Printer Friendly

APPLIED IMMUNE SCIENCES RECEIVES FDA APPROVAL TO BEGIN BREAST CANCER TRIALS

 APPLIED IMMUNE SCIENCES RECEIVES FDA APPROVAL
 TO BEGIN BREAST CANCER TRIALS
 MENLO PARK, Calif., March 26 /PRNewswire/ -- Applied Immune Sciences, Inc. (NASDAQ-NMS: AISX), today announced that it has received approval from the U.S. Food and Drug Administration to commence clinical trials of its autologous bone marrow treatment for breast cancer.
 The company said that these clinical trials will start within the next two weeks at the Indiana University Hospital, Indianapolis, under the direction of E. Randolph Broun, M.D., assistant professor of medicine, University of Indiana.
 Thomas B. Okarma, Ph.D., M.D., chief executive officer and chief scientist of Applied Immune Sciences, said, "In contrast to other commercial applications involving bone marrow transplantation, AIS' clinical trials will be conducted under an Investigational Device Exemption. This is consistent with the characterization of the AIS CELLector(TM) technology as a medical device, even though it has biological components. AIS believes this may well result in a more rapid product approval process than traditional approaches taken by others in bone marrow transplantation procedures."
 The breast cancer clinical trials involve rescue therapy to restore patients' immune systems after receiving high-dose chemotherapy and radiation. Clinical investigators will harvest the patients' own bone marrow, then subject the patients to high levels of chemo- and radiation therapy that kills existing tumor cells and weakens the body's immune system. The patients' marrow is then processed through two types of AIS CELLector devices that collect and selectively isolate the patients' CD34 stem cells, the precursors of white and red blood cells. The immunologically isolated CD34 stem cells, free of detectable tumor cells, are then reintroduced into the patients to restore natural immune and blood cells.
 In pre-clinical trials, this process resulted in selective enrichment of bone marrow so that CD34 stem cells increased from less than 1 percent of the extracted marrow to greater than 90 percent purity. At the same time, tumor cells were reduced from 10 percent of the extracted marrow to undetectable levels. The cells were not found to be contaminated by any biologicals such as monoclonal antibodies, which allows safe repeated infusions of cells processed by AIS CELLectors, and offers the possibility of greater safety to the patient.
 Okarma added, "The breast cancer trials are the latest of several clinical investigations of major life-threatening diseases using Applied Immune Sciences' technology. We have just completed Phase I trials of our AIDS treatment, and expect Phase II to begin in the next quarter. We are also in clinical trials for our treatments of kidney cancer and bone marrow transplantation in connection with leukemia. We believe that the results in the trials under way, as well as in pre-clinical trials of our breast cancer treatment, are very encouraging, and the investigational data suggest the promise of our approach to enhancing the body's immune system by outside-the-body cell therapy."
 The company also announced that it has received FDA approval to begin clinical trials for its treatment of Hodgkins and non-Hodgkins lymphoma. These trials will start later this year at medical facilities in the United States and United Kingdom.
 Applied Immune Sciences is actively engaged in the treatment of life-threatening illnesses by ex vivo (outside-the-body) treatment at the cellular level. The treatment consists of cellular engineering that attacks disease mechanisms or enhances the immune system without the severe toxic side-effects that can occur when treatment takes place inside the body.
 -0- 3/26/92
 /CONTACT: Jim Smith of AIS, 415-326-7302; or Susan Loewe of Clark & Weinstock, 212-953-2550, for AIS/
 (AISX) CO: Applied Immune Sciences, Inc. ST: California, Indiana IN: MTC SU:


GK-OS -- NY023 -- 1837 03/26/92 09:25 EST
COPYRIGHT 1992 PR Newswire Association LLC
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 1992 Gale, Cengage Learning. All rights reserved.

Article Details
Printer friendly Cite/link Email Feedback
Publication:PR Newswire
Date:Mar 26, 1992
Words:602
Previous Article:3M TO PRESENT 1991 TRANSPORTATION QUALITY ACHIEVEMENT AWARDS
Next Article:CHARTER ONE FINANCIAL, INC. AND FIRST AMERICAN BANCORP COMPLETE DUE DILIGENCE
Topics:


Related Articles
Pharmexa Presents Data from the HER-2 Protein AutoVac(TM) Breast Cancer Trial at a Conference in Hamburg.
Therion Biologics Corporation Receives FDA Agreement to Initiate Phase III Clinical Trial With PANVAC(TM)-VF In Advanced Pancreatic Cancer; --...
Dendreon Names Ernest Bognar General Manager of Hanover, NJ Manufacturing Facility.
Introgen's ADVEXIN Therapy Shows Promise in the Treatment of Breast Cancer.
Bevacizumab approved for metastatic breast Ca.

Terms of use | Copyright © 2016 Farlex, Inc. | Feedback | For webmasters