Exhibit 99.1
Oncophage(R) Cancer Vaccine Significantly
Prolongs Recurrence-Free Survival by 45 Percent in Patients With
Intermediate-Risk Kidney Cancer
Overall Survival Improvement Also Observed in Intermediate-Risk
Kidney Cancer Patients Who Received Oncophage
Antigenics Presents Updated Phase 3 Results at the American
Urological Association Annual Meeting
Conference Call To Be Held Today at 1:30 p.m. ET
ANAHEIM, Calif.--(BUSINESS WIRE)--May 21, 2007--Antigenics Inc.
(NASDAQ: AGEN) today announced additional follow-up data on the
company's Phase 3 investigational therapeutic cancer vaccine
Oncophage(R) (vitespen). The end-of-study results, which reflect an
additional 17 months' data collection, showed that in a substantial
subset of patients (n = 362) at intermediate risk for disease
recurrence, Oncophage demonstrated a clinically significant
improvement in recurrence-free survival (RFS) of approximately 45
percent (P less than 0.01; hazard ratio (HR) = 0.55). In addition,
updated analysis in this group of patients revealed a new potential
benefit associated with Oncophage treatment: for intermediate-risk
patients there was a trend towards improved overall survival, the
study's secondary endpoint. Furthermore, the positive overall survival
trend observed to date correlates with the RFS improvement
demonstrated in previous analyses. This is the largest, randomized
Phase 3 kidney cancer trial ever completed in the adjuvant treatment
setting.
Christopher G. Wood, MD, associate professor of urology at M. D.
Anderson Cancer Center in Houston, presented the Phase 3 end-of-study
results at the annual meeting of the American Urological Association
(AUA; abstract #633).
"These results continue to underscore the significant potential
benefit of Oncophage in a well-defined, clinically and biologically
relevant subset of patients who are the most appropriate candidates
for cancer vaccines," said Dr. Wood. "In addition, there are currently
no approved therapies for these patients, which represent a growing
and significant population due to increased use of early detection
techniques."
"We are particularly encouraged to see that the clinically
significant trend observed from our earlier analysis has been
strengthened by the updated data from an additional 17-month follow-up
of patients," said Garo H. Armen, PhD, chairman and CEO of Antigenics.
"Although there are challenges associated with interpretation of
subset analyses, the improvement demonstrated in this group of
patients supports the opinion of key experts that patients with better
prognostic factors are the most appropriate population to benefit from
therapeutic cancer vaccines. Combined with decades of preclinical and
clinical cancer vaccine data, we believe our results provide a higher
level of reliability than that generally associated with outcomes from
typical subset analyses."
Study Findings
Results from the investigator-reported data, which represented all
data collected through the end of study (March 31, 2007), showed that:
-- Patients receiving Oncophage in the intermediate-risk
population (stages I/II high-grade, III T1/2/3a low-grade) who
were without disease at baseline (n = 362) demonstrated a
clinically significant improvement in recurrence-free survival
of approximately 45 percent (P less than 0.01; HR = 0.55).
This patient population is defined by the Eastern Cooperative
Oncology Group (ECOG) as at intermediate risk for disease
recurrence*. Although the median survival has not yet been
reached, results from the 25th percentile indicate that
recurrence-free survival was extended by approximately 1.8
years in the Oncophage arm.
-- Analysis of overall survival showed improvement associated
with Oncophage in the intermediate-risk population. As of data
cut-off on January 2, 2006, one additional patient had died in
the Oncophage arm versus 13 patients in the observation arm.
This now brings the total reported deaths to 15 patients (8.2
percent) in the Oncophage arm compared with 25 deaths (14.0
percent) in the observation arm. The overall survival data are
still immature due to the small number of deaths that have
occurred to date; patients will continue to be monitored for
survival through a global patient registry.
-- Among all eligible patients (intermediate- and high-risk
patients without baseline disease; n = 604), Oncophage was
associated with an 11.4 percent improvement in recurrence-free
survival, which was not statistically significant (HR = 0.89).
