Techniclone Corporation Announces Update On Status Of Clinical Trials.TUSTIN, Calif.--(BW HealthWire)--August 29, 1997--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 cancer therapeutics company, announced today that Alpha Therapeutic Corporation (Alpha) has scheduled a meeting with the U.S. Food and Drug Administration (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. ) for October 28, 1997 to discuss expansion of the Phase III clinical trial Noun 1. phase III clinical trial - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the of I-131 LYM-1 (OncolymTM) and to discuss certain requested protocol changes for patient selection and treatment during the remainder of the expanded Phase III trial. Alpha completed the patient imaging portion of the Phase III trial and submitted the final imaging and dosimetry dosimetry /do·sim·e·try/ (do-sim´e-tre) scientific determination of amount, rate, and distribution of radiation emitted from a source of ionizing radiation, in biological d. data reports to the FDA in August 1997. The Phase III trial of I-131 LYM-1 (OncolymTM) is being sponsored by Alpha and involves the treatment of patients with intermediate and high-grade non- Hodgkins B-cell lymphoma. "We are enthusiastic about reaching this milestone meeting with the FDA regarding our LYM-1 product", said Techniclone's Vice President, Clinical Affairs, Jamie C, Oliver, Pharm.D. "Several protocol changes have been requested by Alpha in their submittal to the FDA. We believe, if allowed, these changes will ease patient entry criteria for the remainder of the trial. Also, the changes will set up new initial trial endpoints which are in line with recent changes at the FDA that evaluate drug efficacy based on the combination of partial and complete remissions, rather than focusing entirely on complete remissions. We believe that these protocol changes will provide for an even more meaningful evaluation of the clinical effectiveness of LYM-1." Additionally, Techniclone announced today that it has initiated discussions with Alpha to redefine Techniclone's role in the continuing Phase III LYM-1 trial. The purpose of these discussions is to reach an agreement whereby Techniclone will manage the maintenance of clinical trial sites, patient recruitment and testing, and interface with the FDA. Discussions are ongoing regarding these matters, however no definitive agreement has yet been reached. Initiation of TNT TNT: see trinitrotoluene. TNT in full trinitrotoluene Pale yellow, solid organic compound made by adding nitrate (−NO2) groups to toluene. Clinical Trials Techniclone announced today that the Company has made significant progress toward the expected filing of two Investigational New Drug Applications (INDs) for initiation of Tumor Necrosis tumor necrosis Death of tumor tissue, a common event in aggressive CAs in which the tumor rapidly outgrows its blood supply, resulting in tumor cell death. Cf Apoptosis. Therapy (TNT) Phase I/II clinical trials in the U.S. The Company expects that the first IND for a TNT Phase I/II brain cancer trial will be filed with the FDA by late September 1997, and a second IND for a Phase I/II lung cancer lung cancer, cancer that originates in the tissues of the lungs. Lung cancer is the leading cause of cancer death in the United States in both men and women. Like other cancers, lung cancer occurs after repeated insults to the genetic material of the cell. trial will be filed in late 1997. "We are looking forward to the filing of theses INDs for initiation of clinical trials for our TNT technology," said Lon H. Stone, Techniclone's President, 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. "Based on TNT results obtained in previous limited testing in the U.S., and in tests conducted by USC An abbreviation for U.S. Code. and Brilliance Pharmaceuticals in China The profile of China within the pharmaceutical industry is still low. China accounts for 20% of the world’s population but only 1.5% of the global drug market, although that market has been expanding by a 10% plus annually over the last 10 years. we believe that TNT holds significant promise as a broad spectrum therapeutic agent for cancer. We are anxious to demonstrate TNT's effectiveness in these upcoming U.S. trials, which will be managed by Dr. Jamie Oliver, our Vice President, Clinical Affairs, and our expanding internal clinical trial department." Techniclone's Product Portfolio Techniclone Corporation's most advanced drug development program is I-131 LYM-1 (Oncolym), a non-Hodgkin's B-cell lymphoma therapy product currently being studied in a multi- center Phase II/III clinical trial. The Company's world leadership in Collateral Targeting Agents also includes the following technologies: Tumor Necrosis Therapy (TNT), an innovative pharmaceutical compound that has the potential to destroy large tumors at the necrotic (dead) core without damaging surrounding healthy tissue; Vasopermeation Enhancing Agents (VEAs), a technology which targets tumor vessels with vasoactive vasoactive /vaso·ac·tive/ (va?zo-) (vas?o-ak´tiv) exerting an effect upon the caliber of blood vessels. va·so·ac·tive adj. agents (molecules that cause tissues to become temporarily permeable) and causes enhanced levels of drug and isotope uptake within a tumor; and Vascular Targeting Agents (VTAs), a pharmaceutical compound targeting the capillaries and vessels inside a tumor to deliver a clot- inducing drug, potentially causing the tumor to be "starved" of vital oxygen and nutrients necessary for its survival. Additional corporate and product pipeline information can be obtained from Techniclone Corporation's Internet Web Site (www.techniclone.com). This release contains certain forward-looking statements, including statements regarding the use of funds, timing concerning completion of production and radiolabeling radiolabeling incorporation of a radioactive element into a compound in order to investigate its metabolism, fate and utilization. requirements, approval and commercialization of products, and capital requirements Capital requirements Financing required for the operation of a business, composed of long-term and working capital plus fixed assets. , that involve a number of risks and uncertainties. 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 Exchange Commission (including, but not limited to, the report on Form 10-Q for the quarter ended Jan. 31, 1997, and the Company's report on Form 10-K for the year ended April 30, 1997). CONTACT: Nicole Scarcello Cynthia DeMonte Investor Relations Manager Institutional Investor Contact (714) 838-0500 (212) 420-0088 |
|
||||||||||||||

Printer friendly
Cite/link
Email
Feedback
Reader Opinion