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09-01-2012: AiCuris announced that AIC246 (Letermovir), the Company’s inhibitor against the human cytomegalovirus HCMV, has been granted Orphan Drug Designation in the US for the prevention of HCMV viremia and disease in at risk populations. This decision was made on 12 December 2011 by the FDA Office of Orphan Products Development.
Letermovir has recently successfully completed a phase IIb trial for the prophylaxis of HCMV infection and disease in bone marrow transplanted patients. Results will be announced shortly.
“After orphan drug designation was granted earlier last year in Europe, we are very pleased to have now also received this designation in the USA. For the further development of this innovative drug, the Orphan Drug Designation will provide easier access to scientific support by the agencies, which will help to develop new treatment paradigms against this dangerous virus” commented AiCuris CEO, Prof. Rübsamen-Schaeff.
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AiCuris GmbH &Co KG announced positive results from its placebo-controlled and dose-ranging trial with Letermovir (AIC246). In addition to excellent efficacy Letermovir demonstrates superior tolerability and safety and thus defines a novel standard for the control of HCMV in transplant pati ... more
AiCuris Receives Orphan Drug Designation for Letermovir (AIC246) from FDA
AiCuris announced that AIC246 (Letermovir), the Company’s inhibitor against the human cytomegalovirus HCMV, has been granted Orphan Drug Designation in the US for the prevention of HCMV viremia and disease in at risk populations. This decision was made on 12 December 2011 by the FDA Office ... more
AiCuris: No Resistant Herpes Simplex Virus (HSV) Observed in Phase II Trial with Herpes Drug AIC316
AiCuris announces that it will present the results of the resistance analysis from the recently completed phase II clinical trial with AIC316 at the 51st Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in USA, Chicago. AIC316 is one of AiCuris lead compounds and was ... more
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