Octapharma Enrolling More Patients and Sites for PANS/PANDAS Multicenter Superiority Study Utilizing panzyga®
Immunoglobulin National Society Organizing PANS/PANDAS Breakfast Symposium Supported by Octapharma USA
PARAMUS, N.J. , March 23, 2023 /PRNewswire/ -- Octapharma USA has provided a grant for an educational program on pediatric acute-onset neuropsychiatric syndrome (PANS) and PANDAS, a subset of PANS associated with strep, to be held during the National Home Infusion Association (NHIA) Annual Conference scheduled for March 25 – 27 in Washington, D.C.
Octapharma is enrolling more patients and sites for its phase 3 multicenter superiority study comparing the effectiveness of panzyga® (immune globulin intravenous, human - ifas) 10% liquid preparation versus placebo in patients with the disorder. PANS is diagnosed in children who experience sudden dramatic, often overnight, onset of obsessive-compulsive symptoms and/or severe eating restrictions, along with at least two other cognitive, behavioral, or neurological symptoms. Brain inflammation can occur when the body's immune system mistakenly attacks healthy brain cells.
The Octapharma educational grant supports the Immunoglobulin National Society (IgNS) breakfast symposium, "PANS/PANDAS in Children: Controversies, Evidence, Research and Treatment Guidelines for Challenging Cases," to be held Monday, March 27th at 7:30 a.m. The educational session will be presented by Michael Daines, M.D. and Sydney A. Rice, M.D., both of the University of Arizona College of Medicine Tucson and investigators leading the Octapharma PANS/PANDAS clinical trial. The program will focus on the criteria for diagnosis, the pathogenic mechanism, and current treatment options. Interactive case studies will allow audience participation in diagnosing and treating these challenging cases.
"Octapharma is looking forward to sharing valuable information on PANS/PANDAS with NHIA attendees," said Octapharma USA President Flemming Nielsen. "We encourage medical providers to attend the conference and the breakfast symposium. We are hopeful that panzyga® in the future can make a difference in the lives of children and adolescents impacted by these autoimmune disorders."
Octapharma is enrolling patients from age 6 to 17 with a confirmed diagnosis of moderate to severe PANS in the prospective, randomized, double-blind, parallel group, placebo-controlled superiority study. The primary objective of the trial is to evaluate if panzyga® is superior to placebo (0.9% w/v sodium chloride) for reducing the severity of symptoms associated with PANS in pediatric patients. The secondary objectives of this study are to determine the sustainability of the reduction of the severity of symptoms in pediatric patients treated with panzyga®; and to assess the efficacy of panzyga® treatment in reducing functional impairment associated with PANS.
The study will include three infusions of panzyga® or placebo administered over two days every three weeks for a total of nine weeks, with an additional double-blind, crossover safety and efficacy follow-up phase of three infusions of panzyga® or placebo administered over two days every three weeks for a total of nine weeks. The trial will be conducted in a two-stage adaptive design with one interim analysis. An unblinded interim analysis will be performed by an independent statistician after 40 patients have completed the first nine-week treatment period, to adjust sample size, if required. The study team will remain blinded until the end of the study.
For more study information, please contact Huub Kreuwel, Ph.D., Octapharma USA, Vice President of Scientific and Medical Affairs, at [email protected] or visit ClinicalTrials.gov (Identifier: NCT04508530).
About
panzyga®
Panzyga® is an immune globulin intravenous (human) - ifas 10% liquid preparation indicated for the treatment of primary humoral immunodeficiency (PI) in patients two years of age and older; chronic immune thrombocytopenia (ITP) in adults; and chronic inflammatory demyelinating polyneuropathy (CIDP) in adults.
WARNING: THROMBOSIS, RENAL DYSFUNCTION, and ACUTE RENAL FAILURE
Thrombosis may occur with immune globulin intravenous (IGIV) products, including panzyga®. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling vascular catheters, hyperviscosity, and cardiovascular risk factors.
Renal dysfunction, acute renal failure, osmotic nephropathy, and death may occur with the administration of IGIV products in predisposed patients. Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products containing sucrose. Panzyga® does not contain sucrose.
For patients at risk of thrombosis, renal dysfunction, or renal failure, administer panzyga® at the minimum infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity.
Please see full prescribing information for complete boxed warning at .
About the Octapharma Group
Headquartered in Lachen, Switzerland, Octapharma is one of the largest human protein manufacturers in the world, developing and producing human proteins from human plasma and human cell lines.
Octapharma employs more than 11,000 people worldwide to support the treatment of patients in 118 countries with products across three therapeutic areas: Hematology, Immunotherapy and Critical Care.
Octapharma has seven R&D sites and five state-of-the-art manufacturing facilities in Austria, France, Germany and Sweden, and operates more than 190 plasma donation centers across Europe and the US. The company's American subsidiary, Octapharma USA, is located in Paramus, N.J. For more information, please visit octapharmausa.com.
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