NeoRx Phase I/II Clinical Results for STR in Multiple Myeloma to Be Presented at International Congress on Hematological Malignancies.Business Editors/Health/Medical Writers SEATTLE--(BUSINESS WIRE)--March 9, 2004 Clinical Sites Preparing for Phase III Patient Enrollment NeoRx 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 : NERX), a cancer therapeutics development company, today announced that William Bensinger, MD, Member, Fred Hutchinson Cancer Research Center, Seattle, will present results of phase I/II studies of STR STR abbr. synchronous transmitter receiver (TM) (Skeletal Targeted Radiotherapy) in patients with multiple myeloma multiple myeloma A malignant proliferation of abnormal plasma cells that populate the marrow-containing bones of the body. The affected plasma cells produce myeloma protein, a monoclonal antibody that replaces normal antibodies in the blood, thereby increasing susceptibility at the Workshop on Novel Therapeutic Approaches to Myeloma myeloma /my·elo·ma/ (mi?e-lo´mah) a tumor composed of cells of the type normally found in the bone marrow. giant cell myeloma see under tumor (1). , International Congress on Hematological Malignancies: Focus on Leukemias, Lymphomas, and Myelomas, on March 12, 2004, in Whistler, BC. NeoRx is developing STR for use with high-dose chemotherapy high-dose chemotherapy Oncology The administration of chemotherapeutics in excess of BM toxicity; given the risk of aplastic anemia, HDC requires autologous BMT and use of 'rescue' factors such as G-CSF, GM-CSF, and erythropoietin. See Bone marrow transplantation. and stem cell transplantation Stem Cell Transplantation Definition Stem cells are basic human cells that reproduce (replicate) easily, providing a continuous source of new, sometimes different types of cells. to treat multiple myeloma and other cancers that arise in or spread to the bone marrow. As previously announced, NeoRx is preparing to begin 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 STR under a Special Protocol Assessment (SPA) agreement with the US 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. ). The planned phase III trial is a randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. , controlled study of STR in patients with primary refractory multiple myeloma (i.e., patients who have failed to respond to conventional first-line therapy). The FDA accepted complete response at six months post-transplant as a surrogate endpoint, placing STR on an Accelerated Approval path. The Company has stated previously that it expects to open the phase III trial of STR to patient enrollment in the first quarter of 2004, and plans to conduct the trial at approximately 40 clinical sites in the US and Canada. In an effort to accomplish these goals, NeoRx has prioritized its list of prospective sites according to their readiness, experience and projected rate of patient accrual, and is working to open the sites on a rolling basis. Presently, the first tier of sites is expected to open for patient enrollment late in the first quarter or early in the second quarter of 2004, with others to follow on a continuing basis. NeoRx believes that it continues to be on track to reach its goal of filing a New Drug Application (NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any ) for STR in multiple myeloma in mid 2007. NeoRx is a cancer therapeutics company developing products for targeted delivery of anti-cancer agents, including radiopharmaceuticals, to tumor sites. This release contains forward-looking statements relating to the development of the Company's products and future operating results that are subject to certain risks and uncertainties that could cause actual results to differ materially from those projected. The words "believe," "expect," "intend," "anticipate," variations of such words, and similar expressions identify forward-looking statements, but their absence does not mean that the statement is not forward-looking. These statements are not guarantees of future performance and are subject to certain risks, uncertainties and assumptions that are difficult to predict. Factors that could affect the Company's actual results include conditions in the capital markets in general and in the life science sector in particular, specifically those that may affect potential financing sources for the development of NeoRx's business, the progress and costs of clinical trials and the timing of regulatory approvals, the availability of clinical materials from third-party suppliers, NeoRx's ability to manufacture STR in a timely and cost-effective manner and commercialize products and other risks and uncertainties described in NeoRx's current and periodic reports filed with the Securities and Exchange Commission, including NeoRx's Annual Report on Form 10-K Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 10-K. for the year ended December 31, 2003. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. The Company undertakes no obligation to update any forward-looking statement to reflect new information, events or circumstances after the date of this release or to reflect the occurrence of unanticipated events. NeoRx and STR are registered trademarks or trademarks of NeoRx Corporation in the United States and/or foreign countries. (C) 2004 NeoRx Corporation. All Rights Reserved. |
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