[Ip-health] NCI - Samoan gov - AIDS Research Alliance research on experimental AIDS drug

[Mike Palmedo]

http://www.aidsresearch.org/prostratin.html

AIDS ReSearch Alliance of America Announces Landmark Agreement To Share
Drug Profits With Samoan Village Healers

Promising rain forest-derived anti-AIDS compound is first ever licensed
by National Cancer Institute to a nonprofit research institution

(West Hollywood, CA, December 13, 2001)=97=97AIDS ReSearch Alliance of
America (ARA) today announced a landmark agreement to return 20 percent
of any commercial revenues from an experimental but promising anti-HIV
compound called prostratin to the people of Samoa who helped American
researchers discover the plant-derived potential therapy. The
arrangement provides a share in the potential revenues from the first
compound ever licensed by the National Cancer Institute for development
by a nonprofit research institution.

"We are thrilled with the agreement," said Hans J. Keil, Samoa's
Minister of Trade and Tourism. "This is a breakthrough=97a 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."



Homalanthus nutans (mamala) is the Samoan plant from which prostratin is
derived. Drawing by Michael Rothman.
 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 nonprofit 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=97before I
began my research=97that 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 rain forest canopy
walkway in Falealupo village on the Samoan island of Savaii.

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 to a nonprofit 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=97including NCI, ARA and UCLA=97who
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.

ARA's Director of Clinical Research Stephen J. Brown, M.D., Paul Alan
Cox, Ph.D., Director of the National Tropical Botanical Garden, and
ARA's Executive Director Irl. S. Barefield in Samoa.

About AIDS ReSearch Alliance of America

AIDS ReSearch Alliance of America is a community-based nonprofit medical
organization fighting HIV/AIDS on multiple fronts. ARA works to find and
accelerate the development of betters therapies to treat HIV. The
organization remains committed to the possibility that HIV may
ultimately be cured. 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.

Contact: Irl S. Barefield, Executive Director, AIDS ReSearch Alliance,
621-A North San Vicente Boulevard., West Hollywood, CA 90069,
310.358.2423, ext. 190, info@aidsresearch.org.

--
Mike Palmedo
Consumer Project on Technology
T-202-387-8030
F-703-409-7211
mpalmedo@cptech.org