Immtech International, Inc. has announced that the U.S. Food and Drug Administration has granted Immtech's first oral drug, DB289, fast track drug development designation for use to treat human African sleeping sickness (Trypanosomiasis).
The FDA's fast track designation is recognition that DB 289 potentially represents an important new drug to combat and treat this life-threatening disease for which no other oral treatment exists. Most importantly, studies have demonstrated DB 289's effectiveness to treat human African sleeping sickness without the serious side effects associated with alternative (non-orally deliverable) drugs. Fast track designation also allows DB 289 to be eligible for expedited FDA review.
The World Health Organization (WHO) has reported that over 60 million people are considered at risk of infection in 36 African countries in which human African sleeping sickness is endemic. Immtech believes that between 300,00 and 500,000 new cases occur each year. Immtech maintains that DB289, a dicationic pharmaceutical compound, will be the first commercially available oral drug capable of treating and preventing African sleeping sickness. Stephen Thompson, President and CEO said, "The FDA's fast track designation for DB289 indicates the importance and great potential of our technology platform, and validates the value of Immtech's prodrug technology for oral delivery of dictation compounds. DB289 will substantially benefit people infected with this fatal disease endemic in sub-Sahara Africa."