|By PR Newswire||
|January 4, 2013 10:30 AM EST||
BOTHELL, Wash. and CHICAGO, Jan. 4, 2013 /PRNewswire/ -- PharmaIN Corporation and LAT Pharma LLC today announced that the US Food and Drug Administration (FDA) has granted their request for orphan-drug designation for terlipressin for the treatment of ascites due to all etiologies except for cancer. Ascites, or fluid accumulation in the abdomen, is a serious complication of liver cirrhosis. The companies' lead new drug candidate PHT101 (or PGC-C12E-Terlipressin) incorporates novel drug delivery technologies that may enable once-daily administration via subcutaneous injection dosing in chronic outpatient populations.
Chronic liver disease/cirrhosis is the 12th leading cause of death due to disease in the US, killing an estimated 27,000 people each year. Approximately 60% of cirrhosis patients eventually develop ascites. Ascites patients face a significantly increased risk of other life-threatening complications, such as spontaneous bacterial peritonitis (SBP) and hepatorenal syndrome (HRS), with a very poor prognosis of 50% survival two years after onset. Current treatments include salt-restricted diet, high doses of diuretics, and frequent paracentesis, the removal of large volumes of ascitic fluid with a needle through the abdominal wall. People with ascites are also often candidates for liver transplantation.
Elijah Bolotin, PhD, President of PharmaIN, said, "Orphan-drug designation by the FDA indicates the importance of this new drug candidate to a desperately ill group of patients. We are excited about the medical potential of PHT101, which synergistically incorporates two of our proprietary technologies designed to enable safer and more effective drug therapy: PGC-Hydrophobic Core nanocarrier-based delivery and unique fatylation that leads to a pro-drug."
"Orphan-drug designation represents a major milestone toward making PHT101 available to patients suffering from ascites due to liver cirrhosis," said John Thottathil, PhD, Chief Scientific Officer of LAT Pharma. "PHT101 would bring a novel, mechanistic approach to ascites therapy as opposed to the current standard of care involving symptom relief. Orphan status may accelerate our clinical development program. It also opens the door to special funding opportunities, such as the Orphan Product Grants Program, and provides important incentives to investors, including seven years of market exclusivity and certain tax credits."
Terlipressin reduces portal vein pressure and increases mean arterial pressure (MAP) in cirrhotic patients with splanchnic vasodilation. Increasing MAP in ascites patients could potentially down-regulate the excessive salt and water retention that leads to ascitic fluid buildup. For more than 20 years unmodified IV-bolus terlipressin has been used in Europe and Asia as rescue therapy for hepatorenal syndrome (HRS) and esophageal variceal bleeding (EVB). Scores of publications have demonstrated the safety and efficacy of IV terlipressin in hospitals, and many have suggested the medical potential of an outpatient version of the drug.
PHT101 is in preclinical testing and is protected by a US patent issued in 2011. International patent applications have been filed. The novel drug delivery technologies are covered by a separate patent estate.
About PharmaIN Corporation
Based in Bothell, WA, PharmaIN is focused on improving the efficacy, safety, and speed to market of injectable peptides/proteins (biologics) for the treatment of cirrhotic liver disease, congestive heart failure (CHF), cancer, inflammation, and other serious medical conditions. The Company has developed proprietary Protected Graft Copolymer (PGC) nanocarrier excipients (15 patent families) and other drug delivery and fatylation technologies. Unique benefits of these technologies include prolonging circulation time in the blood by protecting against enzymatic degradation while preserving drug activity; creating optimal pharmacokinetic/pharmacodynamic profiles to avoid peaks and troughs in drug concentrations; and enabling more effective targeting of cancer, inflammation, and infection sites because of the carrier's uniquely small size (10-20nm). PGC is a highly versatile nanocarrier platform as demonstrated by the improved performance of small peptides through very large proteins, both for subcutaneous and intravenous administration. For more about PharmaIN visit www.pharmain.com.
About LAT Pharma LLC
LAT Pharma was founded in 2006 with the express goal of inventing, developing, and commercializing a lifesaving new therapy for people afflicted with advanced liver disease and its deadly complications. Each member of the Chicago-based management team has decades of pharma/biotech industry experience primarily in the area of new drug development and commercialization. The company is supported by medical advisors who are worldwide leaders in chronic liver disease. LAT Pharma holds an exclusive global license to all unique terlipressin compounds arising from its collaboration with PharmaIN and is responsible for clinical development, marketing, and out-licensing of PHT101. For more about LAT Pharma visit www.lat-pharma.com.
