Hoodia Cactus plant and P57 Research
P57 is a plant based product for the treatment of obesity which is now in clinical development. The product was licensed to Pfizer Inc in 1998 in a global licensing agreement.The cactus from which P57 was derived from the Hoodia Gordonii Cactus plant species.
P57 is a fully characterised extract derived from a single plant which is subject to patent applications covering raw materials, active substances and mode of action. It appears to have novel pharmacological properties and may in fact be the first ever true appetite suppressant to be discovered. Unlike many of the conventional treatments currently available it has no effects on behaviour. The mechanism of action is novel and distinct from those of recently available compounds. Efficacy has been established with a profound weight loss and a good emergent safety profile.
Considerable progress has been achieved with this project. Phase I clinical development continues alongside an extensive research programme. In parallel to these activities, additional plantations for the plant material have been established world-wide in collaboration with the CSIR and Pfizer and a clinical supplies unit, dedicated to the manufacture of the material, has been opened in South Africa.
Pharmacology of P57 and Hoodia Gordonii Cactus Plant
Anecdotal reports of the use of P57 in humans show that it significantly reduces appetite, food intake and body weight. Considerable work has been undertaken to fractionate this plant material and a number of compounds have been isolated from the mixture, some of which have biological activity. The mechanism of action of P57 and its active constituents is currently under investigation. Additional pharmacological properties have recently been established.
To date 24 obese (BMI>26) and 42 non-obese non-patient volunteers have received doses of P57P 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 serious adverse events have been reported.
P57 Intellectual Property
Through an extensive programme of research a molecule has been identified which appears to be responsible for part if not all of the desired therapeutic activity. This molecule and synthetic derivatives are subjects for patent activity.
A programme designed to achieve registration of a product as a prescription medicine for human use in Europe and USA has been initiated.
Stage Phase II
Developer Phytopharm and Pfizer
What P57 and Hoodia Gordonii does - Suppresses appetite.
P57 is an appetite suppressant with novel pharmacological properties that has no effects on behavior. It is extracted from the Hoodia cactus, 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. Once its patents are published the company will disclose the mode of action. Last year Dr. Richard Dixey, CEO of Phytopharm, told the Wall Street Transcript, "We will not disclose the mode of action at this time because P57 is the subject of a very active patenting program. There is no point in early disclosure of such information until the patent is eventually published and the information enters the public domain. All one would be doing would be to give ones potential competitors useful information".
In 1997 Phytopharm licensed the rights to P57 from the Council for Scientific and Industrial Research in South Africa. Only about 5 percent of the 250,000 plant species have been examined for medicinal purposes. In August 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.
Controversy. Outside of regulatory hurdles, Phytopharm and the CSIR are facing demands for compensation. South Africa's Kung tribe asserts that their ancient knowledge has been "stolen". The Kung people (a subdivision of the San Bushman of the Kalahari), have traditionally eaten the Hoodia cactus to avoid feelings of hunger and thirst while hunting. Phytopharm had obtained rights to commercialize P57, which contains the appetite-suppressing active compound of the Hoodia cactus, from South Africa's Council for Scientific and Industrial Research (CSIR). However, the Kung people say that they were never consulted on the matter, and have accused Phytopharm and Pfizer for "plundering" their ancient medicinal knowledge of the plant. Phytopharm claims that it never consulted the Kung as it believed the tribe was extinct. CSIR executives are ready to enter negotiations to settle the matter.,p>
In a July 2001 press release, Phytopharm announced the successful completion of its phase Ib "proof of principle" trial, and expects Phase II to begin in November of this year. Sixty-two healthy male volunteers participated in the three stage phase Ib study. The first stage evaluated the safety, tolerability and pharmacokinetics of ascending single doses of the product. The second stage assessed the effects of repeated dosing, in healthy overweight volunteers. The data obtained from the first two stages was used to determine the dosing regimen (dose and duration) for the final repeat dose stage. On October 1, Phytopharm CEO Richard Dixey reported that the company is starting Phase IIa testing, and expects results in mid November. In the Phase IIa trial obese subjects will be given P57 over a ten-day period to demonstrate efficacy in reducing caloric intake. Industry analysts predict that if all goes well this drug will be available on pharmacy shelves in three years.
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