Exhibit 99.1
[CANCERVAX LOGO GRAPHIC OMITTED]
CONTACT:
Julie Ames Vince Reardon
CancerVax Corporation CancerVax Corporation
Director, Corporate Communications Sr. Director, Investor Relations
760-494-4252 760-494-4850
CANCERVAX COMPLETES PLANNED ENROLLMENT IN PHASE 3 CLINICAL
TRIAL OF CANVAXIN
FOR THE TREATMENT OF STAGE III MELANOMA
PHASE 3 TRIAL FOR STAGE IV MELANOMA CONTINUES TO ENROLL PATIENTS
CARLSBAD, CA - SEPTEMBER 22, 2004 - CancerVax Corporation (NASDAQ: CNVX)
announced today that it has completed the planned enrollment of 1,118 patients
into its Phase 3 clinical trial of Canvaxin(TM) for the treatment of patients
with Stage III melanoma. The international, randomized, double-blinded,
placebo-controlled trial is designed to evaluate the ability of Canvaxin(TM), a
specific active immunotherapy or therapeutic cancer vaccine, to extend the
survival of patients with Stage III melanoma following surgical resection of
their tumors. With enrollment of new patients in this clinical trial complete,
CancerVax will focus on completing the treatment and follow-up of patients
already enrolled in this study, as well as continue to enroll new patients in
its ongoing Phase 3 clinical trial of Canvaxin(TM) for the treatment of patients
with Stage IV melanoma.
"The completion of enrollment in this Phase 3 clinical trial is an important
milestone in our efforts to complete the clinical development of, seek
regulatory approval for and, if we are successful, make Canvaxin(TM) available
to treat patients with this deadly disease," said David F. Hale, President and
CEO of CancerVax. "Reaching this milestone is a tribute to the dedication of the
CancerVax team and the many physicians and patients around the world who are
participating in this clinical trial."
Canvaxin(TM) is one of the most widely studied specific active immunotherapies
for the treatment of cancer. More than 1,500 patients have been enrolled in
CancerVax's two Phase 3 clinical trials of Canvaxin(TM) in patients with
advanced-stage melanoma at over 80 clinical trial sites around the world, and
more than 2,600 patients with melanoma were treated with Canvaxin(TM) in Phase 1
and 2 clinical trials. The two ongoing Phase 3 clinical trials, in addition to
measuring a primary endpoint of overall survival, will also evaluate whether
Canvaxin(TM) will prolong disease-free survival and disease-free interval
compared to placebo.
During the first quarter of 2005, CancerVax anticipates that the independent
data safety monitoring board (DSMB) with responsibility for oversight of the
Phase 3 clinical trial of Canvaxin(TM) in Stage III melanoma will complete its
review of the third and final interim analysis of data from the clinical trial.
The final analysis of data from this clinical trial will occur after 392 deaths,
which the Company anticipates will occur in the fourth quarter of 2005 or the
first quarter of 2006.
CancerVax will concentrate on completing the enrollment of patients in the
Company's Phase 3 clinical trial of Canvaxin(TM) for patients with Stage IV
melanoma at 70 clinical trial sites around the world. As of September 21, 424
patients out of a planned 670 have been enrolled in this clinical trial. Based
on a re-
assessment of the rate of deaths, CancerVax now believes that the DSMB will
perform its second interim analysis of data from this clinical trial during the
first quarter of 2005.
Treatment with Canvaxin(TM) in Phase 1 and 2 clinical trials has been well
tolerated and retrospective, matched pair analyses have shown a significant
improvement in median overall survival of patients with Stage III and Stage IV
melanoma who received Canvaxin(TM) in one of the Phase 2 clinical trials when
compared with historical control patients who did not receive Canvaxin(TM).
"While patients who are diagnosed early and receive appropriate surgical
treatment for Stage I and II melanoma have high survival rates, at least 50
percent of patients with Stage III melanoma will recur after surgery and only
seven to 19 percent of patients diagnosed with Stage IV melanoma survive five
years," said Merrick Ross, M.D., Professor of Surgical Oncology at the
University of Texas M.D. Anderson Cancer Center and one of the principal
investigators for the Phase 3 clinical trial of Canvaxin(TM) for patients with
Stage III melanoma. "The Canvaxin(TM) clinical trials for Stage III and Stage IV
melanoma will evaluate a large patient population. I am excited to be involved
in exploring ways to utilize the immune system to fight this deadly disease."
Dr. Ross is a paid consultant to CancerVax Corporation. This arrangement is
managed by M. D. Anderson Cancer Center in accordance with its conflict of
interest policies.
"Melanoma is one of the fastest growing types of cancers. According to the
American Cancer Society, an estimated 55,000 new cases will be diagnosed in the
United States in 2004, double the number from 30 years ago," said Mary Loh,
Executive Director of the American Melanoma Foundation. "Prevention and early
detection are the best defenses against early-stage melanoma, but we desperately
need new treatment options for patients suffering with advanced stages of this
disease."
