Exhibit 99.1
Antigenics Presents Phase 3 Data from Trial of Oncophage in Metastatic Melanoma
at ASCO Meeting; Overall Median Survival 29 Percent Longer in Patients Who
Received at Least 10 Injections of Oncophage
ATLANTA--(BUSINESS WIRE)--June 5, 2006--
Combined Population of Stage IV M1a and M1b Melanoma Patients Who
Received at Least 10 Vaccinations Experienced Increased Survival of
143 Percent
Antigenics Inc. (NASDAQ: AGEN) today announced in an oral
presentation at the 42nd annual meeting of the American Society of
Clinical Oncology (ASCO) updated findings from a Phase 3 clinical
trial of the company's investigational cancer vaccine Oncophage(R)
(vitespen; formerly HSPPC-96) in metastatic melanoma (abstract #8002).
In the study, patients who received at least 10 doses of vaccine
experienced an extension in median survival of 29 percent compared
with those who received physician's choice (hazard ratio = 0.749;
nominal, one-sided P value = 0.130). In a subset analysis, Oncophage
was associated with a potentially clinically relevant benefit (hazard
ratio = 0.427; nominal, one-sided P value = 0.017) compared with
physician's choice for patients with stages IV M1a and M1b melanoma,
if at least 10 doses of vaccine were administered.
"This is the first time a cancer vaccine has shown evidence of a
potential survival benefit in this patient population," Jon Richards,
MD, PhD, of the Oncology-Hematology department at Lutheran General
Cancer Care Center, Park Ridge, IL, and lead investigator of the
study. "These findings are consistent with preclinical and early
clinical research conducted to date and lay a solid foundation for the
continued exploration of Oncophage vaccine in better-prognosis stage
IV melanoma patients."
Study Findings
The Phase 3, international, multicenter, open-label trial
(protocol C-100-21) randomized 322 patients with stage IV melanoma to
one of two treatment arms: Oncophage or physician's choice, in a 2:1
ratio favoring Oncophage, and prospectively stratified based on AJCC
metastatic stage (M1a, M1b, M1c). Physician's choice included
interleukin 2 (IL-2) and/or dacarbazine-/temozolomide-based therapy
and/or complete tumor resection, and could also include any other
licensed treatments for cancer. The primary endpoint of the trial was
overall survival, and comparison of survival data was made using the
Kaplan-Meier method (an estimate of the cumulative probability of
survival for a set of data) and a one-sided log-rank test. Overall, in
the intent-to-treat analysis, patients in the Oncophage arm (M1a, -b
and -c combined) fared similarly to those in the physician's choice
arm in terms of survival (9.4 months vs. 10.7 months, respectively;
hazard ratio = 1.157; nominal, one-sided P value = 0.157).
Researchers also found that patients who received at least 10
doses of vaccine (44 patients) experienced an extension in median
survival of 29 percent compared with those who received physician's
choice (72 patients; 16.5 months vs. 12.8 months, respectively; hazard
ratio = 0.749; nominal, one-sided P value = 0.130). A more pronounced
effect was observed in M1a and M1b patients who received at least 10
vaccines (25 patients) compared with those who received physician's
choice (33 patients), with an improved survival of 31.2 months vs.
12.8 months, respectively (hazard ratio = 0.452; nominal, one-sided P
value= 0.017).
Adverse events reported during the trial were generally mild and
expected. The more frequently reported adverse events were mainly
constitutional in nature and included, but were not limited to nausea,
pyrexia (fever), fatigue, constipation, dyspnea (difficulty
breathing), arthralgia (pain in the joints), headache, back pain and
abdominal pain. Approximately 50 percent of patients receiving
Oncophage reported a serious adverse event (SAE), but only two SAEs
were considered by the investigators to be related and unexpected.
These events included one report of a thyroid disorder and another
report of cellulitis (inflammation of connective tissue).
