Navigation Links
NW Bio Provides Guidance On Phase III Trial Enrollment Timing: Completion Expected To Be Faster Or More Efficient Than Relevant Comparison Trials

BETHESDA, Md., March 7, 2013 /PRNewswire/ -- Northwest Biotherapeutics (NASDAQ: NWBO) (NW Bio), a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, announced today that it expects to complete enrollment in its 312-patient Phase III clinical trial for Glioblastoma multiforme (GBM) brain cancer within a period that is faster or more efficient than relevant comparison trials with immune therapies for the same brain cancer.  The Company anticipates completing enrollment of its Phase III trial by Q1 or early Q2 of next year, and expects to reach its first interim analysis for efficacy by approximately Q3 of this year. 


Relevant comparisons include the following (according to information publicly reported on and in company announcements and filings):

  • Celldex Therapeutics (NASDAQ: CLDX) is conducting a Phase III trial with 440 patients, at 164 clinical trial sites worldwide, which began enrolling in November 2011, and appears likely to continue enrolling over at least a 4-year period through the end of 2015, with topline results expected at the end of 2016. 
  • Immunocellular Therapeutics (NYSE MKT: IMUC) is conducting a Phase II trial with 124 patients, which were enrolled over the course of 7 calendar quarters from Q1 2011 through Q3 2012.  (IMUC apparently screened 278 patients, but actually enrolled and treated less than half of them:  only 124 patients were enrolled, in aggregate, and treated in either the treatment arm or the placebo arm of the trial.) 
  • Agenus, Inc. (NASDAQ: AGEN) is conducting a Phase II trial with 55 patients, which began recruiting in Q2, 2009 and stopped recruiting in Q2, 2012.
  • NW Bio has primarily been enrolling its Phase III trial since Q2 of 2011.  The Company undertook a limited period of enrollment in 2008, and then kept the trial going with the patients already enrolled, but suspended new enrollment due to resource constraints during the worst of the economic downturn, through the end of 2010.  The Company began the process of reactivating clinical trial sites for new enrollment in Q1 2011, and resumed screening in Q2 of 2011.

    NW Bio expects to complete enrollment in its phase III trial by Q1 or early Q2 of next year – an overall enrollment period of 14 or 15 calendar quarters, including both the 2008 period and the period since Q2 2011. 

    This represents a rate of enrollment that compares as follows with Celldex, IMUC and Agenus: Total Trial




    Pace of Enrollment to

    Completion, Based On

    Enrollment Period 

    NW Bio

    Ph. III


    312 patients

    14 quarters or

    15 quarters

    22.3 patients per quarter or

    20.8 patients per quarter 


    Ph. II


    124 patients

    7 quarters

    17.7 patients per quarterCelldex

    Ph. III

    440 patients

    ≥16 quarters [est.]


    27.5 patients per quarter*


    *[164 clinical trial sites worldwide]



    Ph. II


    55 patients

    12 quarters

    4.6 patients per quarterNotably, even if the completion of NW Bio's Phase III trial enrollment were to take substantially longer than the Company's projection of Q1 or early Q2 2014, the Company's enrollment would still compare favorably with these relevant comparison trials."There has been widespread confusion in the investment community about the size and pace of clinical trials being conducted with various immune therapies for brain cancer," commented Linda F. Powers , CEO of NW Bio.  "It is basic to clinical trials that the sponsor must screen more patients than they enroll.  Normally, there is no confusion about the fundamental difference between these: 'enrollment' means only the patients actually being treated (with drug or placebo) in the trial.  This is a key metric for investors:  it is the measure of the size and the pace of a trial.  By providing detailed information here, our intention is to help correct the misunderstandings about the actual enrollment (both size and pace) of certain immune therapy trials in brain cancer."

    The Company plans to provide periodic updates of this enrollment guidance through various communication channels. 

    About Northwest BiotherapeuticsNorthwest Biotherapeutics is a biotechnology company focused on developing immunotherapy products to treat cancers more effectively than current treatments, without toxicities of the kind associated with chemotherapies, and on a cost-effective basis, in both the United States and Europe.  The Company has a broad platform technology for DCVax dendritic cell-based vaccines.  The Company's lead program is a 312-patient Phase III trial in newly diagnosed Glioblastoma multiforme (GBM).  GBM is the most aggressive and lethal brain cancer.  The Company also previously received clearance from the FDA for a 612-patient Phase III trial in prostate cancer, and clearance from the FDA for Phase I/II trials in multiple other cancers.  The Company has also conducted a Phase I/II trial with DCVax for metastatic ovarian cancer together with the University of Pennsylvania. 

