Exhibit 99.1
Antigenics Reports Phase 3 Results for
Oncophage in Kidney Cancer; Study Did Not Meet Endpoints; Number of
Events Insufficient for Analysis
NEW YORK--(BUSINESS WIRE)--March 24, 2006--Antigenics Inc.
(NASDAQ: AGEN):
-- Independent Panel Review Found Number of Events That Occurred
Was Significantly Lower Than That Reported by Investigators
-- Company to Focus on Further Data Analysis and Early-Stage
Development Programs
-- Conference Call Scheduled for 9 a.m.
Antigenics Inc. (NASDAQ: AGEN) today announced top-line results
from its Phase 3 study of Oncophage(R) (vitespen) in kidney cancer
patients who are at high risk of recurrence after surgery. The
analysis was triggered based on the number of events (defined as
recurrence of disease or death of a patient prior to recurrence)
reported by study investigators. However, an independent review by the
trial's Clinical Events Committee (CEC) revealed that a substantially
smaller number of events had actually occurred. The analysis showed a
trend in favor of Oncophage for recurrence-free survival (the study's
primary endpoint), and a trend against Oncophage for overall survival
(secondary endpoint); both findings were not statistically
significant.
The results of the CEC review revealed that the required number of
events to conduct analysis of the recurrence-free survival endpoint
was not met. The analysis of the overall survival endpoint is
considered an interim assessment. At this time it is unclear as to why
opposing trends were observed between recurrence-free survival and
overall survival. There is no readily apparent adverse safety signal
associated with the vaccine that the company believes could be
contributing to this finding. Antigenics is continuing to conduct a
thorough review of the safety and efficacy data, and plans to meet
with the US Food and Drug Administration at the end of April to
discuss the findings from this trial.
The company expects to subsequently present these data at
scientific meetings and will work with study investigators to publish
the findings in a peer-reviewed medical journal.
"We believe that further work is necessary to properly interpret
these results," said Garo H. Armen, PhD, chairman and CEO of
Antigenics. "Upon completion of full analysis of the data, we will
further refine our Oncophage strategy, which includes testing
Oncophage in combination with other agents, and development of a
higher-activity Oncophage. We will move expeditiously and in a
fiscally responsible manner to complete this process in the coming
weeks."
The Phase 3, randomized, international, multicenter, open-label
trial (C-100-12) involved 728 eligible patients whose renal cell
carcinoma was at high risk of recurrence after nephrectomy (surgical
removal of the diseased kidney). Patients were randomized in a 1:1
ratio into two arms: nephrectomy plus Oncophage vaccination (treatment
arm) or nephrectomy alone (observation arm). The arms were well
balanced for all known prognostic factors. Although the study protocol
required that eligible patients be free of disease at baseline, an
independent review by the trial's Clinical Events Committee
subsequently found that of the 728 patients enrolled in the trial, 124
had disease at baseline. Furthermore, of the 218 events reported by
investigators, 92 of these occurred in patients who had metastatic or
residual disease at baseline. These patients should have been deemed
ineligible for the trial but were included in the intent-to-treat
(ITT) analysis, per statistical convention. The CEC consisted of two
primary radiologists who reviewed all available patient images, and an
adjudicating radiologist and oncologist.
Next Steps
In view of these results, the company has decided to suspend Part
2 of the kidney cancer trial until the data from Part 1 are fully
analyzed. Antigenics expects additional analysis of the data will be
completed within the next four to six weeks, with full analysis to be
presented at a scientific meeting. The company will continue to follow
the large number of patients in the trial who have yet to undergo an
event (disease recurrence or death). Patients who are currently
receiving Oncophage in the trial will continue to receive vaccine, as
will patients in other ongoing Oncophage studies.
Antigenics will also implement a restructuring plan, with the
expectation of further reducing its burn rate immediately. This
restructuring will involve temporarily discontinuing all late-stage
clinical programs and concentrating on Phase 1 and preclinical
programs, including Aroplatin(TM), AG-707, higher-activity Oncophage
and AU-801. In addition, Antigenics will continue to support and
develop its QS-21 business partnerships, with the goal of generating
royalties as early as 2009.
Conference Call Information
Antigenics executives will host a conference call at 9:00 a.m. ET
today. To access the live call, dial 888.271.9082 (domestic) or
706.679.7741 (international); the access code is 7125894. The call
will also be webcast and will be accessible from the company's website
at www.antigenics.com/webcast/. A replay will be available
approximately two hours after the call through midnight ET on April 7,
2006. The replay number is 800.642.1687 (domestic) or 706.645.9291
(international), and the access code is 7125894. The replay will also
be available on the company's website approximately two hours after
the live call.
About Antigenics
Antigenics is a biotechnology company working to develop
treatments for cancers, infectious diseases and autoimmune disorders.
This press release contains forward-looking statements, including
statements regarding the company's planned analysis of the Oncophage
Part 1 trial data; the potential publication of such data and the
future development of Oncophage; the company's plans for restructuring
and reduction of its burn rate; its future preclinical and Phase 1
clinical programs involving Aroplatin, AG-707, higher-activity
Oncophage and AU-801; and its corporate partnering activities,
including future revenue from such collaborations involving Aroplatin
and QS-21. These risks and uncertainties include, among others, the
risk of unfavorable data resulting from further analysis of the
Oncophage Part 1 trial data; retention of key employees; clinical
trial enrollment; decisions by corporate partners; decisions by
regulatory agencies; timing and results of preclinical studies; and
the factors described under Factors That May Impact Future Results in
the Management's Discussion and Analysis of Financial Condition and
Results of Operations section of Antigenics' Form 10-K as filed with
the Securities and Exchange Commission on March 15, 2006. Antigenics
cautions investors not to place considerable reliance on the
forward-looking statements contained in this press release. These
statements speak only as of the date of this document, and Antigenics
undertakes no obligation to update or revise the statements. All
forward-looking statements are expressly qualified in their entirety
by this cautionary statement. Antigenics' business is subject to
substantial risks and uncertainties, including those identified above.
When evaluating Antigenics' business and securities, investors should
give careful consideration to these risks and uncertainties.
CONTACT: for Antigenics Inc.
Corporate Communications:
Sunny Uberoi, 212-994-8206
suberoi@antigenics.com
or
Investor Relations
Shalini Sharp, 800-962-2436
ir@antigenics.com