AiCuris today announced that Dr Marie-Paule Richard has assumed the responsibility of Chief Medical Officer at AiCuris, Germany. Dr Richard has over 24 years of experience in the pharmaceutical industry in leading global clinical development projects, supervising clinical-regulatory strategies, clinical operations, pharmacovigilance, medical affairs, and managing multicultural and cross-functional teams and departments. She has been responsible for the global development of a large number of anti-infectives and vaccines that she led successfully to international registrations.
Showing posts with label AiCuris. Show all posts
Showing posts with label AiCuris. Show all posts
Wednesday, 19 January 2011
Wednesday, 8 December 2010
Phase II genital herpes trial with AIC316 completed
AiCuris announced today that the last subject has completed their Phase-II trial "A double-blind randomized placebo controlled dose-finding trial to investigate different doses of a new antiviral drug in subjects with genital HSV Type 2 infection".
The trial has been completed two months earlier than planned. Indeed, in the later stages of the trial, enrolment had to be restricted as the number of subjects was higher than the number that was required to be enrolled according to the trial protocol.
“We were surprised by the interest in our trial and the number of requests for participation that we received from people infected with herpes simplex virus” said Dr. Burkhard Timmler, Associate Director Clinical Development at AiCuris. “In spite of available therapeutic options there seems to be a great demand for a new, well tolerated and efficacious drug for people suffering from genital herpes”.
AiCuris plans to have the first data available in early 2011. “We hope that the results will allow us to determine the efficacious dose of AIC316 and confirm the potential for once daily oral dosing in genital herpes. Our ultimate goal is to address the still existing unmet medical need in the field of genital herpes infections with this drug which acts by a unique mode of action”, adds Prof. Rübsamen-Schaeff, CEO of AiCuris.
Herpes simplex viruses (HSV) are widespread in the human population (seroprevalence up to 100%, depending on geographic area and subpopulation), and are divided into herpes simplex virus type 1 (HSV-1) and type 2 (HSV-2). While HSV-1 predominantly causes oral lesions (cold sores), HSV-2 manifests in the genital region and is mainly transmitted sexually. However, the past decade has seen an increase in HSV-1 genital infections, which now account for at least half of first episodes of genital herpes in some countries. Both labial and genital herpes are generally self-limiting but can recur frequently. HSV infections have also been associated with a three-fold increase in the risk of sexually acquired HIV. In immune compromised individuals large and painful ulcerations may result, and newborns infected with HSV are at risk of developing herpes encephalitis. Unlike most of the current herpes drugs, which inhibit a specific viral enzyme, the DNA polymerase, AIC316 acts by a unique mechanism of viral inhibition. Currently available therapies share the same mode of action and are therefore similar in their efficacy, whilst in addition exhibiting possible cross-resistance.
AiCuris
The trial has been completed two months earlier than planned. Indeed, in the later stages of the trial, enrolment had to be restricted as the number of subjects was higher than the number that was required to be enrolled according to the trial protocol.
“We were surprised by the interest in our trial and the number of requests for participation that we received from people infected with herpes simplex virus” said Dr. Burkhard Timmler, Associate Director Clinical Development at AiCuris. “In spite of available therapeutic options there seems to be a great demand for a new, well tolerated and efficacious drug for people suffering from genital herpes”.
AiCuris plans to have the first data available in early 2011. “We hope that the results will allow us to determine the efficacious dose of AIC316 and confirm the potential for once daily oral dosing in genital herpes. Our ultimate goal is to address the still existing unmet medical need in the field of genital herpes infections with this drug which acts by a unique mode of action”, adds Prof. Rübsamen-Schaeff, CEO of AiCuris.
Herpes simplex viruses (HSV) are widespread in the human population (seroprevalence up to 100%, depending on geographic area and subpopulation), and are divided into herpes simplex virus type 1 (HSV-1) and type 2 (HSV-2). While HSV-1 predominantly causes oral lesions (cold sores), HSV-2 manifests in the genital region and is mainly transmitted sexually. However, the past decade has seen an increase in HSV-1 genital infections, which now account for at least half of first episodes of genital herpes in some countries. Both labial and genital herpes are generally self-limiting but can recur frequently. HSV infections have also been associated with a three-fold increase in the risk of sexually acquired HIV. In immune compromised individuals large and painful ulcerations may result, and newborns infected with HSV are at risk of developing herpes encephalitis. Unlike most of the current herpes drugs, which inhibit a specific viral enzyme, the DNA polymerase, AIC316 acts by a unique mechanism of viral inhibition. Currently available therapies share the same mode of action and are therefore similar in their efficacy, whilst in addition exhibiting possible cross-resistance.
AiCuris
Monday, 29 November 2010
AiCuris gains Bio.NRW research promotion
AiCuris GmbH & Co KG has been awarded a three-year research grant together with the Universities of Bochum, Düsseldorf and Bonn as well as the company Squarix (Marl). This grant is a part of the research promotion programme “Bio.NRW” by the Ministry of Innovation, Science and Research of North Rhine-Westphalia. AiCuris will obtain 833,582 Euro.
Thursday, 21 October 2010
AiCuris announces AIC246 to be successful in treatment of Multiorgan HCMV disease
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.
“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.
“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.
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