|By PR Newswire||
|January 6, 2014 06:00 AM EST||
EDGEWATER, N.J., Jan. 6, 2014 /PRNewswire/ -- DiaVacs, Inc. announced today that the Office of Orphan Products Development of the Food and Drug Administration (FDA) has granted orphan drug designation for the company's type 1 diabetes mellitus (T1DM) therapy. DV-0100 is proprietary, novel and safe. The therapy halt's the body's autoimmune reaction against the pancreatic islet cells which are responsible for producing insulin, thus allowing them to produce insulin normally and reversing the trajectory of the disease. Orphan designation qualifies DV-0100 for seven years of marketing exclusivity in the U.S. if the company is the first to obtain marketing approval for this product in T1DM and also qualifies the company for certain tax credits and waivers for prescription drug user fees.
"The granting of this orphan drug designation represents a key milestone for the company," commented Dr. Haro Hartounian, CEO of DiaVacs. "We are excited by the promise that DV-0100 showed in our Phase 1 clinical trial and look forward to assessing its therapeutic potential in the ongoing Phase 2 clinical trial for this indication."
The proprietary DiaVacs technology is derived from a deep understanding of the human immune system. The company has perfected the immunology and technology to take a patient's own dendritic cells (DC) from their blood, modify the cells through the use of small interfering oligonucleotides, and vaccinate the patient by injection of these modified cells under the skin with a small needle. The cells are absorbed, trafficked to the pancreatic lymph nodes, and thereby induce tolerance. This therapy has been shown to be safe and effective in animal models of T1DM, and evidenced no safety signals in human Phase 1 trials in patients with established type 1 diabetes for five years or longer. In some patients in our Phase 1 human trial, production of endogenous insulin was measured, even after 10 years of disease. The FDA has approved, and the company has initiated, a Phase 2 human trial.
DiaVacs, Inc. is a clinical stage biotechnology company focused on the audacious goal of curing auto-immune diseases. The proprietary technology we utilize is designed to re-induce tolerance into the patient's immune system so that the vicious cycle of auto-immunity is halted. The company's goal is to demonstrate that once the autoimmune reaction is halted, early in the disease course, the remaining cells either regenerate or have enough cell mass and functionality remaining so that the disease progress is halted or cured.
Our first indication is Type 1 Diabetes mellitus (T1DM). T1DM, formerly known as juvenile-onset diabetes, is a condition that can occur at any age but predominantly affects children and adolescents, requires lifelong insulin injections and regular glucose monitoring. Precise insulin regulation and normalized glucose control remain elusive goals, and as a result, affected persons remain at risk for diabetes-related complications, including visual impairment, kidney disease, amputations, cardiovascular disease events and premature mortality. Historically, there are excess health care costs associated with this disease over the lifetime of affected persons, primarily due to management of late stage complications. T1DM disease is caused by the triggering of an autoimmune response against the beta cells of the pancreatic islets, which are destroyed over the course of several months, resulting in insulin dependency.
For more information visit the company's website at www.diavacs.com
SOURCE DiaVacs, Inc.
Join IBM November 2 at 19th Cloud Expo at the Santa Clara Convention Center in Santa Clara, CA, and learn how to go beyond multi-speed it to bring agility to traditional enterprise applications. Technology innovation is the driving force behind modern business and enterprises must respond by increasing the speed and efficiency of software delivery. The challenge is that existing enterprise applications are expensive to develop and difficult to modernize. This often results in what Gartner calls ...
Apr. 25, 2017 04:30 AM EDT Reads: 2,946
SYS-CON Events announced today that Super Micro Computer, Inc., a global leader in compute, storage and networking technologies, 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. Supermicro (NASDAQ: SMCI), the leading innovator in high-performance, high-efficiency server technology, is a premier provider of advanced server Building Block Solutions® for Data Center, Cloud Computing, Enterprise IT, Hadoop/...
Apr. 25, 2017 04:30 AM EDT Reads: 1,967
Amazon has gradually rolled out parts of its IoT offerings in the last year, but these are just the tip of the iceberg. In addition to optimizing their back-end AWS offerings, Amazon is laying the ground work to be a major force in IoT – especially in the connected home and office. Amazon is extending its reach by building on its dominant Cloud IoT platform, its Dash Button strategy, recently announced Replenishment Services, the Echo/Alexa voice recognition control platform, the 6-7 strategic...
Apr. 25, 2017 04:15 AM EDT Reads: 4,964
All organizations that did not originate this moment have a pre-existing culture as well as legacy technology and processes that can be more or less amenable to DevOps implementation. That organizational culture is influenced by the personalities and management styles of Executive Management, the wider culture in which the organization is situated, and the personalities of key team members at all levels of the organization. This culture and entrenched interests usually throw a wrench in the work...
