Valentis Announces the Issuance of Two Broad Patents
BURLINGAME, Calif., May 28 /PRNewswire-FirstCall/ --
Lipids for gene delivery
Valentis, Inc. (Nasdaq: VLTS - News), today announced the issuance of US Patent No. 6,387,395, which broadly covers the use of positively charged lipids (cationic lipids) for delivery of nucleic acids to cells (gene delivery). The patent issued to Syntex (U.S.A.) Inc. and, under a license agreement, Syntex and Valentis share exclusive rights for in vivo gene delivery.
President and CEO, Dr. Benjamin F. McGraw III, stated, "We are very pleased by the issuance of this important patent, which provides very broad protection in the United States for the use of cationic lipids in delivery of any nucleic acids to cells, whether in vitro or in vivo. Cationic lipids are one of the fundamental means by which genes can be efficiently introduced into cells without having to resort to the use of viruses. Within the over 600 human gene therapy clinical trials that have been initiated to date, over 80% of patients treated with non-viral gene therapeutics have received cationic lipid-based formulations. Relative to viral methods for gene delivery, cationic lipid:nucleic acid complexes are inexpensive to manufacture, stable during storage & shipping and can be re-administered. We believe the issuance of this patent further substantiates Valentis' strong position in non-viral gene delivery."
PEGylation of GM-CSF
Valentis, Inc. also announced that its wholly-owned subsidiary, PolyMASC Pharmaceuticals Plc, has been issued US Patent No. 6,384,195 covering PEGylated granulocyte-macrophage stimulating factor ("GM-CSF"). GM-CSF is a protein important in the growth and maturation of hematopoietic progenitor cells and is used as an adjunctive therapy in the treatment of white blood cell deficiencies occurring as a result of cancer treatment such as bone marrow transplantation and following chemotherapy for acute myelogenous leukemia. PEGylation extends circulation lifetime in the blood after administration, thus potentially providing greater efficacy with less frequent dosing.
Valentis has three product platforms for the development of novel therapeutics: the GeneMedicine(TM), GeneSwitch(TM) and OptiPEG(TM) platforms. The GeneMedicine(TM) platform includes a comprehensive array of proprietary nucleic acid delivery systems, including the broad cationic lipid portfolio, from which appropriate formulations and modalities may be selected and tailored to fit selected genes, indications, and target tissues. The Del-1 GeneMedicine(TM) therapeutic is the lead product for the GeneMedicine(TM) platform of non-viral gene delivery technologies. Del-1 is an angiogenesis gene that is being developed for peripheral arterial disease and ischemic heart disease. The EpoSwitch(TM) therapeutic for anemia is the lead product for the GeneSwitch® platform and is being developed to allow control of erythropoietin protein production from an injected gene by an orally administered drug. The OptiPEG(TM) platform, consisting of proprietary PEGylation technologies, potentially allows for improved dosing of biopharmaceuticals. OptiPEG(TM) is being developed through licensing to partners. Additional information is available at 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-based therapeutics 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 company's operations and business environments. These are described more fully in the Valentis Annual Report on Form 10-K for the period ended June 30, 2001 and Quarterly Report on Form 10-Q for the period ended March 31, 2002, each as filed with the Securities and Exchange Commission.
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SOURCE: Valentis, Inc |
