Navigation Links
First Interim Analysis Of NW Bio's Phase III GBM Trial Triggered By Reaching Required Number Of "Events"

BETHESDA, Md., Dec. 10, 2013 /PRNewswire/ -- Northwest Biotherapeutics, Inc. (NASDAQ: NWBO) ("NW Bio"), a biotechnology company developing non-toxic DCVax® personalized immune therapies for solid tumor cancers, announced today that the number of events required to trigger the first interim analysis of its Phase III clinical trial in patients with Glioblastoma multiforme (GBM) brain cancer has been reached, and the analysis process is under way which will culminate in the independent Data Monitoring Committee's assessment.


This important milestone is measured by "events," which are defined as either a tumor recurrence or a death.  The pre-specified trigger number for this first interim analysis of NW Bio's international Phase III trial is 66 such events, comprising 60% of the 110 events required to reach the primary endpoint of the Phase III trial.  Another interim analysis will occur when 88 events, comprising 80% of the total 110 events, have been reached.

As is normally the case, this interim analysis of the Company's Phase III trial data is being conducted by an independent Data Monitoring Committee (DMC), with assistance from the independent CRO (contract research organization) managing the trial.  The independent CRO audits and confirms the raw data, and delivers it to the DMC.  The DMC then reviews and evaluates the data and reaches an assessment, which it delivers to the Company.  The most common DMC recommendation is to continue the trial as originally planned, although it is possible in rare instances that the DMC may recommend that the trial be stopped, either because of safety or futility concerns or because of unexpectedly high levels of success.  The Company does not participate in the interim analysis process or the assessment, and both the Company and the clinical trial sites remain completely blinded. 

Due to the work involved in auditing and preparing the data, and conducting the review, it is anticipated that the DMC may complete its evaluation and recommendation approximately six to eight weeks from now.

"We are very pleased to reach this significant milestone in our Phase III GBM trial in accordance with our projections, reflecting our steady progress as we work towards completing this important trial" commented Linda F. Powers, CEO of NW Bio.  "We are grateful to all the clinical trial sites and all the patients who have helped reach this milestone, and we look forward to ramping up the trial as a growing number of European sites open."

About Northwest Biotherapeutics

Northwest Biotherapeutics is developing cancer vaccines designed to treat a broad range of solid tumor cancers more effectively than current treatments, and without the side effects of chemotherapy drugs.  NW Bio's proprietary manufacturing technology enables the Company to produce its personalized vaccine in an efficient, cost-effective manner.  The Company has a broad platform technology for DCVax dendritic cell-based vaccines.  The Company's lead product, DCVax-L, is currently in a 312-patient Phase III trial for patients with newly diagnosed Glioblastoma multiforme (GBM), the most aggressive and lethal brain cancer.  The Company's second product, DCVax-Direct, is currently in a 60-patient Phase I/II trial for direct injection into all types of inoperable solid tumor cancers.  The Company has also conducted a Phase I/II trial with DCVax for metastatic ovarian cancer together with the University of Pennsylvania.  The Company previously received clearance from the FDA for a 612-patient Phase III trial with its third product, DCVax-Prostate, for late stage prostate cancer.


Statements 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 patient s 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, Inc.
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Varian Medical Systems Schedules First Quarter FY2014 News Release and Conference Call
2. Henry Ford Hospital Performs First Minimally Invasive Laser Brain Surgeries in Michigan
3. Janssen, the Pharmaceutical Companies of Johnson & Johnson, Announces First-of-its-Kind Drug Donation Program for HIV Treatment-Experienced Children
4. Heptares Initiates Clinical Study With First Selective Muscarinic M1 Receptor Agonist for Improving Cognition in Patients With Alzheimers Disease
5. DesignRx Introduces The First Steps Program
6. Cantel Medical Reports 19% Sales Growth And EPS Of $0.27 vs. $0.23 For The First Quarter Ended October 31, 2013
7. The Approval Of The First Biosimilar Monoclonal Antibody In Europe Has Major Implications For 2014 And Beyond
8. Germany, Japan and Russia Will be the First Markets to Experience Peak Cases in Several Commercially Significant Drug Markets
9. VeriMed Introduces RADAR(SM): The First Patient Risk Assessment Empowering Pain Physicians To Identify Patients Who May Abuse Or Divert Prescription Drugs
10. NeuroPhage to Participate in Worlds First G8 Dementia Summit
11. MinuteClinic Opens First Clinic Locations in New Hampshire
Post Your Comments:
(Date:11/25/2015)... 25, 2015 On Tuesday, November 24, ... trial against Wright Medical Technology, Inc. for product ... metal-on-metal hip implant device, awarded $11 million in ... week trial and three days of deliberations, the ... was defectively designed and unreasonably dangerous, and that ...
(Date:11/25/2015)...  Trovagene, Inc. (NASDAQ: TROV ), a developer ... Officer Antonius Schuh, Ph.D., is scheduled to present a ... Jaffray Healthcare Conference. th Annual Piper ... in New York on Tuesday, ... will be available for one-on-one meetings during the conference. ...
(Date:11/25/2015)... , November 25, 2015 ... self-monitoring blood glucose devices was valued at $11,171.1 million ... a CAGR of 5.7% during 2015 - 2022. The ... and increasing prevalence of diabetes. In addition, the increase ... is also contributing to the growth of the market. ...
Breaking Medicine Technology:
(Date:11/26/2015)... ... , ... Inevitably when people think Thanksgiving, they also think Holiday sales and ... Friday and Cyber Monday massage chair sales to receive the best pricing ... to find the best massage chair deals, they can see all of the coupons ...
(Date:11/26/2015)... ... November 26, 2015 , ... Jobs in hospital medical ... professionals and offered by healthcare staffing agency Aureus Medical Group . ... of October 2015 among those searching for healthcare jobs through the company’s website, ...
(Date:11/26/2015)... ... November 26, 2015 , ... ... wellness consultation, has collaborated with Women’s Web – an online resource for ... topics on mental and emotional well-being relationship, life balance, stress, professional development, ...
(Date:11/25/2015)... ... November 25, 2015 , ... The holiday ... dish and pleasing the palates of attendees is of the utmost importance. Whether ... a seasonal get-together, give these recipes a try this holiday season. , Turkey ...
(Date:11/25/2015)... ... 2015 , ... Dr. John Pierce, Medical Director at the Ageless Forever clinic ... the Capillus272™ Pro laser therapy cap. FDA cleared for safety and efficacy, the Capillus272 ... need for surgery, prescription pills, or topical foams. , “Capillus272™ Pro is a ...
Breaking Medicine News(10 mins):