02.08.12
The Council for Scientific and Industrial Research (CSIR) in South Africa has published a synopsis on the clinical studies done on hoodia from 1999 to 2003. 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,” said Dr. Vinesh Maharaj, a technology manager at the CSIR. “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.”
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, according to CSIR.
When CSIR signed a cooperation agreement with Phytopharm, a U.K.-based pharmaceutical development company in November 2010 for the further development and commercialisation of Hoodia gordonii, CSIR acquired the rights to substantial know-how and IP developed when the former license agreement was in place.
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,” said Dr. Vinesh Maharaj, a technology manager at the CSIR. “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.”
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, according to CSIR.
When CSIR signed a cooperation agreement with Phytopharm, a U.K.-based pharmaceutical development company in November 2010 for the further development and commercialisation of Hoodia gordonii, CSIR acquired the rights to substantial know-how and IP developed when the former license agreement was in place.