Nov. 15 /PRNewswire/ -- Valentis, Inc. (Nasdaq: VLTS - news) today announced the publication of data detailing improvements to the Company's GeneSwitch(TM) gene regulation system including the ability to completely shut off expression of potent therapeutic proteins and more stringently control the level and duration of expression of selected therapeutic genes. The report entitled ``Ligand-Dependent Regulation of Vascular Endothelial Growth Factor and Erythropoietin Expression by a Plasmid-Based Autoinducible GeneSwitch System'' appeared in the September 2000 issue of the journal Molecular Therapy (vol. 2, no. 3, pages 276-287.) The GeneSwitch(TM) system is a key component of the Company's regulated erythropoietin (EPO) gene medicine, which is scheduled to begin clinical testing next year. Valentis delivers the EPO gene and GeneSwitch(TM) into muscle tissue to achieve controlled expression levels of proteins, which are secreted into the bloodstream.
The improved GeneSwitch(TM) system has several advantages for application to gene-based products:
* it is being developed as a plasmid-based system to avoid the use of viral vectors;
* it requires only a single regulator protein, which is modeled after a human steroid receptor, and
* it is controlled in a dose dependent manner by low levels of mifepristone, a drug recently approved for use in the U.S. by the FDA.
``The improvement to the GeneSwitch(TM) system results in a significant decrease in unwanted background levels of therapeutic gene expression,'' stated Jeffrey Nordstrom, Ph.D., Valentis' Director and Program Head, Systemic Proteins. ``Because of the tight control provided by the GeneSwitch(TM) system, we can now pursue development of gene medicines that would not otherwise have been possible.''
The supporting data for the journal article demonstrate the ability of the improved GeneSwitch(TM) system to regulate expression of both EPO, an anemia treatment, and vascular endothelial growth factor (VEGF), which is a potential product for a number of cardiovascular diseases. Prolonged, uncontrolled expression of VEGF could lead to tumor formation while over-expression of EPO could lead to polycythemia and hypertension. In preclinical tests with the GeneSwitch(TM) system, Valentis saw no EPO or VEGF expression until the oral inducer drug was administered to the test animals. The data indicate the potential usefulness of the improved system as a ``safety switch,'' where complete shut-off of protein expression is the desired result.
Valentis, Inc. is a leader in the field of biopharmaceutical delivery. We develop a broad array of products, proprietary technologies and intellectual property and apply our preclinical and early clinical development expertise to create novel therapeutics and improved versions of existing marketed biopharmaceuticals. Our 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. We focus our 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, Flemington Pharmaceuticals 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. |
