Since 2004, the DNDi office in Malaysia has supported a variety of R&D activities across the Asian region, including key preclinical and early clinical studies for the FACT Project, as well as the fostering of the PAN4ND, a regional research platform that focused on the discovery and development of natural substances as therapeutics to neglected diseases. The office is now involved in DNDi’s hepatitis C clinical studies that will take place in the country.
Projects
DNDi South-East Asia
L10-7, Menara Sentral Vista,
150, Jln Sultan Abdul Samad
Brickfields
50470 Kuala Lumpur
Malaysia
Tel: +60 3 2716 4159
Highlights
2019
- R&D: Launched the STORM C-1 Stage 2 clinical trials in Thailand and Malaysia to confirm the efficacy and safety of ravidasvir/sofosbuvir combination for HCV
- Access: Launched new initiative with Malaysian Ministry of Health and FIND to demonstrate feasibility of ‘test-and-treat’ strategies using rapid diagnostic tests to screen people for HCV
- Partnerships: Supported the launch of Malaysia’s National Strategic Plan for HBV and HCV; ongoing collaborations and partnerships in Thailand around GARDP STI and Neonatal sepsis study; and with Pharmaniaga towards registration of RDV in Malaysia
2018
- Presented the interim results from the Phase II/III STORM-C-1 trial (Thailand & Malaysia) at the International Liver Conference in Paris, showing that the combination of ravidasvir/sofusbuvir is comparable to the very best hepatitis C therapies available today.
- Presented interim Phase II/III STORM-C-1 trial data on 301 patients to national stakeholders in Malaysia, as six sites were based in Malaysia (and 220 patients were recruited from Malaysia) and four in Thailand.
- Invited to be a supporting partner of the Malaysian Health Ministry’s National Hepatitis Conference 2018 – Eliminating Viral Hepatitis.
- Became an implementation partner for the decentralization of testing in Malaysia, partnering with the Foundation for Innovative New Diagnostics (FIND) in this project.
- Supported the Ministry of Health in Malaysia as it scales up a public health approach to hepatitis C, which now includes the provision of free hepatitis treatment in 18 public hospitals.
- Supported GARDP‘s global observational study of newborns with sepsis.
2017
- After completion of patient recruitment in the sofosbuvir/ravidasvir clinical study for hepatitis C in Malaysia, start of recruitment in Thailand
- Approval by Malaysia of a “government use” licence to secure access to more affordable treatments for hepatitis C
- Agreement signed between pharmaceutical companies Pharmaniaga (Malaysia) and Pharco Pharmaceuticals (Egypt), and DNDi to supply affordable hepatitis C treatment in Malaysia
2016
- DNDi collaborates closely with the Malaysian MoH to develop and produce a new affordable HCV combination treatment.
- Clinical trial starts in six sites in Malaysia to test the sofosbuvir and ravidasvir combination in 220 HCV patients.
- DNDi engages R&D and civil society actors in Malaysia, Thailand, and other South-East Asian countries.
- DNDi office moves to Kuala Lumpur and new Head of Office is hired.
