GENEMEDICINE Receives Broad Patent Covering the Use of Cationic Lipids for Gene Therapy.THE WOODLANDS, Texas--(BW HealthWire)--October 15, 1997-- Worldwide exclusive license to Vanderbilt University Vanderbilt University, at Nashville, Tenn.; coeducational; chartered 1872 as Central Univ. of Methodist Episcopal Church, founded and renamed 1873, opened 1875 through a gift from Cornelius Vanderbilt. Until 1914 it operated under the auspices of the Methodist Church. patent issued in U.S. and in Europe covers widely used non-viral gene delivery technology GENEMEDICINE, INC inc - /ink/ increment, i.e. increase by one. Especially used by assembly programmers, as many assembly languages have an "inc" mnemonic. Antonym: dec. . (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :GMED) announced today the issuance both in the U.S. and in Europe of a major gene therapy patent. The patent claims broadly cover the use for gene therapy of any cationic cationic having qualities dependent on having free cations available. cationic detergents are wetting agents that disrupt or damage cell membranes, denature proteins and inactivate enzymes. lipid combined with DNA DNA: see nucleic acid. DNA or deoxyribonucleic acid One of two types of nucleic acid (the other is RNA); a complex organic compound found in all living cells and many viruses. It is the chemical substance of genes. and administered by injection or inhalation, the most common routes of administration. Cationic lipids are widely used in non-viral gene therapy. Numerous published studies have demonstrated the capability of cationic lipids to deliver effective levels of genes and other nucleic acids Nucleic acids The cellular molecules DNA and RNA that act as coded instructions for the production of proteins and are copied for transmission of inherited traits. to target cells in the body. Dr. Kenneth Brigham at Vanderbilt University discovered this utility of cationic lipids which forms the basis of the patent. GENEMEDICINE has an exclusive worldwide license to the technology covered by the Vanderbilt patent. "The issuance of the Vanderbilt patent in the U.S. and in Europe is a major milestone in advancing GENEMEDICINE leadership in non-viral gene therapy technology. Its claims provide GENEMEDICINE with a strong proprietary position in the development and commercialization of cationic lipid-based gene medicines," stated Eric Tomlinson, D.Sc., Ph.D., President and Chief Executive Officer of GENEMEDICINE. "We believe that injection and inhalation will be the principal routes of gene therapy administration and that cationic lipids will prove to be one of the primary delivery systems. Such utility of cationic lipids already has been demonstrated by GENEMEDICINE and others for delivery of therapeutic genes to tumors and the lung blood vessel blood vessel n. An elastic tubular channel, such as an artery, a vein, a sinus, or a capillary, through which the blood circulates. blood vessel(s), n the network of muscular tubes that carry blood. cells. The Vanderbilt patent adds significantly to the Company's broad proprietary position in the field of non-viral gene therapy technology." The patent claims cover formulations of cationic lipid and DNA, including those containing additional components such as neutral lipids, polymers or peptides, used for gene therapeutic products and gene-based vaccines that are injected into or inhaled in·hale v. in·haled, in·hal·ing, in·hales v.tr. 1. To draw (air or smoke, for example) into the lungs by breathing; inspire. 2. by the patient. Cationic lipids are fatty substances with a net positive electrical charge which, when combined in a complex with a therapeutic gene, enhance the entry of the gene in to target cells of the body. The subsequent expression of the administered gene in the target cell leads to the production of the therapeutic protein. GENEMEDICINE, in collaboration with Boehringer Mannheim, is employing a proprietary cationic lipid formulation for its IL-2 Gene Medicine, and Phase I human clinical trials recently commenced. The IL-2 Gene Medicine is administered to head and neck cancer patients by direct intra-tumoral injection. Cationic lipid gene delivery systems are employed in most of the current clinical trials of non-viral gene therapies including intended treatments for several cancers and the genetic disease cystic fibrosis cystic fibrosis (sĭs`tĭk fībrō`sĭs), inherited disorder of the exocrine glands (see gland), affecting children and young people; median survival is 25 years in females and 30 years in males. . "GENEMEDICINE believes that cationic lipid gene delivery systems have certain significant advantages compared to gene therapy approaches which use viral elements as `vectors' for gene delivery," Dr. Tomlinson added. "Such advantages include reduced risk of an autoimmune response, allowing for repeat administrations of the gene medicine, and reduced risk of irreversible genetic alterations caused by integration of the administered DNA into the patient's own chromosomal DNA." There are several different classes of cationic lipids being developed for non-viral gene therapy purposes. These include the cationic lipid DOTMA that GENEMEDICINE is employing in the IL-2 Gene Medicine. GENEMEDICINE and Roche Bioscience hold co-exclusive rights to the DOTMA technology. GENEMEDICINE is a leader in the development of gene medicines, a novel class of gene therapy products, designed for the treatment or prevention of serious diseases. GENEMEDICINE has rights to over 250 U.S. and foreign patents and patent applications which encompass the complete range of technologies to create and use gene therapeutic products, from gene delivery systems and gene expression systems to manufacturing technologies. The Company is developing gene medicines for treating certain cancers and neuromuscular neuromuscular /neu·ro·mus·cu·lar/ (-mus´ku-ler) pertaining to nerves and muscles, or to the relationship between them. neu·ro·mus·cu·lar adj. 1. disorders, and is developing nucleic acid nucleic acid, any of a group of organic substances found in the chromosomes of living cells and viruses that play a central role in the storage and replication of hereditary information and in the expression of this information through protein synthesis. vaccines for the prevention or treatment of infectious diseases infectious diseases: see communicable diseases. . Gene medicines work with the body's own systems to fight and defend against disease. Gene medicines deliver genetic instructions to targeted cells in the body to produce therapeutic proteins or desired immune responses and are intended to be handled and administered like traditional pharmaceutical products. Gene medicines are designed for both acute and chronic use and to be administered to patients through conventional means such as intramuscular intramuscular /in·tra·mus·cu·lar/ (-mus´ku-ler) within the muscular substance. in·tra·mus·cu·lar adj. Abbr. IM Within a muscle. or intravenous injection Noun 1. intravenous injection - an injection into a vein fix - something craved, especially an intravenous injection of a narcotic drug; "she needed a fix of chocolate" , or inhalation. The Company's core technology includes lipid-, peptide-, carbohydrate- and polymer-based gene delivery systems, each able to be applied to specific clinical targets, and gene expression systems to regulate the production of multiple genes. The GENEMEDICINE technology is potentially applicable to the treatment of a wide variety of diseases and disorders because of its capability to deliver therapeutic genes to several tissue and cell types and to control the expression of desired proteins. Except for the historical information contained herein, this press release contains forward-looking statements. Actual results may differ materially. Factors that could cause or contribute to differences include continued scientific progress in its research and development programs, the costs involved in the filing, prosecuting and enforcing of patent claims, the scope and results of preclinical testing and clinical trials, the time and costs involved in obtaining regulatory approvals, competing technological developments, the cost of manufacturing and scale-up and effective commercialization activities and arrangements. These factors and others are more fully discussed in periodic reports filed with the Securities and Exchange Commission including the Company's Form 10-K Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 10-K. for the year ended December 31, 1996. CONTACT: GENEMEDICINE, INC. Richard A. Waldron Vice President and Chief Financial Officer 281/364-1150 waldrr@genemedicine.com |
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