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EXHIBIT 99.1
NEORX SUSPENDS ACCRUAL ON ITS STR TRIALS PENDING RESOLUTION WITH FDA
DATA SAFETY MONITORING BOARD (DSMB) RECOMMENDS PHASE III STUDY PROCEED
SEATTLE, WA, NOVEMBER 7, 2000--NEORX CORP. (NASDAQ: NERX) today announced that,
pending resolution with the U.S. Food and Drug Administration (FDA), it has
suspended accrual and treatment under its phase III clinical trial in patients
with multiple myeloma and other Skeletal Targeted Radiotherapy (STR) studies. A
delayed side effect has appeared in a small number of phase I/II patients who
received STR at one site. Current data suggests that differences in procedure
may have been a contributing factor. An independent Data Safety Monitoring Board
(DSMB) has investigated this side effect and has unanimously recommended that
the phase III study proceed, but with additional monitoring and standardization
of study methods. Yesterday, NeoRx received a letter from the FDA suspending
these STR trials until further information is supplied and evaluated by the FDA
and the FDA gives approval to restart the studies.
"We believe we can address the concerns raised by the FDA," said Paul G. Abrams,
M.D., J.D., NeoRx's Chief Executive Officer. "We are gathering information that
was requested by the FDA, and hope to resolve the matter as soon as possible."
Four patients treated at one of the major phase I/II study sites, and none
treated at the other major site, developed a serious delayed toxicity referred
to as TTP/HUS (thrombotic thrombocytopenic purpura/hemolytic uremic syndrome).
TTP/HUS involves a combination of symptoms, including abnormal clotting of blood
in small blood vessels. This can lead to anemia, a low platelet count that can
result in bleeding, and potential damage to organs. Although relatively uncommon
, TTP/HUS has many potential triggering causes, including food contamination,
toxic shock syndrome, post-viral infection, bone marrow transplantation and drug
effects. Each of the affected patients had at least two known potential triggers
of TTP/HUS.
"This is an unfortunate occurrence," said Dr. Abrams, "but not unlike the course
of many oncology drugs, where unexpected toxicities are noted, likely causes
identified and handled, and, with modifications, drug development proceeds. For
example, cis-platinum, one of the most widely used anti-cancer drugs, caused
renal failure before the importance of hydration and diuretics was understood.
In the case of STR, based on our current findings, we believe bladder irrigation
helps prevent bladder wall damage by preventing radiation from sitting in the
bladder, and may help eliminate an increased incidence of TTP/HUS. We also
believe that bladder irrigation has helped to prevent the more common problem of
blood in the urine."
The method of STR administration at the only site reporting TTP/HUS differs from
that used at the other major phase I/II site and from the current phase III
protocol in the
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following respects: 1) the drug was infused more rapidly; 2) the calculated dose
to be received by patients was somewhat higher; and, 3) the patients did not
receive bladder irrigation during the procedure. The Company believes that lack
of bladder irrigation can result in a dose of radiation to the bladder wall that
is 3-fold higher than in the irrigated patients. Radiation damage to the bladder
wall may result in blood in the urine (hemorrhagic cystitis) and could cause
further problems to the bladder. A large fraction of the patients who did not
receive bladder irrigation developed blood in the urine, whereas to date no
patients who have had bladder irrigation had blood in the urine attributable to
STR. Bladder irrigation is required by the current phase III protocol. The
patients with TTP/HUS are all being treated and are improving. Three of these
patients have achieved complete remissions of multiple myeloma, and one has
relapsed.
For more information, please join the NeoRx Conference Call at 6:00 a.m. Pacific
// 9:00 a.m. Eastern on Wednesday, November 8, 2000. The call in number is (800)
946-0741, confirmation number 685984 - or - listen via our live webcast at
www.vcall.com. or via our website at www.neorx.com. The conference call audio
will remain available through November 15, 2000.
ABOUT NEORX
Seattle-based, NeoRx Corporation is developing innovative products designed to
provide improved treatments for patients with cancer.
This release contains forward-looking statements relating to the development of
the Company's products and future operating results that are subject to certain
risks and uncertainties that could cause actual results to differ materially
from those projected. The words "believe," "expect," "intend," "anticipate,"
variations of such words, and similar expressions identify forward-looking
statements, but their absence does not mean that the statement is not
forward-looking. These statements are not guarantees of future performance and
are subject to certain risks, uncertainties and assumptions that are difficult
to predict. Factors that could affect the Company's actual results include the
progress, costs and results of clinical trials, the availability, cost and
timely delivery of materials and services from third party suppliers and
collaborative partners, the satisfaction of regulatory requirements, and the
receipt, timing, terms and conditions of required regulatory approvals.
Reference is made to the Company's latest Quarterly Report on Form 10 - Q filed
with the Securities and Exchange Commission for a more detailed description of
such factors. Readers are cautioned not to place undue reliance on these
forward-looking statements that speak only as of the date of this release. The
Company undertakes no obligation to publicly update any forward-looking
statement to reflect new information, events or circumstances after the date of
this release or to reflect the occurrence of unanticipated events.
Visit NeoRx at www.neorx.com.
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www.neorx.com/news/pr.html.
NeoRx is a registered trademark of NeoRx Corporation in the United States and/or
foreign countries.
(C) 2000 NeoRx Corporation. All Rights Reserved.
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