|By PR Newswire||
|February 25, 2014 08:01 AM EST||
EASTBOURNE, England, February 25, 2014 /PRNewswire/ --
Daval International, the emerging life sciences company focused on the development of novel treatments for serious unmet medical needs, today announced receipt of Orphan Drug Designation from the U.S. Food and Drug Administration (FDA), Office of Orphan Products Development, for AIMSPRO® for the treatment of systemic sclerosis (scleroderma).
"The granting of Daval's request for Orphan Drug Designation represents a significant milestone in the development of AIMSPRO," said James Shotton, Daval's Chief Executive Officer "and should prove helpful in our dialogue with the FDA as the compound's development progresses. It is Daval's intention to find ways to continue the development of AIMSPRO using the benefits conferred by gaining Orphan Drug designation. Further, this designation alerts the FDA that we are dedicated to bringing a better therapy to patients suffering with scleroderma."
The Orphan Drug Act (ODA) provides for granting special status to a product to treat a rare disease or condition upon request of a sponsor and if the disease or condition for which the drug is intended affects fewer than 200,000 people in the United States. In addition, the combination of the product to treat the rare disease or condition must meet strict certain criteria. The granting of Orphan designation qualifies the sponsor of the product for a tax credit during the course of the development of the product, waiver of the prescription drug user fee and seven years of marketing exclusivity in the US for the drug or biologic upon FDA approval.
AIMSPRO recently completed a Double-Blind Placebo-Controlled Phase II Clinical Study evaluating its safety and tolerability given as a monotherapy to patients with Late Stage Established Diffuse Cutaneous Systemic Sclerosis (diffuse scleroderma) and which was published in the globally renowned Annals of the Rheumatic Diseases journal, the EULAR journal.
To view the abstract of the publication, please click on this link.
and the poster is available on the Daval website at http://www.davalinternational.com/news/news_17.html
Notes to Editors
AIMSPRO® (Hyperimmune Caprine Sera, HICS) is a proprietary, purified, protein-multi-peptide conjugate com-plex being developed as a novel, first-in-class biological treatment for a number of immune diseases where regulation and stabilisation of the immune system is required. It is believed that the drug has a unique mechanism of action that supports its broad potential application in neuro-degenerative diseases. AIMSPRO has been granted a Specials License by the UK's MHRA and is also available in Australia under Categories A and B of the TGA's Special Access Scheme.
About Daval International Limited
DAVAL INTERNATIONAL LIMITED is an emerging life sciences company focused on the development and delivery of novel and distinctive treatments for serious unmet medical needs through a combination of innovation, dedication, entrepreneurship, skilled science and partnership. From its inception in 2000, the founder and management team of Daval have had a vision of bringing effective treatments that noticeably improves the quality of life of patients suffering from the most serious debilitating neuro-degenerative, inflammatory and autoimmune diseases and to offer a choice over and above some of the disease modifying treatments available currently.
SOURCE Daval International
Interested in leveraging automation technologies and a cloud architecture to make developers more productive? Learn how PaaS can benefit your organization to help you streamline your application development, allow you to use existing infrastructure and improve operational efficiencies. Begin charting your path to PaaS with OpenShift Enterprise.
Oct. 4, 2015 06:00 PM EDT Reads: 307
SYS-CON Events announced today that Harbinger Systems will exhibit at SYS-CON's 17th International Cloud Expo®, which will take place on November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. Harbinger Systems is a global company providing software technology services. Since 1990, Harbinger has developed a strong customer base worldwide. Its customers include software product companies ranging from hi-tech start-ups in Silicon Valley to leading product companies in the US a...
Oct. 4, 2015 06:00 PM EDT Reads: 717
Clutch is now a Docker Authorized Consulting Partner, having completed Docker's certification course on the "Docker Accelerator for CI Engagements." More info about Clutch's success implementing Docker can be found here. Docker is an open platform for developers and system administrators to build, ship and run distributed applications. With Docker, IT organizations shrink application delivery from months to minutes, frictionlessly move workloads between data centers and the cloud and achieve 2...
Oct. 4, 2015 05:45 PM EDT Reads: 374
SYS-CON Events announced today that Machkey International Company will exhibit at the 17th International Cloud Expo®, which will take place on November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. Machkey provides advanced connectivity solutions for just about everyone. Businesses or individuals, Machkey is dedicated to provide high-quality and cost-effective products to meet all your needs.
Oct. 4, 2015 05:45 PM EDT Reads: 255
SYS-CON Events announced today that JFrog, maker of Artifactory, the popular Binary Repository Manager, will exhibit at SYS-CON's @DevOpsSummit Silicon Valley, which will take place on November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. Based in California, Israel and France, founded by longtime field-experts, JFrog, creator of Artifactory and Bintray, has provided the market with the first Binary Repository solution and a software distribution social platform.