-- There was also a promising trend for overall survival
associated with Oncophage in the eligible patient population
(n = 604). As of data cut-off on January 2, 2006, 24
additional deaths have been reported, with six in the
Oncophage arm and 18 in the observation arm, bringing the
total to 37 (12.3 percent) and 40 (13.2 percent) deaths,
respectively.
-- Adverse events reported during the trial were generally mild
and expected. The more frequently reported adverse events were
mainly constitutional in nature or related to the actual
injection.
The company is working with study investigators to publish the
final findings in a peer-reviewed medical journal.
Antigenics To Continue To Follow Patients for Recurrence-Free
Survival and Overall Survival Through a Global Patient Registry
A global patient registry is being launched to continue collecting
data on all patients from the trial for recurrence-free survival and
overall survival. The registry, which is expected to provide
additional data on the effectiveness of Oncophage, will follow
patients for an additional three years from closure of the initial
trial, providing more than five years' worth of data collection from
the last patient enrolled.
Global Registrational Strategy
Antigenics intends to seek a meeting with US Food and Drug
Administration to discuss the results of the updated analyses
utilizing data through March 2007 to determine whether there is an
opportunity to file a biologics license application (BLA) on the basis
of these results along with appropriate commitments to conduct further
clinical investigations to support the efficacy of Oncophage in renal
cell carcinoma. Antigenics also plans to explore the need for further
clinical studies to support approval of Oncophage in ex-US markets.
Conference Call Information
Antigenics executives and Dr. Christopher Wood will host a
conference call at 1:30 pm ET today. To access the live call, dial
888.271.9082 (domestic) or 706.679.7741 (international); the access
code is 9197359. 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 June 4, 2007. The replay number is 800.642.1687
(domestic) or 706.645.9291 (international), and the access code is
9197359. The replay will also be available on the company's website
approximately two hours after the live call.
About Renal Cell Carcinoma
Renal cell carcinoma is the most common type of kidney cancer. The
American Cancer Society estimates that there will be approximately
51,190 new cases of kidney cancer in the United States in 2007, and
about 12,890 people will die from the disease. Renal cell carcinoma
accounts for about 90 percent of all kidney tumors. By the time renal
cell carcinoma is diagnosed in these patients, about one third of them
will have developed metastatic disease.
The current standard of care for patients with nonmetastatic renal
cell carcinoma consists of a nephrectomy (surgical removal of the
kidney) followed by observation. There is no treatment approved by the
US Food and Drug Administration for nonmetastatic renal cell carcinoma
at the present time.
*Haas N. Update on targeted therapy adjuvant trials (ECOG/MRC).
Paper presented at: Fifth International Symposium of the Kidney Cancer
Association, 2006; Chicago.
About Antigenics
Antigenics (NASDAQ: AGEN) is a biotechnology company working to
develop treatments for cancers and infectious diseases. The company's
investigational product portfolio includes Oncophage(R) (vitespen), a
patient-specific therapeutic cancer vaccine being evaluated in several
indications; Aroplatin(TM) (L-NDDP), a liposomal, third-generation
platinum chemotherapeutic; AG-707, a therapeutic vaccine for the
treatment of genital herpes; and QS-21, an adjuvant being evaluated by
Antigenics' corporate partners in more than twenty indications,
several in late-stage clinical trials. For more information, please
visit antigenics.com.
This press release contains forward-looking statements, including
statements regarding the potential clinical benefit of Oncophage in
kidney cancer based on a subgroup analysis; the planned future data to
be collected and analyzed in connection with the future development of
Oncophage; and potential strategies for pursuing the registration of
Oncophage. These forward-looking statements are subject to risks and
uncertainties that could cause actual results to differ materially.
These risks and uncertainties include, among others, unfavorable data
resulting from further analysis of the Oncophage Phase 3 Part 1 trial
data; retention of key employees; the risk that survival data from
patients that withdrew from the study or were lost to follow-up may
not be available for collection or review, or that future survival
data from patient monitoring may not support further development or
registration of Oncophage; decisions by regulatory agencies; the
ability to raise capital and finance future development of Oncophage;
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-Q as filed with
the Securities and Exchange Commission on May 10, 2007. 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.
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CONTACT: Antigenics Inc.
Media Relations:
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suberoi@antigenics.com
or
Investor Relations:
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ir@antigenics.com