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SANBio as one of the four regional networks under the NEPAD secretariat has its hub
housed at CSIR Biosciences. One of the projects identified by this regional network is a
flagship project entitled “Scientific validation of traditional medicines for the affordable
treatment of HIV and opportunistic infections for people suffering from HIV/AIDS” and the
project is being co-ordinated by CSIR Biosciences since 2006. The first traditional remedy
selected for research is from Zambia; code named Sondashi Formula 2000 (code named
SF2000) and is a mixture of 4 plants. Literature studies aimed at identifying published
information on the identified plants indicated no scientific research conducted validating the
use of the plants for the treatment of people suffering from HIV/AIDS. The four plants were
identified at the South African National Biodiversity Institution (SANBI).
Initial Bio-assaying of the freeze-dried aqueous extract of the SF-2000 consisting of all four
plants showed a significant anti-viral activity against the HIV-1IN/93/101 Subtype C strain with
a corresponding significantly higher viral selectivity index for peripheral blood mononuclear
cells (PBMC). The Subtype C strain is the more relevant strain to Africa. Of the four plants
which form the SF2000 mixture, the freeze dried aqueous extract of one plant showed a
significant higher activity and of the same degree as the SF2000 extract when tested against
PBMC’s infected with HIV-1 virus of subtype C.The results have provided early scientific
evidence which substantiates the traditional use of Sondashi Formula 2000 and further
research and development aimed at further proof of concept was conducted.
The traditional dosage protocol as used by Dr. Sondashi recommends taking 8g of plant
material in 200ml of water 4 times daily. The dosage was formulated into capsules containing
1 g of plant material which is 8 capsules per dose. The 1g capsules are large and could be
difficult to swallow thereby risk compliance with a high dose. The dosage was significantly
reduced by substituting the traditional preparation with a manufacturing process for the
preparation of a spray dried extract in the CSIR’s Clinical and Botanical Supplies Unit. The
manufacturing process for the spray dried extract includes the mixing of the four plants in the
ratios used by Dr Sondashi, addition of water, stirring, removal of solids through filtration,
and spray drying the liquid extract. Based on the solids content this powder was formulated
into capsules which resulted in the reduction of the dose to two capsules (0.5 grams each)
four times a day. This method also eliminates consuming plant fibres which present with a
difficulty in swallowing. HPLC method was used to compare the spray dried extract and the
freeze-dried extract, the result indicated similarity in chemical composition. An acute and
sub-chronic in vivo toxicity study has been commissioned with the MRC in South Africa.
Primary measures include behavioural observation of the animals and haematology. These
preliminary results suggest that there is early scientific evidence which substantiates further
research and development aimed at large scale production of the spray dried extract which
will be formulated into capsules to be used for Phase I clinical trials. The primary measures
for the study will be to assess the safety and tolerable dosages of the spray dried extract in a
capsules.
At least two scientists from foreign countries in the region were identified for training at the
CSIR in drug discovery and development. One of them from the University of Malawi is
currently working in the CSIR labs focused on manufacturing and quality control procedures.
The countries, Swaziland and Zambia responsible for the other scientists indicated that they
had other commitments and could not attend training in 2008. As an alternative to this
some of the funds were made available to a student from Tanzania who is currently studying
for a PhD and supervised by the CSIR on Tanzanian plants used for the treatment of HIV and
opportunistic infections. The traditional healer Dr Sondashi was trained to harvest plants in
compliance with Good Harvesting Practices including the using the necessary documentation.
The early research has paved the way for the further development of SF2000 to evaluation in
the clinic. The key studies for the further development will include a thorough phytochemical
analysis and bioassay guided fractionation to identify biomarkers and active ingredients,
manufacturing of several batches of spray dried extract, quality control and release of
material, formulation into capsules, completion of in vivo toxicology, in vitro toxicology and
a Phase I clinical study in healthy volunteers to evaluate safety and tolerability of the novel
formulation consisting of a spray dried extract within gelatin capsules.
A multi-disciplinary research team comprising two postgraduate students under mentorship
of senior scientists in the region will be involved in this project. Where specialized analytical
equipment and bioassay technology and preclinical and clinical technology is required,
participating institutions in the Samba region will be used and only when such technology
cannot be located, international institutions will be approached for their services. A workshop
will be held to in South Africa as a means to expose scientists from the region to share with
the legal model used for collaboration, progress made on the development of SF2000,
Identification of a new leads based on biodiversity and indigenous knowledge from the
region for further research by Samba.
Seventy percent of the world's HIV/AIDS cases are in Africa and the statistics of people
living with HIV/AIDS on this continent are staggering. Twenty million people have already
died of AIDS and about 7,000 die of AIDS every day in Africa. More than 29 million people
in sub-Saharan Africa are HIV-positive. A particular challenge associated with the disease is
the treatment of Opportunistic Infections (OIs) suffered by virtually all HIV-infected
individuals at different stages of disease progression.
Treatment and management of such people using conventional therapeutic interventions is
beyond the reach of most governments because of the cost of imported medicines. The WHO
has approved the strategy and promotion of the use of Traditional Medicine in Health
Systems and this concept was further developed and adopted by the Fiftieth Session of the
WHO Regional Committee for Africa, held in Burkina Faso in 2000. One of the priority
interventions in the regional strategy is research promotion. The aim of the Regional Strategy
is to contribute to the achievement of the Health for all in the region by optimizing the use of
traditional medicines. WHO defines traditional medicine as "the total combination of
knowledge and practices, whether explicable or not, used in diagnosing, preventing or
eliminating physical, mental or social diseases and which may rely exclusively on past
experience and observation handed down from generation to generation , verbally or in
writing". In the African Region, where about 80% rely in traditional Medicine for their
health care needs, this traditional medical knowledge is transmitted principally through oral
tradition while some recipes are disclosed only to family members for some specific diseases.
Traditional Medicine has been used since the existence of mankind in all nations for the
management of various diseases from self-limited to life-threatening illness in both
developed and developing countries. The availability of effective, safe and affordable herbal
treatments for OIs will not only improve the quality of life of people living with HIV/AIDS
but will even allow a significant portion of those affected by the disease to return to
work and contribute to the economy.
The biodiversity of Africa (e.g. plants and mushrooms) is a major resource that has not yet
been exploited fully for economic and social benefit of people of the region. The rich heritage
of indigenous knowledge on the medicinal plants and mushrooms of the continent may
provide leads to effective treatments for HIV and OIs. Biosciences are the key that can
unlock the potential of these indigenous African resources to yield effective treatments for
OIs.
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