• 78% of “difficult-to-treat” patients responded to Cytotect® CP administration
  • 70% of patients cleared CMV infection to undetectable levels
  • Good tolerability confirmed

DREIEICH, Germany I May 23, 2018 I Cytomegalovirus (CMV) infection is a frequent complication leading to significant morbidity and mortality in patients after hematopoietic stem cell transplantation (HSCT). Approximately, 40,000 stem cell transplantations are performed in Europe annually, most often to treat certain types of blood cancers, such as myeloma or leukaemia. A recently published retrospective data collection from France highlights the benefit of Cytotect® CP, a CMV-specific hyperimmunoglobulin, for treatment of CMV in HSCT patients.1 . This is the first study that investigated the efficacy and safety of Cytotect® CP in patients with CMV infection in case of antiviral failure or resistance after HSCT from a genetically different (allogeneic) donor. Almost 50% of all stem cell transplantations are performed in the allogeneic setting. In France, Cytotect® CP can only be administered on a named-patient basis as last-line therapy in the compassionate use setting.

The study was designed as a retrospective data analysis and included 23 allogeneic HSCT patients from eight French transplant centres. High-risk patients received Cytotect® CP after failure of antiviral drugs. In those patients, no clinically significant adverse events were observed due to administration of the CMV-specific hyperimmunoglobulin. The overall response rate in patients was 78%. Notably, 16/23 patients, i.e. 70% of all patients, cleared CMV infection, which is an excellent result considering the previous failure of alternative treatment approaches in those patients.

The authors of the study recommend Cytotect® CP to be considered not only in the last-line setting, but also as CMV prophylaxis after HSCT, where the unmet medical needs remain high. Cytotect® CP is authorised in more than 15 countries for the prophylaxis of clinical manifestations of CMV infection in patients receiving immunosuppressive treatment, particularly transplant recipients.

Cytotect® CP is also marketed under the brand name Megalotect® in some countries. Biotest currently is in a process of applying for approval for Cytotect® CP in additional markets.

1 Alsuliman et al. “Cytotect® CP as salvage therapy in patients with CMV infection following allogeneic hematopoietic cell transplantation: a multicenter retrospective study”. Bone Marrow Transplant (2018)

About Cytotect® CP
Cytotect® CP is a cytomegalovirus (CMV)-specific hyperimmunoglobulin preparation with a high antibody titre against CMV. The product is approved for prophylaxis of clinical manifestations of CMV infection in patients subjected to immunosuppressive therapy, particularly in transplant recipients.

About Biotest
Biotest is a provider of plasma proteins and biological drugs. With a value added chain that extends from pre-clinical and clinical development to worldwide sales, Biotest has specialised primarily in the areas of clinical immunology, haematology and intensive medicine. Biotest develops and markets immunoglobulins, coagulation factors and albumins based on human blood plasma. These are used for diseases of the immune and haematopoietic systems. In addition Biotest develops monoclonal antibodies in the indications of cancer of plasma cells and systemic lupus erythematosus which are produced by recombinant technologies. Biotest has more than 1,600 employees worldwide. The preference shares of Biotest AG are listed in the SDAX on the Frankfurt stock exchange.

SOURCE: Biotest