Orphan drug status granted to Immtech for malaria treatment pafuramidine

Immtech Pharmaceuticals, Inc. has announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for pafuramidine (DB289) for the treatment of malaria.

In addition to providing a seven-year term of market exclusivity for pafuramidine upon final FDA approval, orphan drug designation also positions Immtech to take advantage of a range of financial and regulatory benefits, including government grants for conducting clinical trials, waiver of the Prescription Drug User's Fee for submission of the New Drug Application for pafuramidine to treat malaria, and certain tax credits.

Carol Olson, MD, PhD, Immtech's Sr. Vice President and Chief Medical Officer, stated: "Malaria is a devastating global health threat and the second leading cause of death in the world. Current treatments often present significant risks of side effects that make them poor options for many patients with malaria, especially pregnant women and children. No new class of agents for malaria have been introduced in more than 15 years, the last new drug approved for the treatment of malaria in the US was more than 10 years ago. New treatments for patients are needed in the developing world, as well as for millions of travelers from developed countries to endemic areas."

Pafuramidine, Immtech's oral drug candidate, is currently in Phase II clinical trials in patients with malaria. Prior trials have demonstrated 96% cure rates with 5-day treatment. The current trial is assessing the possibility to treat patients for 3 days by increasing the dose of pafuramidine or using pafuramidine in combination with artesunate. The current standard for treatment in the developing world is combination therapy, in order to prevent later development of resistance in the malaria parasite. The combination of pafuramidine and artesunate could be used in these patients. Pafuramidine as monotherapy (without another drug) could be used in the US to treat returning travelers who develop malaria.

"Immtech is committed to meeting the worldwide demand for safer, more effective options to treat malaria," commented Eric L. Sorkin, Chairman and Chief Executive Officer. "With orphan drug status and the ability to consider a range of related options such as grants and tax credits, Immtech is better positioned than ever to advance pafuramidine as an effective and commercially promising new treatment for global diseases."