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: December 18, 1996
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
MEDIMMUNE, INC.
Current Report on Form 8-K
ITEM 5. OTHER EVENTS
MedImmune, Inc. reported the information contained in the following
press release dated December 18, 1996.
MEDIMMUNE AND BIOTRANSPLANT BEGIN PHASE 2 TRIAL EVALUATING
BTI-322 IN TREATMENT OF GRAFT-VERSUS-HOST DISEASE
Gaithersburg, MD, and Charlestown, MA, December 18, 1996 -- MedImmune,
Inc. (Nasdaq:MEDI) and BioTransplant Incorporated (Nasdaq:BTRN) today
announced they have begun a multi-center Phase 2 clinical trial to
evaluate BTI-322 in the treatment of acute graft-versus-host disease
(GvHD). BTI-322 is being developed by MedImmune in collaboration with
BioTransplant. Acute GvHD, a common and potentially fatal complication
after bone marrow transplantation, occurs when immune cells of the
foreign graft, i.e., the donor bone marrow, initiate an inflammatory
reaction against the tissues of the recipient.
"Graft-versus-host disease remains one of the most common and
debilitating complications of bone marrow transplantation despite
numerous attempts to improve treatment options," commented James F.
Young, Ph.D., Senior Vice President, Research and Development at
MedImmune. "BTI-322's unique mechanism of action suggests its
potential utility for GvHD as well as for several other applications
both inside and outside the transplantation field."
BTI-322 will be evaluated in adult recipients of allogeneic (non-self-
donated) bone marrow or stem cells, who are experiencing acute GvHD and
who have not responded previously to corticosteroid treatment. Safety,
efficacy and pharmacokinetic parameters will be monitored during the
study which is expected to be completed six to twelve months after its
commencement.
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
for its ability to treat GvHD. In a small ongoing European study, BTI-
322 has shown initial promise in treating GvHD. In addition,
preliminary analyses of data from two Phase 1/2 clinical studies were
presented in August at the XVI International Congress of the
Transplantation Society in Barcelona, Spain. BTI-322 in these studies
appeared well-tolerated and showed initial promise in preventing and
treating kidney transplant rejection. A Phase 1/2 clinical trial
evaluating BTI-322 in the treatment of acute kidney rejection is
underway at the Massachusetts General Hospital under an Investigational
New Drug (IND) application submitted to the FDA by BioTransplant.
BTI-322, previously known as LO-CD2a, was discovered by Drs. Herve
Bazin and Dominique Latinne at the Catholic University of Louvain in
Belgium. BTI-322 is a rat monoclonal antibody that binds to the CD2
molecule on T cells and NK cells. T cells are implicated in the
rejection of transplanted organs and both types of cells are implicated
in progression of GvHD. Laboratory studies have suggested that BTI-322
primarily inhibits the response of T cells directed at transplant
antigens while subsequently allowing immune cells to respond normally
to other antigens. The specificity and long lasting effects of this
inhibition suggest that BTI-322 could have potential utility in
applications other than transplantation, such as in autoimmune
diseases. MedImmune is currently preparing MEDI-507, a humanized form
of the product, which is expected to enter clinical trials in 1997 for
selected applications in transplantation and autoimmune diseases.
Acute GvHD is a major complication of allogeneic bone marrow
transplantation, usually occurring within the first three months after
transplantation. Approximately 50% of bone marrow transplants result
in GvHD. Patients with mild GvHD often experience a rash which usually
responds well to corticosteroid treatment. Patients with moderate or
severe GvHD develop serious disease and have up to a 90% chance of
death despite diverse treatments. Lack of understanding of the
physiologic mechanism of disease has been a major impediment to the
development of more effective treatments. Both T cells and NK cells
may play a role in the pathophysiology of GvHD. An agent which
specifically inhibits both types of cells may provide certain
advantages over current therapies.
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. 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 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 both Companies'
filings with the U.S. Securities and Exchange Commission.
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: December 18, 1996 David M. Mott
President and Chief Operating Officer
(Principal financial and accounting
officer)
