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The CSIR has published a synopsis on the clinical
studies done on Hoodia during the period 1999 to
2003.
Dr Vinesh Maharaj, a Technology Manager at the CSIR,
said: "It is important to publish these clinical studies for public
awareness." The CSIR has also acquired the reports to 14 clinical
studies in which Hoodia has been assessed, using
crude extracts and concentrated active ingredients formulated in a
number of different ways. In many of these studies Hoodia
was found to be generally safe and well tolerated, though in some
subjects adverse events and tolerability issues were noted with the
concentrated active ingredient extracts.”
“The clinical studies during the period 1999 to 2003
were performed on a spray-dried sap extract and a concentrated active
ingredient extract, both formulated as capsules. In the safety studies,
the spray-dried sap extract was shown to be safe and well tolerated at
all dosages while some level of efficacy including caloric reduction
was observed at the higher dosages. In a 14-day repeat dose study using
the extract, there was a good safety and tolerance profile, however no
signs of efficacy were observed mainly due to the low dosage.”
“This was not surprising considering that some levels
of efficacy in the safety studies were observed at higher dosages
suggesting that future development should focus on the formulation of
higher doses of the spray-dried sap extract. In a 5 and 15-day repeat
dose study using the concentrated active ingredient extract there was a
clear anorectic effect and a substantial reduction in caloric intake
compared to the placebo.”
“In the 15-day repeat dose study there were mild side
effects such as taste perversion and isolated reversible
hyperbilirubinaemia (excess of bile pigment in the blood). There were
no signs of abnormal ECG, vital signs or physical examination findings
during the study. The exaggerated effect on caloric intake suggests
lower dosage levels for further evaluation of the concentrated extract
in a solid formulation,” added Dr Maharaj.
A full synopsis of the findings of these is made
available through the CSIR web-based research space and includes the
following:
- A single Phase I, double-blind, placebo-controlled,
ascending single oral dose, safety, tolerability and pharmacokinetic
study in obese male subjects using a spray-dried extract of Hoodia as
the active substance formulated as capsules (coded P57FP). The study
intended to include both male and female, but only males were enrolled.
- A Phase I, double-blind, placebo-controlled, single
ascending oral dose study to investigate the safety, tolerability,
pharmacokinetics and pharmacodynamics of a spray-dried extract of
Hoodia formulated into capsules (coded P57FP) in male volunteers.
- A Phase I, placebo-controlled, 14-day repeat dose
study in an ascending dose parallel group design to establish the
safety, tolerability and effects of a spray-dried extract of Hoodia
formulated into capsules (coded P57FP) in suppressing appetite in
non-patient male volunteers.
- A randomised, double-blind, placebo-controlled,
15-day repeat dose study, with a single dose escalation stage, to
establish the pharmacokinetics, safety, tolerability and effects of the
concentrated spray-dried extract (coded PYM50027) in healthy male
subjects.
- An independent expert review of laboratory data from
Hoodia studies.
“Commercialisation of Hoodia gordonii as a dietary
supplement has created major interest around the world and further
development of Hoodia as a functional food for management of weight
remains important,” said Dr Maharaj.
“The development going forward requires clinical
studies which are typically multi-million rand investments. The
clinical studies have not been scoped yet, so no precise budgets are
available at this stage. The CSIR does not have a budget for further
development at this stage - as is typical of the model for funding
projects of this nature in the National System of Innovation, the CSIR
will engage with all stakeholders, public funding institutions and
potential licensees to support further development. Funds are allocated
on properly motivated, stage gated applications with detailed plans,”
he added.
When the CSIR signed a cooperation agreement with
Phytopharm, a United Kingdom-based pharmaceutical development company
in November 2010 for the further development and commercialisation of Hoodia
gordonii , the CSIR acquired the rights to substantial
know-how and IP developed when the former license agreement was in
place. During this time, many technical issues around the agronomy,
extraction of the active ingredients, and other processing or
manufacturing related challenges were resolved.
Story: CSIR e-News, December 2011
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Hoodia
plant in flower |
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