UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
DC 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of the
Securities
Exchange Act of 1934
Date
of Report (Date of earliest event reported)
December
26, 2007
IMMTECH
PHARMACEUTICALS, INC.
(Exact
name of registrant as specified in its charter)
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(State
or Other Jurisdiction of Incorporation)
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(Commission
File Number)
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(IRS
Employer Identification No.)
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One
North End Avenue
New
York, New York 10282
(Address
of Principal Executive Offices, including Zip Code)
(212)
791-2911
(Registrant’s
telephone number, including area code)
Check
the
appropriate box below if the Form 8-K filing is intended to simultaneously
satisfy the filing obligation of the registrant under any of the following
provisions (see General Instruction A.2. below):
¨ Written
communications pursuant to Rule 425 under the Securities Act (17 CFR
230.425)
¨ Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
¨ Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b))
¨ Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c))
ITEM
8.01
Other Events.
On
December 26, 2007, Immtech Pharmaceuticals, Inc. (the “Company”) (Amex: IMM )
announced that it is working with clinical investigators at one South African
site where a safety study is in progress for its drug candidate pafuramidine
(DB289), an investigational therapy. In preliminary findings from
this study, abnormal laboratory values were found in several volunteers
following treatment with pafuramidine. The Company has discussed the preliminary
findings with the U.S. Food and Drug Administration (“FDA”), and as a
precautionary measure, the pafuramidine program has been placed on clinical
hold. The clinical hold may be released after the FDA has received
satisfactory data regarding the safety of pafuramidine.
Volunteers
in this safety study were dosed with either 100mg of pafuramidine or a placebo
twice daily for 14 days. Subjects are being monitored for any changes
in the status of their liver function, and no subject has required any medical
treatment or hospitalization for the abnormalities. The Company is
working closely with independent experts and the Data Safety Monitoring Board
for pafuramidine to determine the cause for the abnormalities observed in
this
single study. This evaluation will continue until patients stabilize
or return to baseline status. At that time, the Company and these experts
will
prepare a summary of the available safety data and recommendations for
presentation to the FDA.
The
Company is conducting this safety study in one location in South Africa,
separate from all of the Company’s Phase
II and
Phase III trials. This study involves collecting additional safety
data regarding pafuramidine from healthy volunteers to support the indications
of Pneumocystis pneumonia and African sleeping sickness. These two diseases
affect a relatively small number of patients (they are considered as orphan
drug
indications), and so there are fewer patients available than are generally
required for Phase III trials. The safety study was planned in 2005,
after discussions with the FDA, in order to increase the number of subjects
treated with pafuramidine.
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant
has
duly caused this report to be signed on its behalf by the undersigned hereunto
duly authorized.
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Date:
December 26, 2007
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IMMTECH
PHARMACEUTICALS, INC.
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Eric
L. Sorkin
Chairman,
Chief Executive Officer and
President
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