Immtech Conducts Pneumonia Drug Trials on the Fast Track

Immtech Pharmaceuticals (IMM) has enlisted Jubo Liu, PhD, to serve as Development Liaison for Clinical Trials in China. Currently, Immtech is conducting a Phase III trial of pafuramidine as a treatment for pneumocystis pneumonia [PCP, a fungal infection affecting patients with compromised immune systems. This includes people with HIV/AIDS and transplant patients. An estimated 1 million people worldwide suffer from the disease, while another 5 million people are treated prophylactically for the disease.

The China State Food & Drug Administration recently granted Fast Track Status to the Phase III trial of pafuramidine.

Most recently, Dr. Liu was working for Vertex Pharmaceuticals (VRTX) and has previously served as Director of Marketing and Regulatory Registration at Beijing Zhenlingxin Health Consulting. He received a Bachelor of Pharmacy from the Pharmaceutical University of Shenyang and a PhD from the Department of Pharmaceutical Sciences at the University of Toronto.

The China Phase III trial will be part of an ongoing Phase III trial of pafuramidine, which previously was being conducted in the US and five South American countries. The goal of the trial is to prove the pafuramidine is just as effective as the current standard, trimethoprim-sulfamethoxazole (TMP-SMX). Data was expected before the end of 2007, but enrollment has been proceeding slowly. The Phase III trial is being conducted under a SPA agreed to by the FDA and Immtech, and the China arm of the trial will also adhere to that trial design, as well as support Immtech’s request for marketing approval of pafuramidine. In its Phase II test, pafuramidine was found to be 100% effective in HIV patients who had failed or were intolerant of TMP-SMX.

In June, Immtech accepted a rather low $3 million upfront from Par Pharmaceuticals (PRX) for an exclusive right to sell pafuramidine to HIV/AIDS patients in the US with PCP. Par already markets other drugs to that population. Par has also agreed to an additional $29 million in development/regulatory milestones and $115 million in sales milestones. Immtech has the right to co-promote the drug to other patient populations. The market for PCP among HIV patients is a modest $40 million, but if used as a preventative, pafuramidine could be worth five times as much just among patients who are susceptible to PCP. Par’s agreement with Immtech does not include exclusive right to the at-risk populations.

Immtech also is conducting a Phase III trial of pafuramidine as a treatment for African sleeping sickness and Phase II trials for prevention and treatment of malaria.

Disclosure: none.