NeoRx Suspends Accrual on its STR Trials Pending Resolution with FDA; Data Safety Monitoring Board -- DSMB -- Recommends Phase III Study Proceed.Business and Health Editors SEATTLE--(BUSINESS WIRE)--Nov. 7, 2000 NeoRx Corp. (Nasdaq:NERX) today announced that, pending resolution 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. ), it has suspended accrual and treatment under its 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 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 and other Skeletal Targeted Radiotherapy (STR STR abbr. synchronous transmitter receiver ) studies. A delayed side effect has appeared in a small number of phase I/II patients who received STR at one site. Current data suggests that differences in procedure may have been a contributing factor. An independent Data Safety Monitoring Board (DSMB DSMB Data & Safety Monitoring Board Clinical research A committee of independent clinical research experts who review data in ongoing clinical trials, ensuring that participants are not exposed to undue risk, and look for any differences in effectiveness ) has investigated this side effect and has unanimously recommended that the phase III study proceed, but with additional monitoring and standardization of study methods. Yesterday, NeoRx received a letter from the FDA suspending these STR trials until further information is supplied and evaluated by the FDA and the FDA gives approval to restart the studies. "We believe we can address the concerns raised by the FDA," said Paul G. Abrams, M.D., J.D., NeoRx's Chief Executive Officer. "We are gathering information that was requested by the FDA, and hope to resolve the matter as soon as possible." Four patients treated at one of the major phase I/II study sites, and none treated at the other major site, developed a serious delayed toxicity referred to as TTP/HUS (thrombotic thrombocytopenic thrombocytopenic of the nature of or pertaining to thrombocytopenia. purpura/hemolytic uremic uremic pertaining to or emanating from uremia. uremic poisoning see uremia, visceral gout. uremic toxins syndrome). TTP/HUS involves a combination of symptoms, including abnormal clotting of blood in small blood vessels Blood vessels Tubular channels for blood transport, of which there are three principal types: arteries, capillaries, and veins. Only the larger arteries and veins in the body bear distinct names. . This can lead to anemia, a low platelet count Platelet Count Definition A platelet count is a diagnostic test that determines the number of platelets in the patient's blood. Platelets, which are also called thrombocytes, are small disk-shaped blood cells produced in the bone marrow and involved in that can result in bleeding, and potential damage to organs. Although relatively uncommon, TTP/HUS has many potential triggering causes, including food contamination, toxic shock syndrome toxic shock syndrome (TSS). acute, sometimes fatal, disease characterized by high fever, nausea, diarrhea, lethargy, blotchy rash, and sudden drop in blood pressure. It is caused by Staphylococcus aureus, an exotoxin-producing bacteria (see toxin). , post-viral infection, bone marrow transplantation Bone Marrow Transplantation Definition The bone marrow—the sponge-like tissue found in the center of certain bones—contains stem cells that are the precursors of white blood cells, red blood cells, and platelets. and drug effects. Each of the affected patients had at least two known potential triggers of TTP/HUS. "This is an unfortunate occurrence," said Dr. Abrams, "but not unlike the course of many oncology drugs, where unexpected toxicities are noted, likely causes identified and handled, and, with modifications, drug development proceeds. For example, cis-platinum, one of the most widely used anti-cancer drugs, caused renal failure renal failure n. Acute or chronic malfunction of the kidneys resulting from any of a number of causes, including infection, trauma, toxins, hemodynamic abnormalities, and autoimmune disease, and often resulting in systemic symptoms, especially edema, before the importance of hydration hydration /hy·dra·tion/ (hi-dra´shun) the absorption of or combination with water. hy·dra·tion n. 1. The addition of water to a chemical molecule without hydrolysis. 2. and diuretics Diuretics Definition Diuretics are medicines that help reduce the amount of water in the body. Purpose Diuretics are used to treat the buildup of excess fluid in the body that occurs with some medical conditions such as congestive heart was understood. In the case of STR, based on our current findings, we believe bladder irrigation irrigation, in agriculture, artificial watering of the land. Although used chiefly in regions with annual rainfall of less than 20 in. (51 cm), it is also used in wetter areas to grow certain crops, e.g., rice. helps prevent bladder wall damage by preventing radiation from sitting in the bladder, and may help eliminate an increased incidence of TTP/HUS. We also believe that bladder irrigation has helped to prevent the more common problem of blood in the urine." The method of STR administration at the only site reporting TTP/HUS differs from that used at the other major phase I/II site and from the current phase III protocol in the following respects: 1) the drug was infused more rapidly; 2) the calculated dose to be received by patients was somewhat higher; and, 3) the patients did not receive bladder irrigation during the procedure. The Company believes that lack of bladder irrigation can result in a dose of radiation to the bladder wall that is 3-fold higher than in the irrigated patients. Radiation damage to the bladder wall may result in blood in the urine (hemorrhagic cystitis) and could cause further problems to the bladder. A large fraction of the patients who did not receive bladder irrigation developed blood in the urine, whereas to date no patients who have had bladder irrigation had blood in the urine attributable to STR. Bladder irrigation is required by the current phase III protocol. The patients with TTP/HUS are all being treated and are improving. Three of these patients have achieved complete remissions of multiple myeloma, and one has relapsed. For more information, please join the NeoRx Conference Call at 6 a.m. Pacific // 9 a.m. Eastern on Wednesday, November 8, 2000. The call in number is 800/946-0741, confirmation number 685984 -- or -- listen via our live webcast at www.vcall.com. or via our website at www.neorx.com. The conference call audio will remain available through November 15, 2000. About NeoRx Seattle-based, NeoRx Corporation is developing innovative products designed to provide improved treatments for patients with cancer. 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 the progress, costs and results of clinical trials, the availability, cost and timely delivery of materials and services from third party suppliers and collaborative partners, the satisfaction of regulatory requirements, and the receipt, timing, terms and conditions of required regulatory approvals. Reference is made to the Company's latest Quarterly Report on Form 10 - Q 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)2000 NeoRx Corporation. All Rights Reserved. |
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