AiCuris Receives Orphan Drug Designation for its Innovative Phase II Drug AIC246 for the Prevention of HCMV Disease
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|Thursday, 21 April 2011 09:45 (UTC + 2)|
“We are very pleased to have received Orphan Drug status for AIC246. This decision by the authorities confirms our view that this innovative drug will be of significant benefit to those at risk of developing HCMV disease which is a very serious and life-threatening condition. The Orphan Drug status will also support AiCuris in the development of AIC246 as it gives easier access to scientific support by the agencies, e.g. by advice during the product development phase” commented AiCuris CEO, Prof. Rübsamen-Schaeff.
“Clinicians and patients need an effective and safe means to treat HCMV with well tolerated drugs. Current treatment options suffer from dose-limiting toxicities and offer very few solutions to advance patient care, leaving these patients with a deteriorating disease condition, in particular after development of drug resistance. We believe that we are developing a therapy that will prove to be both effective and safe and at the same time remains efficacious, if resistance has developed against the marketed drugs”, added AiCuris CSO, Dr. Holger Zimmermann. “This will provide the patient with a much better treatment outcome.”
Besides transplant recipients, newborn children are highly threatened by HCMV infections. The infection can be acquired before, during or after birth and can lead to severe neurological damage or death. 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.
In addition, recent evidence shows that even when HIV patients are well-suppressed by HAART they may not be able to control HCMV very well and may, as a consequence, suffer from a chronic and deleterious inflammation caused by HCMV.