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
SYS-CON Events announced today that T-Mobile will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. As America's Un-carrier, T-Mobile US, Inc., is redefining the way consumers and businesses buy wireless services through leading product and service innovation. The Company's advanced nationwide 4G LTE network delivers outstanding wireless experiences to 67.4 million customers who are unwilling to compromise on ...
Have you ever noticed how some IT people seem to lead successful, rewarding, and satisfying lives and careers, while others struggle? IT author and speaker Don Crawley uncovered the five principles that successful IT people use to build satisfying lives and careers and he shares them in this fast-paced, thought-provoking webinar. You'll learn the importance of striking a balance with technical skills and people skills, challenge your pre-existing ideas about IT customer service, and gain new in...
In his session at @ThingsExpo, Eric Lachapelle, CEO of the Professional Evaluation and Certification Board (PECB), will provide an overview of various initiatives to certifiy the security of connected devices and future trends in ensuring public trust of IoT. Eric Lachapelle is the Chief Executive Officer of the Professional Evaluation and Certification Board (PECB), an international certification body. His role is to help companies and individuals to achieve professional, accredited and worldw...
SYS-CON Events announced today that Juniper Networks (NYSE: JNPR), an industry leader in automated, scalable and secure networks, will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Juniper Networks challenges the status quo with products, solutions and services that transform the economics of networking. The company co-innovates with customers and partners to deliver automated, scalable and secure network...
SYS-CON Events announced today that Infranics will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Since 2000, Infranics has developed SysMaster Suite, which is required for the stable and efficient management of ICT infrastructure. The ICT management solution developed and provided by Infranics continues to add intelligence to the ICT infrastructure through the IMC (Infra Management Cycle) based on mathemat...
SYS-CON Events announced today that SD Times | BZ Media has been named “Media Sponsor” of SYS-CON's 20th International Cloud Expo, which will take place on June 6–8, 2017, at the Javits Center in New York City, NY. BZ Media LLC is a high-tech media company that produces technical conferences and expositions, and publishes a magazine, newsletters and websites in the software development, SharePoint, mobile development and commercial UAV markets.
SYS-CON Events announced today that Cloudistics, an on-premises cloud computing company, has been named “Bronze Sponsor” of SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Cloudistics delivers a complete public cloud experience with composable on-premises infrastructures to medium and large enterprises. Its software-defined technology natively converges network, storage, compute, virtualization, and management into a ...
SYS-CON Events announced today that Loom Systems will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Founded in 2015, Loom Systems delivers an advanced AI solution to predict and prevent problems in the digital business. Loom stands alone in the industry as an AI analysis platform requiring no prior math knowledge from operators, leveraging the existing staff to succeed in the digital era. With offices in S...
Now that the world has connected “things,” we need to build these devices as truly intelligent in order to create instantaneous and precise results. This means you have to do as much of the processing at the point of entry as you can: at the edge. The killer use cases for IoT are becoming manifest through AI engines on edge devices. An autonomous car has this dual edge/cloud analytics model, producing precise, real-time results. In his session at @ThingsExpo, John Crupi, Vice President and Eng...
SYS-CON Events announced today that HTBase will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. HTBase (Gartner 2016 Cool Vendor) delivers a Composable IT infrastructure solution architected for agility and increased efficiency. It turns compute, storage, and fabric into fluid pools of resources that are easily composed and re-composed to meet each application’s needs. With HTBase, companies can quickly prov...
There are 66 million network cameras capturing terabytes of data. How did factories in Japan improve physical security at the facilities and improve employee productivity? Edge Computing reduces possible kilobytes of data collected per second to only a few kilobytes of data transmitted to the public cloud every day. Data is aggregated and analyzed close to sensors so only intelligent results need to be transmitted to the cloud. Non-essential data is recycled to optimize storage.
Historically, some banking activities such as trading have been relying heavily on analytics and cutting edge algorithmic tools. The coming of age of powerful data analytics solutions combined with the development of intelligent algorithms have created new opportunities for financial institutions. In his session at 20th Cloud Expo, Sebastien Meunier, Head of Digital for North America at Chappuis Halder & Co., will discuss how these tools can be leveraged to develop a lasting competitive advanta...
"I think that everyone recognizes that for IoT to really realize its full potential and value that it is about creating ecosystems and marketplaces and that no single vendor is able to support what is required," explained Esmeralda Swartz, VP, Marketing Enterprise and Cloud at Ericsson, in this SYS-CON.tv interview at @ThingsExpo, held June 7-9, 2016, at the Javits Center in New York City, NY.
SYS-CON Events announced today that SoftLayer, an IBM Company, has been named “Gold Sponsor” of SYS-CON's 18th Cloud Expo, which will take place on June 7-9, 2016, at the Javits Center in New York, New York. SoftLayer, an IBM Company, provides cloud infrastructure as a service from a growing number of data centers and network points of presence around the world. SoftLayer’s customers range from Web startups to global enterprises.
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...