BUSINESS WIRE: New Data Show IgPro20 Delivers Highest Available Subcutaneous
Ig Concentration
with Tolerability Comparable to Current Treatments
MITTEILUNG UEBERMITTELT VON BUSINESS WIRE. FUER DEN INHALT IST ALLEIN DAS
BERICHTENDE UNTERNEHMEN VERANTWORTLICH.
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KING OF PRUSSIA, Pa. --(BUSINESS WIRE)--01.03.2010--
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, 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 products 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 and 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.
[CT]
Kontakt: CSL Behring Sheila A. Burke, Director, Communications & Public
Relations Worldwide Commercial Operations Tel: 610-878-4209 Cell:
484-919-2618 Sheila.Burke@cslbehring.com or Weber Shandwick Emma
Spencer-Smith Tel: +44 207 067 0307 espencer-smith@webershandwick.com
Pressekontakt:
BUSINESS WIRE
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t. +49 (0)69-91 50 66-0
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Telefon: +49 69 50701-0
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E-Mail: info@vwd.com
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Montag, 1. März 2010
BUSINESS WIRE: New Data Show IgPro20 Delivers High...
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