Immtech Initiates Phase IIb Clinical Trial to Develop Malaria Prevention and Treatment Therapies

11 Apr 2007
PR.com
Immtech Pharmaceuticals, Inc. (AMEX: IMM) announced today  that it has initiated a Phase IIb clinical trial for the Company's oral drug candidate, pafuramidine maleate (pafuramidine), to treat patients with uncomplicated malaria caused by Plasmodium falciparum, (the deadliest form of malaria).

This dose-ranging trial will involve total daily doses of 400 mg or 600 mg, given either once daily or divided into twice daily doses. Three days will be the treatment duration in the first stage of this trial. The primary objective is to establish a dose of pafuramidine that can be studied as mono-therapy in a subsequent Phase III trial. The trial will also explore the efficacy of the combination of pafuramidine and artesunate as a treatment for malaria. Additionally, data from this trial will support Immtech's malaria prevention development efforts. Currently Immtech is conducting a Phase II trial of pafuramidine for malaria prevention.

Eric L. Sorkin, Chairman and Chief Executive Officer of Immtech, stated "According to the World Health Organization (WHO), malaria is a life- threatening disease and approximately 40% of the world's population reside in malaria-infected areas. Each year an estimated 300 million new cases of malaria occur, resulting in more than one million deaths. Global efforts to control the disease are hampered by malarial drug resistance as well as by dangerous side effects associated with some current therapies.

Immtech is committed to developing an entirely new class of safe and oral therapies for malaria prevention and treatment."Pafuramidine given twice daily (total daily dose of 200 mg) for 5 days resulted in an excellent cure rate of 96% in Immtech's Phase IIa malaria treatment trial, setting a minimum effective dosage rate. Prior Phase II trials for malaria treatment were conducted with a capsule formulation of pafuramidine. This new trial will use the recently developed tablet formulation, which is expected to perform better in clinical practice.

Carol Olson, M.D., Ph.D., Sr. Vice President and Chief Medical Officer of Immtech, stated "Malaria continues to cause a high incidence of death and significant illness in malaria endemic countries. In addition, 125 million travelers from developed countries visit malaria-infected regions annually, making the need for a new malaria prophylaxis an urgent global health issue. The results of this malaria treatment trial, along with the results of our ongoing malaria prevention trial, will further enhance Immtech's development of pivotal studies and subsequent regulatory submissions for malaria prevention and malaria treatment.

"In addition to the Phase IIa treatment trial, Immtech completed a Phase IIb clinical trial of pafuramidine to treat uncomplicated P. falciparum malaria in 120 patients in Thailand. The trial established a minimally effective dose, pafuramidine 100 mg twice daily for 3 days, which was one of the objectives of that trial. Data from the prior Phase IIb trial is essential for understanding pafuramidine's activity and for designing this new trial and subsequent malaria trials for both prophylaxis and for treatment.

According to the WHO, the vast majority of malaria deaths occur in sub- Saharan Africa, where malaria also presents major obstacles to social and economic development (i,ii). About 75% of malaria deaths are in African children less than five years old and infected with P. falciparum. In fact, malaria accounts for one in five of all childhood deaths in Africa(iii). Every 30 seconds a child dies in Africa from malaria.

Pregnant women are the main adult risk group for malaria in most endemic areas of the world. In areas of Africa with infrequent or episodic (seasonal) malaria transmission (where most adult women have not developed significant immunity to malaria), pregnant women are at a two-to-three-fold greater risk than non-pregnant women of developing severe disease, increasing their risk of maternal and infant complications or death. HIV-infected people are also considered particularly vulnerable to malaria. In areas with endemic malaria, HIV increases the risk of malaria infection and clinical malaria in adults, especially in those with advanced immunosuppression(iv).

(i) Centers for Disease Control and Prevention. Frequently asked questions about malaria. Available at http://www.cdc.gov/malaria/faq.htm, accessed July 14, 2006 (ii) Centers for Disease Control and Prevention. Malaria Facts. Available at http://www.cdc.gov/malaria/facts.htm, accessed July 14, 2006 (iii) World Health Organization: Roll Back Malaria. Children and malaria. Geneva. Available at: http://www.rbm.who.int/cmc_upload/0/000/015/367/RBMInfosheet_6.htm. Accessed September 7, 2006. (iv) World Health Organization: Roll Back Malaria. Malaria and HIV interactions and their implications for public health policy. Geneva 2004. Available at: http://www.who.int/malaria/malaria_HIV/MalariaHIVinteractions_report.pdf. Accessed September 8, 2006.

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