This Day On The Street
Continue to site
This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here

Neoprobe v. Short Seller Over Lymphoseek

Dr. Michael Sabel of the University of Michigan critiqued the Lymphoseek clinical trials during a session at the American Society of Clinical Oncology (ASCO) annual meeting last week. He called Lymphoseek a "good first step" but raised questions about the use of vital blue dye as the comparator in the two phase III studies, noting that the standard of care in lymph node mapping is vital blue dye plus a sulfur colloid agent.

Neoprobe's Pykett says Shkreli and other critics are making a fundamental mistake because the company is not seeking Lymphoseek approval (at least initially) for sentinel lymph node biopsy -- a procedure in which doctors map the lymphatic system to find the first lymph node closest to the primary tumor. Finding the sentinel node is important because it's the point at which cancer spreads, or metastasizes, throughout the body.

"Sentinel lymph node biopsy has a specific meaning and requires a higher burden of proof," says Pykett. Neoprobe is conducting a third phase III study in head and neck cancer patients which compares Lymphoseek to regional nodal dissection, a current standard of care in that type of cancer. If the study is positive, Neoprobe will seek expanded approval for Lymphoseek for the detection of sentinel lymph nodes.

Pykett says the decision to move ahead with Lymphoseek's initial approval filing based on studies comparing Lymphoseek to vital blue dye alone came after "at length" discussions with FDA in which the agency made a clear distinction between a lymph node mapping indication similar to vital blue dye and sentinel lymph node detection.

"I think the FDA will appreciate that the two are the same," responds Shkreli. "Neoprobe is trying to make the distinction that anatomic delineation of the lymphatic system doesn't imply that they're selecting the sentinel node. However, the only reason blue dye is used is to identify the sentinel node. So in essence, they're trying to piggyback on something that needs to be clinically validated, which the regulators won't like."

--Written by Adam Feuerstein in Boston.

>To contact the writer of this article, click here: Adam Feuerstein.

>To follow the writer on Twitter, go to

>To submit a news tip, send an email to:
Adam Feuerstein writes regularly for TheStreet. In keeping with company editorial policy, he doesn't own or short individual stocks, although he owns stock in TheStreet. He also doesn't invest in hedge funds or other private investment partnerships. Feuerstein appreciates your feedback; click here to send him an email.
3 of 3

Check Out Our Best Services for Investors

Action Alerts PLUS

Portfolio Manager Jim Cramer and Director of Research Jack Mohr reveal their investment tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
Quant Ratings

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
Stocks Under $10

David Peltier uncovers low dollar stocks with serious upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
14-Days Free
Only $9.95
14-Days Free
Dividend Stock Advisor

David Peltier identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Updates with exact steps to take - BUY, HOLD, SELL
Trifecta Stocks

Every recommendation goes through 3 layers of intense scrutiny—quantitative, fundamental and technical analysis—to maximize profit potential and minimize risk.

Product Features:
  • Model Portfolio
  • Intra Day Trade alerts
  • Access to Quant Ratings
Real Money

More than 30 investing pros with skin in the game give you actionable insight and investment ideas.

Product Features:
  • Access to Jim Cramer's daily blog
  • Intraday commentary and news
  • Real-time trading forums
Only $49.95
14-Days Free
14-Days Free
MNTA $9.48 3.16%
TEVA $53.83 -0.68%
AAPL $94.19 -1.04%
FB $118.06 0.54%
GOOG $695.70 0.48%


Chart of I:DJI
DOW 17,651.26 -99.65 -0.56%
S&P 500 2,051.12 -12.25 -0.59%
NASDAQ 4,725.6390 -37.5850 -0.79%

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs