Neoprobe Submits New Drug Application For Lymphoseek
Neoprobe Corporation (AMEX: NEOP), a diversified developer of innovative oncology surgical and diagnostic products, today announced it has submitted a New Drug Application (NDA) for Lymphoseek ® (tilmanocept) to the U.S. Food and Drug Administration (FDA). Neoprobe seeks clearance to market Lymphoseek in the United States for use in Intraoperative Lymphatic Mapping (ILM), a surgical oncology procedure in which lymph nodes draining the area around a tumor are identified and biopsied to determine if cancer has spread to the lymph nodes. In the U.S. today, ILM is performed primarily for patients with breast cancer and melanoma. According to the American Cancer Society, approximately 209,000 new cases of breast cancer and 68,000 new cases of melanoma were diagnosed in the United States in 2010. i
“The Lymphoseek NDA marks a significant clinical and regulatory milestone for our novel, receptor-targeted radiopharmaceutical agent, Lymphoseek, that has undergone extensive clinical evaluation over many years by nearly thirty investigators in over five hundred patients,” said Dr. Frederick O. Cope, Neoprobe Senior Vice President, Pharmaceutical Research and Clinical Development, of Neoprobe.
“We look forward to continuing to work closely with the FDA to shepherd the Lymphoseek NDA through its review process and to approval,” said Rodger A. Brown, Neoprobe Vice President, Regulatory Affairs and Quality Assurance.
About the Lymphoseek NDA SubmissionThe NDA submission for Lymphoseek includes results from two Phase 3 trials of Lymphoseek, NEO3-05 and NEO3-09. The primary endpoint for both the NEO3-05 and NEO3-09 trials was the comparison (the Concordance Rate, or the rate of agreement) of Lymphoseek versus vital blue dye, a long-standing, FDA-approved, on-label agent for lymphatic mapping and appropriate requisite “Truth Standard” comparator for registration purposes. The Concordance Rate was analyzed on both a per-node and per-patient basis. On a per node basis, a meta-analysis of the results of the two Phase 3 studies (NEO3-05, NEO3-09) yielded a Concordance Rate of 99.99%, a highly statistically significant result (p<0.0001). A meta-analysis of the results of the two Phase 3 studies (NEO3-05, NEO3-09) yielded a per-patient Concordance Rate of 99.99%, again a highly statistically significant result (p<0.0001).
Select the service that is right for you!COMPARE ALL SERVICES
Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.
- $2.5+ million portfolio
- Large-cap and dividend focus
- Intraday trade alerts from Cramer
- Weekly roundups
Access the tool that DOMINATES the Russell 2000 and the S&P 500.
- Buy, hold, or sell recommendations for over 4,300 stocks
- Unlimited research reports on your favorite stocks
- A custom stock screener
- Upgrade/downgrade alerts
Jim Cramer's protege, David Peltier, identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.
- Diversified model portfolio of dividend stocks
- Alerts when market news affect the portfolio
- Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
All of Real Money, plus 15 more of Wall Street's sharpest minds delivering actionable trading ideas, a comprehensive look at the market, and fundamental and technical analysis.
- Real Money + Doug Kass + 15 more Wall Street Pros
- Intraday commentary & news
- Ultra-actionable trading ideas
Our options trading pros provide daily market commentary and over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.
- 100+ monthly options trading ideas
- Actionable options commentary & news
- Real-time trading community
- Options TV