Contact Information:

Media Contact

Violaine Dällenbach
vdallenbach@dndi.org
41-794-241-474

Twitter: DNDi

http://www.dndi.org




Kredyty mieszkaniowe Kredyty mieszkaniowe

Sprawdź aktualny ranking najlepszych kredytów mieszkaniowych w Polsce - atrakcyjne kredytowanie nieruchomości.

PRESS-NEWS.org - Press Release Distribution
FREE PRESS RELEASES DISTRIBUTION
RSS - Press News Release
Add Press Release

Clinical trial for first oral drug candidate specifically developed for sleeping sickness

Phase I study shows favorable safety profile and can be tested in patients


2015-09-08
(Press-News.org) [Basel, Switzerland - 8 September 2015] The Drugs for Neglected Diseases initiative (DNDi) has announced today at the 9th European Congress on Tropical Medicine and International Health (ECTMIH) in Basel, Switzerland, the successful completion of Phase I human clinical trials for SCYX-7158 (AN5568), the first oral drug candidate specifically developed from the earliest drug discovery stage to combat human African trypanosomiasis, or sleeping sickness, a deadly parasitic disease transmitted by the tsetse fly.

The Phase I study, conducted in France, assessed the safety, tolerability, pharmacokinetics and pharmacodynamics of SCYX-7158 after single oral ascending doses in 128 healthy human volunteers of sub-Saharan origin. It allowed for the therapeutic dose to be determined at 960 mg administered once as three tablets, with a favourable safety profile. As the drug has a long half-life (400 hours), the study was extended to ensure extensive safety monitoring of the healthy volunteers up to 210 days. This pharmacological finding has the advantage of translating into prolonged exposure with just one dose. These Phase I results confirm that the drug penetrates the brain, which is crucial to treat the late stage of the disease, where the parasite crosses the blood-brain barrier and kills patients if no treatment is given. Based on the results of this study, DNDi and partners plan to proceed to pivotal Phase IIb/III studies in 2016 at sites in the Democratic Republic of the Congo (DRC), where 90% of cases occur.

'We are encouraged by the results of this important milestone for SCYX-7158, which is the fruit of collaboration and hard work of many partners', said Dr Antoine Tarral, Head of the Human African Trypanosomiasis Clinical Programme, DNDi. 'The motivation has been the drug candidate's potential of becoming the first ever, oral-only, single-dose treatment for this deadly disease.' SCYX-7158 was discovered by Anacor Pharmaceuticals, Inc. The compound was identified through DNDi's lead optimization programme and successfully progressed through pre-clinical development in 2011.

'We are particularly excited about SCYX-7158 because it is the first drug candidate to come from the early discovery efforts of our lead optimization programme', said Dr Rob Don, Discovery & Pre-clinical Director, DNDi.

Sleeping sickness cases are decreasing but the disease remains persistent in remote, hard-to-reach areas of Africa. One of the major advancements in the treatment of the disease was the introduction of nifurtimox-eflornithine combination therapy (NECT) in 2009, developed by DNDi, Médecins Sans Frontières/Doctors Without Borders (MSF), and partners. NECT replaced an old, arsenic-based medicine, and today the vast majority of all late-stage sleeping sickness patients receive this combination as first-line treatment. Yet NECT still requires skilled staff in a hospital setting to administer the injections. Patients often travel days to get to health centres. Fexinidazole, administered for ten days with food, is currently being tested in clinical trials as an oral-only treatment that could treat all stages of the disease. SCYX-7158, if successful, would have the additional benefit of its unique single-dose, simple oral tablet administration. Recruitment for patient trials is targeted to begin in 2016 at remote sites in the DRC, where DNDi has been carrying out fexinidazole clinical trials.

INFORMATION:

Funding support for this project Funding for this project, including lead optimization, pre-clinical, and Phase I, has been provided by Médecins Sans Frontières (MSF) / Doctors Without Borders, the Swiss Agency for Development and Cooperation, the UK Department for International Development (DFID), the Dutch Ministry of Foreign Affairs (DGIS), Germany's Federal Ministry of Education and Research (BMBF) through KfW and part of the EDCTP 2 Programme supported by the European Union, the Norwegian Agency for Development Cooperation (NORAD), the Bill & Melinda Gates Foundation, the French Ministry of Foreign and European Affairs (MAEE), the Spanish Agency of International Cooperation for Development (AECID). A total budget of EUR 27.1 million for the development of SCYX-7158 has been spent to date, including EUR 5 million for the Phase I trial.

