Welcome!

News Feed Item

NW BIO REFUTES FURTHER FALSE AND MISLEADING CLAIMS BY FEUERSTEIN

Company Reports Phase III Trial Progress, Positive Regulatory and ASCO Decisions;

BETHESDA, Md., March 28, 2014 /PRNewswire/ -- Northwest Biotherapeutics (NASDAQ: NWBO) (NW Bio), a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, today refuted false and misleading claims by Adam Feuerstein in an article posted Thursday, March 27, after NW Bio's public presentation of significant positive news about all of the Company's programs.  

Northwest Biotherapeutics Logo

Feuerstein's headline falsely claims that NW Bio's CEO, Linda Powers, "disclosed problems" with the Company's Phase III clinical trial.  On the contrary, Ms. Powers announced entirely positive news about the Company's Phase III trial as well as its other programs, and Ms. Powers emphasized in her presentation that prior claims by a commentator (i.e., Feuerstein) that there were problems with the Company's Phase III trial were unfounded and wrong.  Ms. Powers reiterated that the Phase III trial is progressing well, and further centers of excellence are joining the trial. 

The Company urges investors, analysts and other interested parties to view Ms. Powers' presentation (which is available via webex on the Company's website) to hear the correct, positive information and form their own opinions.

Feuerstein makes a series of false and misleading claims in his article.  First, Feuerstein describes the Company's Phase III trial as "requiring a p value of 0.02 to reach statistical significance" and claims that this makes it more difficult for this trial to succeed.  Feuerstein is factually wrong on both points: the Company's trial does not "require" a p value of 0.02 to reach statistical significance, and the Company's trial design increases, not decreases, the trial's ability to succeed. 

The Company's Phase III trial, like all other trials, will be considered to reach statistical significance if it reaches a p value of 0.05.  "P value" is a measure of the probability that trial results were due to chance, and not the result of the experimental treatment being tested.  So, the lower the p value, the better it is.  The p value generally required by regulators for statistical significance is 0.05. 

The Company has created a significant cushion or buffer for achieving this p value of 0.05 by designing its trial to a level of 0.02 rather than designing to the exact 0.05 level.  Having this cushion makes the Company's trial design more likely for the trial to succeed, not less likely as Feuerstein claims.  If the trial were designed to aim just for a p value of 0.05 (as Feuerstein tries to argue would be better), there would be no cushion at all, the risk would be correspondingly higher, and it would be more difficult for the trial to achieve success.

A second false claim by Feuerstein in his article is a "guess" that the Company's Phase III trial has been "poorly run" and that the trial data "have been looked at some [sic] many times already that the 'alpha spend' has been gobbled up" -- meaning that unblinded reviews of the data have used up some of the statistical cushion.  Feuerstein's "guess" is utterly baseless and is factually wrong again.  There has been no such "alpha spend" to date.  Further, the interim analyses in the Company's Phase III trial are structured so that there will never be large amounts of "alpha spend" in this trial.

Feuerstein further tries to claim that the Company's trial could originally have been considered statistically significant with a p value of 0.05 but somehow must now meet a totally different standard and reach a p value of 0.02 in order to be considered statistically significant.  Once again, Feuerstein's claim is baseless and wrong.  There has been no such change:  the Company's trial design and target p value are the same now as they have been throughout the trial.  The Company has consistently reported throughout the trial that it is designed to the 0.02 level.  That is a major strength and an intentional trial design, as already explained – not a weakness or the result of problems, as Feuerstein falsely asserts.

A third false claim by Feuerstein in his article is that if the Company makes a choice to increase the number of patients in the Phase III trial, the Company "will do so out of concern that the original enrollment figure (312 patients) is too small to produce a positive result," and that for the Company to exercise this choice (or even to have the possibility for this choice built into the Company's trial design) is something negative.  Once again, Feuerstein is factually wrong.  If the Company exercises its choice, the Company will be doing so on an entirely blinded basis.  The Company will have no access to any accumulated trial data, and will not be acting out of such alleged "concern."  

As Ms. Powers conveyed in her March 27 presentation (and prior presentations), the key to successful trials and regulatory approvals is strongly powered trial results.  The Company has shaped it Phase III trial design in order to provide strong powering, reduce risks, and provide cushions.  An increase in patient numbers is simply another way to enhance the cushion relating to the p value – and thereby further reduce risks and make it easier for the trial to succeed.

"We can only conclude that Feuerstein and those with whom he is allied are disturbed by NW Bio's continued and increasing strong progress in all of its programs," commented Linda Powers, CEO of NW Bio.  "We note that his attacks seem to regularly coincide with positive NW Bio news and with substantial short seller activity.  Perhaps they are all just coincidences."

"Feuerstein's long history of false and unfounded attacks on NW Bio is directly contrary to the major validations we have received and continue to receive from leading medical institutions, and the most demanding regulatory agencies and health care authorities.  We encourage investors, analysts and other interested parties to take a close look at these validations, compare them to Feuerstein's ongoing attacks, and form their own opinions about whom to believe."

About Northwest Biotherapeutics

Northwest 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 form of brain cancer, and is an "orphan disease."  The Company is under way with a 60-patient Phase I/II trial with DCVax-Direct for all inoperable solid tumors cancers, with a primary efficacy endpoint of tumor regression.  The Company previously received clearance from the FDA for a 612-patient Phase III trial in prostate cancer.  The Company conducted a Phase I/II trial with DCVax for metastatic ovarian cancer together with the University of Pennsylvania.   

