NEW YORK, June 20 /PRNewswire-FirstCall/ -- Immtech Pharmaceuticals, Inc. announced today that it has completed the dosing and exposure protocol for a Phase II malaria prevention trial in the United States of its oral drug candidate pafuramidine (DB289). The study is designed to determine whether pafuramidine would be effective in preventing malaria infections for travelers. The World Health Organization estimates that there are 125 million people who travel to malaria endemic regions each year. The study protocol was reviewed by the U.S. Food & Drug Administration.
The primary purpose of this randomized, double-blind, placebo-controlled study is to determine whether pafuramidine can prevent the initial infection of the liver as well as infection of red blood cells associated with infection by Plasmodium falciparum.
Volunteer participants enrolled in this malaria prevention trial have completed the screening phase and have been dosed with either pafuramidine or placebo and then exposed to (“challenged with”) malaria-infected mosquitoes. Subjects were divided into three randomized groups: one group received pafuramidine eight days prior to the challenge, the second received pafuramidine one day prior to challenge, and the third received placebo (sugar pill) on both days prior to challenge. All subjects will be carefully monitored for malaria and promptly treated if they should become infected. For the study to be considered successful, at least one group of subjects who received pafuramidine will not develop malaria, and the subjects who received placebo will have evidence of the disease.
“We are pleased to have completed the dosing and exposure to the mosquitoes in this malaria prevention study. This is a major milestone in the assessment of pafuramidine as a new drug for preventing malaria,” stated Carol Olson, M.D., Ph.D., Sr. Vice President and Chief Medical Officer of Immtech. “In clinical results thus far, pafuramidine has shown promise as both a potential prophylaxis and as a treatment option for malaria caused by Plasmodium falciparum, the most dangerous malaria parasite. Furthermore, pafuramidine has not been associated with the significant neurological, gastrointestinal, or photosensitivity-related side effects or psychotic episodes that are often experienced by travelers who use currently-available malaria prevention medications. We believe pafuramidine could provide an alternative for malaria prevention that would be safe, well-tolerated and more convenient than drugs currently available.”
About Immtech Pharmaceuticals, Inc.
Immtech Pharmaceuticals, Inc. is focused on developing and commercializing drugs to treat infectious diseases, and the Company is expanding its targeted markets by applying its proprietary pharmaceutical platform to treat other disorders. Immtech has advanced clinical programs that include new oral treatments for Pneumocystis pneumonia (PCP), malaria, and trypanosomiasis (African Sleeping Sickness), and a well defined, expanding library of compounds targeting fungal infections, Hepatitis C and other serious diseases. Immtech holds the exclusive worldwide licenses to certain patents, patent applications and technology for products derived from a proprietary pharmaceutical platform. For additional information, please go to http://www.immtechpharma.com
“Safe Harbor” Statement under the Private Securities Reform Act of 1995: Statements in this press release regarding Immtech Pharmaceuticals, Inc.'s business, including the future prospects for PCP, which are not historical facts are “forward-looking statements” that involve risks and uncertainties. Actual results could differ materially from these forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those discussed under the headings “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and “Risk Factors” in Immtech’s annual report on Form 10-K for the year ended March 31, 2007 and in its other SEC filings and include: (i) Immtech’s ability to develop commercially viable products; (ii) Immtech’s ability to achieve profitability; (iii) Immtech’s ability to retain key personnel; (iv) the ability of Immtech’s scientists and collaborators to discover new compounds; (v) the availability of additional research grants; (vi) Immtech’s ability to obtain regulatory approval of its drug candidate, including PCP; (vii) the success of Immtech’s clinical trials; (viii) Immtech’s ability to manufacture or to have a third party manufacture its drug candidate at a reasonable cost; (ix) Immtech’s ability to protect its intellectual property; (x) competition and alternative technologies; (xi) Immtech’s ability to obtain reimbursement from third party payers for any product it commercializes; (xii) dependence upon and contractual relationships with partners; and (xiii) potential exposure to significant product liability.
Immtech Pharmaceuticals, Inc.
CONTACT: Paul Hendley or Stephen Zoegall, +1-212-253-8881, for ImmtechPharmaceuticals, Inc.
Web site: http://www.immtechpharma.com/
