AEGiS-UPI: FDA grants Immtech's drug orphan status

Important note: Information in this article was accurate in 2006. The state of the art may have changed since the publication date.

FDA grants Immtech's drug orphan status

United Press International - November 21, 2006

NEW YORK - Immtech said Tuesday the U.S. Food and Drug Administration granted orphan drug status for pafuramidine, a potential pneumonia treatment.

The orphan designation covers use of the drug for Pneumocystis jiroveci pneumonia, or PCP, a life-threatening opportunistic infection that strikes HIV/AIDS and immunosuppressed patients.

"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," said Carol Olson, Immtech's senior vice president and chief medical officer.

"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," Olson added. "Thus, a new effective and more tolerable drug for treating PCP would be a significant benefit to these patients."

Pafuramidine is currently in phase 3 trials involving HIV/AIDS patients with PCP. Immtech said it also is initiating studies to evaluate pafuramidine as a potential prophylaxis for PCP.

061121
UP061125

Copyright © 2006 - United Press International. All rights reserved. Reproduced with permission. Reproduction of this article (other than one copy for personal reference) must be cleared through United Press International, Permissions Desk, 1510 H St. N.W. Washington DC 2005. Main Phone Switchboard: 202-898-8000 FAX: 202-898-8057 or 202-898-8147 Email: info@upi.com.

AEGiS is a 501(c)3, not-for-profit, tax-exempt, educational corporation. AEGiS is made possible through unrestricted funding from Boehringer Ingelheim, Bridgestone/Firestone Charitable Trust, Elton John AIDS Foundation UK, the National Library of Medicine, AIDS Walk of Orange County, and donations from users like you.

Always watch for outdated information. This article first appeared in 2006. This material is designed to support, not replace, the relationship that exists between you and your doctor.

AEGiS presents published material, reprinted with permission and neither endorses nor opposes any material. All information contained on this website, including information relating to health conditions, products, and treatments, is for informational purposes only. It is often presented in summary or aggregate form. It is not meant to be a substitute for the advice provided by your own physician or other medical professionals. Always discuss treatment options with a doctor who specializes in treating HIV.

Copyright ©1980, 2006. AEGiS. All materials appearing on AEGiS are protected by copyright as a collective work or compilation under U.S. copyright and other laws and are the property of AEGiS, or the party credited as the provider of the content. .