapy," said Russell Basser, MD, Senior Vice President, Global Clinical R&D. "The PATH study is an important undertaking. Results will guide our planning in the neurological arena as we strive to meet significant unmet needs in this key patient population."
"IVIg has long been the standard of care in the treatment of CIDP," said Ivo van Schaik, M.D., principal investigator for PATH. "However, a clear need exists for additional, proven treatments that help avoid the wear-off effect often associated with current Ig therapies, and that can provide the autonomy and flexibility that subcutaneous administration offers to patients who are managing this very difficult disease. We are very pleased that the PATH study is now fully under way."About Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) CIDP is a rare disorder of the peripheral nerves characterized by symmetrical weakness in the arms and legs that progressively worsens for longer than 2 months. It is often but not always associated with impaired sensation, absent or diminished tendon reflexes, an elevated cerebrospinal fluid protein level, and changes in nerve-conduction. CIDP can occur at any age, with peak prevalence in the sixth and seventh decade, and is twice as common in men as in women. CIDP is believed to be underdiagnosed and undertreated. Therefore, its prevalence is difficult to determine, with some estimates ranging up to 8.9 per 100,000 adults. If left untreated, approximately 30 percent of CIDP patients will progress to wheelchair dependence. Early recognition and treatment can help prevent disability and improve recovery.
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