Immtech Pharmaceuticals,
Inc. (Amex: IMM) announced that it has completed its first malaria
prevention (or "malaria challenge") trial of pafuramidine, Immtech's oral
drug candidate. The exploratory study was designed to determine whether the
Company should focus on commercializing a blood-stage or a liver-stage
malaria prevention drug. The information obtained from this study is needed
by Immtech in order to design the appropriate subsequent trials for
pafuramidine's registration to target malaria prevention, and by the
Independent Ethics Committees and the regulatory agencies in order to
review and approve subsequent studies for this indication.
Malaria prevention potentially represents a significant market
opportunity for Immtech. Datamonitor estimates the market potential for a
product with pafuramidine's expected profile to exceed US $1.0 billion
globally.
Eric L. Sorkin, Immtech's Chairman & Chief Executive Officer stated,
"The completion of this study gives us a clear direction in our plans to
commercialize pafuramidine as a malaria prevention drug. The market for
malaria prevention represents an enormous market opportunity which Immtech
intends to pursue vigorously."
The malaria parasite initially travels to the liver where it grows for
about 7 days before spreading to the blood. Malaria prevention drugs can
work by preventing the infection in the liver or in the blood stream. A
liver stage regimen would continue for 7 days after travel and a blood
stage regimen would continue for 30 days after travel. The results of this
study indicate that the Company should commercialize a prevention drug to
target the blood stage form of malaria.
In this study a single dose of 100mg of pafuramidine was administered
once only to prevent malaria infection in the liver, which represents the
earliest stage of infection. Healthy volunteers were recruited for the
trial because they are representative of travelers to malaria-endemic
areas. The 100 mg dosing was determined based on results of blood levels of
the active drug form of pafuramidine recorded in previous human and animal
model studies. The low dosages and rigorous study design were used to help
distinguish the effect of pafuramidine on liver stage infection versus the
effect demonstrated on blood stage infection.
Carol Olson, MD, PhD, Immtech's Sr. Vice President and Chief Medical
Officer, stated, "A prior study of pafuramidine given as 100 mg for 5 days
in uncomplicated malaria showed a 96% cure rate 28 days after treatment.
Based on those results, we believe that continued treatment of travelers
with pafuramidine for 30 days after travel will be protective against blood
stage malaria. The malaria challenge study was designed specifically to
evaluate the effect of pafuramidine on the liver stage, and to have no
effect on the blood stage of malaria infection. With the results of this
study we can now advance our malaria prevention program with the goal of
preventing blood stage infection, which would represent a major advance in
global health. We will work with our advisors to design the appropriate
trials that will be acceptable to the US Food and Drug Administration as
well as to regulatory agencies in other countries."
Participants in the randomized placebo controlled trial were treated
with placebo (sugar pill), a dose of pafuramidine that was expected not to
be effective (administered eight days before subjects were exposed to
malaria), and a dose of pafuramidine that was considered to be potentially
effective (administered one day prior to exposure).
Immtech Pharmaceuticals will hold a conference call on Friday, November
9th. Dial-in instructions will be announced on November 6th.
About Immtech Pharmaceuticals, Inc.
Immtech Pharmaceuticals, Inc. is focused on developing and
commercializing drugs to treat infectious diseases, and the Company is
expanding its targeted markets by applying its proprietary pharmaceutical
platform to treat other disorders. Immtech has advanced clinical programs
that include new oral treatments for pneumocystis pneumonia (PCP), malaria,
and trypanosomiasis (HAT or African sleeping sickness), and a well defined,
expanding library of compounds targeting drug-resistant Gram-positive
bacteria, fungal infections, Hepatitis C and other serious diseases.
Immtech holds the 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, including the future prospects for PCP, which are not
historical facts are "forward- looking statements" that involve risks and
uncertainties. 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, 2007 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, including PCP; (vii) the success of Immtech's clinical
trials; (viii) dependence upon and contractual relationship with partners;
(ix) Immtech's ability to manufacture or to have a third party manufacture
its drug candidate at a reasonable cost; (x) Immtech's ability to protect
its intellectual property; (xi) competition and alternative technologies;
(xii) Immtech's ability to obtain reimbursement from third party payers for
any product it commercializes; and (xiii) potential exposure to significant
product liability.
Immtech Pharmaceuticals, Inc.
immtechpharma