CancerVax Corporation
Filed by CancerVax Corporation
Pursuant to Rule 425 under the Securities Act of 1933
and deemed filed pursuant to Rule 14a-12
under the Securities Exchange Act of 1934
Subject Company: CancerVax Corporation
Commission File No. 333-131817
CANCERVAX ANNOUNCES RESULTS OF
PHASE 3 CLINICAL TRIALS OF CANVAXIN
IN PATIENTS WITH STAGE III AND STAGE IV MELANOMA
Carlsbad,
CA March 24, 2006 CancerVax Corporation (NASDAQ: CNVX) announced that data from its
Phase 3 clinical trials of Canvaxin in the treatment of patients with advanced-stage melanoma will
be presented today at the Society for Surgical Oncologys Annual Meeting in San Diego, California.
On October 3, 2005, CancerVax announced the discontinuation of its Phase 3 clinical trial of
Canvaxin in patients with Stage III melanoma. The decision followed the recommendation of the
independent Data and Safety Monitoring Board (DSMB) with oversight responsibility for this clinical
trial that, based upon the data reviewed at the third interim analysis, it was unlikely that the
trial would provide significant evidence of a survival benefit for Canvaxin-treated patients versus
those receiving placebo. In April 2005, the Company announced the discontinuation of the other
Phase 3 clinical trial of Canvaxin in patients with Stage IV melanoma based upon a similar
recommendation of the independent DSMB following its review of data from the second interim
analysis of this clinical trial.
The presentation, which is entitled Multi-center Double-Blind Phase 3 Clinical Trial of Canvaxin
vs. Placebo as a Post-surgical Adjuvant in Metastatic Melanoma, concludes that, while Canvaxin was
well tolerated and there was little difference in adverse events between the two study arms,
Canvaxin did not demonstrate efficacy as a post-surgical adjuvant treatment for patients with
advanced-stage melanoma. However, the median survival in the clinical trial with Canvaxin in
patients with Stage III melanoma (i.e., > 5.75 years) and the clinical trial in patients with
Stage IV melanoma (3 years) are better than or comparable to the median survival in earlier
published results of large, multi-center studies with similar patient groups.
Background
All patients participating in these clinical trials were required to have histologically confirmed
Stage III or IV metastatic melanoma, and to have been surgically rendered free of clinically
detectable disease, prior to enrollment. Both studies were blinded, and
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patients were randomized into either Canvaxin plus Bacillus Calmette Guerin (BCG), an adjuvant, or
placebo plus BCG treatment arms. In accordance with international guidelines, an independent DSMB
was established to review unblinded safety data and results of interim analyses, which were
pre-specified to occur at 25%, 50% and 75% of the total number of events. As the studies were
blinded, the investigators and the Company knew neither the patient treatment assignments
nor the outcome of the interim analyses until after the studies were discontinued. The primary
endpoint for both studies was overall survival, one of the secondary endpoints was disease-free
survival, and both studies were designed to have 80% power to detect a hazard ratio of 0.75, or an
increase in survival of 33%, at p<0.05.
Results of the Clinical Trial in Patients with Stage IV Melanoma
A total of 496 patients, out of a planned total enrollment of 670 patients, were enrolled in this
clinical trial. The overall survival of the combined Canvaxin and placebo treatment arms of this
study was better than overall survival reported for previous clinical trials in resected patients
with Stage IV melanoma. The median overall survival for patients who received Canvaxin was 31.5
months, and 38.7 months for patients who received placebo. The five-year overall survival rate was
39.6% for patients who received Canvaxin, and 44.9% for patients who received placebo (p= 0.245).
The median disease-free survival for patients who received Canvaxin was 8.3 months, as compared to
7.2 months for patients who received placebo, and the 5-year disease-free survival rate was 27.4%
for patients who received Canvaxin and 20.9% for patients who received placebo (p= 0.418). The
difference in these results was not statistically significant.
Results of the Clinical Trial in Patients with Stage III Melanoma
A total of 1,160 patients were enrolled in this clinical trial. The median overall survival for the
combined patient population in this clinical trial, including those who received Canvaxin and those
who received placebo, was greater than 69 months, which is better than or equivalent to overall
survival reported in previous clinical trials in resected patients with Stage III melanoma. The
five-year survival rate was 59.1% for patients who received Canvaxin, and 67.7% for patients who
received placebo (p= 0.04). The difference in overall survival between the patients who received
Canvaxin and the patients who received placebo is not statistically significant given the fact that
the boundary for statistical significance for the third interim analysis (p= 0.013) was not met.
