| What
is Hoodia P57 Molecule?
P57 is extracted from the Hoodia Gordonii, a cactus
like plant. Hoodia Gordonii is a South African plant which
has been eaten by Bushmen for thousands of years to stave off thirst and hunger
during long hunting trips.
Phytopharm has six patents in progress covering the
use of the plant, its active molecules, derivatives and mode of action. In 1997 Phytopharm licensed
the rights to P57 from the Council for Scientific and Industrial Research in
South Africa. Then, in 1998, Pfizer acquired the rights to
develop and market P57 world-wide, with Phytopharm receiving up to $32 million
in license fees, in addition to royalties on sales. Pfizer made a payment of $1
million to Phytopharm April 29, 2000 on completion of the phase I dose
escalation studies. The agreement was extended in August 2000 to enable further
collaborative research. Pfizer has already contributed over $8 million to the
drug's development.
In a July 2001 press
release, Phytopharm announced the successful completion of its phase I "proof
of principle" trial. Evaluations have been conducted to study the
safety, tolerability and pharmacogology
of single doses of the product. Moreover, studies to assesses the effects
of repeated dosing, in healthy overweight volunteers has also been conducted. The data obtained from these
evaluations was used to determine the dosing regimen (dose and duration)
for the final repeat dose stage. Industry
experts predict that if all goes well this drug will be available on pharmacy
shelves in three years. P57 the molecule
in the plant Hoodia Gordonii that has been studied to aid in suppression
of appetite leading to its use for the
treatment of obesity. While results to date are very promising, Hoodia
P57 is currently in clinical trials which can take years to refine
and obtain pre-requisite data for approval as a drug. Initial
Hoodia P57 was
licensed to Pfizer Inc. in 1998 and millions were spent to try and economically
sythesis the P57 molecule without success thus far. Only the
natural plant, Hoodia Gordonii have proven to offer the P57 molecule
at an economical cost.
Pharmacology of Hoodia Gordonii P57
MoleculeReports of the use of P57 in humans show that it
can significantly reduce appetite, food intake and body weight. The
properties and makeup of the Hoodia Gordonii P57 molecule is under
investigation.
Hoodia Gordonii's P57 seems to have pharmacological appeite
suppressant properties and may indeed be a truly powerful appetite suppressant with
no kowns side effects to be discovered. Thus far, efficacy has been established with a profound weight loss
and a good emergent safety profile.
Phase I clinical
trials continue while simultaneously cultivation in large Hoodia plantations have and
continue to be
established in collaboration with the CSIR and Pfizer in
South Africa.
Clinical Studies Hoodia Gordoniii
P57 MoleculeTo date 24 obese
(BMI>26) and 42 non-obese non-patient volunteers have received doses of P57
ranging from 3 to 4000 mg. Primary measures in these studies included clinical
toleration, haematological and biochemical assessments of safety and
pharmacokinetics. No treatment related adverse events have been
reported.
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