Immtech Initiates Phase IIb Clinical Trial To Develop Malaria Prevention And Treatment Therapies
May 28, 2017
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.
About Malaria
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).
About Immtech Pharmaceuticals, Inc.
Immtech Pharmaceuticals, Inc. is focused on developing and
commercializing drugs to treat infectious diseases. Immtech has advanced
clinical programs that include new oral treatments for Pneumocystis
pneumonia (PCP), malaria, and trypanosomiasis (African sleeping sickness),
and a well defined, expanding library of compounds targeting Hepatitis C,
fungal infections, bacterial infections and other serious diseases. Immtech
holds exclusive worldwide licenses to certain patents, patent applications
and technology for products derived from a proprietary pharmaceutical
platform. For additional information, please go to
immtechpharma.
"Safe Harbor" Statement under the Private Securities Reform Act of
1995: Statements in this press release regarding Immtech Pharmaceuticals,
Inc.'s business which are not historical facts are "forward-looking
statements" that involve risks and uncertainties. These forward-looking
statements include statements with respect to Immtech's plans with respect
to its pivotal trial and the distribution of pafuramidine. Actual results
could differ materially from these forward-looking statements. Factors that
could cause or contribute to such differences include, but are not limited
to, those discussed under the headings "Management's Discussion and
Analysis of Financial Condition and Results of Operations" and "Risk
Factors" in Immtech's annual report on Form 10-K for the year ended March
31, 2006 and in its other SEC filings and include: (i) Immtech's ability to
develop commercially viable products; (ii) Immtech's ability to achieve
profitability; (iii) Immtech's ability to retain key personnel; (iv) the
ability of Immtech's scientists and collaborators to discover new
compounds; (v) the availability of additional research grants; (vi)
Immtech's ability to obtain regulatory approval of its drug candidate;
(vii) the success of Immtech's clinical trials; (viii) Immtech's ability to
manufacture or to have a third party manufacture its drug candidate at a
reasonable cost; (ix) Immtech's ability to protect its intellectual
property; (x) competition and alternative technologies; (xi) Immtech's
ability to obtain reimbursement from third party payers for any product it
commercializes; and (xii) potential exposure to significant product
liability.
References
(i) Centers for Disease Control and Prevention. Frequently asked questions
about malaria. Available at cdc/malaria/faq.htm, accessed
July 14, 2006.
(ii) Centers for Disease Control and Prevention. Malaria Facts. Available
at cdc/malaria/faq.htm, accessed July 14, 2006.
(iii) World Health Organization: Roll Back Malaria. Children and malaria.
Geneva.
(iv) World Health Organization: Roll Back Malaria. Malaria and HIV
interactions and their implications for public health policy. Geneva 2004.
Immtech Pharmaceuticals, Inc.
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