Techniclone Announces Grant From NYSE Multinational Pharmaceutical Company to Initiate Phase I/II TNT Solid Tumor Trial.TUSTIN, Calif.--(BUSINESS WIRE)--August 5, 1998-- Mexico's NIH "Not invented here." See digispeak. NIH - The United States National Institutes of Health. to Test TNT TNT: see trinitrotoluene. TNT in full trinitrotoluene Pale yellow, solid organic compound made by adding nitrate (−NO2) groups to toluene. Concept in a Variety of Solid Tumor Cancers If Accepted 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. , Result May Speed U.S. Process Techniclone Corporation (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 :TCLN), a developer of leading-edge, unique therapeutics for the advanced treatment of cancer, announced today that it has entered into an agreement with a New York Stock Exchange New York Stock Exchange (NYSE) World's largest marketplace for securities. The exchange began as an informal meeting of 24 men in 1792 on what is now Wall Street in New York City. (NYSE NYSE See: New York Stock Exchange ) multinational pharmaceutical company, whereby Techniclone will receive an unrestricted grant to initiate a Phase I/II clinical investigation of its Tumor Necrosis Therapy (TNT) radiolabeled I131-chTNT-1/B in a variety of solid tumor cancers. The clinical investigation will be co-monitored by Techniclone and the pharmaceutical company, and is expected to begin in the next few weeks at Salvador Zubrian National Nutrition Institute in Mexico City, under the direction of Dr. Gabriela Cesarman, Physician, Department of Hematology and Oncology. The Company expects that the results from this study, if accepted by the FDA, would replace the need for 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 study and therefore potentially reduce the U.S. approval timeline by six to twelve months. The study is expected to include treatment of patients with advanced prostate, pancreatic and liver cancers and will explore the benefits of alternative delivery procedures (which include intratumoral and intravenous injection) for chTNT-1B. Under the terms of the agreement, Techniclone is prohibited from disclosing the identity of the pharmaceutical company in this press release. "This clinical program is an important test of the TNT concept and investigation of alternative administration methods for TNT as applied to various solid tumor cancers", commented Dr. Jamie Oliver, Techniclone's Vice President of Clinical and Regulatory Affairs. "The resulting data will be valuable in constructing future protocols for submission to the FDA in the initiation of expanded U.S. trials in addition to our ongoing Phase I human clinical trial for malignant glioma glioma /gli·o·ma/ (gli-o´mah) a tumor composed of neuroglia in any of its states of development; sometimes extended to include all intrinsic neoplasms of the brain and spinal cord, as astrocytomas, ependymomas, etc. (brain cancer)." "A grant from this major pharmaceutical company and the participation of Mexico's National Institute of Health (NIH) certainly demonstrates the interest in this technology," concluded Larry O. Bymaster, President and Chief Executive Officer of Techniclone. "This study has the potential to reduce the time required for clinical trials in the U.S. by six to twelve months and to yield the data necessary to assist in the design of future U.S. trials for a broad range of solid tumor therapeutics. Techniclone is committed to expanding the clinical testing of TNT. We believe TNT has both the therapeutic and market potential for broad applicability." Safe Harbor Statement. This release may contain certain forward-looking statements that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995. Actual events or results may differ from the Company's expectations as a result of risk factors discussed in Techniclone's reports on file with the U.S. Securities and Exchange Commission, including, but not limited to, Company's report on Form 10 K for the year ended April 30, 1998. Company Overview. Techniclone Corporation is engaged in the research and development of unique therapeutics for the treatment of cancer. The Company utilizes innovative targeting technologies to develop products capable of destroying cancerous tumors throughout the body. Presently in Phase I clinical testing, the Company's Tumor Necrosis Therapy (TNT) is designed to deliver high doses of radiation directly to the core of the tumor while causing no damage to surrounding tissue. Oncolym(R), a therapy for the treatment of advanced B-Cell Non-Hodgkin's Lymphoma, is currently undergoing Phase II/III human testing. The Company is also developing two additional technologies for the treatment of solid tumors, Vasopermeation Enhancement Agents (VEA VEA Virginia Education Association VEA Virtual Environment Architecture VEA Value Engineering Analysis VEA video encryption algorithm VEA Value Efficiency Analysis VEA Vida Ecología y Ambiente (Spanish, Guatemala) ) and Vascular Targeting Agents (VTA VTA Valley Transportation Authority (San Jose, California) VTA Ventral Tegmental Area VTA Vacuum Triode Amplifier VTA VFR Terminal Area VTA Martha's Vineyard Transit Authority (Massachusetts) ). VEAs act on tumors to increase the concentration of conventional c hemotherapy in the tumor site while VTA's attach to tumor blood vessels creating a blood clot which kills the tumor by eliminating its oxygen and nutrient supply. CONTACT: Elizabeth Gorbett-Frost, CPA (Computer Press Association, Landing, NJ) An earlier membership organization founded in 1983 that promoted excellence in computer journalism. Its annual awards honored outstanding examples in print, broadcast and electronic media. The CPA disbanded in 2000. , Chief Financial Officer William V. Moding, CPA, Vice President, Operations and Administration 714-508-6000 or Cynthia DeMonte, Investor Communications, 212-420-0088 Clint Cantwell, Rubenstein Public Relations, Media Contact, 212-843-8051 |
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