AiCuris announced today that its novel HCMV inhibitor AIC246 has been used successfully to treat a patient with multi-organ HCMV disease caused by multi-resistant virus. Details will be presented at the 48th IDSA meeting on October 23, presentation number LB-38.
"This is the first case, where HCMV disease has been treated and resolved the infection of the lung, the colon and the eyes under AIC246 therapy", says Susanne Stoelben, the responsible AiCuris physician for the drug. "While we designed AIC246 to be resistance-breaking and already knew from pre-clinical studies that it works against viruses resistant against all marketed drugs, we are very pleased to see this powerful result in a very difficult clinical situation" adds AiCuris CEO, Prof. Helga Rübsamen-Schaeff. In a previous phase IIa trial, the compound had already shown very good activity against multi-resistant HCMV in a pre-emptive setting, in which no disease had been present, yet.
The compound currently is being tested in a phase IIb trial, in which stem cell recipients at risk for developing HCMV viraemia and disease are being treated prophylactically after transplantation. "The trial is well underway in the US and Germany and we are now looking forward to see, if the drug will also show powerful suppression of viraemia in a prophylactic setting" comments Dr. Holger Zimmermann, CSO of AiCuris.
About HCMV
Human cytomegalovirus (HCMV), a beta herpes virus, represents an important pathogen for immune compromised individuals. It is the most common virus pathogen in solid organ transplant recipients (kidney, heart, liver, lung and pancreas) as well as bone marrow transplant recipients and is the major cause of morbidity and mortality during the first six months after transplantation.
Besides transplant recipients, newborn children are highly threatened by HCMV infections. The infection might be acquired before, during or after birth. Because of the side effects of presently available drugs against HCMV, it is nearly impossible to treat these children. Neither can pregnant women with an active HCMV infection be treated.
Patients with AIDS might suffer from a HCMV infection if HIV has already caused a massive immune deficiency. In these patients, the virus might lead to blindness as well as to life threatening pneumonia. Thanks to HAART, severe AIDS cases have become rare in the Western world. But in countries where not everybody has access to anti-viral medication, these consequences are more common.
Apart from immune compromised patients, another group of individuals may also become affected by HCMV: Lately, an American research group found that HCMV also poses a risk to patients under intensive care (e.g. after heart attack, suspected sepsis or burn). In this patient group, an active HCMV infection was associated with longer hospital detention and death. Increasing evidence is accumulating that even a subclinical HCMV replication may be harmful, as HCMV is immune-suppressive.
CMV disease is characterised by fever, leucopenia (very low white blood cells) and thrombocytopenia (very low platelet numbers) with or without specific organ dysfunction. Two main strategies to prevent CMV disease have been adopted: prophylaxis of organ recipients with antiviral agents, or pre-emptive treatment of organ recipients, who develop evidence of CMV infection during routine screening.
"This is the first case, where HCMV disease has been treated and resolved the infection of the lung, the colon and the eyes under AIC246 therapy", says Susanne Stoelben, the responsible AiCuris physician for the drug. "While we designed AIC246 to be resistance-breaking and already knew from pre-clinical studies that it works against viruses resistant against all marketed drugs, we are very pleased to see this powerful result in a very difficult clinical situation" adds AiCuris CEO, Prof. Helga Rübsamen-Schaeff. In a previous phase IIa trial, the compound had already shown very good activity against multi-resistant HCMV in a pre-emptive setting, in which no disease had been present, yet.
The compound currently is being tested in a phase IIb trial, in which stem cell recipients at risk for developing HCMV viraemia and disease are being treated prophylactically after transplantation. "The trial is well underway in the US and Germany and we are now looking forward to see, if the drug will also show powerful suppression of viraemia in a prophylactic setting" comments Dr. Holger Zimmermann, CSO of AiCuris.
About HCMV
Human cytomegalovirus (HCMV), a beta herpes virus, represents an important pathogen for immune compromised individuals. It is the most common virus pathogen in solid organ transplant recipients (kidney, heart, liver, lung and pancreas) as well as bone marrow transplant recipients and is the major cause of morbidity and mortality during the first six months after transplantation.
Besides transplant recipients, newborn children are highly threatened by HCMV infections. The infection might be acquired before, during or after birth. Because of the side effects of presently available drugs against HCMV, it is nearly impossible to treat these children. Neither can pregnant women with an active HCMV infection be treated.
Patients with AIDS might suffer from a HCMV infection if HIV has already caused a massive immune deficiency. In these patients, the virus might lead to blindness as well as to life threatening pneumonia. Thanks to HAART, severe AIDS cases have become rare in the Western world. But in countries where not everybody has access to anti-viral medication, these consequences are more common.
Apart from immune compromised patients, another group of individuals may also become affected by HCMV: Lately, an American research group found that HCMV also poses a risk to patients under intensive care (e.g. after heart attack, suspected sepsis or burn). In this patient group, an active HCMV infection was associated with longer hospital detention and death. Increasing evidence is accumulating that even a subclinical HCMV replication may be harmful, as HCMV is immune-suppressive.
CMV disease is characterised by fever, leucopenia (very low white blood cells) and thrombocytopenia (very low platelet numbers) with or without specific organ dysfunction. Two main strategies to prevent CMV disease have been adopted: prophylaxis of organ recipients with antiviral agents, or pre-emptive treatment of organ recipients, who develop evidence of CMV infection during routine screening.
