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US FDA Grants Orphan Drug Status to Immtech's Pafuramidine for Treatment of African Sleeping Sickness
Date:9/19/2007

NEW YORK, Sept. 19 /PRNewswire-FirstCall/ -- Immtech Pharmaceuticals, Inc. (Amex: IMM) announced today that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to pafuramidine (DB289) for treating Human African Trypanosomiasis (HAT), also known as African sleeping sickness. Orphan drug designation provides Immtech with numerous financial and regulatory benefits during pafuramidine's development, including government grants for conducting clinical trials, waiver of New Drug Application submission fees, tax credits, and a seven-year market exclusivity upon final FDA approval.

Pafuramidine is currently in phase III clinical trials for African sleeping sickness at six trial sites in Africa. The infectious disease, spread by tsetse flies, threatens approximately 60 million people in over 30 countries in sub-Saharan Africa. Current treatments for the disease are associated with high levels of toxicity and are difficult to administer. Safety data for pafuramidine has been positive to date, and the FDA and Ethics Committees responsible for the study oversight currently allow adolescents, pregnant women and nursing mothers to participate in these clinical trials. These groups are particularly vulnerable to the disease.

"The FDA's decision reflects the significant need for new treatments for African sleeping sickness," stated Carol Olson, MD, PhD, Immtech's Sr. Vice President and Chief Medical Officer. "Pafuramidine has the potential to be the first oral treatment for this fatal and neglected disease. Patients often put off screening and treatment because current drugs must be given by injection. A safe and effective pill that is readily available should facilitate cure for more patients i
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SOURCE Immtech Pharmaceuticals, Inc.
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