Announcement • Jul 13
Kamada Ltd. Highlights CYTOGAM Study Results Presented at The 2026 ISHLT Annual Meeting
Kamada Ltd. highlighted results of an Investigator-Initiated Study recently presented at the 2026 International Society for Heart and Lung Transplant (ISHLT) annual meeting, held in Toronto, Canada. The study results were presented by Dr. Daniel Calabrese, MD, Associate Professor of Medicine at the UCSF Lung Transplant Program. The study is part of a comprehensive post-marketing research program aimed at generating key data in support of the benefits of CYTOGAM, the Company’s Cytomegalovirus Immune Globulin (CMVIG), in the management of cytomegalovirus (CMV) in solid organ transplantation. The translational and observational clinical study results were presented as three posters. In a retrospective analysis of clinical data, researchers found that among CMV high-risk lung transplant recipients, patients who did not receive CMVIG prophylaxis experienced worse clinical outcomes compared with those who received CMVIG prophylaxis and other CMV serotype groups. A paired analysis of patient blood cells found less activated innate immune cells in the group that received CMVIG prophylaxis. These results build on a hypothesis that CMVIG may interrupt an injurious innate immune response against the allograft. In a non-clinical in-vivo model, researchers found that key innate immune cells were increased after acute lung injury and that CMVIG blunted lung injury and improved mortality. Together, these data underscore the clinical relevance of this high-risk population and the potential mechanistic and clinical roles of CMVIG as a targeted intervention. Collectively, these data may shift the paradigm of how CMV in the lung transplant setting, where CMV carries risk of reactivation but also graft injury, is understood. The finding that CMVIG is associated with immune modulation, in addition to effects on CMV viremia alone, may also suggest additional benefit. The results presented by Dr. Calabrese are consistent with a prior Investigator-Initiated Study conducted by Fernando Torres, M.D., Clinical Chief, Division of Pulmonary and Critical Care at University of Texas Southwestern Medical Center and presented at IDWeek 2023. This five-year retrospective study consisted of 324 lung-transplant patients, evaluating the real-world use of CYTOGAM in combination with anti-viral agents for the prevention of CMV disease in high-risk CMV mismatch lung transplant recipients. The results demonstrated an association between a proactive multimodality CMV prophylaxis approach consisting of antivirals and immune augmentation with CMV immunoglobulin and improved outcomes among high-risk CMV mismatch lung transplant recipients. The translational and observational clinical study results were presented as three posters: Reeves JN, et al. “CMV Immunoglobulin Is Associated with Improved Peak Lung Function and Better CLAD-Free Survival.” Poster presentation with senior authorship by Calabrese DR at the International Society for Heart and Lung Transplantation (ISHLT) 2026 Annual Meeting; Toronto, Canada. Shemesh A, et al. “Reduced NK Cell Activation in Lung Transplant Recipients Treated with Cytomegalovirus Immunoglobulin.” Poster presentation with senior authorship by Calabrese DR at the International Society for Heart and Lung Transplantation (ISHLT) 2026 Annual Meeting; Toronto, Canada. Bharti R, et al. “Lung Ischemia Reperfusion Injury Is Amplified by Latent Cytomegalovirus in an NK Cell-Dependent Manner.” Poster presentation with senior authorship by Calabrese DR at the International Society for Heart and Lung Transplantation (ISHLT) 2026 Annual Meeting; Toronto, Canada. CYTOGAM (Cytomegalovirus Immune Globulin Intravenous [Human]) (CMV-IGIV) is indicated for the prophylaxis of cytomegalovirus disease associated with the transplantation of the kidney, lung, pancreas and heart. The product is the sole FDA-approved immunoglobulin (IgG) product for this indication. CYTOGAM is contraindicated in individuals with a history of a prior severe reaction associated with the administration of this or other human immunoglobulin preparations. People with selective immunoglobulin A deficiency have the potential for developing antibodies to immunoglobulin A and could have anaphylactic reactions to subsequent administration of blood products that contain immunoglobulin A, including CYTOGAM. Immune Globulin Intravenous (Human) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis and death. Patients predisposed to acute renal failure include patients with any degree of preexisting renal insufficiency, diabetes mellitus, age greater than 65, volume depletion, sepsis, paraproteinemia, or patients receiving known nephrotoxic drugs. Especially in such patients, IGIV products should be administered at the minimum concentrations available and the minimum rate of infusion practicable. Agents containing sucrose as a stabilizer (CYTOGAM contains sucrose) have been associated with reports of renal dysfunction given at daily doses of 350 mg/kg or greater. During administration, the patient’s vital signs should be monitored continuously, and careful observation made for any symptoms throughout the infusion. Epinephrine and diphenhydramine should be available for the treatment of an acute anaphylactic reaction. Increases in serum creatinine and blood urea nitrogen (BUN) have been observed as soon as one to two days following IGIV infusion. Progression to oliguria or anuria requiring dialysis has been observed. Immune Globulin Intravenous (Human) products can contain blood group antibodies which may act as hemolysins and induce in vivo coating of red blood cells with immunoglobulin, causing a positive direct antiglobulin reaction and, rarely, hemolysis. CYTOGAM 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. Minor reactions, such as flushing, chills, muscle cramps, back pain, fever, nausea, vomiting, arthralgia, and wheezing, were the most frequent adverse reactions observed during the clinical trials for CYTOGAM.
