Techniclone Corporation Announces LYM-1 Oncolym Update.TUSTIN, Calif.--(BW HealthWire)--July 16, 1997--Techniclone Corporation announced today that its strategic partner Alpha Therapeutic Corporation has completed the final analysis and summarization of the quantitative 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. portion of the ongoing Phase II/III study of I131 LYM-1 (Oncolym(TM)) for presentation to 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. . The data further substantiates that Oncolym(TM) targets lymphoma cells, rather than healthy cells, and indicates that radiolabeled LYM-1 antibody can be delivered intravenously without the nausea, hair loss and other debilitating de·bil·i·tat·ing adj. Causing a loss of strength or energy. Debilitating Weakening, or reducing the strength of. Mentioned in: Stress Reduction side effects Side effects Effects of a proposed project on other parts of the firm. seen with most forms of cancer treatment. "We are optimistic about the future of the trial, and look forward to Alpha's meeting with the FDA, so that they may expand the trials into additional sites. These findings suggest that Oncolym(TM) is positioned to treat the aggressive intermediate and high grade lymphomas which must be treated with higher levels of radioisotope radioisotope: see radioactive isotope. Radioisotope (biology) A radioactive isotope used in studying living systems, such as in the investigation of metabolic processes. than low grade lymphoma," said Techniclone 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 of the Board, Lon H. Stone. "Initial results from dosimetry patients who continued on to the treatment portion of the trial appear to be consistent with earlier published Phase I and II data." Alpha is funding and conducting the phase II/III clinical trial for Oncolym(TM), a treatment for intermediate- and high-grade non-Hodgkin's B-cell lymphoma. The quantitative dosimetry patients were required to go through an extensive imaging study as part of the FDA review process, which determined the radiolabeled antibody's distribution in all tissues and organs in the body. Non-Hodgkin's lymphoma non-Hodg·kin's lymphoma n. Any of various malignant lymphomas characterized by the absence of Reed-Sternberg cells. Non-Hodgkin's lymphoma is divided into three distinct segments: low grade, intermediate grade and high grade. While low-grade lymphomas are being studied by several companies using radiolabeled and unlabeled products, Oncolym is being evaluated for intermediate- and high-grade lymphoma high-grade lymphoma Oncology An aggressive lymphoma that responds poorly to chemotherapy and comprises 20% of lymphomas Prognosis HGLs have a mean survival of < 1 yr without therapy. See Lymphoma. , which represents 65 percent of all B-cell lymphoma patients, representing a market potential of $320 million. Techniclone's Product Portfolio Techniclone Corporation's most advanced drug development program is I-131 LYM-1 (Oncolym(TM)), 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 position in Collateral Targeting Agents also includes the following technologies: Tumor Necrosis Therapy (TNT TNT: see trinitrotoluene. TNT in full trinitrotoluene Pale yellow, solid organic compound made by adding nitrate (−NO2) groups to toluene. ), an innovative drug delivery system that has the potential to destroy large tumors at the necrotic (dead) core without damaging surrounding healthy tissue; Vasopermeation Enhancement, 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 drug delivery system 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. The Company plans to initiate Phase I/II clinical trials for TNT in the U.S. in late 1997, with trials in Europe to follow shortly thereafter. Additional corporate and product pipeline information can be obtained on Techniclone Corporation's Internet Web Site (www.techniclone.com). -0- Any statements released by Techniclone that are forward looking 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. Investors are cautioned that forward-looking statements involve risks and uncertainties which may affect the Company's business and prospects, including economic, competitive, government, technological and other factors discussed in the Company's filings with the Securities and Exchange Commission. CONTACT: Nicole Scarcello Investor Relations Manager 714/838-0500 or Cynthia DeMonte Institutional Investor Contact 212/420-0088 |
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