ABOUT CANVAXIN(TM)
Canvaxin(TM), one of a new class of products being developed in the area of
specific active immunotherapy, is based on a proprietary technology that may
potentially be applied to treat a number of cancers. Canvaxin(TM) is polyvalent,
expressing at least 38 tumor-associated antigens; allogeneic, which may result
in lower manufacturing costs than patient-specific immunotherapies; and is made
of whole cells, which may stimulate a strong immune response. Canvaxin(TM) has
both orphan drug and fast track designations from the FDA for the treatment of
invasive and metastatic melanoma, respectively, and is currently being studied
in two international Phase 3 clinical trials for the treatment of patients with
Stage III and Stage IV melanoma.
ABOUT MELANOMA
According to the American Cancer Society, melanoma is the deadliest type of skin
cancer and is the sixth most commonly diagnosed cancer in the United States. As
reported by the World Health Organization, the worldwide incidence, or number of
newly diagnosed cases, of melanoma in 2000 was 132,600, with 37,000 people dying
of the disease. The American Cancer Society estimates that in the United States,
approximately 55,000 people will be diagnosed with melanoma and 7,900 will die
as a result of the disease in 2004. Furthermore, according to the National
Cancer Institute, since 1997 the incidence of new melanoma cases in the United
States has increased at an average rate of more than 5% per year, one of the
highest growth rates for any type of cancer. In 2000, over 510,000 patients in
the United States were alive who had been diagnosed with melanoma.
ABOUT CANCERVAX CORPORATION (WWW.CANCERVAX.COM)
CancerVax Corporation is a biotechnology company focused on the research,
development and commercialization of novel biological products for the treatment
and control of cancer. The Company's lead product candidate, Canvaxin(TM), is
one of a new class of products being developed in the area of specific active
immunotherapy, also known as therapeutic cancer vaccines. Canvaxin(TM) is
currently being
studied in two international Phase 3 clinical trials for the treatment of
patients with Stage III or Stage IV, or advanced-stage, melanoma. The Company is
also finalizing the design of exploratory Phase 2 clinical trials for patients
with other advanced-stage solid tumors. In addition to Canvaxin(TM), CancerVax
has licensed three specific active immunotherapeutic product candidates
targeting the epidermal growth factor receptor signaling pathway, including
SAI-EGF, which has been studied in Phase 2 clinical trials. The Company plans to
identify and develop new product candidates based on its proprietary specific
active immunotherapy, anti-angiogenesis and T-oligo, or telomere homolog
oligonucleotide, technology, as well as on its human monoclonal antibodies.
CancerVax's corporate headquarters and research and development facility is
located in Carlsbad, California, and its biologics manufacturing facility is
located in the Los Angeles area.
FORWARD-LOOKING STATEMENTS
CancerVax cautions you that statements included in this press release that are
not a description of historical facts are forward-looking statements. The
inclusion of forward-looking statements should not be regarded as a
representation by CancerVax that any of its plans will be achieved. Actual
results may differ materially from those set forth in this release due to the
risks and uncertainties inherent in CancerVax's business including, without
limitation: CancerVax's dependence on the success of its lead product candidate,
Canvaxin(TM); the progress, timing and success of its clinical trials of
Canvaxin(TM) and its other product candidates; the potential that results of
Phase 1 and 2 clinical trials of Canvaxin(TM), which were evaluated using
retrospective survival analyses that may be subject to potential selection
biases, may not be predictive of future results of CancerVax's ongoing Phase 3
clinical trials; the impact of government regulation, which may increase the
cost and uncertainty associated with gaining regulatory approval of Canvaxin(TM)
and its other product candidates; CancerVax's dependence on clinical
investigators and medical institutions to enroll patients in its clinical trials
and other third parties to perform related data collection and analysis, which
may increase costs or delay the completion of its clinical trials; difficulties
or delays in developing, testing, producing and marketing its technologies and
product candidates; unexpected adverse side effects or inadequate therapeutic
efficacy of its products that could delay or prevent product development or
commercialization, or that could result in recalls or product liability claims;
its ability to obtain additional financing to support its operations; and other
risks detailed in CancerVax's Securities and Exchange Commission filings,
including CancerVax's Annual Report on Form 10-K for the fiscal year ended
December 31, 2003 and its Quarterly Report on Form 10-Q for the fiscal quarter
ended June 30, 2004. You are cautioned not to place undue reliance on these
forward-looking statements, which speak only as of the date hereof. All
forward-looking statements are qualified in their entirety by this cautionary
statement and CancerVax undertakes no obligation to revise or update this news
release to reflect events or circumstances after the date hereof.
CancerVax(R) is a registered trademark of CancerVax Corporation.
Canvaxin(TM) is a trademark of CancerVax Corporation.
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