Genetic Therapy, Inc. Announces Start of Gene Therapy Protocol to Protect Patients' Blood Cells During High Dose Chemotherapy.GAITHERSBURG, Md.--(HealthWire)--July 18, 1995--Genetic Therapy, Inc. (Nasdaq: GTII) announced today the initiation of a Phase I clinical trial Noun 1. phase I clinical trial - a clinical trial on a few persons to determine the safety of a new drug or invasive medical device; for drugs, dosage or toxicity limits should be obtained phase I for a gene therapy protocol designed to protect patients' blood systems from the destructive effects of high dose chemotherapy. The treatment approach uses the Company's vector technology to transfer a gene for multiple drug resistance (MDR-1) into progenitor cells ("stem cells stem cells, unspecialized human or animal cells that can produce mature specialized body cells and at the same time replicate themselves. Embryonic stem cells are derived from a blastocyst (the blastula typical of placental mammals; see embryo), which is very young ") that give rise to all other cells in the blood system. Expression of the MDR-1 gene mdr-1 gene multi-drug resistance gene; normally responsible for maintaining the blood-brain barrier to certain drugs. A deletion mutation in this gene is responsible for the sensitivity to ivermectin observed in Collie dogs and related breeds. makes cells resistant to certain chemotherapeutics by enabling cells to pump toxic chemotherapeutic drugs out before cell death occurs. Because high dose chemotherapy can severely damage patients' blood systems, a treatment method called autologous bone marrow transplantation autologous bone marrow transplantation Transplantation medicine The administration to an individual 'X' of his/her own BM, often to a leukemic Pt in relapse who, because a suitable HLA-matched donor is not available, would otherwise die of the disease. See Bone marrow. (ABMT ABMT Anti-Ballistic Missile Treaty ABMT Autologous Bone Marrow Transplant ABMT Atlantic Blue Marlin Tournament ABMT American Board of Medical Toxicology ) is commonly employed. In ABMT, bone marrow cells are removed from the patient prior to chemotherapy treatment, then reintroduced following treatment to aid in repopulation repopulation 1. introduction of new animals to a farm or part of it after it has been depopulated for health or production reasons. 2. the additional growth of normal cells around a tumor that is being destroyed by irradiation. of the blood system. According to the trial protocol, patients with metastatic Metastatic The term used to describe a secondary cancer, or one that has spread from one area of the body to another. Mentioned in: Coagulation Disorders metastatic pertaining to or of the nature of a metastasis. breast cancer will initially receive four to five cycles of chemotherapy. Those patients who achieve a partial response and who do not show bone marrow involvement, will undergo both peripheral blood stem cell (PBSC PBSC Peripheral Blood Stem Cell PBSC Performance-Based Service Contracting PBSC Pro Bono Students Canada PBSC Polar Bear Software Company PBSC Public Buildings and Site Commission ) and bone marrow stem cell harvest procedures. Of the sample collected, 70% will be cryopreserved. CD34+ cells (which include stem cells) will be separated from the remaining 30% and incubated with a retroviral vector containing the human MDR-1 gene in order to transfer the resistance trait to the cells. The genetically altered stem cells, combined with the cryopreserved unmodified cells, will be reintroduced to patients' blood streams following high dose ICE (ifosfamide, carboplatin and etoposide) chemotherapy treatment. It is hoped that the MDR-1 stem cells will contribute to the regeneration of the patient's blood system, and provide blood cells that have greater resistance to subsequent chemotherapy treatments. The trial will be headed by Kenneth H. Cowan, M.D., Ph.D., of the National Cancer Institute. Approximately 18 patients will be enrolled in the study, which will be conducted at the National Institutes of Health. While the Company is pleased to commence this study, there can be no assurance that any clinical trial will be successful or, if successful, will lead to product approval by the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. . "We are excited to begin a clinical study of a treatment approach for cancers designed to support patient survival following high dose chemotherapy. Use of this new gene therapy protocol may ultimately permit the use of higher doses of chemotherapeutic compounds, and may also reduce or eliminate the need for additional ABMT procedures following chemotherapy for recurrent cancer," commented M. James Barrett, Ph.D., CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. and Chairman of the Board of Genetic Therapy, Inc. "In addition, gene therapy may prove beneficial in treating other cancers, such as leukemia, in which high dose chemotherapy and ABMT protocols have been applied." Genetic Therapy, Inc., based in Gaithersburg, MD, is a leader in the development of human gene therapy products for the treatment of genetic and acquired diseases. Founded in 1986, Genetic Therapy and its collaborators represent one of the largest groups of scientists dedicated to research and development in this field. On July 10, 1995, Genetic Therapy entered into an Agreement and Plan of Merger with Sandoz Ltd. who has commenced a cash tender offer to purchase all of the outstanding shares of Genetic Therapy common stock. CONTACT: Marc R. Schneebaum Chief Financial Officer Genetic Therapy, Inc. (301) 208-2415 or John M. Nugent (Investor Relations) Karen L. Bergman (Media Relations) Burns McClellan, Inc. (212) 505-1919 |
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