    DisclaimerStatements made in this news release that are not historical facts, including statements concerning future treatment of patients using DCVax and future clinical trials, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.  Words such as "expect," "believe," "intend," "plan," "continue," "may," "will," "anticipate," and similar expressions are intended to identify forward-looking statements.  Actual results may differ materially from those projected in any forward-looking statement.  Specifically, there are a number of important factors that could cause actual results to differ materially from those anticipated, such as the Company's ability to raise additional capital, risks related to the Company's ability to enroll patients in its clinical trials and complete the trials on a timely basis, the uncertainty of the clinical trials process, uncertainties about the timely performance of third parties, and whether the Company's products will demonstrate safety and efficacy.  Additional information on these and other factors, including Risk Factors, which could affect the Company's results, is included in its Securities and Exchange Commission ("SEC") filings.  Finally, there may be other factors not mentioned above or included in the Company's SEC filings that may cause actual results to differ materially from those projected in any forward-looking statement.  You should not place undue reliance on any forward-looking statements.  The Company assumes no obligation to update any forward-looking statements as a result of new information, future events or developments, except as required by securities laws.

    SOURCE Northwest Biotherapeutics
    Copyright©2012 PR Newswire.
    All rights reserved

    Related medicine technology :

    1. Medical Alarm Concepts Provides Investor Update - Signs Deal with Health Care Insurance Provider for Medical Alarms
    2. Arena Pharmaceuticals Provides Corporate Update and Reviews Fourth Quarter and Full Year 2012 Financial Results
    3. Compass Diversified Holdings Provides Shareholders with 2012 Tax Information
    4. Volcano Corporation Provides Additional Guidance For 2013
    5. Lexicon Pharmaceuticals Provides Clinical Pipeline Update And Reports 2012 Fourth Quarter And Full Year Financial Results
    6. AcelRx Pharmaceuticals Provides Clinical Trial Updates
    7. Masimo Reports Fourth Quarter and Full Year 2012 Financial Results; Provides 2013 Financial Guidance
    8. US Peptides Provides New Article Discussing HGH and Athletic Performance
    9. BioMed Realty Trust Provides Notice of Redemption of 7.375% Series A Cumulative Redeemable Preferred Stock
    10. Genomic Health Announces Year-End 2012 Financial Results, Provides 2013 Financial Outlook
    11. Breakthrough Procedure Provides Relief for Acid Reflux
    Post Your Comments:
    (Date:11/25/2015)... SYDNEY , Nov. 26, 2015  The total global ... nearly 7% over 2015-2016. Latin America ... Asia , (excluding Japan ), is ... continues to face increased healthcare expenditure. In 2013-2014, ... expenditure declined from 43.5% in 2008-2009 to 41.2% in 2013-2014. ...
    (Date:11/25/2015)... Nov. 25, 2015 On Tuesday, November ... bellwether trial against Wright Medical Technology, Inc. for ... Conserve metal-on-metal hip implant device, awarded $11 million ... two week trial and three days of deliberations, ... device was defectively designed and unreasonably dangerous, and ...
    (Date:11/25/2015)... 25, 2015  Trovagene, Inc. (NASDAQ: TROV ), ... Chief Executive Officer Antonius Schuh, Ph.D., is scheduled to ... Annual Piper Jaffray Healthcare Conference. th ... Palace Hotel in New York ... Mr. Schuh will be available for one-on-one meetings during ...
    Breaking Medicine Technology:
    (Date:11/25/2015)... ... November 26, 2015 , ... Ministers, senior government and UN ... African Centres of Excellence, and public R&D institutions, civil societies and other partners ... the 5th African Network for Drugs and Diagnostics Innovation, ANDI, Stakeholders Meeting. The ...
    (Date:11/25/2015)... , ... November 25, 2015 , ... According to an ... robot is being more and more widely heralded as a breakthrough for performing hernia ... method has over traditional laparoscopic surgery is that it can greatly reduce the pain ...
    (Date:11/25/2015)... ... 2015 , ... On November 25, 2015, officials of Narconon Arrowhead , ... release of a new cutting edge recovery program that has been 50 years in ... and alcohol-addicted individuals with the purpose to free addicts from the symptoms and negative ...
    (Date:11/25/2015)... ... ... On November 23rd 2015 Cozy Products, a division of Bird-X ... Products explains what this means for business moving forward. , The Tri Lite heater ... model: to sell personal heaters that reduce energy consumption, are economical and keep people ...
    (Date:11/25/2015)... (PRWEB) , ... November 25, 2015 , ... Beddit® has ... Beddit Classic sleep tracking systems. The new app features a more intuitive SleepScoreā„¢ that ... understand how well you slept. The SleepScore is created by a proprietary algorithm. Beddit ...
    Breaking Medicine News(10 mins):