Vical Updates Leuvectin(TM) Kidney Cancer Program

Apr 19, 2001, 01:00 ET from Vical Incorporated

    SAN DIEGO, April 19 /PRNewswire/ -- Vical Incorporated (Nasdaq:   VICL)
 today announced that the company is discontinuing the current Phase II
 clinical trial with Leuvectin(TM) for patients with metastatic kidney cancer
 and planning a new Phase II clinical trial using a new dose and dosing
 regimen.
     In the current Phase II kidney cancer trial with Leuvectin(TM), the study
 protocol required an interim analysis of data from the first 37 patients.
 Based on that analysis, the company determined that efficacy failed to meet
 the level needed to continue the study.  The efficacy also appears to be lower
 than that observed in prior kidney cancer trials with Leuvectin(TM).  The
 Leuvectin(TM) used in the current trial was formulated with a different
 process than the Leuvectin(TM) used in earlier trials.  Comparative analysis
 suggests that expression of interleukin-2 (IL-2) for the product used in the
 current trial may be below historical levels.  The new trial would use
 high-dose Leuvectin(TM) formulated with an optimized process.
     "Clinical testing is intended to identify such issues," said Vijay B.
 Samant, Vical's President and Chief Executive Officer, "and our internal
 systems worked as designed in doing so.  The safety profile for Leuvectin(TM)
 has been excellent compared with systemic IL-2 therapy and efficacy results
 from our earlier trials were promising."  The safety database for
 Leuvectin(TM) now includes more than 235 patients, with less than 3 percent
 requiring even brief hospitalization for drug-related adverse events.  The
 drug-related hospitalization rate for systemic IL-2 therapy is significantly
 higher.  "We are confident," added Mr. Samant, "that continued development of
 Leuvectin(TM) can lead to a better treatment option for patients with
 metastatic kidney cancer."
 
     Leuvectin(TM)
     The active ingredient in Leuvectin(TM), a DNA-based product candidate, is
 a gene encoding IL-2, a naturally occurring protein that stimulates the immune
 system.  Administration occurs by direct injection into a tumor, leading to
 uptake by the tumor cells and subsequent expression of the IL-2 protein.  The
 company expects that local expression of IL-2 by cancer cells may stimulate
 the patient's immune system to attack and destroy the tumor cells.
     Recombinant IL-2 protein is an FDA-approved anti-cancer agent for the
 treatment of advanced kidney cancer.  When given systemically, it is
 frequently associated with serious side effects.  Because Leuvectin(TM)
 delivers IL-2 locally within the tumor, it may provide similar benefits with
 fewer side effects than the systemic protein therapy.
 
     Vical Incorporated, The Naked DNA Company(TM), is focused on the
 development of pharmaceutical product candidates based on its patented gene
 delivery technology.  A number of therapeutic and vaccine product candidates
 are currently under development for the prevention or treatment of cancer,
 infectious diseases and metabolic disorders by Vical and its collaborative
 partners, including Merck & Co., Pfizer Inc., Aventis Pasteur, Aventis Pharma,
 Human Genome Sciences, Centocor Inc., Merial and Boston Scientific
 Corporation.  Allovectin-7(R), which uses a lipid-DNA complex to help the
 immune system recognize and attack cancer cells, is in Phase II and Phase III
 testing in certain patients with metastatic melanoma and in Phase II testing
 in patients with head and neck cancer.  Leuvectin(TM), which uses a lipid-DNA
 complex to stimulate an immune response against cancer cells, is in Phase II
 testing in patients with kidney cancer and prostate cancer.  Vaxid, a naked
 DNA vaccine to prevent relapse of B-cell lymphoma, is in Phase I/II testing.
 In collaboration with the National Cancer Institute, a naked DNA vaccine to
 treat metastatic melanoma is in Phase I/II testing.  If you are interested in
 any of Vical's clinical trials, please see our website at www.vical.com, or
 contact Tammy Boyce by phone at 858/646-1120 or by e-mail at tboyce@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.  Forward-looking statements include statements about the
 company's focus, collaborative partners, product candidates, and developmental
 status.  Risks and uncertainties include whether any product candidates will
 be shown to be safe and efficacious in clinical trials, the timing of clinical
 trials, whether Vical or its collaborative partners will seek or gain approval
 to market 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.
 
     For news releases and other information about the company, visit the Vical
 web site at www.vical.com.
 
