Welcome!

News Feed Item

Nuvilex Eyes FDA Accelerated Approval Process by Improving Quality of Life in Pancreatic Cancer Patients

NEW YORK, NY -- (Marketwired) -- 05/23/14 -- Nuvilex (OTCQB: NVLX) is calling it a "two pronged attack" on pancreatic cancer, but investors may be calling it an "end-around" or another avenue of sorts, a quicker avenue to FDA approval. This week Nuvilex peeled back another layer of its work with pancreatic cancer, and this time it was to tell the market that the well-respected Translational Drug Development (TD2) will be studying the company's pancreatic cancer treatment, the combination of Cell-in-a-Box®/ifosfamide, for the deadly disease. TD2 will study an area of great interest to the Food and Drug Administration (FDA), and an area that may be key to the FDA granting accelerated approval -- "quality of life."

Nuvilex and TD2 have begun preparing for US-based preclinical and then clinical studies on the unbearable pain and the accumulation of fluid, referred to as ascites, in the abdominal cavity. These are two commonly occurring symptoms associated with advanced pancreatic cancer as well as other abdominal cancers.

In two earlier Phase I/II clinical trials, Nuvilex's pancreatic cancer treatment was shown to reduce the size of tumors in a significant portion of those patients being treated, and thereby reduced their pain, improved their quality of life, and did so with no negative side-effects. Nuvilex and TD2 may very well be on the path to proving that the combination of Cell-in-a-Box/ifosfamide can benefit those suffering from pancreatic cancer and all other abdominal cancers where the growth of tumors is causing intense pain and where ascites is prevalent.

Nuvilex could be about to demonstrate a real breakthrough for cancer patients and increase their willingness to live with an improved "quality of life." This "quality of life" angle is a much talked about topic inside the FDA, and is a basis for accelerated approval if the studies performed by TD2 appear to provide a "clinical benefit." Accelerated approval is based on a surrogate endpoint that is reasonably likely to predict a "clinical benefit," such as prolonged life or a better "quality of life."

Although improvement in survival (being developed in Nuvilex's Phase 2b) is the gold standard, a better "quality of life" is an acceptable bases for regular approval of a drug or biological product. Drug and biological product approvals that are based on a better "quality of life" have generally included drugs or biological products that prevent or ameliorate cancer-related symptoms, including, those that prevent or relieve pain.

So, let's set the scene for investors. Preclinical studies can be relatively quick to discern a potential "clinical benefit" or to recognize an endpoint such as any amount of shrinkage in a tumor that can lead to the relief of associated pain, and the duration of time for the onset of ascites with and without the use of Nuvilex's Cell-in-a-Box/ifosfamide combination. If TD2 is successful, the company could then enter Phase 1 clinical trials in humans and again, these trials could be relatively short, and if they too are successful, Nuvilex could receive accelerated approval using Phase 1 data. Yes, companies have been granted accelerated approval based solely on Phase 1 data as the designation is designed for drugs or biological products in early phase trials.

TD2 and its world class Pancreatic Cancer Research Team (PCRT) obviously saw the results from earlier Phase I/II trials and feel Nuvilex's pancreatic cancer treatment can make a difference in the "quality of life" for those suffering what will be the second leading cancer killer in the US by 2030 according to a new report published this week in the American Association for Cancer Research's journal.

About Stock Market Media Group
SMMG is a Research and Content Development IR firm offering a platform for corporate stories to unfold in the media with Reports, Interviews and Articles. SMMG is compensated for Nuvilex content by a third party who reserves the right to buy, sell or remain neutral on securities after the publication of this article. SMMG has received total compensation of $87,580 for content related to Nuvilex. Additionally, a principal at SMMG currently owns 200,000 total shares of Nuvilex issued by the company through a consulting agreement which has since ended for work unrelated to content development. The shares have been held for the requisite period under Rule 144 as of October 31, 2013 and April 30, 2014, and are eligible to be sold immediately without further notice. For more information: www.stockmarketmediagroup.com.

Contact:
Stock Market Media Group
Email Contact

More Stories By Marketwired .

Copyright © 2009 Marketwired. All rights reserved. All the news releases provided by Marketwired are copyrighted. Any forms of copying other than an individual user's personal reference without express written permission is prohibited. Further distribution of these materials is strictly forbidden, including but not limited to, posting, emailing, faxing, archiving in a public database, redistributing via a computer network or in a printed form.

