Why Northwest Biotheraputics, Inc. Shares Were Flying High Today

Although we don't believe in timing the market or panicking over market movements, we do like to keep an eye on big changes -- just in case they're material to our investing thesis.

What: Shares of Northwest Biotheraputics, (NASDAQ: NWBO  ) finished the trading day with a 12% gain after the company reported excellent early results in its preliminary trials for its DCVax-Direct dendritic cell-based cancer treatment.

So what: Northwest's ongoing clinical trials of DCVax have been targeting patients with inoperable solid tumors. Of the 36 patients in the trial, 19 have completed at least half of the six DCVax treatments (none have made it all the way through the eight-month six-treatment trial period), and of these 19, 11 are showing positive responses. Eight of the 11 patients show signs of tumor necrosis (cell death) and disease stabilization, with biopsies showing "substantial to extensive" tumor necrosis and substantial accumulations of immune cells infiltrating the tumors. Six of those eight patients also showed signs of tumor shrinkage or stabilization, and while the other two patients showed some tumor growth, these enlarged tumors were largely full of dead cells.

The remaining three of the 11 positive-response patients only show signs of stabilization thus far. The remaining eight patients to complete more than half of the treatments are not yet showing any improvement, apparently.

Now what: It's too early to conclude that DCVax-Direct is an unqualified success, but this is certainly very good news for Northwest shareholders, who'd already enjoyed a double this year before shares pulled back in the spring. DCVax is also in other trials under other formulations, as its phase 3 trial for treating brain cancer is currently under way. However, that trial has come under fire in recent months for weak methodology, and the DCVax-Direct trial's small patient sample size should also keep investors from speculating too much on the drug's wider effectiveness. Treat this report with cautious optimism, but make sure you dig deeper into the data before diving in.

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Comments from our Foolish Readers

Help us keep this a respectfully Foolish area! This is a place for our readers to discuss, debate, and learn more about the Foolish investing topic you read about above. Help us keep it clean and safe. If you believe a comment is abusive or otherwise violates our Fool's Rules, please report it via the Report this Comment Report this Comment icon found on every comment.

  • Report this Comment On May 27, 2014, at 7:21 PM, steves22 wrote:

    When you say that the trial has come under fire in recent months for weak methodology, what organization or person is questioning it?

  • Report this Comment On May 27, 2014, at 9:54 PM, DrCDB123 wrote:

    I don't want to mention his name because it feeds his ego and his pocketbook but there is an internet writer who has written virtually every negative article about NWBO. He clearly has a hidden agenda which is benefitting him or someone else. His only credentials I know of are that he was an undergraduate political science major. He demonstrates little to no understanding of fundamental research designs.

  • Report this Comment On May 28, 2014, at 10:19 AM, VijayS23 wrote:

    RECIST recommendations are being quoted to negate this study. Here is the information published by the recommending authority (www.recist.com) about RECIST measurements:

    --------------

    Cancer trials are increasingly complex, involving dozens or even hundreds of investigators from centers around the world. While the RECIST rules are highly dependent upon measurement of tumor size, different clinicians may vary greatly in their methods of performing these measurements.

    Consistency in following the imaging requirements and rules is even more challenging. When investigators vary in how they follow RECIST as a trial endpoint, the study results may be placed in jeopardy by significant levels of variability.

    -------------

    Negating the study based on a single number is not a scientific conclusion. Further, the caveats already mentioned by the recommending body reduces its significance as a "criteria" even further.

  • Report this Comment On June 02, 2014, at 9:55 AM, steves22 wrote:

    I have no issue saying its Adam Feurstein of TheStreet. He has a personal vendetta against the company for some unknown reason, perhaps shorting. My point for asking was if you are going to say that the company trial is under fire for weak methodology, you should state where that is coming from. It is coming from Adam that has the credentials mentioned above and clearly has some issue with the company. If the company says they cured cancer in 50% of the patients, he would write an article that day that says "NWBO kills 50% of their patients". Yes, their technology and results are preliminary and their should be cautious optimism - that should be the end of the story without essentially quoting an idiot and placing doubt when there is none.

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