VERNON HILLS, Ill., March 6 /PRNewswire-FirstCall/ -- Immtech International, Inc. announced today that a Special Protocol Assessment has been completed with the U.S. Food and Drug Administration (FDA) for the pivotal Phase III study of our oral drug candidate, DB289, for the treatment of Pneumocystis pneumonia (PCP) in patients with HIV/AIDS. A Special Protocol Assessment documents the FDA's agreement that the design and planned analysis of the study adequately addresses objectives in support of a regulatory submission such as a New Drug Application (NDA).
The randomized, double-blind trial will evaluate the efficacy, safety and tolerability of DB289, when administered as 100 mg tablets twice daily for 14 days versus the standard of care, which is trimethoprim-sulfamethoxazole (TMP-SMX) tablets, administered three times a day for 3 weeks. The study is expected to involve approximately 270 patients in the US, Mexico, Colombia, Peru, Chile and Argentina. Patients will be evaluated for clinical success on Day 22 of the study. They will have an additional evaluation 42 days after initiation of treatment to determine sustained clinical success.
Carol Olson, MD, PhD, Vice President and Chief Medical Officer, said, "We are pleased that the FDA has completed the Special Protocol Assessment, and we can initiate our pivotal trial in PCP. PCP is the most common opportunistic infection in patients with AIDS, and is a significant cause of morbidity and mortality globally. DB289 is a potential first-line alternative to TMP-SMX for treatment of PCP , as a significant number of patients are intolerant of TMP-SMX, and other currently available treatments are considered to be second line. In addition, DB289 will significantly decrease the daily pill burden for the patients who take treatment for PCP."
The development of DB289 for the treatment of PCP was sponsored in part by a National Cooperative Drug Discovery Groups (NCDDG) grant from the National Institutes of Health, US Department of Human Health and Services, to the University of North Carolina at Chapel Hill. DB289 was initially synthesized at Georgia State University. Immtech is developing DB289 for use in PCP, African sleeping sickness (trypanosomiasis), and malaria.
About Immtech International
Immtech International, Inc. is a pharmaceutical company developing and commercializing drugs to treat infectious diseases, and the Company is expanding targeted markets by applying its proprietary pharmaceutical platform to treat many other disorders. Immtech has advanced clinical programs that include new treatments for malaria, Pneumocystis pneumonia and African sleeping sickness (Trypanosomiasis) and drug development programs for tuberculosis and fungal infections. The Company has worldwide licensing and exclusive commercialization rights to a large library of well-defined compounds from which a pipeline of therapeutic products could be developed. For additional information, please go to http://www.immtech-international.com.
"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.CONTACT: F. C. Thompson, 1-877-898-8038
Web site: http://www.immtech-international.com/
