First Patient Enrolled in CSL Behring PATH Trial to Evaluate Immune Globulin Subcutaneous (Human) 20% Liquid, Hizentra®, in the Treatment of CIDP
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.”
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.
Hizentra® (Immune Globulin Subcutaneous [Human]), part of the immunoglobulin (Ig) franchise of CSL Behring, is the first and only 20 percent SCIg developed for subcutaneous use and approved in the United States. It is also registered in Europe and Canada. Hizentra is stable at 25 degrees C (77 degrees F) for 30 months due to formulation with L-proline.
CSL Behring manufactures Hizentra at its state-of-the art facility in Bern, Switzerland, where advanced technologies are applied to help ensure product safety and ample supply. This facility represents the long-term commitment of CSL Behring to global Ig markets. CSL Behring’s comprehensive Ig product portfolio also includes the first U.S. FDA-approved subcutaneous immunoglobulin and the first proline-stabilized intravenous immunoglobulin.
In the United States, Hizentra is indicated as replacement therapy for patients with primary immunodeficiency (PI). (In Europe and Canada, Hizentra is indicated for PI and for secondary immunodeficiency.) It is contraindicated in individuals with a history of anaphylactic or severe systemic response to immune globulin preparations or components of Hizentra, and in persons with selective immunoglobulin A deficiency who have known antibody against IgA and a history of hypersensitivity. Because Hizentra contains the stabilizer L-proline, it is contraindicated in patients with hyperprolinemia.
Hizentra should be administered subcutaneously only.
If anaphylactic reactions are suspected, administration should be discontinued immediately and the patient treated as medically appropriate. The most common drug-related adverse reactions (observed in 5% or more of study subjects receiving Hizentra) were local reactions at the injection site, headache, diarrhea, fatigue, back pain, nausea, extremity pain, cough, rash, pruritis, vomiting, upper abdominal pain, pain, and migraine.
Monitor patients for reactions associated with IVIg treatment that might occur with Hizentra, including renal dysfunction/failure, thrombotic events, aseptic meningitis syndrome (AMS), hemolysis and transfusion-related acute lung injury (TRALI).
Hizentra is derived from human plasma. The risk of transmission of infectious agents including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent, cannot be eliminated completely.
For more information about use in the United States, visit www.hizentra.com. For full U.S. prescribing information, visit www.hizentra.com/consumer/prescribing-information.aspx.
About CSL Behring
CSL Behring is a leader in the plasma protein therapeutics industry. Committed to saving lives and improving the quality of life for people with rare and serious diseases, the company manufactures and markets a range of plasma-derived and recombinant therapies worldwide. CSL Behring therapies are indicated for the treatment of coagulation disorders including hemophilia and von Willebrand disease, primary immune deficiencies, hereditary angioedema and inherited respiratory disease. The company’s products are also used in cardiac surgery, organ transplantation, burn treatment and to prevent hemolytic diseases in newborns. CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. CSL Behring is a subsidiary of CSL Limited (ASX: CSL), a biopharmaceutical company headquartered in Melbourne, Australia. For more information, visit www.cslbehring.com.
SOURCE CSL Behring