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 Full Title Panacea Capacity Building Networking & Associated Project Management
 Short Title Panacea Cap Dev
 Project Leader Klaus Reither
 Description PanACEA will advance the development of therapeutics for shortening and simplifying TB treatment by (a) supporting regulatory-quality Phase IIa, IIb and Phase III clinical trials, and (b) developing enhanced clinical trial capacity in sub- Saharan Africa. By forming a network of six European research organizations, twelve sub-Saharan clinical trial sites, and three pharmaceutical companies, PanACEA will realize synergies across the proposed trials and develop processes, tools, and capacity for more efficient and effective future clinical trials for TB drug candidates currently in the development pipeline.

The portfolio of drugs proposed for clinical trials in PanACEA include one anti-infective approved for non-TB indications(moxifloxacin), one current TB drug with potential for enhanced efficacy at higher doses (high-dose rifampicin [HIGHRIF]), and a new chemical entity (SQ-109) with potential as a more effective replacement for ethambutol (EMB).

The trials presented in the proposal are intended to evaluate these three drugs in new regimens that will shorten TB therapy by one third the time; from the standard 6-month to 4-month therapy. A fourth project proposed for a delayed start represents a pharmaceutical company’s re-development of a TB drug (rifapentine) in new regimens based on promising results in animals indicating potential for treatment shortening.

A Consortium Board comprising the PIs from each of the clinical trials and each of the 12 clinical trial sites will provide transparency, accountability, and synergy across the consortium activities. The Board, with the assistance of a Secretariat, will monitor the progress of all studies by the established schedules and go/no-go milestones, providing EDCTP with an integrated report on the consortium’s activities, progress, and accomplishments. The Board may seek external scientific expertise to review studies and offer consultation on study design and analysis. Working Groups, drawn from the PanACEA participants, will be established by the Board to address common issues, such as data management, clinical trial monitoring, statistical design and analysis, and compliance with international and national standards of research and ethical issues in the conduct of TB clinical trials.

A key function of the Board will be to realize synergies across the clinical trials and trial sites through collaborations, developing standard methods, and by the sharing of tools. For example, the REMox trial has worked with pharmaceutical companies to develop, produce, and analyse placebos of standard TB drugs required for clinical trials. Sharing the results of this development effort will reduce costs and expedite the start of other proposed trials as well as future trials for drug candidates currently in preclinical development.
 Collaborators Fred Lwilla                    Ifakara Health Institute                  

 Source of funding European & Developing Countries Clinical Trials Partnership (EDCTP)
 Start Date November 2010                End Date     November 2012
     

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