The median disease-free survival for patients who received Canvaxin was 42.6 months, as compared to
over 47 months for patients who received placebo, and the 5-year disease-free survival rate was
47.2% for patients who received Canvaxin and 52.1% for patients who received placebo (p= 0.047).
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
Companys leading product candidate is D93, an anti-angiogenic, humanized, monoclonal antibody. In
February 2006, CancerVax filed an investigational new drug (IND) application and plans to initiate
a Phase 1 clinical trial of D93.
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In January 2006, CancerVax announced that it had entered into a definitive agreement to merge with
Micromet, AG, a private, Munich, Germany-based biotechnology company with a focus on the
development of novel, proprietary antibody-based products for cancer and inflammatory and
autoimmune diseases. The merger, which is subject to a number of conditions, is expected to close
in the second quarter of 2006. Upon closing of the transaction, the Companys shares are expected
to continue to trade on the NASDAQ National Market. CancerVax will be renamed Micromet, Inc.,
and application will be made to NASDAQ to change the ticker symbol to MITI. On February 13, 2006,
CancerVax filed a registration statement on Form S-4 with the U.S. Securities and Exchange
Commission (SEC) in connection with the transaction. This registration statement contains a proxy
statement/prospectus.
Forward-Looking Statements
This release contains certain forward-looking statements that involve risks and uncertainties that
could cause actual results to be materially different from historical results or from any future
results expressed or implied by such forward-looking statements. Such forward-looking statements
include statements regarding the proposed transaction between CancerVax and Micromet AG, the
efficacy, safety, and intended utilization of the companies respective product candidates, the
conduct and results of future clinical trials, and plans regarding regulatory filings, future
research and clinical trials and plans regarding partnering activities. Factors that may cause
actual results to differ materially include the risk that CancerVax and Micromet may not be able to
complete the proposed transaction, the risk that product candidates that appeared promising in
early research and clinical trials do not demonstrate safety and/or efficacy in larger-scale or
later clinical trials, the risk that CancerVax and Micromet will not obtain approval to market
their respective products, the risks associated with reliance on outside financing to meet capital
requirements, and the risks associated with reliance on collaborative partners for further clinical
trials, development and commercialization of product candidates. You are urged to consider
statements that include the words may, will, would, could, should, believes,
estimates, projects, potential, expects, plans, anticipates, intends, continues,
forecast, designed, goal, or the negative of those words or other comparable words to be
uncertain and forward-looking. These factors and others are more fully discussed in CancerVaxs
periodic reports and other filings with the SEC. Any forward-looking statements are made pursuant
to Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities
Exchange Act of 1934, as amended, and, as such, speak only as of the date made. CancerVax
undertakes no obligation to publicly update any forward-looking statements, whether as a result of
new information, future events or otherwise.
Additional Information about the Merger and Where to Find It
In connection with the proposed transaction described herein, on February 13, 2006, CancerVax filed
with the SEC a registration statement that contains a proxy statement/prospectus. Investors and
securityholders of CancerVax and Micromet are urged to read the proxy statement/prospectus
(including any amendments or supplements
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to the proxy statement/prospectus) regarding the proposed transaction because it contains important
information about CancerVax, Micromet and the proposed transaction. CanxerVaxs stockholders can
obtain a free copy of the proxy statement/prospectus, as well as other filings containing
information about CancerVax and Micromet, without charge, at the SECs Internet site
(http://www.sec.gov). Copies of the proxy statement/prospectus and the filings with the SEC that
are incorporated by reference in the proxy statement/prospectus can also be obtained, without
charge, by directing a request to CancerVax Corporation, 2110 Rutherford Road, Carlsbad, CA 92008,
Attention: Investor Relations, Telephone: (760) 494-4200.
Participants in the Solicitation
CancerVax and its directors and executive officers and Micromet and its directors and executive
officers may be deemed to be participants in the solicitation of proxies from the stockholders of
CancerVax in connection with the proposed transaction. Information regarding the special interests
of these directors and executive officers in the merger transaction are included in the proxy
statement/prospectus referred to above. Additional information regarding the directors and
executive officers of CancerVax is also included in CancerVaxs proxy statement for its 2005 Annual
Meeting of Stockholders, which was filed with the SEC on April 28, 2005. This document is available
free of charge at the SECs web site (http://www.sec.gov) and from Investor Relations at CancerVax
at the address described above.
CancerVax® is a registered trademark of CancerVax Corporation.
Canvaxin is a trademark of CancerVax Corporation.
CancerVax Contact:
William R. La Rue
CancerVax Corporation
Chief Financial Officer
+1 760-494-4200
http://www.cancervax.com
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