About SCYX-7158 SCYX-7158 (AN5568) is a product of Anacor's novel boron chemistry which has produced a number of compounds with efficacy against a range of fungal, inflammatory, and bacterial diseases. Realizing this technology could also be used for neglected diseases, Anacor, with the help of the Sandler Center for Drug Discovery of the University of California, San Francisco, screened its library of boron-based compounds for activity against the sleeping sickness parasites and identified an attractive lead series. In order to ensure further development of these compounds, Anacor approached DNDi, which was actively seeking compounds for its lead optimization programme. DNDi, Anacor, SCYNEXIS, and a consortium including Pace University and the Swiss Tropical and Public Health Institute then worked on the series of molecules in pre-clinical studies that resulted in the DNDi-led Phase I studies now completed.

About the Drugs for Neglected Diseases initiative (DNDi) A not-for-profit research and development organization, DNDi works to deliver new treatments for neglected diseases, in particular leishmaniasis, human African trypanosomiasis, Chagas disease, specific filarial infections, paediatric HIV, mycetoma, and hepatitis C. Since its inception in 2003, DNDi has delivered six treatments: two fixed-dose antimalarials (ASAQ and ASMQ), nifurtimox-eflornithine combination therapy (NECT) for late-stage sleeping sickness, sodium stibogluconate and paromomycin (SSG&PM) combination therapy for visceral leishmaniasis in Africa, a set of combination therapies for visceral leishmaniasis in Asia, and a paediatric dosage form of benznidazole for Chagas disease. DNDi has established regional disease-specific platforms, which bring together partners in disease-endemic countries to strengthen existing clinical research capacity, as well as to build new capacity where necessary. http://www.dndi.org

Press Contacts

USA - Ilan Moss
imoss@dndi.org / +1 646 266 5216

Europe - Gabrielle Landry
glandry@dndi.org / +41 79 309 3910


ELSE PRESS RELEASES FROM THIS DATE:

Lazing away the summer

2015-09-08
Edible dormice (Glis glis) spend about eight months on average in hibernation. Wildlife biologists from the Research Institute of Wildlife Ecology of the Vetmeduni Vienna have shown for the first time that these animals can hibernate for up to 11.4 months. "This may be a world record," says Claudia Bieber, co-author of the study. "Dormice in our climate zone don't just spend the winter months underground, they sometimes begin hibernating in summer." The animals do not hibernate for so long every year, but only in years when beech trees produce few beechnuts. Successful ...

Trust game increases rate synchrony

2015-09-08
In the new study 'Building trust: Heart rate synchrony and arousal during joint action increased by public goods game' (Journal of Physiology and Behavior) PhD and assistant professor Panagiotis Mitkidis and colleagues from the Interacting Minds Centre at Aarhus University studied the link between heart rate and trust. They had 37 pairs of participants do a cooperative task involving building LEGO cars. The control group only did the LEGO task, while a second group played an investment game in between the building sessions. The game, known as the 'Public Goods Game', had ...

Transcatheter aortic valve replacement is safe, effective for very elderly patients

2015-09-08
Select patients age 90 years and older with aortic stenosis (AS) can benefit from a relatively new, minimally invasive surgery for aortic valve replacement, according to an article in the September 2015 issue of the Annals of Thoracic Surgery. Key points Both transfemoral and transapical approaches to TAVR appear to be safe and effective for treatment of aortic stenosis in select patients age 90 years and older. By 6 months post-surgery, most quality-of-life measures had stabilized at a level considerably better than baseline, meaning patients quality of life was ...

Brands are perceived in the same way as faces

2015-09-08
Lueneburg. A recent study on the psychology of trademarks shows that they are perceived by the same psychological mechanisms as those, which enable the recognition of faces. The survey, whose result is particularly interesting for the advertising industry and brand management, originated at the Institute for Experimental Business Psychology at Leuphana University of Lueneburg. For their investigation, Leuphana researchers Rainer Hoeger and Anne Lange compared the reactions of viewers to 16 well-known brands, such as Coca Cola, Rolex, Porsche or Apple and 18 computer-generated ...

Volunteer black hole hunters as good as the experts

Volunteer black hole hunters as good as the experts
2015-09-08
Trained volunteers are as good as professional astronomers at finding jets shooting from massive black holes and matching them to their host galaxies, research suggests. Scientists working on citizen science project Radio Galaxy Zoo developed an online tutorial to teach volunteers how to spot black holes and other objects that emit large amounts of energy through radio waves. Through the project, volunteers are given telescope images taken in both the radio and infrared part of the electromagnetic spectrum and asked to compare the pictures and match the "radio source" ...

