SUMMARY IPR J 5 HUMAN MONOCLONAL ANTIBODY

File: 120396_sep96_decls85_0004.txt
Page: 0004
Total Pages: 9

Subject: SUMMARY IPR J 5 HUMAN MONOCLONAL ANTIBODY                       

Unit: OTSG        

Parent Organization: HSC         

Box ID: BX003203

Folder Title: SUMMARY OF CORRESPONDENCE IN-PROCESS REVIEW                                                     

Document Number:          1

Folder SEQ  #:        135




                               DEPARTMENT OF THE ARMY
                           LIS ARMY MEDICAL MATEFUEL DEVELOPMENT ACNMTY
                            FORTDETFUCK FREDEFUCK MARYLAND 21701-WM


                @Y70
                A'N@OP


          SGRD-UMB (70-1r)                                  22 February 1990


          MEMORANDUM FOR

          Commandant, Academy of Health Sciences, U.S. Armyt ATTN: HSHA-
              CDM (CPT Mahr), Fort Sam Houston, Texas 78234-6100
          Commander, U.S. Army Medical Materiel Agency, ATTN: SGMMA-RMP
              (Ms. Diana Smith), Fort Detrick, Frederick, Maryland
              21701-5009
          Director, Walter Reed Army Institute of Research, ATTN: SGRD-UWF
              (COL Sadoff), Washington, DC 20307-5100

          SUBJECT: Correspondence Informal In-Process Review (IPR) for
          the J-5 Human Monoclonal (HA-lA) Antibody


          1. The Materiel Developer submits this Correspondence Informal
          In-Process Review (enclosure 1), J-5 Human Monoclonal Antibody,
          for approval by voting members and concurrence by the Walter Reed
          Army Institute of Research. Request your signature on
          enclosure 2.

          2. The following background is provided:

              a. The purpose of the IPR is to decide whether or not to
          continue development of the subject product. The U.S. Army has
          participated in clinical testing and evaluation of this product
          for Approximately two years. The product manufacturer and
          sponsor of the Phase 3 trial, Centocor, Malvern, Pennsylvania,
          has discontinued clinical studies of J-5 Human Monoclonal
          Antibody and they have filed a product license application with
          the Food and Drug Administration (FDA).

              b. One course of action open to the Materiel Developer is to
          renew clinical trials at military hospitals, with approval of FDA
          and Centocor. Such testing would emphasize treatment of
 patients with wounds or burns.

              c. Alternatively, the Materiel Developer could discontinue
          developmental funding for J-5 Human Monoclonal Antibody and,
          should it be granted a license, subsequently consider a non-
          developmental approach.

Document 9 f:/Week-36/BX003203/SUMMARY OF CORRESPONDENCE IN-PROCESS REVIEW/summary ipr j 5 human monoclonal antibody:11259610133425
Control Fields 17
File Room = sep96_declassified
File Cabinet = Week-36
Box ID = BX003203
Unit = OTSG
Parent Organization = HSC
Folder Title = SUMMARY OF CORRESPONDENCE IN-PROCESS REVIEW
Folder Seq # = 135
Subject = SUMMARY IPR J 5 HUMAN MONOCLONAL ANTIBODY
Document Seq # = 1
Document Date =
Scan Date =
Queued for Declassification = 01-JAN-1980
Short Term Referral = 01-JAN-1980
Long Term Referral = 01-JAN-1980
Permanent Referral = 01-JAN-1980
Non-Health Related Document = 01-JAN-1980
Declassified = 25-NOV-1996