PARAMUS, N.J. (December 2, 2020) - Clinical research presented by Octapharma USA at the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition will highlight the investigational use of high-dose Octagam® 10% [Immune Globulin Intravenous (Human)] for the most severe COVID-19 patients. Octapharma's intravenous immunoglobulin (IVIg) portfolio also will be featured in a study design poster focused on primary infection prophylaxis in patients with chronic lymphocytic leukemia during ASH, to be held virtually December 5 - 8 due to the coronavirus pandemic.
The poster, "Use of Intravenous Immunoglobulin Therapy Reduces Progression to Mechanical Ventilation in COVID?19 Patients with Moderate to Severe Hypoxia," reports on a randomized open label study that evaluated the standard of care (SOC) plus high-dose Octagam® 10% compared to SOC alone in the treatment of COVID-19 infection. The study enrolled 33 COVID-19 patients experiencing hypoxia who were at risk of requiring mechanical ventilation. The investigator-initiated study (IIS) reported that IVIg significantly improved hypoxia and reduced hospital length of stay and progression to mechanical ventilation in patients with COVID-19 pneumonia. Principal investigator: George Sakoulas, M.D. of Sharp Memorial Hospital and the Sharp Rees-Stealy Medical Group in San Diego, Calif.
"IVIg has been used to treat patients with immune-mediated diseases for almost 40 years," said Octapharma USA President Flemming Nielsen. "Octapharma is very pleased to share this research with colleagues at ASH. Our team believes the use of IVIg in the prophylaxis of severe infections, especially in immunocompromised patients, may be an attractive therapeutic possibility for COVID-19."
Octapharma USA is conducting a larger multicenter, randomized, double-blind, placebo-controlled study approved by the U.S. Food and Drug Administration (FDA) under an Investigational New Drug Application. The primary objective of this study is to determine if high-dose Octagam® 10% therapy will slow or stop respiratory deterioration in patients with severe coronavirus disease. The secondary objectives of the study are to measure the effects of a high-dose of Octagam® 10% on slowing or stopping the clinical progression of COVID-19 by improving pulmonary function, quality of life, and correlated impact on metabolic factors. For more information, please visit clinicaltrials.gov (NCT04411667).
The investigational use of IVIg in Lymphocytic Leukemia is the focus of an Octapharma study design poster to be presented at ASH entitled, "The Prosid Study: Evaluating Efficacy and Safety of Intravenous Immunoglobulin 10% in Primary Infection Prophylaxis in Patients with Chronic Lymphocytic Leukemia." Secondary immunodeficiency (SID) occurs, among other reasons, as a consequence of hematological malignancies, most commonly in chronic lymphocytic leukemia (CLL) and multiple myeloma. About 25% of patients present with SID at diagnosis of CLL and this incidence may increase to 85% during the course of disease. This increase is also due to recent advances in CLL therapy leading to cumulative immunosuppression. Infections are the main cause of morbidity and mortality in CLL patients, causing between 30% and 50% of deaths within the first year after diagnosis. IVIg is established as secondary prophylaxis to reduce infectious complications in patients with hypogammaglobulinemia. To date, no large randomized study has established efficacy of IVIg as primary prophylaxis in CLL patients with hypogammaglobulinemia although several small studies suggest an up to four-fold reduction of infection rates. This prospective, placebo-controlled study will evaluate the efficacy and safety of IVIg 10% as primary prophylaxis of infections in CLL patients with SID in a large clinical setting for the first time. Principal investigator: Anthony Mato, MD, MSCE, Memorial Sloan Kettering Cancer Center, New York, N.Y.
For more information on the ASH annual meeting, please visit hematology.org.
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About Octagam® 10%
Octagam® 10% [Immune Globulin Intravenous (Human)] is an immune globulin intravenous (human) liquid preparation indicated for the treatment of chronic immune thrombocytopenic purpura (ITP) in adults.
WARNINGS
Thrombosis may occur with immune globulin intravenous (IGIV) products, including Octagam® 10%. 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 immune globulin intravenous (Human) (IGIV) products in predisposed patients. Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products containing sucrose. Octagam® 10% does not contain sucrose. For patients at risk of thrombosis, renal dysfunction or renal failure, administer Octagam® 10% 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. For full prescribing information, including complete boxed warning and other important information, please visit octagamus.net.
About the Octapharma Group
Headquartered in Lachen, Switzerland, Octapharma is one of the largest human protein products manufacturers in the world and has been committed to patient care and medical innovation since 1983. Its core business is the development and production of human proteins from human plasma and human cell lines. Octapharma employs more than 10,000 people worldwide to support the treatment of patients in over 115 countries with products across the following therapeutic areas: Hematology (coagulation disorders), Immunotherapy (immune disorders) and Critical Care. The company's American subsidiary, Octapharma USA, is located in Paramus, N.J. Octapharma operates three state-of-the-art production sites licensed by the U.S. Food and Drug Administration (FDA), providing a high level of production flexibility. For more information, please visit http://www.octapharmausa.com.
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