Excellent Safety Profile at Highest Doses in NeoRx's Skeletal Targeted Radiotherapy Trial; Phase II trial enrollment close to completion.Business Editors, Health/Medical Writers SEATTLE--(BUSINESS WIRE)--Jan. 13, 2000 NeoRx Corporation (Nasdaq:NERX) NeoRx Corporation today announced that its Skeletal Targeted Radiotherapy (STR STR abbr. synchronous transmitter receiver ) product has demonstrated an excellent safety profile at the highest doses in the Phase I portion of its study, supporting the Company's intention to use that dose in the Phase III Noun 1. phase III - 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 FDA trial scheduled to begin this year. Efficacy data on these patients will be available later in the year once the patient responses have been evaluated. The Company also reported that it is close to completing the Phase II portion of its trial in which 14 patients were treated at the highest STR doses. NeoRx previously reported that 12 of 27 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 patients evaluated for response had achieved complete remission complete remission Complete response Oncology Disappearance of all signs and symptoms of disease–eg, cancer, multiple sclerosis, with normalization of all biochemical and radiologic parameters, as well as a negative repeat biopsy–pathologic remission. of their cancers, and that these patients had been treated at lower doses. "Even at the highest doses of STR, multiple myeloma patients exhibited no significant side effects Side effects Effects of a proposed project on other parts of the firm. ," said Robert Caspari, MD, NeoRx's Vice President of Medical and Regulatory Affairs Regulatory Affairs (RA), also called Government Affairs, is a profession within regulated industries, such as pharmaceuticals, medical devices, energy, and banking. Regulatory Affairs professionals usually have responsibility for the following general areas: tr.v. grat·i·fied, grat·i·fy·ing, grat·i·fies 1. To please or satisfy: His achievement gratified his father. See Synonyms at please. 2. because it enables us to deliver high radiation doses to the site of a tumor without the patient experiencing toxicity beyond that believed caused by the co-administered chemotherapy, opening prospects for treating older patients with intensive and effective treatments and expanding the potential indications to other diseases such as prostate cancer prostate cancer, cancer originating in the prostate gland. Prostate cancer is the leading malignancy in men in the United States and is second only to lung cancer as a cause of cancer death in men. . We intend to meet with 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. this quarter to agree on the final design of the Phase III study." STR is a drug that delivers a unique radionuclide radionuclide /ra·dio·nu·clide/ (-noo´klid) a nuclide that disintegrates with the emission of corpuscular or electromagnetic radiations. ra·di·o·nu·clide n. , holmium-166, to bone and that accumulates preferentially around cancers in the bone. No binding to other organs has been observed in preclinical or clinical studies, and the portion that is not bound to bone is rapidly excreted in the urine. It is this distribution in the body and rapid clearance that is believed to result in the high doses to the tumor and excellent safety profile. STR is, therefore, potentially applicable to treating cancers that arise in bone, such as multiple myeloma, leukemia, some lymphomas and primary tumors of bone, and cancers that spread to bone, such as prostate and breast cancer. NeoRx Corporation is developing innovative products designed to provide improved, cost-effective treatments for patients with cancer. This release contains forward-looking statements relating to relating to relate prep → concernant relating to relate prep → bezüglich +gen, mit Bezug auf +acc 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 the progress and costs of clinical trials and the timing of regulatory approvals. Reference is made to the Company's latest Annual Report on Form 10 - K filed with the Securities and Exchange Commission for a more detailed description of such factors. Readers are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date of this release. The Company undertakes no obligation to publicly 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. Visit NeoRx at www.neorx.com. To receive NeoRx news releases via email, register at www.neorx.com/news/pr.html. NeoRx is a registered trademark of NeoRx Corporation in the United States and/or foreign countries. (c) 1999 NeoRx Corporation. All Rights Reserved. |
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