SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
Date of Report: May 13, 1997
MEDIMMUNE, INC.
(Exact name of registrant as specified in its charter)
Commission File Number: 0-19131
Delaware 52-1555759
(State of Incorporation) (I.R.S. Employer
Identification No.)
35 West Watkins Mill Road, Gaithersburg, MD 20878
(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code (301) 417-0770
No Exhibits are being filed with this report
CytoGam and RespiGam are registered trademarks of the Company.
MEDIMMUNE, INC.
Current Report on Form 8-K
ITEM 5. OTHER EVENTS
MedImmune, Inc. reported the information contained in the following
press release dated May 13, 1997.
FOR IMMEDIATE RELEASE
Ccontacts:
Mark E. Kaufmann Elliot Lebowitz, Ph.D.
Associate Director, President and Chief
Strategic Planning and Investor Executive Officer
Relations BioTransplant Incorporated
MedImmune, Inc. 617-241-5200
301-417-0770 x321
Gretchen L.P. Schweitzer
Julie M. Adamou, Ph.D. Manager
Investor and Media Relations Feinstein Kean Partners
MedImmune, Inc. 617-577-8110
301-417-0770 x295
http://www.medimmune.com
BIOTRANSPLANT AND MEDIMMUNE REPORT PHASE 1/2 RESULTS
OF BTI-322 INDUCTION THERAPY TRIAL
-- FDA Gives Clearance to Commence Clinical Trials with Humanized Version --
Gaithersburg, MD, and Charlestown, MA, May 13, 1997 -- MedImmune,
Inc. (Nasdaq:MEDI) and BioTransplant, Incorporated (Nasdaq:BTRN) today
reported one year follow-up results from a Phase 1/2 trial in which BTI-
322 monoclonal antibody given at the time of organ transplantation
reduced the incidence of kidney graft rejection episodes by 58 percent
compared to conventional triple drug therapy alone. These data and
recent laboratory studies are being presented this week by Dr. Jean
Paul Squifflet of Cliniques St. Luc at the University of Louvain in
Belgium, and Dr. James A. Hope of BioTransplant, at the 15th Annual
Meeting of The American Society of Transplant Physicians (ASTP) in
Chicago. Additionally, the companies today announced they received
clearance from the U.S. Food and Drug Administration (FDA) to begin
human clinical trials with MEDI-507, a humanized form of BTI-322.
"The clinical and laboratory data presented today continue to support
the potential of BTI-322," commented Elliot Lebowitz, Ph.D., President
and Chief Executive Officer of BioTransplant. "We are pleased to be
moving ahead with clinical trials to evaluate if MEDI-507 retains the
unique activities of BTI-322. From laboratory studies, it appears that
BTI-322 and MEDI-507 are eliminating only those T cells which initiate
organ rejection while not affecting other T cells. If this selectivity
could be achieved in patients, the applications of such a product would
be wide-ranging and could include many in the transplantation field as
well as in autoimmune diseases."
The one year follow-up data from a controlled, randomized Phase 1/2
induction study of BTI-322 included a total of 40 kidney graft
recipients. All patients received a conventional triple drug regimen
of cyclosporine, azathioprine and steroids. Twenty of the patients
received BTI-322 (5 mg/day for 10 days) at the time of transplantation
in addition to the triple therapy. The incidence of graft rejection
was reduced by 58 percent (12/20 control; 5/20 BTI-322) in the group
that received BTI-322. In addition, 85 percent (6/20 control; 1/20 BTI-
322) fewer patients experienced delayed graft function (DGF) when
treated with BTI-322. DGF suggests that the transplanted organ is not
functioning normally immediately after surgery and can be associated
with transplant rejection. BTI-322 was generally safe and well-
tolerated with limited side effects that were easily manageable.
Recent laboratory studies presented at ASTP by BioTransplant scientists
suggest that the mechanism of BTI-322 relies on specifically depleting
T cells involved in graft rejection, while leaving others unaffected.
The studies showed that low doses of BTI-322 were able to knock out T
cells which were specifically stimulated in a mixed lymphocyte
reaction, a commonly used test to assess immune cell responses. The
cells which were not stimulated were unaffected. These results confirm
the unique ability of BTI-322 to eliminate certain T cells selectively
while allowing other T cells to respond normally.
"Only a small subset of T cells in the body are stimulated by a foreign
organ," commented Dr. Scott Koenig, Vice President of Research at
MedImmune. "It's the stimulation of that small group of T cells which
initiates a cascade of events leading to organ rejection. While most
immunosuppressive antibodies affect many different T cells, in certain
circumstances BTI-322 and MEDI-507 have the ability to deplete only
those potentially involved in the rejection reaction, leaving the
others available to fight infection."
BTI-322 and MEDI-507 bind to the CD2 receptor on T cells and natural
killer (NK) cells. BTI-322 has been evaluated in over 60 patients in
the United States and Europe for its potential to prevent and treat
organ graft rejection and to treat graft-versus-host disease (GvHD).
Currently, BTI-322 is being evaluated in a multi-center Phase 2 trial
for treatment of acute GvHD. BTI-322, previously known as LO-CD2a, was
discovered by Drs. Herve Bazin and Dominique Latinne at the Catholic
University of Louvain in Belgium. MedImmune and BioTransplant recently
filed an Investigational New Drug (IND) application with the FDA to
begin clinical trials with MEDI-507, the humanized form of BTI-322. The
first clinical trial planned with MEDI-507 is an open-label, dose-
escalating, kidney transplantation induction trial to evaluate its
safety and pharmacokinetics.
MedImmune, Inc. is a biotechnology company focused on developing and
marketing products for the prevention and treatment of infectious
diseases and for use in transplantation medicine. MedImmune currently
markets two products through its hospital-based sales force and has six
new product candidates in clinical trials. In October 1995, MedImmune
and BioTransplant established a strategic alliance for development of
BTI-322, MEDI-500 (T10B9) and any future generations of these products
(such as MEDI-507) for use in organ transplantation and other
indications. MedImmune is located in Gaithersburg, MD.
BioTransplant, Incorporated is developing proprietary anti-rejection
pharmaceuticals and organ transplantation systems which represent a
comprehensive approach to inducing long-term specific transplantation
tolerance in humans. The Company's product candidates are intended to
reduce or eliminate the need for lifelong immunosuppressive therapy,
reduce the cost of treating end-stage organ disease and increase the
supply of transplantable organs. BioTransplant is located in
Charlestown, MA.
This announcement may contain, in addition to historical information,
certain forward-looking statements, including statements about the
potential therapeutic benefits of BTI-322 and MEDI-507 that involve
risks and uncertainties. Such statements reflect management's current
views and are based on certain assumptions. Actual results could
differ materially from those currently anticipated as a result of a
number of factors, including risks and uncertainties discussed in the
Company's filings with the U.S. Securities and Exchange Commission.
Commercialization of MEDI-507 and BTI-322 will require prior approval
from regulatory authorities including the Food and Drug Administration
in the U.S. There can be no assurance that such approvals will be
obtained.
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934,
the Registrant has duly caused this report to be signed on its behalf
by the undersigned thereunto duly authorized.
MEDIMMUNE, INC.
Registrant)
Date: May 13, 1997 David M. Mott
President and Chief Operating Officer
(Principal financial and
accounting officer)
