Immtech Announces Interim Analysis in Phase III African Sleeping Sick...(the 12-month follow up which is theprima...),Health

Date:10/4/2007

the 12-month follow up, which is the primary endpoint for the trial, in second quarter 2008. Subject to having favorable primary analysis results, Immtech plans to submit a New Drug Application (NDA) to the US Food and Drug Administration in the second half of 2008. The FDA has agreed to consider "accelerated approval" of the 12-month data. The 24-month follow up data will be submitted later to fulfill requirements. The FDA has also granted to pafuramidine's African sleeping sickness indication Fast Track and Orphan Drug status, which is expected to accelerate review and provides for waiver of the Prescription Drug Users Fee.

The interim analysis was specified in the clinical trial protocol to evaluate the efficacy of pafuramidine compared to pentamidine, as well as the safety and tolerability of pafuramidine. The interim analysis was performed after half of the enrolled patients had completed the 12-month follow up protocol. The DSMB reviewed the data in an unblinded manner. However, the sponsor, Immtech, is blinded to the results until all patients have completed the 12-month follow up protocol.

A DSMB is a committee of physicians, scientists, and at least one non- scientific member who review clinical trial data in order to ensure protection of participants and to provide scientific and medical oversight for the trial. The DSMB operates under a trial-specific Charter and also according to the trial protocol. The DSMB could recommend discontinuing a trial if they observe any significant safety or efficacy problems for the test drug. The Charter also allows the DSMB to recommend halting the trial if enrollment is inadequate to complete the trial in a timely manner.

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. Immtec
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SOURCE Immtech Pharmaceuticals, Inc. Copyright©2007 PR Newswire. All rights reserved

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