 

SOURCE Vical Incorporated
    SAN DIEGO, April 19 /PRNewswire/ -- Vical Incorporated (Nasdaq:   VICL)
 today announced that the company is discontinuing the current Phase II
 clinical trial with Leuvectin(TM) for patients with metastatic kidney cancer
 and planning a new Phase II clinical trial using a new dose and dosing
 regimen.
     In the current Phase II kidney cancer trial with Leuvectin(TM), the study
 protocol required an interim analysis of data from the first 37 patients.
 Based on that analysis, the company determined that efficacy failed to meet
 the level needed to continue the study.  The efficacy also appears to be lower
 than that observed in prior kidney cancer trials with Leuvectin(TM).  The
 Leuvectin(TM) used in the current trial was formulated with a different
 process than the Leuvectin(TM) used in earlier trials.  Comparative analysis
 suggests that expression of interleukin-2 (IL-2) for the product used in the
 current trial may be below historical levels.  The new trial would use
 high-dose Leuvectin(TM) formulated with an optimized process.
     "Clinical testing is intended to identify such issues," said Vijay B.
 Samant, Vical's President and Chief Executive Officer, "and our internal
 systems worked as designed in doing so.  The safety profile for Leuvectin(TM)
 has been excellent compared with systemic IL-2 therapy and efficacy results
 from our earlier trials were promising."  The safety database for
 Leuvectin(TM) now includes more than 235 patients, with less than 3 percent
 requiring even brief hospitalization for drug-related adverse events.  The
 drug-related hospitalization rate for systemic IL-2 therapy is significantly
 higher.  "We are confident," added Mr. Samant, "that continued development of
 Leuvectin(TM) can lead to a better treatment option for patients with
 metastatic kidney cancer."
 
     Leuvectin(TM)
     The active ingredient in Leuvectin(TM), a DNA-based product candidate, is
 a gene encoding IL-2, a naturally occurring protein that stimulates the immune
 system.  Administration occurs by direct injection into a tumor, leading to
 uptake by the tumor cells and subsequent expression of the IL-2 protein.  The
 company expects that local expression of IL-2 by cancer cells may stimulate
 the patient's immune system to attack and destroy the tumor cells.
     Recombinant IL-2 protein is an FDA-approved anti-cancer agent for the
 treatment of advanced kidney cancer.  When given systemically, it is
 frequently associated with serious side effects.  Because Leuvectin(TM)
 delivers IL-2 locally within the tumor, it may provide similar benefits with
 fewer side effects than the systemic protein therapy.
 
     Vical Incorporated, The Naked DNA Company(TM), is focused on the
 development of pharmaceutical product candidates based on its patented gene
 delivery technology.  A number of therapeutic and vaccine product candidates
 are currently under development for the prevention or treatment of cancer,
 infectious diseases and metabolic disorders by Vical and its collaborative
 partners, including Merck & Co., Pfizer Inc., Aventis Pasteur, Aventis Pharma,
 Human Genome Sciences, Centocor Inc., Merial and Boston Scientific
 Corporation.  Allovectin-7(R), which uses a lipid-DNA complex to help the
 immune system recognize and attack cancer cells, is in Phase II and Phase III
 testing in certain patients with metastatic melanoma and in Phase II testing
 in patients with head and neck cancer.  Leuvectin(TM), which uses a lipid-DNA
 complex to stimulate an immune response against cancer cells, is in Phase II
 testing in patients with kidney cancer and prostate cancer.  Vaxid, a naked
 DNA vaccine to prevent relapse of B-cell lymphoma, is in Phase I/II testing.
 In collaboration with the National Cancer Institute, a naked DNA vaccine to
 treat metastatic melanoma is in Phase I/II testing.  If you are interested in
 any of Vical's clinical trials, please see our website at www.vical.com, or
 contact Tammy Boyce by phone at 858/646-1120 or by e-mail at tboyce@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.  Forward-looking statements include statements about the
 company's focus, collaborative partners, product candidates, and developmental
 status.  Risks and uncertainties include whether any product candidates will
 be shown to be safe and efficacious in clinical trials, the timing of clinical
 trials, whether Vical or its collaborative partners will seek or gain approval
 to market 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.
 
     For news releases and other information about the company, visit the Vical
 web site at www.vical.com.
 
 SOURCE  Vical Incorporated