Vical Licensee AnGes MG Announces Positive Results of Phase 3 Angiogenesis Trial in Japan

    SAN DIEGO, June 18 /PRNewswire-FirstCall/ -- Vical Incorporated
 (Nasdaq:   VICL) today announced that the company's licensee, AnGes MG, Inc.
 reported positive results following interim analysis of data from the first
 41 subjects to complete a Phase 3 trial of an angiogenesis product
 candidate using Vical's DNA delivery technology. Based on the findings that
 the primary efficacy endpoint in the trial had been achieved with
 statistical significance and that there were no major safety concerns
 related to treatment, an Independent Data Monitoring Committee (IDMC)
 recommended stopping the trial early to prevent potential ethical issues
 against the placebo group subjects. AnGes is ending the trial and preparing
 to file an application for Japanese marketing approval.
     "The successful Phase 3 results from our Japanese licensee position the
 AnGes product candidate to be the first approved for human use based on our
 DNA delivery technology and provide proof of concept for DNA delivery in
 the treatment of disease," said Vijay B. Samant, President and Chief
 Executive Officer of Vical. "This novel approach has the potential to
 address an important, unserved medical need in a significant commercial
 market. We look forward to further updates from AnGes as they advance
 through the regulatory approval process."
     The treatment uses Vical technology to deliver a gene encoding
 Hepatocyte Growth Factor (HGF), a human protein that causes angiogenesis
 (growth of blood vessels) in areas of ischemia (restricted blood flow). In
 the trial, 40 subjects with critical limb ischemia (advanced peripheral
 arterial disease) were evaluated for efficacy. The primary endpoints,
 improvement of rest pain ((VAS (Visual Analog Scale)) or ischemic ulcer
 size, at 12 weeks post dosing, showed 30.8% improvement in the placebo
 group and 70.4% improvement in the treatment group, a statistically
 significant difference (p=0.014).
     The following English translation of the original Japanese news release
 was provided by AnGes.
              Announcement of Results of Phase III Clinical Trials
                          of HGF Gene Therapy in Japan
     AnGes conducted an interim analysis of the PIII data using HGF Gene
 (AMG 0001) for Critical Limb Ischemia (CLI) in Japan, and is pleased to
 announce that remarkable improvement was observed in the AMG0001 group
 compared with the Placebo group.
     Yesterday, an IDMC (Independent Data Monitoring Committee) was held,
 and now that the efficacy of AMG0001 is confirmed, the committee
 recommended to stop this trial in order to prevent potential ethical issues
 against the placebo group subjects. AnGes has accepted this advice today
 and decided to stop this trial. From now on, AnGes will closely communicate
 with governmental agencies and prepare for NDA filing.
     Outline of Study Results
     This trial is a randomized, placebo-controlled, double blind study for
 CLI subjects using AMG 0001.
     In this efficacy evaluation, 40 subjects with CLI were evaluated. 27
 subjects received AMG0001, and were compared with 13 placebo subjects. (The
 AMG0001 group received 8mg (4mg x 2) of AMG0001.)
     The primary endpoints, which is, improvement of rest pain ((VAS (Visual
 Analog Scale)) or ischemic ulcer size, at 12 weeks post dosing, showed
 30.8% improvement in Placebo group and 70.4% improvement in AMG0001 group
 and verified statistically significant difference (p=0.014)
     As for safety, 41 subjects (AMG0001: 28 subjects, Placebo: 13 subjects)
 were evaluated.
     Adverse drug reaction were equally distributed between AMG0001 group
 and placebo group.
     There were 8 SAEs in 6 subjects in the AMG0001 group (peripheral
 ischemia, cerebella infarction, post procedural hematoma, prostate cancer,
 bladder perforation, acute renal failure, peritonitis, bacterial
 pneumonia). However, causality due to AMG0001 was estimated none or low. In
 Placebo group, there were 4 SAEs in 3 subjects (2 embolism, toe gangrene,
 pain in thigh).
     All SAEs out of all studies using AMG0001 were evaluated by the DSMB
 (Data Safety Monitoring Board) and it was concluded that, as of today,
 there is no major safety concern related to AMG0001.
     While significant improvement was confirmed based on the efficacy
 evaluation, as AMG0001 is a highly novel therapeutic, AnGes will continue
 development by carefully following the safety.
     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.
     About AnGes MG
     AnGes MG, Inc. is a biopharmaceutical company founded December 1999
 based on innovative discoveries by researchers of Osaka University. The
 company specializes in research and development and practical application
 of DNA-based therapeutics. The company, along with its subsidiaries, is
 engaged in developing three new medicines: HGF genetic medicine which
 improves blood circulation by regenerating blood vessels, NFkB decoy which
 controls various inflammations, and HVJ envelope vector for non-viral drug
 delivery and discovery. Additional information on AnGes is available at
 www.anges-mg.com.
     This press release contains forward-looking statements subject to risks
 and uncertainties that could cause actual results to differ materially from
 those projected. Forward-looking statements include statements about the
 potential approval of AnGes' HGF product candidate, as well as Vical's
 focus, collaborative partners, and product candidates. Risks and
 uncertainties include whether AnGes will file for marketing approval in
 Japan; whether the HGF product candidate will be approved in Japan; whether
 the market for the HGF product will be significant; whether any product
 candidates will be shown to be safe and effective in clinical trials; the
 timing, nature and cost of clinical trials; whether Vical or its
 collaborative partners will seek or gain approval to market 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:  www.vical.com
 
 

SOURCE Vical Incorporated