Oct. 4, 2015 05:15 PM EDT Reads: 432
SYS-CON Events announced today that Key Information Systems, Inc. (KeyInfo), a leading cloud and infrastructure provider offering integrated solutions to enterprises, will exhibit at the 17th International Cloud Expo®, which will take place on November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. Key Information Systems is a leading regional systems integrator with world-class compute, storage and networking solutions and professional services for the most advanced softwa...
Oct. 4, 2015 05:15 PM EDT Reads: 269
Cloud computing delivers on-demand resources that provide businesses with flexibility and cost-savings. The challenge in moving workloads to the cloud has been the cost and complexity of ensuring the initial and ongoing security and regulatory (PCI, HIPAA, FFIEC) compliance across private and public clouds. Manual security compliance is slow, prone to human error, and represents over 50% of the cost of managing cloud applications. Determining how to automate cloud security compliance is critical...
Oct. 4, 2015 05:15 PM EDT Reads: 198
“The Internet of Things transforms the way organizations leverage machine data and gain insights from it,” noted Splunk’s CTO Snehal Antani, as Splunk announced accelerated momentum in Industrial Data and the IoT. The trend is driven by Splunk’s continued investment in its products and partner ecosystem as well as the creativity of customers and the flexibility to deploy Splunk IoT solutions as software, cloud services or in a hybrid environment. Customers are using Splunk® solutions to collect ...
Oct. 4, 2015 04:45 PM EDT Reads: 551
SYS-CON Events announced today that Agema Systems will exhibit at the 17th International Cloud Expo®, which will take place on November 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. Agema Systems is the leading provider of critical white-box rack solutions to data centers through the major integrators and value added distribution channels.
Oct. 4, 2015 04:30 PM EDT Reads: 611
SYS-CON Events announced today that Interface Masters Technologies, provider of leading network visibility and monitoring solutions, will exhibit at the 17th International CloudExpo®, which will take place on November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. Interface Masters Technologies is a leading provider of high speed networking solutions focused on Gigabit, 10 Gigabit, 40 Gigabit and 100 Gigabit Ethernet network access and connectivity products. For over 20 ye...
Oct. 4, 2015 04:15 PM EDT Reads: 622
As enterprises capture more and more data of all types – structured, semi-structured, and unstructured – data discovery requirements for business intelligence (BI), Big Data, and predictive analytics initiatives grow more complex. A company’s ability to become data-driven and compete on analytics depends on the speed with which it can provision their analytics applications with all relevant information. The task of finding data has traditionally resided with IT, but now organizations increasingl...
Oct. 4, 2015 04:00 PM EDT Reads: 355
DevOps is gaining traction in the federal government – and for good reasons. Heightened user expectations are pushing IT organizations to accelerate application development and support more innovation. At the same time, budgetary constraints require that agencies find ways to decrease the cost of developing, maintaining, and running applications. IT now faces a daunting task: do more and react faster than ever before – all with fewer resources.
Oct. 4, 2015 04:00 PM EDT Reads: 259
In recent years, at least 40% of companies using cloud applications have experienced data loss. One of the best prevention against cloud data loss is backing up your cloud data. In his General Session at 17th Cloud Expo, Bryan Forrester, Senior Vice President of Sales at eFolder, will present how organizations can use eFolder Cloudfinder to automate backups of cloud application data. He will also demonstrate how easy it is to search and restore cloud application data using Cloudfinder.
Oct. 4, 2015 02:30 PM EDT Reads: 348
Clearly the way forward is to move to cloud be it bare metal, VMs or containers. One aspect of the current public clouds that is slowing this cloud migration is cloud lock-in. Every cloud vendor is trying to make it very difficult to move out once a customer has chosen their cloud. In his session at 17th Cloud Expo, Naveen Nimmu, CEO of Clouber, Inc., will advocate that making the inter-cloud migration as simple as changing airlines would help the entire industry to quickly adopt the cloud wit...
Oct. 4, 2015 02:30 PM EDT Reads: 373
SYS-CON Events announced today that Secure Infrastructure & Services will exhibit at SYS-CON's 17th International Cloud Expo®, which will take place on November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. Secure Infrastructure & Services (SIAS) is a managed services provider of cloud computing solutions for the IBM Power Systems market. The company helps mid-market firms built on IBM hardware platforms to deploy new levels of reliable and cost-effective computing and hig...
Oct. 4, 2015 02:30 PM EDT Reads: 706