|By PR Newswire||
|March 28, 2014 01:03 PM EDT||
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.
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.
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.
SOURCE Northwest Biotherapeutics
Increasing IoT connectivity is forcing enterprises to find elegant solutions to organize and visualize all incoming data from these connected devices with re-configurable dashboard widgets to effectively allow rapid decision-making for everything from immediate actions in tactical situations to strategic analysis and reporting. In his session at 18th Cloud Expo, Shikhir Singh, Senior Developer Relations Manager at Sencha, will discuss how to create HTML5 dashboards that interact with IoT devic...
May. 1, 2016 09:45 AM EDT Reads: 945
Artificial Intelligence has the potential to massively disrupt IoT. In his session at 18th Cloud Expo, AJ Abdallat, CEO of Beyond AI, will discuss what the five main drivers are in Artificial Intelligence that could shape the future of the Internet of Things. AJ Abdallat is CEO of Beyond AI. He has over 20 years of management experience in the fields of artificial intelligence, sensors, instruments, devices and software for telecommunications, life sciences, environmental monitoring, process...
May. 1, 2016 09:45 AM EDT Reads: 907
Peak 10, Inc., has announced the implementation of IT service management, a business process alignment initiative based on the widely adopted Information Technology Infrastructure Library (ITIL) framework. The implementation of IT service management enhances Peak 10’s current service-minded approach to IT delivery by propelling the company to deliver higher levels of personalized and prompt service. The majority of Peak 10’s operations employees have been trained and certified in the ITIL frame...
May. 1, 2016 09:30 AM EDT Reads: 947
SYS-CON Events announced today that Peak 10, Inc., a national IT infrastructure and cloud services provider, will exhibit at SYS-CON's 18th International Cloud Expo®, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. Peak 10 provides reliable, tailored data center and network services, cloud and managed services. Its solutions are designed to scale and adapt to customers’ changing business needs, enabling them to lower costs, improve performance and focus inter...
May. 1, 2016 09:00 AM EDT Reads: 1,083
Much of the value of DevOps comes from a (renewed) focus on measurement, sharing, and continuous feedback loops. In increasingly complex DevOps workflows and environments, and especially in larger, regulated, or more crystallized organizations, these core concepts become even more critical. In his session at @DevOpsSummit at 18th Cloud Expo, Andi Mann, Chief Technology Advocate at Splunk, will show how, by focusing on 'metrics that matter,' you can provide objective, transparent, and meaningfu...
May. 1, 2016 08:45 AM EDT Reads: 586
SYS-CON Events announced today that Ericsson has been named “Gold Sponsor” of SYS-CON's @ThingsExpo, which will take place on June 7-9, 2016, at the Javits Center in New York, New York. Ericsson is a world leader in the rapidly changing environment of communications technology – providing equipment, software and services to enable transformation through mobility. Some 40 percent of global mobile traffic runs through networks we have supplied. More than 1 billion subscribers around the world re...
May. 1, 2016 07:30 AM EDT Reads: 915
There is an ever-growing explosion of new devices that are connected to the Internet using “cloud” solutions. This rapid growth is creating a massive new demand for efficient access to data. And it’s not just about connecting to that data anymore. This new demand is bringing new issues and challenges and it is important for companies to scale for the coming growth. And with that scaling comes the need for greater security, gathering and data analysis, storage, connectivity and, of course, the...
May. 1, 2016 07:00 AM EDT Reads: 798
SYS-CON Events announced today that DatacenterDynamics has been named “Media Sponsor” of SYS-CON's 18th International Cloud Expo, which will take place on June 7–9, 2016, at the Javits Center in New York City, NY. DatacenterDynamics is a brand of DCD Group, a global B2B media and publishing company that develops products to help senior professionals in the world's most ICT dependent organizations make risk-based infrastructure and capacity decisions.
May. 1, 2016 06:30 AM EDT Reads: 2,480
Between the mockups and specs produced by analysts, and resulting applications built by developers, there exists a gulf where projects fail, costs spiral, and applications disappoint. Methodologies like Agile attempt to address this with intensified communication, with partial success but many limitations. In his session at 18th Cloud Expo, Charles Kendrick, CTO & Chief Architect at Isomorphic Software, will present a revolutionary model enabled by new technologies. Learn how business and devel...
May. 1, 2016 04:15 AM EDT Reads: 1,736
You think you know what’s in your data. But do you? Most organizations are now aware of the business intelligence represented by their data. Data science stands to take this to a level you never thought of – literally. The techniques of data science, when used with the capabilities of Big Data technologies, can make connections you had not yet imagined, helping you discover new insights and ask new questions of your data. In his session at @ThingsExpo, Sarbjit Sarkaria, data science team lead ...
Apr. 30, 2016 10:45 PM EDT Reads: 726
So, you bought into the current machine learning craze and went on to collect millions/billions of records from this promising new data source. Now, what do you do with them? Too often, the abundance of data quickly turns into an abundance of problems. How do you extract that "magic essence" from your data without falling into the common pitfalls? In her session at @ThingsExpo, Natalia Ponomareva, Software Engineer at Google, will provide tips on how to be successful in large scale machine lear...
Apr. 30, 2016 10:00 PM EDT Reads: 1,124
If there is anything we have learned by now, is that every business paves their own unique path for releasing software- every pipeline, implementation and practices are a bit different, and DevOps comes in all shapes and sizes. Software delivery practices are often comprised of set of several complementing (or even competing) methodologies – such as leveraging Agile, DevOps and even a mix of ITIL, to create the combination that’s most suitable for your organization and that maximize your busines...
Apr. 30, 2016 08:15 PM EDT Reads: 1,818
In his session at @ThingsExpo, Chris Klein, CEO and Co-founder of Rachio, will discuss next generation communities that are using IoT to create more sustainable, intelligent communities. One example is Sterling Ranch, a 10,000 home development that – with the help of Siemens – will integrate IoT technology into the community to provide residents with energy and water savings as well as intelligent security. Everything from stop lights to sprinkler systems to building infrastructures will run ef...
Apr. 30, 2016 05:30 PM EDT Reads: 729
Whether your IoT service is connecting cars, homes, appliances, wearable, cameras or other devices, one question hangs in the balance – how do you actually make money from this service? The ability to turn your IoT service into profit requires the ability to create a monetization strategy that is flexible, scalable and working for you in real-time. It must be a transparent, smoothly implemented strategy that all stakeholders – from customers to the board – will be able to understand and comprehe...
Apr. 30, 2016 04:45 PM EDT Reads: 1,070