Immtech pneumonia drug granted orphan status

The FDA orphan drug designation is specifically for pneumocystis jiroveci pneumonia (PCP), a common life-threatening opportunistic infection in HIV/AIDS and other immunosuppressed patients.

The designation provides Immtech with financial and regulatory benefits during the development course of Pafuramidine, including seven-year market exclusivity upon final approval.

“We believe Pafuramidine will be an important new agent for the treatment of this life threatening disease because many patients experience significant adverse effects related to current treatments. In addition, scientists and clinicians are concerned about potential loss of the standard treatments’ effectiveness due to emerging resistance to these drugs in the pneumocystis organism,” stated Carol Olson, Immtech’s senior vice president.

Pafuramidine is currently in phase III clinical trials in HIV/AIDS patients with PCP. Previous clinical research has indicated that Pafuramidine could have similar efficacy to the current standard therapy for PCP.

Immtech commented it is initiating studies to evaluate Pafuramidine for the PCP prophylaxis market, which is projected to be worth $1 billion.