Latest Stories
With more than 30 Kubernetes solutions in the marketplace, it's tempting to think Kubernetes and the vendor ecosystem has solved the problem of operationalizing containers at scale or of automatically managing the elasticity of the underlying infrastructure that these solutions need to be truly scalable. Far from it. There are at least six major pain points that companies experience when they try to deploy and run Kubernetes in their complex environments. In this presentation, the speaker will d...
While DevOps most critically and famously fosters collaboration, communication, and integration through cultural change, culture is more of an output than an input. In order to actively drive cultural evolution, organizations must make substantial organizational and process changes, and adopt new technologies, to encourage a DevOps culture. Moderated by Andi Mann, panelists discussed how to balance these three pillars of DevOps, where to focus attention (and resources), where organizations might...
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...
When building large, cloud-based applications that operate at a high scale, it's important to maintain a high availability and resilience to failures. In order to do that, you must be tolerant of failures, even in light of failures in other areas of your application. "Fly two mistakes high" is an old adage in the radio control airplane hobby. It means, fly high enough so that if you make a mistake, you can continue flying with room to still make mistakes. In his session at 18th Cloud Expo, Le...
Machine learning has taken residence at our cities' cores and now we can finally have "smart cities." Cities are a collection of buildings made to provide the structure and safety necessary for people to function, create and survive. Buildings are a pool of ever-changing performance data from large automated systems such as heating and cooling to the people that live and work within them. Through machine learning, buildings can optimize performance, reduce costs, and improve occupant comfort by ...
As Cybric's Chief Technology Officer, Mike D. Kail is responsible for the strategic vision and technical direction of the platform. Prior to founding Cybric, Mike was Yahoo's CIO and SVP of Infrastructure, where he led the IT and Data Center functions for the company. He has more than 24 years of IT Operations experience with a focus on highly-scalable architectures.
The explosion of new web/cloud/IoT-based applications and the data they generate are transforming our world right before our eyes. In this rush to adopt these new technologies, organizations are often ignoring fundamental questions concerning who owns the data and failing to ask for permission to conduct invasive surveillance of their customers. Organizations that are not transparent about how their systems gather data telemetry without offering shared data ownership risk product rejection, regu...
CI/CD is conceptually straightforward, yet often technically intricate to implement since it requires time and opportunities to develop intimate understanding on not only DevOps processes and operations, but likely product integrations with multiple platforms. This session intends to bridge the gap by offering an intense learning experience while witnessing the processes and operations to build from zero to a simple, yet functional CI/CD pipeline integrated with Jenkins, Github, Docker and Azure...
René Bostic is the Technical VP of the IBM Cloud Unit in North America. Enjoying her career with IBM during the modern millennial technological era, she is an expert in cloud computing, DevOps and emerging cloud technologies such as Blockchain. Her strengths and core competencies include a proven record of accomplishments in consensus building at all levels to assess, plan, and implement enterprise and cloud computing solutions. René is a member of the Society of Women Engineers (SWE) and a m...
Dhiraj Sehgal works in Delphix's product and solution organization. His focus has been DevOps, DataOps, private cloud and datacenters customers, technologies and products. He has wealth of experience in cloud focused and virtualized technologies ranging from compute, networking to storage. He has spoken at Cloud Expo for last 3 years now in New York and Santa Clara.
Enterprises are striving to become digital businesses for differentiated innovation and customer-centricity. Traditionally, they focused on digitizing processes and paper workflow. To be a disruptor and compete against new players, they need to gain insight into business data and innovate at scale. Cloud and cognitive technologies can help them leverage hidden data in SAP/ERP systems to fuel their businesses to accelerate digital transformation success.
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 ...
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.
Digital Transformation: Preparing Cloud & IoT Security for the Age of Artificial Intelligence. As automation and artificial intelligence (AI) power solution development and delivery, many businesses need to build backend cloud capabilities. Well-poised organizations, marketing smart devices with AI and BlockChain capabilities prepare to refine compliance and regulatory capabilities in 2018. Volumes of health, financial, technical and privacy data, along with tightening compliance requirements by...
Predicting the future has never been more challenging - not because of the lack of data but because of the flood of ungoverned and risk laden information. Microsoft states that 2.5 exabytes of data are created every day. Expectations and reliance on data are being pushed to the limits, as demands around hybrid options continue to grow.