Vical's Allovectin-7(r) Phase 3 Trial Receives Positive Review From Safety Monitoring...
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Vical's Allovectin-7(r) Phase 3 Trial Receives Positive Review From Safety
Monitoring Board
SAN DIEGO, March 24, 2009 (GLOBE NEWSWIRE) -- Vical Incorporated (Nasdaq:VICL)
today announced that an independent Safety Monitoring Board (SMB) for the
company's Phase 3 AIMM trial of Allovectin-7(r) in patients with metastatic
melanoma has completed the trial's second scheduled safety analysis and
recommended that the trial continue per the protocol. The trial is expected to
complete enrollment of the planned 375 subjects by year-end 2009.
About the AIMM Trial
Vical is conducting the AIMM (Allovectin-7(r) Immunotherapeutic for Metastatic
Melanoma) trial, a Phase 3 pivotal trial of the company's Allovectin-7(r) cancer
immunotherapeutic as first-line therapy in approximately 375 chemotherapy-naive
patients with Stage III or IV metastatic melanoma in accordance with a Special
Protocol Assessment (SPA) agreement completed with the U.S. Food and Drug
Administration (FDA). The SPA specifies the trial objectives and design,
clinical endpoints, and planned analyses expected to be needed for product
approval. The AIMM trial is currently enrolling patients at clinical sites in
key centers worldwide. A patient self-screening tool for trial eligibility is
available online at www.melanomaclinicaltrial.com.
Under a previously announced collaborative agreement, AnGes MG, Inc., is funding
the AIMM trial through a series of cash payments and equity investments. Vical
has received $17.6 million to date of the $22.6 million total committed by
AnGes. In exchange for funding the trial, AnGes received exclusive marketing
rights in Japan and other key Asian countries, and Vical is obligated to pay
AnGes tiered royalties based on defined sales levels in the United States, and
fixed royalties on rest-of-world sales. AnGes is obligated to pay Vical
royalties on product sales in the specified Asian countries, plus certain
sales-based milestone payments if defined sales levels are achieved. Each
company will be responsible for obtaining regulatory approvals in any countries
where it plans to market Allovectin-7(r).
About Allovectin-7(r)
Allovectin-7(r) is a plasmid/lipid complex containing the DNA sequences encoding
HLA-B7 and beta-2 microglobulin, which together form a Class I Major
Histocompatibility Complex, or MHC-I antigen. Injection of Allovectin-7(r)
directly into tumors is designed to stimulate an immune response against both
local and distant metastatic tumors. Vical conducted a large Phase 2 trial
evaluating Allovectin-7(r) immunotherapeutic as a single agent for patients with
Stage III or IV metastatic melanoma. Based on advice from clinical experts and
detailed guidance received from the FDA in an End-of-Phase 2 meeting, Vical
designed the Phase 3 AIMM trial.
Allovectin-7(r) has been granted orphan drug designation for the treatment of
invasive and metastatic melanoma by the FDA's Office of Orphan Products
Development. Orphan drug designation provides U.S. marketing exclusivity for
seven years if marketing approval is received from the FDA, in addition to
certain tax benefits for qualifying expenses.
About Metastatic Melanoma
The American Cancer Society estimated that more than 62,000 new diagnoses of,
and approximately 8,400 deaths from, melanoma would occur in 2008 in the United
States. Currently, there are no consistently effective therapies for advanced
cases of metastatic melanoma where the cancer has spread to other parts of the
body. The toxicity associated with FDA-approved treatments such as dacarbazine
or interleukin-2 is often significant, resulting in serious or life-threatening
side effects in many of the patients treated. Patients with metastatic melanoma
often are treated off-label with drugs such as temozolomide, which has been
approved by the FDA for the treatment of certain types of brain cancer but not
for the treatment of metastatic melanoma. Temozolomide is an orally-delivered
pro-drug that converts in the body into the same active compound as dacarbazine.
About Vical
Vical researches and develops biopharmaceutical products based on its patented
DNA delivery technologies for the prevention and treatment of serious or
life-threatening diseases. Potential applications of the company's DNA delivery
technology include DNA vaccines for infectious diseases or cancer, in which the
expressed protein is an immunogen; cancer immunotherapeutics, in which the
expressed protein is an immune system stimulant; and cardiovascular therapies,
in which the expressed protein is an angiogenic growth factor. The company is
developing certain infectious disease vaccines and cancer therapeutics
internally. In addition, the company collaborates with major pharmaceutical
companies and biotechnology companies that give it access to complementary
technologies or greater resources. These strategic partnerships provide the
company with mutually beneficial opportunities to expand its product pipeline
and address significant unmet medical needs. Additional information on Vical is
available at www.vical.com.
The Vical Incorporated logo is available at
http://www.globenewswire.com/newsroom/prs/?pkgid=5768
This press release contains forward-looking statements subject to risks and
uncertainties that could cause actual results to differ materially from those
projected, including: whether Vical or others will continue development of
Allovectin-7(r); whether Vical will be able to recruit patients into the AIMM
trial as planned, if at all; whether Vical will receive all of the clinical
trial funding from AnGes under the collaborative agreement, which will depend on
continued development of Allovectin-7(r) and certain other conditions; whether
Vical will receive any or all of the sales-based milestone payments and
royalties for sales in the specified Asian countries, which will depend on the
efforts of AnGes in obtaining regulatory approval and commercializing
Allovectin-7(r) in those countries; whether any sales will be generated outside
the specified Asian countries, which will depend on the efforts of Vical and
potentially additional partners in obtaining regulatory approvals and
commercializing Allovectin-7(r) in those regions; whether Allovectin-7(r) or any
other product candidates will be shown to be safe and effective; the timing,
nature and cost of clinical trials; whether Vical or its collaborative partners
will seek or gain approval to market any product candidates; whether Vical or
its collaborative partners will succeed in marketing any product candidates;
whether defined sales levels will be achieved in any markets; and additional
risks set forth in the company's filings with the Securities and Exchange
Commission. These forward-looking statements represent the company's judgment as
of the date of this release. The company disclaims, however, any intent or
obligation to update these forward-looking statements.
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CONTACT: Vical Incorporated
Alan R. Engbring
(858) 646-1127
www.vical.com
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