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

Prestigious Cancer Hospital Rebukes Northwest Bio for 'Inappropriate' Data Disclosures

HOUSTON (TheStreet) -- The prestigious MD Anderson Cancer Center issued a stern rebuke to Northwest Biotherapeutics (NWBO) for making promotional, unjustified claims about results from an ongoing clinical trial of an experimental cancer vaccine known as DCVax-Direct.

"I have read the information that the company has put in the public domain. It is extremely unusual and inappropriate," said Dr. Aman Buzdar, vice president of clinical research at MD Anderson, a unit of the University of Texas system. Buzdar, an oncologist by training, spoke by phone about Northwest Bio on Wednesday.

MD Anderson is running the DCVax-Direct phase I/II clinical trial with funding from Northwest Bio, which makes the hospital's criticism of the company's tactics even more significant.

Northwest Bio has issued five press releases and held a conference call in the past month to disclose preliminary and unconfirmed results from individual cancer patients who have had single, inoperable tumors injected repeatedly with DCVax-Direct. Some of the injected tumors have reportedly shrunk, while others have no evidence of live cancer cells present, Northwest Bio claims. [None of the treated tumors have responded to DCVax-Direct using standard definitions used in clinical trials.]

But Buzdar said investigators at MD Anderson and the two other hospitals conducting the DCVAX-Direct study have not reviewed or analyzed data at all because patients are still being enrolled and treated. The statements being made by Northwest Bio about DCVax-Direct are derived from patient case report forms, which the hospitals are obliged to send to the company because it sponsored the study.

"If you flip the coin and the trial results were negative, do you think the company would be disclosing this type of information? No, the company is trying to create tremendous hype about its product, which is very concerning to me as an academic oncologist," said Buzdar.

"A patient or an investor may read these press releases and see a rosy picture, which may not be so rosy when the entire dataset is analyzed," he added.

DCVax-Direct is a so-called personalized cancer vaccine consisting of dendritic cells harvested from a patient's white blood cells. The harvested dendritic cells are then re-injected directly into the tumor, where they are supposed to prime the patient's immune system to identify and kill cancer cells.

"The weakness of this approach is that there have been many studies in which tumors are injected locally -- the injections could consist of anything -- and you see tumor regression because of necrosis caused by inflammation," said Buzdar. "But it is a tremendous leap to say that this is a real response, which is why what the company is saying is so inappropriate."

Does MD Anderson plan to file a formal complaint against Northwest Bio, or ask the company to stop making claims about the DCVax-Direct study?

Buzdar: "That is a very good question, but I don't know because I've never come across a company that has done something like this before."

-- Reported by Adam Feuerstein in Boston.

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.

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
NWBO $4.70 0.00%
AAPL $117.81 0.00%
FB $105.45 0.00%
GOOG $750.26 0.00%
TSLA $231.61 0.00%


Chart of I:DJI
DOW 17,798.49 -14.90 -0.08%
S&P 500 2,090.11 +1.24 0.06%
NASDAQ 5,127.5250 +11.3820 0.22%

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs