Valentis Clinical Trial of a Novel Intravenous IL-2 Gene Medicine for Cancers In the Lung Is Underway

Apr 19, 2001, 01:00 ET from Valentis, Inc.

    BURLINGAME, Calif., April 19 /PRNewswire/ -- Valentis, Inc. (Nasdaq: VLTS)
 announced today that it has dosed the first four patients in a Phase I
 clinical trial of its intravenously administered human Interleukin-2 (IL-2)
 gene medicine, VLTS-587.  The goal of the trial is to determine the maximum
 tolerated dose of the IL-2 gene medicine in patients with cancers in the lung.
 By expressing the IL-2 gene locally in the lung, VLTS-587 is designed to
 deliver the IL2 protein to lung tumors while minimizing systemic exposure and
 associated adverse effects.
     The clinical trial is being conducted by John Hainsworth, M.D., at the
 Sarah Cannon Cancer Center in Nashville, Tennessee and by Scott Antonia, M.D.,
 at the H. Lee Moffitt Cancer Center in Tampa, Florida.  Up to 36 patients will
 be enrolled in this multi-center clinical study, which is expected to run
 through 2001.  Upon entry into lung cells, VLTS-587 is intended to lead to
 human IL2 protein expression in the pulmonary and tumor vasculature and local
 immune activation.
     Peter Sayre, M.D., Ph.D., who heads Valentis' Clinical Oncology
 Development explained, "This trial represents a significant advance by our
 oncology team.  The ability to deliver our gene medicines intravenously should
 allow us to treat far more patients than can be treated by injections directly
 into tumors.  VLTS-587 is designed to provide an opportunity to focus and
 amplify an immune response against both primary lung tumors as well as cancers
 having pulmonary metastases for which chemotherapy has limited effectiveness.
 VLTS-587 is the first of our next generation oncology gene medicines."
     Valentis' preclinical studies in several animal models including mouse,
 rabbit and non-human primates, verified the expression of human IL2 in the
 lung following the intravenous delivery of VLTS-587.  Efficacy studies in
 mouse model systems, as well as in dogs with spontaneously occurring
 metastatic pulmonary neoplasms, indicated anti-tumor activity as evidenced by
 a significant reduction in tumor burden.
     The systemic IL-2 gene medicine is the next generation of Valentis'
 cytokine-based gene medicines developed for cancer.  The systemic IL-2 gene
 medicine uses an optimized synthetic cationic lipid-based gene delivery system
 that has been shown to efficiently localize in the lungs, and preferentially
 in pulmonary tumor lesions, enabling tumor localization via intravenous
 administration.
     Valentis, Inc. is a leader in the field of biopharmaceutical delivery.
 The Company develops a broad array of products, proprietary technologies and
 intellectual property and applies its preclinical and early clinical
 development expertise to create novel therapeutics and improved versions of
 existing marketed biopharmaceuticals.  Valentis' core technologies include
 multiple gene delivery and gene expression systems and PEGylation technologies
 designed to improve the safety, efficacy and dosing characteristics of genes,
 proteins, peptides, peptidomimetics, antibodies, replicating and
 non-replicating viruses and liposomes.  The Company focuses its research and
 development efforts in several therapeutic areas including cardiovascular
 disorders, oncology, hematology and immunology.
     These technologies are covered by a broad patent portfolio that includes
 issued U.S. and European claims.  Valentis' commercial strategy is to enter
 into corporate collaborations for full-scale clinical development and
 marketing and sales of products.  Together, Valentis and its wholly owned
 subsidiary PolyMASC Pharmaceuticals, currently have corporate collaborations
 with Roche Holdings, Eli Lilly, Glaxo Wellcome, Boehringer Ingelheim, Heska
 Corporation, Eurogene, Transkaryotic Therapies, Onyx Pharmaceuticals, Viragen
 and Bayer International, and a manufacturing partnership (the pAlliance) with
 DSM Biologics and Qiagen N.V.  Additional information about Valentis can be
 found at www.valentis.com.
     Statements in this press release that are not strictly historical are
 "forward-looking" statements as defined in the Private Securities Litigation
 Reform Act of 1995.  The words "believes," "expects," "intends,"
 "anticipates," variations of such words, and similar expressions identify
 forward-looking statements, but their absence does not mean that the statement
 is not forward-looking.  These statements are not guarantees of future
 performance and are subject to certain risks, uncertainties and assumptions
 that are difficult to predict.  Factors that could affect Valentis' actual
 results include the need for additional capital, the early stage of product
 development, uncertainties related to clinical trials, and uncertainties
 related to patent position.  There can be no assurance that Valentis will be
 able to develop commercially viable gene medicines or PEGylated
 biopharmaceuticals, that any of the company's programs will be partnered with
 pharmaceutical partners, that necessary regulatory approvals will be obtained,
 or that any clinical trial will be successful.  Actual results may differ from
 those projected in forward-looking statements due to risks and uncertainties
 that exist in the companies' operations and business environments.  These are
 described more fully in the Valentis Annual Report on Form 10-K for the period
 ended June 30, 2000 and Quarterly Report on Form 10-Q for the period ended
 December 31, 2000, each as filed with the Securities and Exchange Commission.
 
 

SOURCE Valentis, Inc.
    BURLINGAME, Calif., April 19 /PRNewswire/ -- Valentis, Inc. (Nasdaq: VLTS)
 announced today that it has dosed the first four patients in a Phase I
 clinical trial of its intravenously administered human Interleukin-2 (IL-2)
 gene medicine, VLTS-587.  The goal of the trial is to determine the maximum
 tolerated dose of the IL-2 gene medicine in patients with cancers in the lung.
 By expressing the IL-2 gene locally in the lung, VLTS-587 is designed to
 deliver the IL2 protein to lung tumors while minimizing systemic exposure and
 associated adverse effects.
     The clinical trial is being conducted by John Hainsworth, M.D., at the
 Sarah Cannon Cancer Center in Nashville, Tennessee and by Scott Antonia, M.D.,
 at the H. Lee Moffitt Cancer Center in Tampa, Florida.  Up to 36 patients will
 be enrolled in this multi-center clinical study, which is expected to run
 through 2001.  Upon entry into lung cells, VLTS-587 is intended to lead to
 human IL2 protein expression in the pulmonary and tumor vasculature and local
 immune activation.
     Peter Sayre, M.D., Ph.D., who heads Valentis' Clinical Oncology
 Development explained, "This trial represents a significant advance by our
 oncology team.  The ability to deliver our gene medicines intravenously should
 allow us to treat far more patients than can be treated by injections directly
 into tumors.  VLTS-587 is designed to provide an opportunity to focus and
 amplify an immune response against both primary lung tumors as well as cancers
 having pulmonary metastases for which chemotherapy has limited effectiveness.
 VLTS-587 is the first of our next generation oncology gene medicines."
     Valentis' preclinical studies in several animal models including mouse,
 rabbit and non-human primates, verified the expression of human IL2 in the
 lung following the intravenous delivery of VLTS-587.  Efficacy studies in
 mouse model systems, as well as in dogs with spontaneously occurring
 metastatic pulmonary neoplasms, indicated anti-tumor activity as evidenced by
 a significant reduction in tumor burden.
     The systemic IL-2 gene medicine is the next generation of Valentis'
 cytokine-based gene medicines developed for cancer.  The systemic IL-2 gene
 medicine uses an optimized synthetic cationic lipid-based gene delivery system
 that has been shown to efficiently localize in the lungs, and preferentially
 in pulmonary tumor lesions, enabling tumor localization via intravenous
 administration.
     Valentis, Inc. is a leader in the field of biopharmaceutical delivery.
 The Company develops a broad array of products, proprietary technologies and
 intellectual property and applies its preclinical and early clinical
 development expertise to create novel therapeutics and improved versions of
 existing marketed biopharmaceuticals.  Valentis' core technologies include
 multiple gene delivery and gene expression systems and PEGylation technologies
 designed to improve the safety, efficacy and dosing characteristics of genes,
 proteins, peptides, peptidomimetics, antibodies, replicating and
 non-replicating viruses and liposomes.  The Company focuses its research and
 development efforts in several therapeutic areas including cardiovascular
 disorders, oncology, hematology and immunology.
     These technologies are covered by a broad patent portfolio that includes
 issued U.S. and European claims.  Valentis' commercial strategy is to enter
 into corporate collaborations for full-scale clinical development and
 marketing and sales of products.  Together, Valentis and its wholly owned
 subsidiary PolyMASC Pharmaceuticals, currently have corporate collaborations
 with Roche Holdings, Eli Lilly, Glaxo Wellcome, Boehringer Ingelheim, Heska
 Corporation, Eurogene, Transkaryotic Therapies, Onyx Pharmaceuticals, Viragen
 and Bayer International, and a manufacturing partnership (the pAlliance) with
 DSM Biologics and Qiagen N.V.  Additional information about Valentis can be
 found at www.valentis.com.
     Statements in this press release that are not strictly historical are
 "forward-looking" statements as defined in the Private Securities Litigation
 Reform Act of 1995.  The words "believes," "expects," "intends,"
 "anticipates," variations of such words, and similar expressions identify
 forward-looking statements, but their absence does not mean that the statement
 is not forward-looking.  These statements are not guarantees of future
 performance and are subject to certain risks, uncertainties and assumptions
 that are difficult to predict.  Factors that could affect Valentis' actual
 results include the need for additional capital, the early stage of product
 development, uncertainties related to clinical trials, and uncertainties
 related to patent position.  There can be no assurance that Valentis will be
 able to develop commercially viable gene medicines or PEGylated
 biopharmaceuticals, that any of the company's programs will be partnered with
 pharmaceutical partners, that necessary regulatory approvals will be obtained,
 or that any clinical trial will be successful.  Actual results may differ from
 those projected in forward-looking statements due to risks and uncertainties
 that exist in the companies' operations and business environments.  These are
 described more fully in the Valentis Annual Report on Form 10-K for the period
 ended June 30, 2000 and Quarterly Report on Form 10-Q for the period ended
 December 31, 2000, each as filed with the Securities and Exchange Commission.
 
 SOURCE  Valentis, Inc.

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