NERX Neorx (MM)

NeoRx Announces Treatment of First Patient With Picoplatin in Phase 2 Clinical Trial in Small Cell Lung Cancer SEATTLE, July 11 /PRNewswire-FirstCall/ -- NeoRx Corporation (NASDAQ:NERX), a cancer therapeutics development company, today announced treatment of the first patient with picoplatin, its next-generation intravenous platinum therapy, in a Phase 2 clinical trial in small cell lung cancer. The open-label, multi-center study is opening at clinical sites throughout the United States and Canada to enroll patients who suffer from this aggressive and deadly form of lung cancer. "New treatments are needed for small cell lung cancer because the use of existing platinum compounds, which are the current standard of care, is limited by drug resistance and kidney and nervous system toxicities," said Renato Martins, M.D., M.P.H., clinical investigator and assistant professor of medicine, division of oncology, University of Washington School of Medicine and Seattle Cancer Care Alliance. "Also, there is currently no approved therapy for patients with small cell lung cancer whose disease is resistant or refractory to platinum-based therapies. We are excited to study picoplatin because it was designed to overcome platinum resistance and has demonstrated activity in platinum-sensitive, resistant and refractory diseases." Picoplatin has been evaluated in more than 500 patients in Phase I and II safety and efficacy studies. Results showed that picoplatin had a manageable safety profile and demonstrated anti-tumor activity in a variety of solid tumors, including lung, ovarian and hormone refractory prostate cancer. Study Details The Phase 2 trial is confirming the clinical activity of picoplatin as a single agent in small cell lung cancer compared with current practice. The efficacy and safety of picoplatin and topotecan will be evaluated as second-line therapy in 75 patients with platinum-resistant or refractory small cell lung cancer who have failed a prior platinum-based chemotherapy regimen. Several efficacy endpoints will be assessed, including response rates, progression-free survival, overall survival, improvement in disease-related symptoms and disease control (defined as complete response, partial response and stable disease). Two-thirds of the patients will receive picoplatin and the remainder will receive topotecan, a topoisomerase I inhibitor approved by the U.S. Food and Drug Administration for the treatment of platinum-sensitive small cell lung cancer in patients who progress after first-line therapy. The trial, which is anticipated to last approximately 12 to 18 months, will be conducted at approximately 25 centers in the United States and Canada. "Treating the first patient in our Phase 2 study of picoplatin is an important milestone, both for NeoRx and for cancer patients. There is a critical need for new drugs that are active in small cell lung cancer and that can overcome the resistance that occurs with platinum compounds currently on the market. We believe that picoplatin, with its novel chemical structure and superior anti-tumor activity to date, is a very promising agent, and we are committed to its clinical development," said Jerry McMahon, Ph.D., chairman and chief executive officer of NeoRx. "We plan to develop picoplatin for other cancer indications and look forward to announcing our Phase I/II clinical trial of picoplatin in patients with colorectal cancer early next year." About Small Cell Lung Cancer Small cell lung cancer accounts for 15% to 25% of all lung cancers. Approximately 28,000 new cases occur in the United States each year. Small cell lung cancer is most common in people who smoke tobacco; other risk factors include exposure to second-hand smoke and exposure to asbestos or radon. The most common signs and symptoms include coughing, chest pain and shortness of breath. Small cell lung cancer is the most aggressive and deadly form of lung cancer. Without treatment, the median survival of patients is only two to four months. Combination chemotherapy is currently considered standard therapy. Despite the high response rate to first-line chemotherapy, long-term survival is unusual even for patients with limited-stage disease because of relapse and the development of resistance to available agents. Fewer than 20% of patients with limited-stage disease survive five years. For patients with extensive disease, five-year survival is rare, even with multi-agent, intensive therapy. Patients with small cell lung cancer who have refractory disease (defined as no response to first-line chemotherapy or response to first-line therapy followed by progression within 90 days of completing first-line therapy) have an extremely poor prognosis. Among those treated with topotecan as second-line therapy, the median survival is approximately 4.7 months. About NeoRx NeoRx is a cancer therapeutics development company. The Company currently is focusing its development efforts on picoplatin (NX 473), a next-generation platinum therapy that the Company plans to evaluate in the treatment of patients with advanced lung and colorectal cancers. For more information, visit http://www.neorx.com/. 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 effect of the risk of the uncertainty and timing of obtaining additional financing, obtaining required regulatory approvals, the initiation, progress and costs of the Company's picoplatin clinical trials, generating future revenue from product sales or other sources such as collaborative relationships and future profitability, the Company's dependence on patents and other proprietary rights; and the 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 for the year ended December 31, 2004 and its Quarterly Report on Form 10-Q for the quarter ended March 31, 2005. 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. DATASOURCE: NeoRx Corporation CONTACT: Julie Rathbun of NeoRx Corporation, +1-206-286-2517, or Web site: http://www.neorx.com/

Copyright