Immtech begins pneumocystis pneumonia trial

The study is planned to enroll approximately 270 HIV/AIDS patients at multiple sites in the US and Latin America and will provide essential data for Immtech’s first new drug application. The study protocol was reviewed and approved by the FDA through a special protocol assessment.

Pneumocystis pneumonia (PCP) is a fungal infection of the lungs that usually occurs in patients who are immunocompromised due to diseases such as HIV/AIDS, receiving chemotherapy for cancer, or who are recipients of solid organ transplants. PCP is the most common opportunistic infection associated with HIV/AIDS.

The disease is associated with significant morbidity and mortality. According to Immtech, approximately 10-20% of patients will die despite treatment and 80% or more will die of the disease if left untreated.

Approximately 20-50% of patients have significant adverse reactions to the current standard therapy, TMP-SMX (the active component found in Roche’s Bactrim and Glaxo-Welcome’s Septra), which results in those patients being switched to potentially less effective medications. In addition, PCP resistance to TMP-SMX, and subsequent treatment failure, has been reported.

“We expect pafuramidine to have similar efficacy and potentially improved tolerability compared to the current standard therapy. Pafuramidine is expected to be an alternative first line treatment with a shorter course of therapy and fewer tablets than TMP-SMX, which are important factors to HIV/AIDS patients with PCP,” said Dr Carol Olson, vice president and chief medical officer at Immtech.

The trial will assess the efficacy, safety and tolerability of pafuramidine compared to TMP-SMX. Two-thirds of the patients in the trial will be treated with pafuramidine twice daily for 14 days and the remaining third will receive TMP-SMX three times daily for 21 days. Neither the patients nor the investigators will be informed of the treatment assignment during the study.