Disclaimer

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," "design," "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 risks related to 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, uncertainties about the clinical trials process, uncertainties about the timely performance of third parties, risks related to whether the Company's products will demonstrate safety and efficacy, risks related to the Company's and Cognate's abilities to carry out the intended manufacturing expansions contemplated in the Cognate Agreements, risks related to the Company's ability to carry out the Hospital Exemption program and risks related to possible reimbursement and pricing.  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.

Logo - http://photos.prnewswire.com/prnh/20110329/SF73084LOGO

SOURCE Northwest Biotherapeutics

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
When applications are hosted on servers, they produce immense quantities of logging data. Quality engineers should verify that apps are producing log data that is existent, correct, consumable, and complete. Otherwise, apps in production are not easily monitored, have issues that are difficult to detect, and cannot be corrected quickly. Tom Chavez presents the four steps that quality engineers should include in every test plan for apps that produce log output or other machine data. Learn the ste...
The deluge of IoT sensor data collected from connected devices and the powerful AI required to make that data actionable are giving rise to a hybrid ecosystem in which cloud, on-prem and edge processes become interweaved. Attendees will learn how emerging composable infrastructure solutions deliver the adaptive architecture needed to manage this new data reality. Machine learning algorithms can better anticipate data storms and automate resources to support surges, including fully scalable GPU-c...
A valuable conference experience generates new contacts, sales leads, potential strategic partners and potential investors; helps gather competitive intelligence and even provides inspiration for new products and services. Conference Guru works with conference organizers to pass great deals to great conferences, helping you discover new conferences and increase your return on investment.
Poor data quality and analytics drive down business value. In fact, Gartner estimated that the average financial impact of poor data quality on organizations is $9.7 million per year. But bad data is much more than a cost center. By eroding trust in information, analytics and the business decisions based on these, it is a serious impediment to digital transformation.
Containers and Kubernetes allow for code portability across on-premise VMs, bare metal, or multiple cloud provider environments. Yet, despite this portability promise, developers may include configuration and application definitions that constrain or even eliminate application portability. In this session we'll describe best practices for "configuration as code" in a Kubernetes environment. We will demonstrate how a properly constructed containerized app can be deployed to both Amazon and Azure ...
Everyone wants the rainbow - reduced IT costs, scalability, continuity, flexibility, manageability, and innovation. But in order to get to that collaboration rainbow, you need the cloud! In this presentation, we'll cover three areas: First - the rainbow of benefits from cloud collaboration. There are many different reasons why more and more companies and institutions are moving to the cloud. Benefits include: cost savings (reducing on-prem infrastructure, reducing data center foot print, redu...
SYS-CON Events announced today that Silicon India has been named “Media Sponsor” of SYS-CON's 21st International Cloud Expo, which will take place on Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. Published in Silicon Valley, Silicon India magazine is the premiere platform for CIOs to discuss their innovative enterprise solutions and allows IT vendors to learn about new solutions that can help grow their business.
You want to start your DevOps journey but where do you begin? Do you say DevOps loudly 5 times while looking in the mirror and it suddenly appears? Do you hire someone? Do you upskill your existing team? Here are some tips to help support your DevOps transformation. Conor Delanbanque has been involved with building & scaling teams in the DevOps space globally. He is the Head of DevOps Practice at MThree Consulting, a global technology consultancy. Conor founded the Future of DevOps Thought Leade...
We are seeing a major migration of enterprises applications to the cloud. As cloud and business use of real time applications accelerate, legacy networks are no longer able to architecturally support cloud adoption and deliver the performance and security required by highly distributed enterprises. These outdated solutions have become more costly and complicated to implement, install, manage, and maintain.SD-WAN offers unlimited capabilities for accessing the benefits of the cloud and Internet. ...
SYS-CON Events announced today that CrowdReviews.com has been named “Media Sponsor” of SYS-CON's 22nd International Cloud Expo, which will take place on June 5–7, 2018, at the Javits Center in New York City, NY. CrowdReviews.com is a transparent online platform for determining which products and services are the best based on the opinion of the crowd. The crowd consists of Internet users that have experienced products and services first-hand and have an interest in letting other potential buye...
Founded in 2000, Chetu Inc. is a global provider of customized software development solutions and IT staff augmentation services for software technology providers. By providing clients with unparalleled niche technology expertise and industry experience, Chetu has become the premiere long-term, back-end software development partner for start-ups, SMBs, and Fortune 500 companies. Chetu is headquartered in Plantation, Florida, with thirteen offices throughout the U.S. and abroad.
Business professionals no longer wonder if they'll migrate to the cloud; it's now a matter of when. The cloud environment has proved to be a major force in transitioning to an agile business model that enables quick decisions and fast implementation that solidify customer relationships. And when the cloud is combined with the power of cognitive computing, it drives innovation and transformation that achieves astounding competitive advantage.
DXWorldEXPO LLC announced today that "IoT Now" was named media sponsor of CloudEXPO | DXWorldEXPO 2018 New York, which will take place on November 11-13, 2018 in New York City, NY. IoT Now explores the evolving opportunities and challenges facing CSPs, and it passes on some lessons learned from those who have taken the first steps in next-gen IoT services.
The technologies behind big data and cloud computing are converging quickly, offering businesses new capabilities for fast, easy, wide-ranging access to data. However, to capitalize on the cost-efficiencies and time-to-value opportunities of analytics in the cloud, big data and cloud technologies must be integrated and managed properly. Pythian's Director of Big Data and Data Science, Danil Zburivsky will explore: The main technology components and best practices being deployed to take advantage...
Andi Mann, Chief Technology Advocate at Splunk, is an accomplished digital business executive with extensive global expertise as a strategist, technologist, innovator, marketer, and communicator. For over 30 years across five continents, he has built success with Fortune 500 corporations, vendors, governments, and as a leading research analyst and consultant.