Important note: Information in this article was accurate in 2001. The state of the art may have changed since the publication date.
PRNewswire - December 13, 2001
"We are thrilled with the agreement," said Hans J. Keil, Samoa's Minister of Trade and Tourism. "This is a breakthrough -- a plus for indigenous cultures around the world. If prostratin is successful, the return to Samoa is great, and we will put the sum to good use."
The agreement signed by ARA and the Samoan Prime Minister culminates years of research by the National Cancer Institute (NCI) of the National Institutes of Health (NIH) in Bethesda, Maryland, and ARA based on a plant collected by Paul Alan Cox, Ph.D., Director of the National Tropical Botanical Garden, a congressionally-chartered research institution in Hawaii and Florida dedicated to tropical plant conservation and ethnobotany, the study of how indigenous peoples use plants.
Dr. Cox found that Samoan healers used the bark of the plant Homalanthus nutans to treat hepatitis and sent their mixtures to the NCI, which isolated prostratin.
Before beginning his research, Dr. Cox and the Samoan village chiefs agreed that a portion of any future financial benefit would be returned to the village. In licensing the compound for development, NCI requested that there be a negotiation with the Samoan government for a benefit for the Samoan people.
ARA, a non-profit research institution that shared this philosophy, licensed prostratin from NCI to explore the compound's ability to protect cells from HIV and to activate virus that lays dormant in the body and beyond the reach of currently-available HIV drugs.
"Ethnobotanical research in Samoa helped us to learn about this important natural resource and its potential for treating HIV," said Irl Barefield, Executive Director of ARA. "It is only right that the people of Samoa share in any potential reward, and we hope that this agreement will set a standard on ethical dealings with medicines derived from indigenous cultures."
Under the terms of the agreement, money from commercialization of prostratin, perhaps millions of dollars annually, would go to the Samoan government, the village where the compound was found, and each of the families of the healers who helped discover it. ARA will use any revenues it derives from prostratin for additional HIV/AIDS research.
Barefield said he hopes that clinical trials of prostratin in humans can begin within a year.
"Too often in the past, the role of a country's indigenous people has not been recognized in the drug discovery process," noted Dr. Cox. "It was to address that issue that the Samoan chiefs and I agreed -- before I began my research -- that the village should share in any success."
Even before the ARA-Samoa agreement was signed, Dr. Cox said he raised over $480,000 to build schools, clinics, and a rainforest canopy walkway in Falealupo village on the Samoan island of Savaii. (1)
The profit-sharing agreement with Samoa also demonstrates how the NIH encourages such pharmaceutical discovery relationships with other countries.
"The NIH collaborates with many foreign nations, and is concerned with returning benefits both in the short- and long-term," said Gordon Cragg, Ph.D., Chief of the Natural Products Branch of the National Cancer Institute.
"This agreement is an excellent example of how both countries can benefit from the discovery process. This is also the first drug licensed by the NCI to a non-profit research institution for development."
The promise of prostratin
ARA's Medical Director, Stephen J. Brown, M.D., took notice of NCI's work with prostratin in 1999 and began to direct research on the compound. After promising initial results, NCI spoke with ARA about the possibility of negotiating a license. Most recently, a study in the November 15 issue of the journal Blood confirmed the earlier work of researchers at several institutions -- including NCI, ARA and UCLA -- who learned that prostratin exhibited dual action, inhibiting HIV replication while activating dormant, or "latent" HIV. This is significant because cells latently-infected with HIV continue to replicate and reside in the body for up to 60 years, hidden from the immune system despite treatment. Prostratin can stimulate latently-infected cells so that the virus can potentially be recognized by the immune system or eradicated by currently available drugs.
In the study, researchers at the NCI and Jefferson Medical College in Philadelphia showed that in laboratory experiments, prostratin can activate dormant HIV in cells taken from HIV-positive patients. The study authors suggest that future studies should examine combination therapy involving prostratin and other anti-HIV drugs to activate pockets of dormant HIV in the hopes of eradicating the virus.
About AIDS ReSearch Alliance of America
AIDS ReSearch Alliance of America is a community-based non-profit organization fighting HIV/AIDS on multiple fronts. ARA works to find and accelerate the development of better therapies to treat HIV.
Founded in 1989 by a group of Los Angeles area physicians, ARA has grown into a national research organization collaborating with scientists, universities and researchers worldwide. ARA's work is driven by its continued belief that a cure for HIV is attainable. See http://www.aidsresearch.org for more information.
About The National Tropical Botanical Garden
The National Tropical Botanical Garden is dedicated to the conservation of tropical plant diversity, particularly rare and endangered species. Located in the only tropical and sub-tropical regions in the United States, NTBG has assembled what is believed to be the largest collection of federally-listed endangered plant species anywhere, including the largest collection of native Hawaiian flora. See http://www.ntbg.org for more information.
(1) Pharmaceutical News, Vol. 8, No.3, 2001
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