New Data Show IgPro20 Delivers Highest Available Subcutaneous Ig Concentration with Tolerability Comparable to Current Treatments
King of Prussia, PA — 01 March 2010
Data presented today show that IgPro20, the first 20 percent liquid formulation, delivers a higher concentration of treatment, with no trade-off in terms of local tolerability relative to currently marketed subcutaneous immunoglobulin (SCIg) products. The data were presented at the American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting in New Orleans, LA, US.
The data were based on the results of a randomized, double-blind, 4-way cross-over study of 28 healthy volunteers who received 16 percent subcutaneous IG (15mL), IgPro16 (15mL), IgPro20 (12mL) and IgPro20 (15mL) at infusion rates of 25 mL per hour. Local tolerability was evaluated “assessment blinded” at 6 time points during and up to 72 hours after the end of infusion. Tolerability was assessed by evaluation of local pain, erythema, edema/induration, local heat and itching at the injection site. No differences were observed between the products in terms of local tolerability, laboratory or adverse event profile.
Othmar Zenker, MD, Head of Clinical Therapeutic Area Immunology & Pulmonology, CSL Behring GmbH, Germany stated: “These data show that IgPro20 delivers a high concentration of IgG while maintaining comparable tolerability.”
A separate study, also presented today at AAAAI, shows that L-proline stabilized IgPro20, can be stored at room temperature for at least 24 months without loss of functionality and purity. The data further suggest that the addition of stabilizer L-proline, a naturally occurring amino acid, to IgPro20 decreases the product’s viscosity when compared to solution without L-proline.
Dr. Zenker adds: “Room temperature storage further increases the convenience of this treatment option compared with other products.”
Primary immunodeficiencies (PIs) are a group of nearly 100 types of disorder that result from the defective development and maturation of the immune system. The clinical hallmark of these disorders is increased susceptibility to infection. Immunoglobulin replacement therapy is indicated for patients who suffer from recurrent infections due to a lack of protective antibodies. Repeated infections can lead to organ damage, which over time can become life-threatening. In some severe cases of PI, infections may result in a patient being hospitalized repeatedly. Some infections, such as meningitis, can even result in death. Most types of PI are inherited, but in some cases the cause is unknown.
No single treatment works for all types of PI. Infusions of replacement antibodies (immunoglobulins) can help supplement the immune system to prevent infection in the nearly three-quarters of people living with PI whose disease is due to an antibody deficiency.
IgPro20 is currently being reviewed by the FDA for use as weekly immunoglobulin replacement therapy in patients with PI. If approved, it will represent a new treatment option for patients who want the freedom and convenience of self-administering their replacement therapy.
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 recombinant therapies worldwide. CSL Behring therapies are indicated for the treatment of coagulation disorders including hemophilia and von Willebrand disease, primary immune deficiencies 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.
Sheila A. Burke, Director,
Communications & Public Relations
Worldwide Commercial Operations
Tel: +44 207 067 0307