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SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTIONS 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
Date of report (Date of earliest event reported): MARCH 20, 1998
TRANSCEND THERAPEUTICS, INC.
(Exact Name of Registrant as Specified in Its Charter)
DELAWARE 000-22383 04-3174575
(State or Other Jurisdiction (Commission (I.R.S. Employer
of Incorporation or Organization) File Number) Identification No.)
640 MEMORIAL DRIVE, CAMBRIDGE, MA 02139
(Address of Principal Executive Offices) (Zip Code)
Registrant's telephone number, including area code: (617) 374-1200
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ITEM 5. OTHER EVENTS.
Transcend Therapeutics, Inc. (the "Registrant") announced on March 20, 1998
that the Phase III clinical trial evaluating the intravenous administration of
Procysteine for the treatment of Acute Respiratory Distress Syndrome (ARDS) has
been suspended following a recommendation of an independent Safety Monitoring
Board. The information contained in the press release of the Registrant dated as
of March 20, 1998, filed herewith as Exhibit 99, is incorporated herein by
reference.
SIGNATURES
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 hereunto duly authorized.
TRANSCEND THERAPEUTICS, INC.
(Registrant)
Date: March 24, 1998 By: /s/ HECTOR J. GOMEZ
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Hector J. Gomez, M.D., Ph.D.
President and Chief Executive Officer
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EXHIBIT INDEX
Exhibit Description
99 Press release of the Registrant dated March 20, 1998 (set forth below)
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EXHIBIT 99
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CAMBRIDGE, Mass.--(BW HealthWire)-- March 20, 1998--Transcend Therapeutics, Inc.
(NASDAQ NM: TSND - news) today announced that the Phase III clinical trial
evaluating the intravenous administration of Procysteine for the treatment of
Acute Respiratory Distress Syndrome (ARDS) has been suspended following a
recommendation of an independent Safety Monitoring Board.
The protocol for the double-blind, placebo-controlled clinical trial required an
Interim Safety Evaluation after 150 patients were enrolled. That evaluation was
conducted by an independent Safety Monitoring Board (SMB) on patients enrolled
through January 26, 1998. The SMB recommended that the study be continued, as
reported earlier.
However, following an updated review of preliminary mortality data on a total of
213 patients enrolled through March 18, 1998, the SMB concluded that the
incidence of all cause mortality in patients receiving Procysteine i.v. was
higher than the incidence in patients receiving a placebo.
The U.S. Food and Drug Administration (FDA) has been informed of this decision
to suspend the Phase III trial. The Company is also informing international
regulatory authorities and its investigators in North America and Europe.
"We are extremely disappointed with the unexpected mortality finding. We plan to
have a complete and thorough review of all data in order to decide whether to
resume our work with Procysteine i.v. for the treatment of ARDS. The Company
currently plans to continue its clinical work with oral Procysteine for the
treatment of amyotrophic lateral sclerosis and atherosclerosis as well as our
preclinical work with glutathione esters, our so-called TR-500 Compounds," said
Hector J. Gomez, M.D., Ph.D., President and CEO of Transcend Therapeutics. Dr.
Gomez further stated, "We are pursuing our strategy of identifying new product
in-licensing opportunities."
Under a February 1997 agreement between Transcend and Boehringer Ingelheim
International GmbH (BI), BI holds a worldwide license to use and sell
Procysteine i.v. for all pharmaceutical applications. Subject to the oversight
of a joint development team formed by Transcend and BI, Transcend has principal
responsibility for development of Procysteine i.v. for use in the treatment of
ARDS in all countries other than Japan. BI will have principal responsibility to
develop Procysteine i.v. for the treatment of ARDS in Japan.
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Boehringer Ingelheim, with headquarters in Ingelheim, Germany, is an
international R&D-oriented pharmaceutical company with total worldwide sales in
1996 of more than 7.0 billion Deutschemarks ($4.4 billion). Boehringer Ingelheim
spent 1.1 billion Deutschemarks ($750 million) in 1996 on R&D, focusing on
innovative products for the treatment of acute and chronic conditions associated
with respiratory, cardiovascular, CNS and gastrointestinal disorders.
Headquarters for the U.S. operations, Boehringer Ingelheim Pharmaceuticals,
Inc., are located in Ridgefield, Conn.
Transcend Therapeutics, Inc. is dedicated to the development and
commercialization of products for the treatment and prevention of critical care
conditions. For additional information, please refer to the Transcend
Therapeutics home page at http://www.tsnd.com.
"Safe Harbor" Statement under the Private Securities Litigation Reform Act of
1995. The statements which are not historical facts contained in this release
are forward-looking statements that involve risks and uncertainties, including,
but not limited to, the results of research and development efforts, the effect
of regulation by the FDA and other agencies, the impact of competitive products,
product development, commercialization and technological difficulties, and other
risks detailed in the Company's Securities and Exchange Commission filings.
Contact: Transcend Therapeutics, Inc.
Hector J. Gomez
B. Nicholas Harvey
617/374-1200
