Pyronaridine: a new antimalarial agent
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Source: "WHO TDRNEWS" <tdrnews@who.ch>
CLINICAL SITES FOR PHASE IIB OF NEW AGENT FOR THE TREATMENT OF
UNCOMPLICATED MALARIA SOUGHT
TDR is developing a new antimalarial agent, pyronaridine, for the treatment
of uncomplicated malaria. Pyronaridine is a blood schizontocide that was
first synthesized in China in 1970. Available data do not support
international registration of the drug, yet they do indicate that it may be
effective for the treatment of chloroquine-resistant malaria and that it is
well tolerated after oral administration.
TDR is currently conducting a series of Phase I and IIa clinical trials
with a newly designed capsule formulation of pyronaridine that has a better
pharmacokinetic profile than the previously available tablet manufactured
in China and coated for enteric absorption. These trials have been designed
to characterize the pharmacokinetic profile, clinically effective dose, and
the safety and efficacy of the new capsule formulation of pyronaridine when
used for the treatment of uncomplicated malaria. As part of its efforts to
develop and register pyronaridine for the treatment of un-
complicated malaria, according to international regulatory standards, TDR
is in the process of developing a protocol for a Phase IIb randomized,
comparative controlled, clinical trial of a three-day course of
pyronaridine (with a 28 day follow-up) for the treatment of uncomplicated
malaria.
These trials are considered pivotal thus it is essential that they are
conducted in accordance with international regulatory standards. We
anticipate that the Phase IIb trial will start in February 1998.
TDR encourages applications from researchers in clinical sites where it is
possible to:
Follow GCP guidelines for the conduct of clinical trials. Enrol 200-250
evaluable patients with uncomplicated malaria in a one-year period. Ensure
an 80% follow-up rate over a 28 day follow-up period. Store and maintain
whole blood samples in a -400C freezer.
Interested applicants should contact:
Dr Tom Kanyok
Manager, Pyronaridine Product Development Team (PDT)
by letter or fax at:
WHO/TDR, 20 Avenue Appia
CH 1211 Geneva 27
Switzerland
Fax: +41-22-791-4854
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Dieter Neuvians MD
Health Systems Research Southern African Region
P.O.Box 2406
Harare / Zimbabwe
Tel. +263-4-733-696
Fax +263-4-733-695
e-mail: neuvians@harare.iafrica.com
dneuvians@compuserve.com
http://www.healthnet.org/afronets/gtz-hsr.htm
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