Oncophage, Antigenics' lead product in development, is an
investigational personalized cancer vaccine based on the company's
proprietary heat shock protein technology. Derived from each patient's
cancerous tissue or cells, the vaccine is designed to capture the
'antigenic fingerprint' of the patient's particular cancer. This is
designed to reprogram the body's immune system to target and destroy
only cells bearing this fingerprint, leaving healthy tissue unaffected
and minimizing debilitating side effects associated with traditional,
broader-acting cancer treatments. Oncophage has been granted fast
track and orphan drug designations from the US Food and Drug
Administration (FDA) in both metastatic melanoma and renal cell
carcinoma.
"These clinical data add to the growing set of observations in
other clinical research with Oncophage that the potential benefit of
our vaccine may be most apparent when more doses are administered to
better-prognosis patients," said Garo H. Armen, PhD, chairman and CEO
of Antigenics Inc. "We will soon have results from the in-depth
analysis of our Phase 3 kidney cancer trial, the largest study
conducted in the adjuvant setting, which we expect to show a similar
pattern of effect in a much larger patient population. We are also
exploring our next steps from a clinical development perspective,
including potential combination treatments in melanoma as well as
other indications."
About Melanoma
Melanoma is the most serious form of skin cancer. According to the
American Cancer Society, melanoma accounts for only about 4 percent of
skin cancer cases, but causes most skin cancer deaths. It is estimated
that in 2006 there will be 62,190 new cases of melanoma in the United
States and that about 7,910 people will die of the disease.
Oncologists treat advanced or metastatic melanoma, also known as
stage III or IV melanoma, with surgery, radiation therapy,
immunotherapy or chemotherapy, depending on the case. Approximately 15
percent of all melanoma patients at the time of first diagnosis have
stage III or stage IV disease. Existing treatments have not
significantly improved overall survival of patients with melanoma.
According to published literature, the median survival of patients
with late-stage III melanoma is about 24 months, and patients with
stage IV melanoma have a median survival of about seven months.
Although oncologists use various treatments, the only FDA-approved
therapies for patients with metastatic melanoma are high-dose
intravenous interleukin 2 and alpha interferon, another human
cytokine.
About Antigenics
Antigenics is working to develop treatments for cancers,
infectious diseases and autoimmune disorders. The company's
investigational product portfolio includes Oncophage(R) (vitespen;
formerly HSPPC-96), a patient-specific therapeutic cancer vaccine
being evaluated in several indications; Aroplatin(TM), a liposomal,
third-generation platinum chemotherapeutic; ATRA-IV, a liposomal
retinoic acid; AG-707, a therapeutic vaccine for the treatment of
genital herpes; AU-801, a preclinical program targeting autoimmune
disorders; and QS-21, an adjuvant being evaluated by Antigenics'
corporate partners in several late-stage clinical trials. For more
information, please visit www.antigenics.com.
This press release contains forward-looking statements, including
statements regarding the indication of potential clinical benefit to
Oncophage-treated patients in this trial and other trials; the timing
of the release of data from other Oncophage trials; the commencement
and timing of future clinical development of Oncophage; the import of
this data for Antigenics' technology platform; the company's ability
to create personalized cancer vaccines in a real-life setting; the
ability of these preliminary findings to lay the clinical foundation
for use of the HSP approach against a wide range of common solid
cancers; and the presentation and publication of further details of
data from this trial. 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, that
the results may not ultimately demonstrate a statistically significant
survival benefit in this study or future studies; that the safety
profile and any positive efficacy results may not be replicated in
future clinical trials of Oncophage for melanoma or in any other
cancers; that the company may fail to successfully negotiate a
registration plan with the FDA or do so in the time frame
contemplated; the need for and extent of additional clinical trials;
decisions by regulatory agencies; 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 12, 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: Antigenics Inc.
Media Relations:
Sunny Uberoi, 917-443-3325
suberoi@antigenics.com
or
Investor Relations:
Shalini Sharp, 800-962-2436
ir@antigenics.com