Techniclone Obtains Amendment to Oncolym Phase II/III Protocol to Expand Treatment Population.TUSTIN, Calif.--(BUSINESS WIRE)--July 23, 1998-- Trial to Now Include Patients Treated with Other Monoclonal Antibodies for NHL NHL Non-Hodgkin's lymphoma, see there 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) announced today that the Food and Drug Administration has allowed an amendment to the current Phase II/III Oncolym(R) clinical trial protocol A Clinical Trial Protocol is a document that describes the objective(s), design, methodology, statistical considerations, and organization of a clinical trial. The protocol usually also gives the background and reason the trial is being conducted, but these could be provided in to include patients that have failed or relapsed following treatment with other monoclonal antibodies for 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 . The Company feels this protocol change is essential to enhancing the long-term strategic positioning of Oncolym(R) in the treatment of non-Hodgkin's Lymphoma. Dr. James Lee Murray, Professor of Medicine, Director of Immunotherapy and Vaccine Program at the University of Texas M.D. Anderson Cancer Center commented," The need to treat patients who have received prior monoclonal antibodies for non-Hodgkin's Lymphoma is critical. Since the monoclonal antibodies in Oncolym(R) bind to a unique antigen on lymphoma cells, Oncolym(R) may be effective even in patients that have failed to respond or have relapsed following other monoclonal antibody therapy Monoclonal antibody therapy is the use of monoclonal antibodies (or Mab) to specifically target cells. The main objective is stimulating the patient's immune system to attack the malignant tumor cells and the prevention of tumor growth by blocking specific cell receptors. ." Dr. Michael Blend, Professor of Radiology at the University of Illinois College of Medicine The University of Illinois College of Medicine, part of the University of Illinois system, is the largest medical school in the United States, with over 2,600 students and trainees. The college provides scientific and clinical training. in Chicago further commented, "The ability to now study patients needing treatment after receiving a prior monoclonal antibody for non-Hodgkin's Lymphoma is a great benefit. I am very excited about the clinical results seen at the University of Illinois at Chicago This article is about the University of Illinois at Chicago. For other uses, see University of Illinois at Chicago (disambiguation). UIC participates in NCAA Division I Horizon League competition as the UIC Flames in several sports, most notably Basketball. to date." Dr. Jamie Oliver, Techniclone's Vice President of Clinical and Regulatory Affairs, commented, "The protocol change was prompted by the large number of patients who could not enter our trial under the prior protocol due to their previous treatment with other monoclonal antibodies. As part of the current protocol amendment, these patients will be eligible for treatment with Oncolym(R) if they do not demonstrate a HAMA (Human Anti-Murine Antibody) response prior to the administration of Oncolym(R) and if they have passed other trial entry criteria". Larry O. Bymaster, President and Chief Executive Officer of Techniclone, concluded, "This protocol change should improve the market potential of Oncolym(R) as we move toward commercialization and better position Techniclone in licensing and partnering discussions." 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 potentially capable of destroying cancerous tumors throughout the body. Presently in Phase I clinical testing 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), the Company's Tumor Necrosis Therapy (TNT TNT: see trinitrotoluene. TNT in full trinitrotoluene Pale yellow, solid organic compound made by adding nitrate (−NO2) groups to toluene. ) is designed to deliver high doses of radiation directly to the core of the tumor while causing minimal damage to surrounding tissue. Oncolym(R), a therapy for the treatment of advanced non-Hodgkin's B-cell 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 (VEAs) and Vascular Targeting Agents (VTAs). VEAs act on tumors to increase the concentration of conventional chemotherapy in the tumor site while VTAs attach to tumor blood vessels creating a blood clot which kills the tumor by eliminating its oxygen and nutrient supply. 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, the report on Form 10-Q/A for the quarter ended January 31, 1998 and the Company's report on Form 10 K/A K/A Knowledge and Abilities for the year ended April 30, 1997). CONTACT: Techniclone Corporation, Tustin Elizabeth Gorbett-Frost William V. Moding 714/508-6000 or Cynthia DeMonte Investor Communications 212/420-0088 or Clint Cantwell Rubenstein Public Relations, Media Contact 212/843-8051 |
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