Vical Projects Completion of Allovectin-7(R) Registration Program

Apr 03, 2001, 01:00 ET from Vical Incorporated

    SAN DIEGO, April 3 /PRNewswire/ -- Vical Incorporated (Nasdaq:   VICL)
 announced today that the U.S. Food and Drug Administration (FDA) has
 reconfirmed that the company's Phase II and III trial designs could support
 registration of Allovectin-7(R) for melanoma, and that the company expects to
 complete enrollment of patients in its Phase III trial in the third quarter of
 2001.
     Written comments received from the FDA, following a face-to-face status
 review meeting, reconfirmed the acceptability of the company's registration
 program to support marketing approval if the data meet the study objectives.
 A robust clinical outcome in one of the Phase III trial's two endpoints, with
 no detriment in the other, would be sufficient to warrant consideration for
 marketing approval, if the company also meets product manufacturing and other
 typical regulatory requirements.
     In addition, the FDA reconfirmed that the Phase II registration trial
 could, on its own, be the basis for marketing approval, if the data meet the
 clinical endpoints.  Enrollment of patients in the Phase II trial was
 completed in January 2001, and interim results will be presented in May at the
 annual meeting of the American Society of Clinical Oncology.  The FDA further
 confirmed that data from the Phase II trial and prior trials with
 Allovectin-7(R) would support a submission based on Phase III trial results,
 assuming that the Phase III data profile is consistent with prior experience.
     Vijay B. Samant, Vical's President and Chief Executive Officer, said, "We
 are pleased that the FDA has reaffirmed that our current trials could form the
 basis for approval of Allovectin-7(R), and excited that enrollment in our
 registration program is approaching completion.  Everyone involved in this
 program has worked long and hard to reach this point.
     "We are excited that Allovectin-7(R) has the potential to be the first
 gene-based product to gain marketing approval," added Mr. Samant, "and we
 would consider successful commercialization as further validation of naked DNA
 gene delivery.  Preparation for the commercial launch of Allovectin-7(R)
 continues to be the focus of Vical's activities."
 
     Registration Program
     Vical's Allovectin-7(R) registration program consists of two separate
 trials in patients with metastatic melanoma, either or both of which could
 lead to registration for their respective patient populations if endpoints are
 achieved.  The Phase II trial is designed to confirm the efficacy of
 Allovectin-7(R) in patients with refractory (unresponsive to standard therapy)
 melanoma that has not yet spread to multiple internal organs.  The Phase III
 trial is designed to demonstrate the efficacy of Allovectin-7(R) when used
 with standard chemotherapy in patients with metastatic melanoma not previously
 treated with chemotherapy.
     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 3 /PRNewswire/ -- Vical Incorporated (Nasdaq:   VICL)
 announced today that the U.S. Food and Drug Administration (FDA) has
 reconfirmed that the company's Phase II and III trial designs could support
 registration of Allovectin-7(R) for melanoma, and that the company expects to
 complete enrollment of patients in its Phase III trial in the third quarter of
 2001.
     Written comments received from the FDA, following a face-to-face status
 review meeting, reconfirmed the acceptability of the company's registration
 program to support marketing approval if the data meet the study objectives.
 A robust clinical outcome in one of the Phase III trial's two endpoints, with
 no detriment in the other, would be sufficient to warrant consideration for
 marketing approval, if the company also meets product manufacturing and other
 typical regulatory requirements.
     In addition, the FDA reconfirmed that the Phase II registration trial
 could, on its own, be the basis for marketing approval, if the data meet the
 clinical endpoints.  Enrollment of patients in the Phase II trial was
 completed in January 2001, and interim results will be presented in May at the
 annual meeting of the American Society of Clinical Oncology.  The FDA further
 confirmed that data from the Phase II trial and prior trials with
 Allovectin-7(R) would support a submission based on Phase III trial results,
 assuming that the Phase III data profile is consistent with prior experience.
     Vijay B. Samant, Vical's President and Chief Executive Officer, said, "We
 are pleased that the FDA has reaffirmed that our current trials could form the
 basis for approval of Allovectin-7(R), and excited that enrollment in our
 registration program is approaching completion.  Everyone involved in this
 program has worked long and hard to reach this point.
     "We are excited that Allovectin-7(R) has the potential to be the first
 gene-based product to gain marketing approval," added Mr. Samant, "and we
 would consider successful commercialization as further validation of naked DNA
 gene delivery.  Preparation for the commercial launch of Allovectin-7(R)
 continues to be the focus of Vical's activities."
 
     Registration Program
     Vical's Allovectin-7(R) registration program consists of two separate
 trials in patients with metastatic melanoma, either or both of which could
 lead to registration for their respective patient populations if endpoints are
 achieved.  The Phase II trial is designed to confirm the efficacy of
 Allovectin-7(R) in patients with refractory (unresponsive to standard therapy)
 melanoma that has not yet spread to multiple internal organs.  The Phase III
 trial is designed to demonstrate the efficacy of Allovectin-7(R) when used
 with standard chemotherapy in patients with metastatic melanoma not previously
 treated with chemotherapy.
     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