Sub-Analysis of Phase III Study Suggests More than Single Treatment may be Required for Therapeutic Response in Some Patients with CIDP
RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--Sep 23, 2008 - A study of a treatment for chronic inflammatory demyelinating neuropathy (CIDP) suggests that 50 percent of the patients who responded to treatment with Gamunex (Immune Globulin Intravenous (Human), 10% Caprylate/Chromatography Purified) required two treatments before they first exhibited improvements on a standard disability measurement scale, according to data presented at the American Neurological Association meeting in Salt Lake City, Utah. The study authors concluded that "further studies in CIDP are warranted to more clearly define the duration of treatment required to achieve and maintain maximal response to IVIG therapy."
The study of CIDP, a neurological condition that damages peripheral nerves and causes progressive muscle weakness in the arms and legs, was funded by Talecris Biotherapeutics, Inc. in Research Triangle Park, NC.
In yesterday's poster presentation, study author Norman Latov, M.D. from Cornell University, reported that among the patients who responded to IGIV-C therapy, 41 percent (13 patients) improved after the first treatment course (day 16), and 94 percent (30 patients) improved after the second treatment course (week 6). The remaining two individuals treated with IGIV-C who were stable at week 6, improved by weeks 12 and 18. A percentage of responders continued to show improvements on a disability measurement scale after week 6 of treatment, the study showed.
"Our data suggest that some patients may require more than one treatment course to achieve clinical response and additional IGIV-C treatments might clinically benefit a substantial number of CIDP patients," according the study authors.
In the poster presented yesterday, the data describe 117 patients who received Gamunex(R) or placebo every three weeks for up to 24 weeks. Clinical status, including INCAT (inflammatory neuropathy cause and treatment) disability score, was evaluated at day 16 and every 3 weeks. Response to therapy was defined as greater than or equal to one point improvement from baseline in adjusted INCAT score.
The data reported at the Association meeting is a sub-analysis of a larger Phase III study published in the Feb. 2008 issue of The Lancet Neurology. Results of that study were used to support the recent approval of Gamunex by the U.S. Food and Drug Administration as a treatment for CIDP.
Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) is a neurological disorder often characterized by progressive weakness and impaired sensory function in the legs and arms. This disorder is caused by damage to the myelin sheath (the fatty covering that wraps around and protects nerve fibers) of the peripheral nerves. Signs and symptoms -- which usually develop slowly over weeks and progress over several months -- may include weakness of the arms, legs and face; tingling and numbness in the arms and legs (often beginning in the fingers and toes); as well as muscle aches and fatigue.
CIDP, affecting two to seven individuals per 100,000 worldwide, can occur at any age and in both genders, although it is more common in young adults and in men.
Gamunex is an IGIV therapy that contains antibodies purified from the donated blood plasma of thousands of people. Gamunex is indicated as replacement therapy of primary humoral immunodeficiency disease (PI), and as immunomodulatory therapy for both idiopathic thrombocytopenic purpura (ITP) and chronic inflammatory demyelinating polyneuropathy (CIDP).
Important Safety Information
Gamunex is contraindicated in individuals with known anaphylactic or severe systemic response to Immune Globulin (Human). Immune Globulin Intravenous (Human) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis and death. Patients should be instructed to immediately report symptoms of decreased urine output, sudden weight gain, fluid retention/edema, and/or shortness of breath (which may suggest kidney damage) to their physicians. While these reports of renal dysfunction and acute renal failure have been associated with the use of many of the licensed IGIV products, those containing sucrose as a stabilizer accounted for a disproportionate share of the total number. Gamunex does not contain sucrose. Glycine, a natural amino acid, is used as a stabilizer.
There have been reports of noncardiogenic pulmonary edema, rare reports of hemolytic anemia, and very rare reports of aseptic meningitis in patients administered with IGIV. Thrombotic events have been reported in association with IGIV. Patients at risk may include those with a history of atherosclerosis, multiple cardiovascular risk factors, advanced age, impaired cardiac output, and/or known or suspected hyperviscosity. The most common side effects noted during clinical trials included headache, vomiting, fever, nausea, rash, and back pain. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
As with all plasma-derived therapeutics, the potential to transmit infectious agents cannot be totally eliminated.
For additional information about Gamunex, please see www.gamunex.com for Full Prescribing Information. The package insert is currently being revised to incorporate the CIDP indication and supporting information.
About Talecris Biotherapeutics: Inspiration. Dedication. Innovation.
Talecris Biotherapeutics is a global biotherapeutic and biotechnology company that discovers, develops and produces critical care treatments for people with life-threatening disorders in a variety of therapeutic areas including immunology, pulmonology, and hemostasis. Talecris is proudly building upon a 60-year legacy of innovation and a commitment to improving the lives of people who rely on its therapeutic products. With an emphasis on scientific inquiry and technological excellence, Talecris is expanding its current portfolio of products, programs, and services through its own world-class product development organization as well as through strategic initiatives that leverage its strengths with those of its partners.
Talecris, with revenues of approximately $1.2 billion in 2007, is headquartered in biotech hub Research Triangle Park, N.C., and employs more than 4,500 talented people worldwide.
To learn more about Talecris and how its employees are making a difference in the lives of patients and the healthcare community, visit www.talecris.com.
Wendy Wilson, 919-316-2430
Posted: September 2008