CSL Behring completes enrollment for Phase III registration trial of next generation of subcutaneous immunoglobulin
Clinical trial of IgPro20 for primary immune deficiency moves ahead
King of Prussia. PA — 12 July 2007
CSL Behring announced today that it has completed patient enrollment for a Phase III clinical trial of a 20 percent formulation of subcutaneous immunoglobulin (SCIg) to treat patients with primary immune deficiency (PI) who require immunoglobulin replacement therapy. The study will assess the efficacy, tolerability, safety and pharmacokinetics of SCIg stabilized with proline (IgPro20) in subjects with PI. A multicenter, open-label, registration trial, the study incorporates 13 sites across the United States, with 54 patients now enrolled.
“We are pleased to have completed enrollment in this important trial,” said Paul Perreault, Executive Vice President of Worldwide Commercial Operations at CSL Behring. “With this achievement, CSL Behring further secures its leadership position in advancing life-saving subcutaneous immunoglobulin therapies.”
Data from the trial will support a market application submission to the U.S. Food and Drug Administration.
The IgPro20 study will evaluate the rate of serious bacterial infections (SBIs) in male and female subjects diagnosed with primary immunodeficiency, ranging in age from 2 to 75 years old. SBIs are defined to include: bacterial pneumonia, bacteremia and septicemia, osteomyelitis/septic arthritis, bacterial meningitis and visceral abscess. The trial will also aim to show non-inferiority in steady-state area under the curve (AUC) of immunoglobulin G (IgG) levels of weekly subcutaneous infusions of IgG with proline (IgPro20) compared to the previous 3 or 4 weekly intravenous treatments.
About Subcutaneous Immunoglobulin
In January 2006, CSL Behring introduced Vivaglobin® (Immune Globulin Subcutaneous [Human]) to patients in the US. Vivaglobin is the first and only FDA-approved subcutaneous IgG replacement therapy for treating patients with primary immune deficiency. It delivers treatment directly under the skin (subcutaneously), offering a safe and effective alternative to intravenous infusions of immunoglobulin.
Vivaglobin provides another treatment option for patients who do not easily tolerate administration by intravenous infusion because they have poor venous access or experience serious side effects. Vivaglobin is also appropriate for patients who (with physician approval) want the freedom and convenience of safe home self-administration of IgG replacement therapy.
About Primary Immune Deficiency (PI)
Primary immune deficiency (PI) is a usually genetic group of disorders affecting an estimated 50,000 Americans. These disorders compromise the immune system, leaving patients vulnerable to recurrent, life-threatening infections.
Immunoglobulin is a life-sustaining blood product that has become standard immune replacement therapy for most people diagnosed with PI; nearly 70% of PI patients receive Ig replacement therapy. Since the 1980s, the first-line therapy for most PI patients in the U.S. has been intravenous immunoglobulin (IVIg), in which a pump delivers the immunoglobulin through a needle into the vein. Experience has shown IVIg to be an effective, safe, life-saving treatment. However, many patients do not easily tolerate intravenous infusions because they have poor venous access or they experience serious side effects. Vivaglobin allows patients to use a small, portable pump to self-administer their weekly subcutaneous infusions. With weekly administration of Vivaglobin, peak serum Ig levels are lower than those achieved with IVIg; however, Vivaglobin provides greater stability steady-state serum Ig levels. This serum Ig profile for Vivaglobin is representative of that seen in a normal population.
Important Safety Information About Vivaglobin
As with all immunoglobulin products, Vivaglobin is contraindicated in individuals with a history of anaphylactic or severe systemic response to immunoglobulin preparations and in persons with selective immunoglobulin A deficiency who have known antibody against IgA. If anaphylactic or anaphylactoid reactions are suspected, discontinue administration immediately and treat as medically appropriate.
Vivaglobin is derived from human plasma. As with all plasma-derived products, the risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent, cannot be completely eliminated.
In clinical trials, the most frequent adverse event was injection-site reaction, consisting of mild or moderate swelling, redness, and itching. No serious local site reactions were observed, and reactions tended to decrease substantially after repeated use. Other adverse events irrespective of causality included headache, gastrointestinal disorder, fever, nausea, sore throat, and rash.
As with all immunoglobulin (Ig) products, patients receiving Ig therapy for the first time, receiving a new product, or not having received Ig therapy within the preceding eight weeks may be at risk for developing reactions including fever, chills, nausea, and vomiting. On rare occasions, these reactions may lead to shock. Such patients should be monitored in a clinical setting during the initial administration.
Ig administration can transiently impair the efficacy of live attenuated virus vaccines, such as measles, mumps and rubella.
In clinical studies, administration of Vivaglobin has been shown to be safe and well tolerated in both adult and pediatric subjects. No pediatric-specific dose requirements were necessary to achieve the desired serum IgG levels. Safety and efficacy were not studied in pediatric subjects under two years of age.
In clinical studies, Vivaglobin has been shown to be safe in both adults and children over 2 years of age. As with any medication, side effects may accompany treatment.
The frequency of side effects was based on a review of more than 3,600 injections given during the clinical trial in the United States and Canada. The most frequently reported side effect was injection-/infusion-site reaction, which generally consisted of mild or moderate swelling, redness, and itching at the site of injection/infusion. In clinical trials, these reactions tended to decrease substantially after repeated use.
The most frequent adverse events reported by subjects irrespective of causality included headache, gastrointestinal disorder, fever, nausea, sore throat, rash, allergic reaction, pain, diarrhea and increased cough.
Because Vivaglobin is made from plasma, as are all commercial immunoglobulins, the risk of transmitting infectious agents, including viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent, cannot be completely eliminated.
For more details and complete prescribing information on Vivaglobin, please visit www.vivaglobin.com, or call the CSL Behring Medical Information Department at 1-800-504-5434.
About CSL Behring
CSL Behring is a global leader in the plasma protein biotherapeutics industry. Passionate about saving and improving the quality of patients' lives, CSL Behring manufactures and markets a range of safe and effective plasma-derived and recombinant products and related services. The company's therapies are used in the treatment of rare diseases such as immune deficiency disorders, hemophilia, von Willebrand disease, other bleeding disorders and inherited emphysema. Other products are used for the prevention of hemolytic diseases in the newborn, in cardiac surgery, organ transplantation and in the treatment of burns. The company also operates one of the world's largest plasma collection networks, ZLB Plasma. CSL Behring is a subsidiary of CSL Limited, a biopharmaceutical company with headquarters in Melbourne, Australia. For more information, visit www.cslbehring.com.
Sheila A. Burke, Director Public Relations & Communications
Worldwide Commercial Operations, CSL Behring
1020 First Avenue, King of Prussia, PA 19406-0901