Important note: Information in this article was accurate in 1995. The state of the art may have changed since the publication date.
PR Newswire - November 1, 1995
The Phase II/III clinical trial, co-sponsored by the Division of AIDS (DAIDS), National Institute of Allergy and Infectious Diseases (NIAID) and Andrulis Pharmaceuticals Corporation, Beltsville, Maryland, is studying the ability of thalidomide to safely heal severe oral and esophageal ulcers. In a second stage, the trial is studying the ability of thalidomide to prevent recurrence. Finally, the trial will determine if thalidomide can reduce HIV viral load.
The mid-trial review demonstrated that 61% of oral ulcer patients achieved a complete healing of their ulcers. Analysis of safety data for all of the first 73 enrollees found no significant difference in severe side effects between thalidomide and placebo.
"Many patients with HIV infection suffer from these extremely painful mouth ulcers, making eating difficult and contributing to weight loss and debilitation," says Anthony S. Fauci, M.D., Director of NIAID. "Thalidomide is the first treatment shown in a rigorous scientific study to heal these ulcers. As the study continues, we anticipate additional valuable information about the drug's effectiveness and long-term toxicity."
"The results are extremely exciting; it is very gratifying to be able to heal these heretofore untreatable oral ulcers in such a large proportion of patients," says Dr. Peter J. Andrulis, Jr., President and CEO of Andrulis Pharmaceuticals. "We are optimistic that re-treatment will heal unresponsive ulcers, that we will be able to maintain that healed condition, and that esophageal ulcers will respond similarly."
DAIDS AIDS Clinical Trials Group is sponsoring the trial at 38 clinical centers around the country with the intent of enrolling 164 patients. Andrulis Pharmaceuticals is co-sponsoring the trial by producing, encapsulating, testing and providing thalidomide and placebo; assisting protocol design and trial monitoring reviews; and providing regulatory, materiel and other trial support.
Andrulis Pharmaceuticals was the first company to recognize the potential of thalidomide against a range of poorly treated diseases. Andrulis is now the first company to demonstrate the safety and effectiveness of the drug in a controlled clinical trial. Andrulis continues to be the leading firm studying thalidomide against such additional AIDS-related conditions as prurigo nodularis, Kaposi's sarcoma and AIDS itself; and against multiple sclerosis and Crohn's/inflammatory bowel disease.
CONTACT: Diana Hopkins, director, Planning & Administration of Andrulis Pharmaceuticals, 301-419-2400/ 14:40 EST
Copyright (c) 1995/PR NewsWire. Reproduced with permission. Reproduction of this article (other than one copy for personal reference) must be cleared through the Permissions Desk, PR Newswire, 810 Seventh Avenue, New York, NY 10019.
951101
PR951104
Copyright © 1995 - PRNewswire. All rights reserved. Reproduced with permission. Reproduction of this article (other than one copy for personal reference) must be cleared through PRNewswire, Permissions, 810 Seventh Ave., 32nd Floor, New York, NY 10019 http://www.prnewswire.com.
AEGiS is a 501(c)3, not-for-profit, tax-exempt, educational corporation. AEGiS is made possible through unrestricted funding from Broadway Cares/Equity Fights AIDS, Elton John AIDS Foundation, National Library of Medicine, and donations from users like you.
Always watch for outdated information. This article first appeared in 1995. 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, 1995. 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. .