Title: Vical Licensee Sanofi-aventis Initiates Phase 3 Trial to
Reduce Amputations Date: 9/20/2007 6:30:00 AM
SAN DIEGO, Sept. 20 /PRNewswire-FirstCall/ -- Sanofi-aventis, a licensee of Vical
Incorporated (Nasdaq: VICL), announced on Monday the initiation of a 500-patient Phase 3
clinical trial of its NV1FGF angiogenesis therapy, which is based on Vical's non-viral DNA
delivery technology. Assuming successful completion of the trial, called TAMARIS,
sanofi-aventis expects to file for marketing approval in 2010.
The plasmid DNA (pDNA) therapy encodes Fibroblast Growth Factor 1 (FGF-1), a growth
factor that stimulates the growth of blood vessels, and is intended to reduce the need for
amputations in patients suffering from critical limb ischemia. Sanofi-aventis previously
reported results from a Phase 2 trial in 107 patients demonstrating a statistically
significant reduction in the rate of both major amputations and all amputations in
patients receiving NV1FGF compared with those receiving placebo.
"In addition to DNA vaccines for infectious diseases and cancer, angiogenesis is
among the most promising applications of our DNA delivery technology," said Vijay B.
Samant, Vical's President and Chief Executive Officer. "The ability of pDNA to induce
production of a protein locally at the site of injection ideally matches the desired
treatment profile for critical limb ischemia, and perhaps for earlier stages of peripheral
vascular disease. We are pleased that sanofi-aventis, one of our two partners in this
field, has advanced into Phase 3 testing of this novel therapy addressing a major unmet
medical need, and we look forward to successful completion of the trial."
The TAMARIS study is a double-blind, placebo-controlled Phase 3 trial in approximately
500 patients with critical limb ischemia. Four doses of 4 mg each will be administered by
intramuscular injection at two-week intervals, and follow-up will continue for one year.
The primary endpoint is the prevention of major amputation or of death. Additional
information on the trial is available at http://en.sanofi-aventis.com/index.asp.
About Critical Limb Ischemia
Critical limb ischemia is a severe and costly condition. In the twelve months following
the first episode of critical limb ischemia, 55% of patients either require amputation or
die. In the United States and Europe, there are more than 150,000 amputations each year
due to critical limb ischemia, with a direct cost of nearly $6 billion and a total cost of
more than $8 billion. No disease-modifying therapy for critical limb ischemia is currently
available.
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 http://www.vical.com.
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 sanofi-aventis will continue development of NV1FGF as planned; whether
NV1FGF or any other product candidates will be shown to be safe and effective in clinical
trials; whether Phase 3 trial results will support filing for marketing approval by 2010,
if at all; the timing, nature and cost of clinical trials; whether Vical or its
collaborative partners will seek or gain approval to market NV1FGF or any other product
candidates; whether Vical or its collaborative partners will succeed in marketing any
product candidates; 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.
Contacts: Investors: Media:
Alan R. Engbring Susan Neath
Vical Incorporated Porter Novelli Life Sciences
(858) 646-1127 (619) 849-6007
Website: http://www.vical.com
SOURCE Vical Incorporated
-0- 09/20/2007
/CONTACT: Investors, Alan R. Engbring of Vical Incorporated,
+1-858-646-1127; or Media, Susan Neath of Porter Novelli Life Sciences,
+1-619-849-6007, for Vical Incorporated/
/Web site: http://www.vical.com
http://en.sanofi-aventis.com/index.asp /
(VICL)
CO: Vical Incorporated; sanofi-aventis
ST: California
IN: HEA MTC BIO IDC
SU: TRI
KF-CC
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