Rare melanoma carries unprecedented burden of mutations

2015-09-08
A rare, deadly form of skin cancer known as desmoplasmic melanoma (DM) may possess the highest burden of gene mutations of any cancer, suggesting that immunotherapy may be a promising approach for treatment, according to an international team led by UC San Francisco scientists. One of these mutations, never before observed in any cancer, may shield nascent DM tumors from destruction by the immune system and allow further mutations to develop. "The focus of our lab has been to show that there's not just one 'melanoma' but many different types," said senior author Boris ...

Is old rock really as 'solid as a rock'?

2015-09-08
In the course of billions of years continents break up, drift apart, and are pushed back together again. The cores of continents are, however, geologically extremely stable and have survived up to 3.8 billions of years. These cores that are called cratons are the oldest known geological features of our planet. It was assumed that the cratons are stable because of their especially solid structure due to relatively low temperatures compared to the surrounding mantle. A team of German-American scientists now discovered that these cratons that were assumed to be "as solid as ...

Negative symptoms of schizophrenia linked to poor clinical outcomes

2015-09-08
A novel research tool developed by researchers from the Institute of Psychiatry, Psychology & Neuroscience (IoPPN) at King's College London has identified a link between the negative symptoms experienced by people with schizophrenia and adverse clinical outcomes. Negative symptoms can include poor motivation, poor eye contact and a reduction in speech and activity. As a result, people with schizophrenia often appear emotionless, flat and apathetic. These contrast with positive symptoms - psychotic behaviours not seen in healthy people, such as delusions or hallucinations. Published ...

MicroRNAs are digested, not absorbed

2015-09-08
This news release is available in German. The scientific world was astonished when, in 2011, Chinese researchers claimed to have found evidence suggesting that minute fragments of plant genetic material - so-called microRNA molecules - of rice ingested from food could play a role in regulating physiological processes in the human body. If this is indeed true, it might even be possible to deliberately modify human physiological functions via this route, for instance by incorporating microRNAs into novel functional foods. As a strategy, this holds considerable potential. ...

Secukinumab in plaque psoriasis: Manufacturer dossier provided no hint of an added benefit

2015-09-08
Secukinumab (trade name: Cosentyx) has been approved since January 2015 for adults with moderate to severe plaque psoriasis. The German Institute for Quality and Efficiency in Health Care (IQWiG) examined in a dossier assessment whether this drug offers an added benefit over the appropriate comparator therapy. Such an added benefit cannot be derived from the dossier, however: In patients who are candidates for systemic treatment, an indirect comparison provided no suitable data because the minimum study duration had not been reached. In adults in whom other systemic treatments ...

LAST 30 PRESS RELEASES:

How your brain decides blame and punishment -- and how it can be changed

Uniquely human brain region enables punishment decisions

Pinpointing punishment

Chapman University publishes research on attractiveness and mating

E-cigarettes: Special issue from Nicotine & Tobacco Research

Placental problems in early pregnancy associated with 5-fold increased risk of OB & fetal disorders

UT study: Invasive brood parasites a threat to native bird species

Criminals acquire guns through social connections

Restoring ocean health

Report: Cancer remains leading cause of death in US Hispanics

Twin study suggests genetic factors contribute to insomnia in adults

To be fragrant or not: Why do some male hairstreak butterflies lack scent organs?

International team discovers natural defense against HIV

Bolivian biodiversity observatory takes its first steps

Choice of college major influences lifetime earnings more than simply getting a degree

Dominant strain of drug-resistant MRSA decreases in hospitals, but persists in community

Synthetic biology needs robust safety mechanisms before real world application

US defense agencies increase investment in federal synthetic biology research

Robots help to map England's only deep-water Marine Conservation Zone

Mayo researchers identify protein -- may predict who will respond to PD-1 immunotherapy for melanoma

How much water do US fracking operations really use?

New approach to mammograms could improve reliability

The influence of citizen science grows despite some resistance

Unlocking secrets of how fossils form

What happens on the molecular level when smog gets into the lungs?

Using ultrasound to clean medical instruments

Platinum and iron oxide working together get the job done

Tiny silica particles could be used to repair damaged teeth, research shows

A quantum lab for everyone

No way? Charity's logo may influence perception of food in package

[Press-News.org] Clinical trial for first oral drug candidate specifically developed for sleeping sickness
Phase I study shows favorable safety profile and can be tested in patients
Press-News.org is a service of DragonFly Company. All Rights Reserved.
Issuers of news releases are solely responsible for the accuracy of their content.