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REDUCTION OF PARASITE LEVELS IN PATIENTS WITH UNCOMPLICATED MALARIA BY TREATMENT WITH HE2000

16-Bromoepiandrosterone (HE2000) is a synthetic androstane steroid that has immune effects in pre-clinical models of malaria, tuberculosis, and infection with human immunodeficiency virus. In pilot studies, 42 patients with confirmed uncomplicated Plasmodium falciparum malaria were treated with a seven-day course of HE2000 by either buccal administration or intramuscular injection. Of the 42 patients, 41 showed a 50% reduction in blood levels of parasites, the primary endpoint of the study. Of these, 32 (76%) cleared malaria parasites below detectable levels. All febrile patients became afebrile by the end of treatment. There was no reduction in gametocyte forms. Adverse events were transient and mild to moderate in intensity. The anti-malarial response was generally similar with either the intramuscular or buccal routes of administration. HE2000 shows a safety profile and pharmacologic activity worthy of further investigation to understand its role in the treatment of malaria, perhaps in combination with anti-malarial agents.

Received December 13, 2005. Accepted for publication October 20, 2006.

Acknowledgments: We thank the nursing and medical staff of the Division of Tropical Medicine, Mahidol University (Bangkok, Thailand), and David Skarinsky, Karen Schlangen, Liz Morgan, and Judy Addison for their contributions to this project. We also thank the patients and their families for participating in the study.

Financial support: This study was supported by Hollis-Eden Pharmaceuticals, Inc. (San Diego, CA).

Disclaimer: James Frincke, Dwight Stickney, Nanette Onizuka-Handa, Armando Garsd, and Christopher L. Reading are employed by Hollis-Eden Pharmaceuticals. Sornchai Looaresuwan received research support from Hollis-Eden Pharmaceuticals, Inc.

^* Address correspondence to James M. Frincke, Hollis-Eden Pharmaceuticals, Inc., 4435 Eastgate Mall, Suite 400, San Diego, CA, 92121. E-mail: jfrincke{at}holliseden.com

Authors’ addresses: James M. Frincke, Dwight R. Stickney, Nanette Onizuka-Handa, Armando Garsd, and Christopher L. Reading, Hollis-Eden Pharmaceuticals, Inc., 4435 Eastgate Mall, Suite 400, San Diego, CA, 92121, Telephone: 858-587-9333, Fax: 858-320-2590. Sriv-icha Krudsood, Polrat Wilairatana, and Sornchai Looareesuwan, Department of Tropical Medicine, Mahidol University, Bangkok, Thailand, Telephone: 66-2-247-1688, Fax: 66-2-245-7288.

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