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
"We're a cybersecurity firm that specializes in engineering security solutions both at the software and hardware level. Security cannot be an after-the-fact afterthought, which is what it's become," stated Richard Blech, Chief Executive Officer at Secure Channels, in this SYS-CON.tv interview at @ThingsExpo, held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.
Consumers increasingly expect their electronic "things" to be connected to smart phones, tablets and the Internet. When that thing happens to be a medical device, the risks and benefits of connectivity must be carefully weighed. Once the decision is made that connecting the device is beneficial, medical device manufacturers must design their products to maintain patient safety and prevent compromised personal health information in the face of cybersecurity threats. In his session at @ThingsExpo...
In his session at 20th Cloud Expo, Mike Johnston, an infrastructure engineer at Supergiant.io, discussed how to use Kubernetes to set up a SaaS infrastructure for your business. Mike Johnston is an infrastructure engineer at Supergiant.io with over 12 years of experience designing, deploying, and maintaining server and workstation infrastructure at all scales. He has experience with brick and mortar data centers as well as cloud providers like Digital Ocean, Amazon Web Services, and Rackspace. H...
You know you need the cloud, but you’re hesitant to simply dump everything at Amazon since you know that not all workloads are suitable for cloud. You know that you want the kind of ease of use and scalability that you get with public cloud, but your applications are architected in a way that makes the public cloud a non-starter. You’re looking at private cloud solutions based on hyperconverged infrastructure, but you’re concerned with the limits inherent in those technologies.
SYS-CON Events announced today that Grape Up will exhibit at 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. Grape Up is a software company specializing in cloud native application development and professional services related to Cloud Foundry PaaS. With five expert teams that operate in various sectors of the market across the U.S. and Europe, Grape Up works with a variety of customers from emergi...
DevOps is under attack because developers don’t want to mess with infrastructure. They will happily own their code into production, but want to use platforms instead of raw automation. That’s changing the landscape that we understand as DevOps with both architecture concepts (CloudNative) and process redefinition (SRE). Rob Hirschfeld’s recent work in Kubernetes operations has led to the conclusion that containers and related platforms have changed the way we should be thinking about DevOps and...
SYS-CON Events announced today that SkyScale will exhibit at 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. SkyScale is a world-class provider of cloud-based, ultra-fast multi-GPU hardware platforms for lease to customers desiring the fastest performance available as a service anywhere in the world. SkyScale builds, configures, and manages dedicated systems strategically located in maximum-security...
Detecting internal user threats in the Big Data eco-system is challenging and cumbersome. Many organizations monitor internal usage of the Big Data eco-system using a set of alerts. This is not a scalable process given the increase in the number of alerts with the accelerating growth in data volume and user base. Organizations are increasingly leveraging machine learning to monitor only those data elements that are sensitive and critical, autonomously establish monitoring policies, and to detect...
SYS-CON Events announced today that Massive Networks will exhibit at 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. Massive Networks mission is simple. To help your business operate seamlessly with fast, reliable, and secure internet and network solutions. Improve your customer's experience with outstanding connections to your cloud.
The question before companies today is not whether to become intelligent, it’s a question of how and how fast. The key is to adopt and deploy an intelligent application strategy while simultaneously preparing to scale that intelligence. In her session at 21st Cloud Expo, Sangeeta Chakraborty, Chief Customer Officer at Ayasdi, will provide a tactical framework to become a truly intelligent enterprise, including how to identify the right applications for AI, how to build a Center of Excellence to...
Everything run by electricity will eventually be connected to the Internet. Get ahead of the Internet of Things revolution and join Akvelon expert and IoT industry leader, Sergey Grebnov, in his session at @ThingsExpo, for an educational dive into the world of managing your home, workplace and all the devices they contain with the power of machine-based AI and intelligent Bot services for a completely streamlined experience.
Because IoT devices are deployed in mission-critical environments more than ever before, it’s increasingly imperative they be truly smart. IoT sensors simply stockpiling data isn’t useful. IoT must be artificially and naturally intelligent in order to provide more value In his session at @ThingsExpo, John Crupi, Vice President and Engineering System Architect at Greenwave Systems, will discuss how IoT artificial intelligence (AI) can be carried out via edge analytics and machine learning techn...
FinTechs use the cloud to operate at the speed and scale of digital financial activity, but are often hindered by the complexity of managing security and compliance in the cloud. In his session at 20th Cloud Expo, Sesh Murthy, co-founder and CTO of Cloud Raxak, showed how proactive and automated cloud security enables FinTechs to leverage the cloud to achieve their business goals. Through business-driven cloud security, FinTechs can speed time-to-market, diminish risk and costs, maintain continu...
With tough new regulations coming to Europe on data privacy in May 2018, Calligo will explain why in reality the effect is global and transforms how you consider critical data. EU GDPR fundamentally rewrites the rules for cloud, Big Data and IoT. In his session at 21st Cloud Expo, Adam Ryan, Vice President and General Manager EMEA at Calligo, will examine the regulations and provide insight on how it affects technology, challenges the established rules and will usher in new levels of diligence a...
Existing Big Data solutions are mainly focused on the discovery and analysis of data. The solutions are scalable and highly available but tedious when swapping in and swapping out occurs in disarray and thrashing takes place. The resolution for thrashing through machine learning algorithms and support nomenclature is through simple techniques. Organizations that have been collecting large customer data are increasingly seeing the need to use the data for swapping in and out and thrashing occurs ...