Biotest AG: Efficacy and safety of Cytotect(R) CP was demonstrated in patients after stem cell transplantation
News: Biotest AG / Key word(s): Research Update
Efficacy and safety of Cytotect(R) CP was demonstrated in patients after stem cell transplantation
- 78% of "difficult-to-treat" patients responded to Cytotect(R) CP administration
- 70% of patients cleared CMV infection to undetectable levels
- Good tolerability confirmed
A recently published retrospective data collection from France highlights the benefit of Cytotect(R) CP, a CMV-specific hyperimmunoglobulin, for treatment of CMV in HSCT patients. This is the first study that investigated the efficacy and safety of Cytotect(R) 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(R) 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(R) 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(R) 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(R) 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(R) CP is also marketed under the brand name Megalotect(R) in some countries. Biotest currently is in a process of applying for approval for Cytotect(R) CP in additional markets.
About Cytotect(R) CP
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