11-16-2013, 01:23 AM
A ground-breaking Phase II clinical trial has been carried out in Bolivia, the first ever to be run in that country. The trial was carried out by the Drugs for Neglected Diseases initiative (DNDi) to test the safety and efficacy of the experimental drug candidate E1224 on the the parasite that causes Chagas disease. The results of the trial were presented this week at the Annual Meeting of the American Society of Tropical Medicine and Hygiene (ASTMH).
According to the DNDi, Chagas disease is endemic in 21 countries across Latin America, and it kills more people in this region annually than malaria or any other parasite-born disease. Patient numbers are growing in non-endemic, developed countries, carried unwittingly by Latin American immigrants. The disease is caused by the parasite Trypanosoma cruzi, and has both acute and chronic clinical stages. Primary transmission is by large, blood-sucking reduviid insects but also via blood transfusion, organ transplantation, as well as congenital and oral transmission.
The E1224 drug candidate was developed by the Japanese company Eisai, with support from the Wellcome Trust. The Phase II trial was a double-blind, randomized, controlled trial on 231 adult patients with chronic indeterminate (showing no symptoms) Chagas disease, comparing E1224 to both placebo and to the current treatment, benznidazole. E1224 monotherapy was found to clear the Trypanosoma cruzi in patients compared both to placebo and to benznidazole, however parasite clearance was only maintained after 12 months in less than one third of patients treated with E1224 compared to greater than 80% of patients treated with benznidazole.
Despite this demonstration of ineffectiveness of E1224 monotherapy, the drug still holds great promise as an adjunct therapy to be used with existing drugs. Benznidazole, for example, is associated with unpleasant side-effects and treatment typically lasts for 60 days. In this trial, few patients receiving even the highest dose of E1224 stopped treatment due to side effects. The E1224 trial Project Leader, Dr Isabela Ribeiro, Head of the Chagas Clinical Programme at DNDi, is very satisfied with the outcomes, stating : “We now have clear safety and efficacy data on two compounds that will be very useful in guiding future Chagas disease drug research efforts."
The way forward for E1224 is to no longer be tested as monotherapy for Chagas disease, but the researchers are hopeful of testing E1224 in combination therapy with benznidazole. As a result of this study in an endemic country, there is now increased hope for the millions of patients who suffer from this neglected illness, with the prospect of increased treatment access and options.
Sources
http://www.dndi.org/diseases-projects/di...hagas.html [Accessed 15 November 2013].
Drugs for Neglected Diseases Initiative. "Drug trial for top parasitic killer of the Americas." ScienceDaily, 14 Nov. 2013. [Accessed 15 November 2013].
According to the DNDi, Chagas disease is endemic in 21 countries across Latin America, and it kills more people in this region annually than malaria or any other parasite-born disease. Patient numbers are growing in non-endemic, developed countries, carried unwittingly by Latin American immigrants. The disease is caused by the parasite Trypanosoma cruzi, and has both acute and chronic clinical stages. Primary transmission is by large, blood-sucking reduviid insects but also via blood transfusion, organ transplantation, as well as congenital and oral transmission.
The E1224 drug candidate was developed by the Japanese company Eisai, with support from the Wellcome Trust. The Phase II trial was a double-blind, randomized, controlled trial on 231 adult patients with chronic indeterminate (showing no symptoms) Chagas disease, comparing E1224 to both placebo and to the current treatment, benznidazole. E1224 monotherapy was found to clear the Trypanosoma cruzi in patients compared both to placebo and to benznidazole, however parasite clearance was only maintained after 12 months in less than one third of patients treated with E1224 compared to greater than 80% of patients treated with benznidazole.
Despite this demonstration of ineffectiveness of E1224 monotherapy, the drug still holds great promise as an adjunct therapy to be used with existing drugs. Benznidazole, for example, is associated with unpleasant side-effects and treatment typically lasts for 60 days. In this trial, few patients receiving even the highest dose of E1224 stopped treatment due to side effects. The E1224 trial Project Leader, Dr Isabela Ribeiro, Head of the Chagas Clinical Programme at DNDi, is very satisfied with the outcomes, stating : “We now have clear safety and efficacy data on two compounds that will be very useful in guiding future Chagas disease drug research efforts."
The way forward for E1224 is to no longer be tested as monotherapy for Chagas disease, but the researchers are hopeful of testing E1224 in combination therapy with benznidazole. As a result of this study in an endemic country, there is now increased hope for the millions of patients who suffer from this neglected illness, with the prospect of increased treatment access and options.
Sources
http://www.dndi.org/diseases-projects/di...hagas.html [Accessed 15 November 2013].
Drugs for Neglected Diseases Initiative. "Drug trial for top parasitic killer of the Americas." ScienceDaily, 14 Nov. 2013. [Accessed 15 November 2013].
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