Phase III Pivotal Trial of DB289 To Treat Trypanosomiasis (African sleeping sickness)
May 17, 2017
Immtech
International, Inc (Amex: IMM) announced today that it has initiated, in
partnership with the University of North Carolina at Chapel Hill, a Phase III
pivotal trial of its oral drug DB289 in the Democratic Republic of Congo to
treat Trypanosomiasis (African sleeping sickness) and that it is screening
patients for enrollment. The study is planned at multiple sites in the
Democratic Republic of Congo, New Sudan, and Angola. The Company plans to
enroll approximately 250 "stage-one" patients in a randomized trial which will
compare the effectiveness of DB289 to pentamidine, the current first line
therapy in Africa which is difficult to administer in remote areas and is
associated with significant side-effects.
Human African trypanosomiasis, also known as sleeping sickness, is caused
by single-celled parasites, Trypanosoma brucei, which are transmitted to
humans by infected tsetse flies. The illness produces fever, lymph node
inflammation, eventual impairment of the brain and nervous system in its late
stage and, if not treated, death. Stage-one patients are those infected with
the African sleeping sickness parasites in their blood and lymph nodes. If
untreated, the parasites will enter patients' cerebrospinal fluid and brain
and cause a more severe form of the disease. The trial is not blinded because
DB289 is an oral drug and pentamidine is administered as an intramuscular
injection.
One half of the patients with the confirmed disease will receive DB289
twice daily (100 mg) for ten consecutive days. The remaining control group
patients will receive the standard therapy of once daily injections of
pentamidine. Both patient groups will be monitored for clearance of the
parasite during treatment and at specified intervals after the treatment
regimen is completed. The study protocol was reviewed and approved by the
United States Food & Drug Administration (U.S. FDA) as part of a Special
Protocol Assessment. During the Phase III trial, the Company intends to
submit to the U.S. FDA a Treatment IND for approval which, if granted, would
enable DB289 to be sold for the treatment of Trypanosomiasis in desperately
ill patients while the clinical trials are being completed.
T. Stephen Thompson, President and CEO, said, "DB289 is an important new
oral drug that may have a major impact on a devastating disease that has, for
centuries, been a scourge in the sub-Sahara. The entry of DB289 into a Phase
III pivotal trial represents the accomplishment of a major milestone for both
our Company and infected patients, given the significant challenges present in
rural areas where the neediest patients are located. In addition to targeting
against Trypanosomiasis, DB289 is in a Phase IIb trial to treat malaria, and
we are planning to initiate pivotal Phase III trials in malaria treatment and
Pneumocystis pneumonia in AIDS patients. We also plan to initiate clinical
trials of DB289 in malaria prophylaxis."
Doctors Without Borders estimates that the geographical range in sub-
Sahara Africa where human African sleeping sickness occurs encompasses 36
countries, where more than 60 million people are at risk of contracting the
disease. The World Health Organization (WHO) estimates that there are 300,000
to 500,000 active cases of human African sleeping sickness in central Africa.
A WHO survey reports that an "epidemic situation" for African sleeping
sickness exists in the sub-Sahara region of Africa, which includes the
countries of Angola, Sudan, Uganda and the Democratic Republic of the Congo.
About Immtech International
Immtech International, Inc. is a pharmaceutical company advancing the
development and commercialization of oral drugs to treat infectious diseases
and neoplastic (cancer) and metabolic (diabetes) disorders. We are developing
treatments for fungal infections, malaria, tuberculosis, cancer, diabetes,
Pneumocystis pneumonia, and tropical diseases, including African sleeping
sickness (trypanosomiasis) and leishmaniasis. We have a worldwide, exclusive
license to commercialize a dicationic pharmaceutical platform from which a
pipeline of products may be developed to target large, global markets. Our
dicationic pharmaceutical platform, which includes DB289, was developed by a
scientific consortium led by scientists at the University of North Carolina at
Chapel Hill and Georgia State University.
"Safe Harbor" Statement under the Private Securities Reform Act of 1995:
Statements in this press release regarding Immtech International, Inc.'s
business which are not historical facts are "forward-looking statements" that
involve risks and uncertainties. For a discussion of such risks and
uncertainties that could cause actual results to differ from those contained
in the forward-looking statements, see "Risk Factors" in the Company's Annual
Report on Form 10-K for the most recently ended fiscal year.
Immtech International, Inc.
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