NeoRx Announces Orphan Drug Designation for Picoplatin for Treatment of Small Cell Lung Cancer
SEATTLE, Nov. 10 /PRNewswire-FirstCall/ -- NeoRx Corporation (Nasdaq: NERX) today announced that it has received orphan drug designation from the Office of Orphan Products Development at the U.S. Food and Drug
Administration for the Company's investigational product picoplatin, a next-generation platinum therapy, for the treatment of small cell lung cancer
(SCLC).
"We are pleased to have received orphan drug designation for picoplatin in SCLC. While platinum therapies are currently used to treat SCLC, many patients do not respond or relapse within a short time after chemotherapy. As
a result, there is a critical need for new therapies that are active in this disease and that can overcome the resistance that occurs with platinum compounds," said Jerry McMahon, Ph.D., chairman and CEO of NeoRx. "This
designation from the FDA reinforces our belief that picoplatin could be an important potential treatment option for SCLC patients."
Picoplatin is an intravenous platinum chemotherapeutic agent specifically designed to overcome platinum resistance.
In addition, testing in more than 500 patients indicates that picoplatin may have less toxicity than current
platinum-based therapies.
Orphan designation is granted for treatments that offer potential therapeutic value for diseases that affect fewer than 200,000 people in the United States. Orphan drug designation provides an accelerated review process, tax advantages and a seven-year period of market exclusivity in the United States upon product approval.
Phase II SCLC Trial
Picoplatin is currently being studied in an ongoing randomized, open-label, multi-center Phase II clinical trial in patients with platinum-resistant or refractory SCLC.
The trial is presently open to enrollment at
approximately 25 clinical sites throughout the United States and Canada. NeoRx plans to commence clinical trials of picoplatin in Europe in the first quarter
of 2006.
About Small Cell Lung Cancer
Small cell lung cancer is the most aggressive and deadly form of lung cancer, affecting approximately 15 percent of all lung cancer patients.
Approximately 25,000 new cases occur in the United States each year. Although platinum therapies are the preferred treatment, no FDA-approved therapies are available for patients with platinum- refractory or -resistant disease.
About NeoRx
NeoRx is dedicated to the development and commercialization of oncology drugs that impact the lives of individuals afflicted with cancer and metastases. The Company currently is focusing its development efforts on
picoplatin (NX 473), a next-generation platinum therapy with improved safety features that is designed to overcome platinum-based chemoresistance. NeoRx also is collaborating with the Scripps Florida Research Institute on the
discovery of novel, small-molecule, multi-targeted protein kinase inhibitors for the treatment of cancer. For more information, visit neorx.com.
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Link to the trial
clinicaltrials.gov
Official Title: A Randomized Phase II Study of Picoplatin or Topotecan Second-Line Therapy for Subjects with Resistant or Refractory Small Cell Lung Cancer
Further Study Details:
Primary Outcomes: Efficacy and safety (outcomes will be measured approximately 1 year after the last subject has been treated)
Expected Total Enrollment: 75
Study start: June 2005
Last follow-up: June 2005 |