Apr. 25, 2017 04:15 AM EDT
@GonzalezCarmen has been ranked the Number One Influencer and @ThingsExpo has been named the Number One Brand in the “M2M 2016: Top 100 Influencers and Brands” by Analytic. Onalytica analyzed tweets over the last 6 months mentioning the keywords M2M OR “Machine to Machine.” They then identified the top 100 most influential brands and individuals leading the discussion on Twitter.
Apr. 25, 2017 03:45 AM EDT Reads: 743
With billions of sensors deployed worldwide, the amount of machine-generated data will soon exceed what our networks can handle. But consumers and businesses will expect seamless experiences and real-time responsiveness. What does this mean for IoT devices and the infrastructure that supports them? More of the data will need to be handled at - or closer to - the devices themselves.
Apr. 25, 2017 03:45 AM EDT Reads: 120
New competitors, disruptive technologies, and growing expectations are pushing every business to both adopt and deliver new digital services. This ‘Digital Transformation’ demands rapid delivery and continuous iteration of new competitive services via multiple channels, which in turn demands new service delivery techniques – including DevOps. In this power panel at @DevOpsSummit 20th Cloud Expo, moderated by DevOps Conference Co-Chair Andi Mann, panelists will examine how DevOps helps to meet th...
Apr. 25, 2017 03:45 AM EDT Reads: 875
Building a cross-cloud operational model can be a daunting task. Per-cloud silos are not the answer, but neither is a fully generic abstraction plane that strips out capabilities unique to a particular provider. In his session at 20th Cloud Expo, Chris Wolf, VP & Chief Technology Officer, Global Field & Industry at VMware, will discuss how successful organizations approach cloud operations and management, with insights into where operations should be centralized and when it’s best to decentraliz...
Apr. 25, 2017 03:30 AM EDT Reads: 129
Judith Hurwitz is president and CEO of Hurwitz & Associates, a Needham, Mass., research and consulting firm focused on emerging technology, including big data, cognitive computing and governance. She is co-author of the book Cognitive Computing and Big Data Analytics, published in 2015. Her Cloud Expo session, "What Is the Business Imperative for Cognitive Computing?" is scheduled for Wednesday, June 8, at 8:40 a.m. In it, she puts cognitive computing into perspective with its value to the busin...
Apr. 25, 2017 03:30 AM EDT Reads: 3,549
Five years ago development was seen as a dead-end career, now it’s anything but – with an explosion in mobile and IoT initiatives increasing the demand for skilled engineers. But apart from having a ready supply of great coders, what constitutes true ‘DevOps Royalty’? It’ll be the ability to craft resilient architectures, supportability, security everywhere across the software lifecycle. In his keynote at @DevOpsSummit at 20th Cloud Expo, Jeffrey Scheaffer, GM and SVP, Continuous Delivery Busine...
Apr. 25, 2017 03:15 AM EDT Reads: 490
Keeping pace with advancements in software delivery processes and tooling is taxing even for the most proficient organizations. Point tools, platforms, open source and the increasing adoption of private and public cloud services requires strong engineering rigor – all in the face of developer demands to use the tools of choice. As Agile has settled in as a mainstream practice, now DevOps has emerged as the next wave to improve software delivery speed and output. To make DevOps work, organization...
Apr. 25, 2017 03:15 AM EDT Reads: 8,787
In his general session at 19th Cloud Expo, Manish Dixit, VP of Product and Engineering at Dice, discussed how Dice leverages data insights and tools to help both tech professionals and recruiters better understand how skills relate to each other and which skills are in high demand using interactive visualizations and salary indicator tools to maximize earning potential. Manish Dixit is VP of Product and Engineering at Dice. As the leader of the Product, Engineering and Data Sciences team at D...
Apr. 25, 2017 03:00 AM EDT Reads: 5,809
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...
Apr. 25, 2017 02:15 AM EDT Reads: 867
Cognitive Computing is becoming the foundation for a new generation of solutions that have the potential to transform business. Unlike traditional approaches to building solutions, a cognitive computing approach allows the data to help determine the way applications are designed. This contrasts with conventional software development that begins with defining logic based on the current way a business operates. In her session at 18th Cloud Expo, Judith S. Hurwitz, President and CEO of Hurwitz & ...
Apr. 25, 2017 02:15 AM EDT Reads: 9,007
Everyone wants to use containers, but monitoring containers is hard. New ephemeral architecture introduces new challenges in how monitoring tools need to monitor and visualize containers, so your team can make sense of everything. In his session at @DevOpsSummit, David Gildeh, co-founder and CEO of Outlyer, will go through the challenges and show there is light at the end of the tunnel if you use the right tools and understand what you need to be monitoring to successfully use containers in your...
Apr. 25, 2017 01:30 AM EDT Reads: 1,846