NEW YORK, Sept. 19 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 HumanAfrican Trypanosomiasis (HAT), also known as African sleeping sickness.Orphan drug designation provides Immtech with numerous financial andregulatory benefits during pafuramidine's development, including governmentgrants for conducting clinical trials, waiver of New Drug Applicationsubmission fees, tax credits, and a seven-year market exclusivity upon finalFDA approval.
Pafuramidine is currently in phase III clinical trials for Africansleeping sickness at six trial sites in Africa. The infectious disease, spreadby tsetse flies, threatens approximately 60 million people in over 30countries in sub-Saharan Africa. Current treatments for the disease areassociated with high levels of toxicity and are difficult to administer.Safety data for pafuramidine has been positive to date, and the FDA and EthicsCommittees 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 forAfrican sleeping sickness," stated Carol Olson, MD, PhD, Immtech's Sr. VicePresident and Chief Medical Officer. "Pafuramidine has the potential to bethe first oral treatment for this fatal and neglected disease. Patients oftenput off screening and treatment because current drugs must be given byinjection. A safe and effective pill that is readily available shouldfacilitate cure for more patients in the early stage of the disease. Becausepafuramidine is more user-friendly than existing therapies, we anticipate thatit would be available in community clinics as well as at current Africansleeping sickness treatment centers. Patients could be treated close to home,rather than traveling long distances to specialized centers."
Pafuramidine has previously been granted Orphan Drug Designation fortreatment of pneumocystis pneumonia (PCP) and malaria. In addition to trialsfor African sleeping sickness, pafuramidine is currently in Phase III clinicaltrials for PCP, and in Phase II trials targeting malaria treatment and malariaprophylaxis.
"This is another positive milestone for Immtech as pafuramidine advancestowards commercialization," commented Eric L. Sorkin, Immtech's Chairman andChief Executive Officer. "We will continue to work closely with our consortiumof scientists, and global collaborators to develop safer and more effectivetherapies for this and other global health threats."
About Immtech Pharmaceuticals, Inc.
Immtech Pharmaceuticals, Inc. is focused on developing and commercializingdrugs to treat infectious diseases, and the Company is expanding its targetedmarkets by applying its proprietary pharmaceutical platform to treat otherdisorders. Immtech has advanced clinical programs that include new oraltreatments for Pneumocystis pneumonia (PCP), malaria, and trypanosomiasis (HATor African Sleeping Sickness), and a well defined, expanding library ofcompounds targeting drug-resistant Gram-positive bacteria, fungal infections,Hepatitis C and other serious diseases. Immtech holds the exclusive worldwidelicenses to certain patents, patent applications and technology for productsderived from a proprietary pharmaceutical platform. For additionalinformation, 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.'sbusiness, including the future prospects for PCP, which are not historicalfacts are "forward- looking statements" that involve risks and uncertainties.Actual results could differ materially from these forward-looking