After decades with almost no research and development for neglected tropical diseases, this field has gained significant momentum in the past few years. Today, a fair part of the neglected tropical diseases drug development projects are conducted under the umbrella of Public-Private Partnerships (PPP), embracing a public body, one or several private companies and/or academic institutions in a long-term joint venture.

At the STI various units and individuals contribute to R&D for new medicines and vaccines against so-called neglected tropical diseases. The activities embrace a large scientific area from drug discovery to large scale implementation programmes. Various groups of STI are active in drug screening and evaluation, pre-clinical testing and give scientific & medical advice to trial design. In the Medical Department, the outpatient clinic has proven the capacity to recruit patients to clinical trials for different sponsors and the physicians are active in giving medical advice to clinical trials. The conduct of clinical trials in developing countries requires a specialized expertise beyond the in-depth knowledge of the current regulations and guidelines. Ways have to be sought in each individual project to best reconcile the legal requirements with the local needs and capacities. Within the Swiss Centre for International Health, the Pharmaceutical Medicine Unit (STI-PMU) is specialized in the conduct of regulatory clinical trials on neglected tropical diseases.

In the field of human African trypanosomiasis (HAT) the following projects are currently carried out:

 

• Development of a new, oral drug (DB289, pafuramidine maleate) against first stage human HAT within the UNC - Chapel Hill led consortium for parasitic drug development (CPDD): Three Phase II trials, one Phase III trial were designed, organized and carried out in Angola, the Democratic Republic of Congo and South Sudan.
• The combination of the two drugs nifurtimox – eflornithine for treatment of second stage HAT was assessed in a Phase II/III trial by the Drugs for Neglected Diseases initiative (DNDi). The STI-PMU contributed to the site assessment, implemented the trial in two sites in the Democratic Republic of Congo and was responsible for the monitoring.
• In partnership with DNDi the STI-PMU contributed to the HAT clinical trials capacity building and strengthening platform (HATCap) in sub-Saharan Africa

In addition, the following clinical trials on malaria are carried out or supported by the STI-PMU:

 

• A Phase II dose range finding trial was conducted in the frame of the development of a new drug against malaria (RBx11160) on behalf of Medicines for Malaria Venture (MMV) in India, Tanzania, Thailand and Zanzibar.
• Clinical monitoring and site management for a Phase II trial (iv Artesunate) on children with severe malaria in Gabon and Malawi as well as Phase III trials (Pyramax® program) in Gabon and Tanzania on a combination of pyronaridine / artesunate for the treatment of uncomplicated malaria (all for MMV).
• A Phase Ia trial on two virosome formulated anti-malaria vaccine components (PEV 301 and PEV 302) for Pevion Biotech was conducted in Switzerland and a Phase Ib trial to be conducted in Tanzania is currently in planning.
• The field of activities was recently expanded into the auditing of clinical trials. A first work order was received from MMV, and two centers contributing to a Phase III malaria trial were audited in the Democratic Republic of Congo and Kenya.

Dr. Christian Burri
Contact

photo left: Group picture of the Investigators meeting for the DB289 Phase IIIb study held in Kinshasa, Democratic Republic of Congo in April 2007

 

photo right: Source data verification during a monitoring visit carried out in the frame of the DB289 Phase III study at Kikongo, Democratic Republic of Congo. Didier Kalemwa, Representative of the STI in Kinshasa, Natalie Nkoy, laboratory technician at the Programme Nationale de Lutte contre la Trypanosomiase Humaine Africaine (PNLTHA) and member of the local supervision team to the study.

 

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