SOURCE LAT Pharma LLC
Internet of @ThingsExpo, taking place November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA, is co-located with 19th Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry players in the world. The Internet of Things (IoT) is the most profound change in personal and enterprise IT since the creation of the Worldwide Web more than 20 years ago. All major researchers estimate there will be tens of billions devices - comp...
Aug. 25, 2016 02:00 PM EDT Reads: 3,540
Kubernetes, Docker and containers are changing the world, and how companies are deploying their software and running their infrastructure. With the shift in how applications are built and deployed, new challenges must be solved. In his session at @DevOpsSummit at19th Cloud Expo, Sebastian Scheele, co-founder of Loodse, will discuss the implications of containerized applications/infrastructures and their impact on the enterprise. In a real world example based on Kubernetes, he will show how to ...
Aug. 25, 2016 01:45 PM EDT Reads: 1,351
SYS-CON Events announced today that Venafi, the Immune System for the Internet™ and the leading provider of Next Generation Trust Protection, will exhibit at @DevOpsSummit at 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Venafi is the Immune System for the Internet™ that protects the foundation of all cybersecurity – cryptographic keys and digital certificates – so they can’t be misused by bad guys in attacks...
Aug. 25, 2016 01:00 PM EDT Reads: 2,584
The 19th International Cloud Expo has announced that its Call for Papers is open. Cloud Expo, to be held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA, brings together Cloud Computing, Big Data, Internet of Things, DevOps, Digital Transformation, Microservices and WebRTC to one location. With cloud computing driving a higher percentage of enterprise IT budgets every year, it becomes increasingly important to plant your flag in this fast-expanding business opportuni...
Aug. 25, 2016 01:00 PM EDT Reads: 3,878
SYS-CON Events announced today that Hitrons Solutions will exhibit at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Hitrons Solutions Inc. is distributor in the North American market for unique products and services of small and medium-size businesses, including cloud services and solutions, SEO marketing platforms, and mobile applications.
Aug. 25, 2016 12:51 PM EDT Reads: 257
As the world moves toward more DevOps and Microservices, application deployment to the cloud ought to become a lot simpler. The Microservices architecture, which is the basis of many new age distributed systems such as OpenStack, NetFlix and so on, is at the heart of Cloud Foundry - a complete developer-oriented Platform as a Service (PaaS) that is IaaS agnostic and supports vCloud, OpenStack and AWS. Serverless computing is revolutionizing computing. In his session at 19th Cloud Expo, Raghav...
Aug. 25, 2016 12:45 PM EDT Reads: 551
Is the ongoing quest for agility in the data center forcing you to evaluate how to be a part of infrastructure automation efforts? As organizations evolve toward bimodal IT operations, they are embracing new service delivery models and leveraging virtualization to increase infrastructure agility. Therefore, the network must evolve in parallel to become equally agile. Read this essential piece of Gartner research for recommendations on achieving greater agility.
Aug. 25, 2016 12:45 PM EDT Reads: 570
DevOps at Cloud Expo – being held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA – announces that its Call for Papers is open. Born out of proven success in agile development, cloud computing, and process automation, DevOps is a macro trend you cannot afford to miss. From showcase success stories from early adopters and web-scale businesses, DevOps is expanding to organizations of all sizes, including the world's largest enterprises – and delivering real results. Am...
Aug. 25, 2016 12:15 PM EDT Reads: 3,378
Fact: storage performance problems have only gotten more complicated, as applications not only have become largely virtualized, but also have moved to cloud-based infrastructures. Storage performance in virtualized environments isn’t just about IOPS anymore. Instead, you need to guarantee performance for individual VMs, helping applications maintain performance as the number of VMs continues to go up in real time. In his session at Cloud Expo, Dhiraj Sehgal, Product and Marketing at Tintri, wil...
Aug. 25, 2016 11:00 AM EDT Reads: 523
Ixia (Nasdaq: XXIA) has announced that NoviFlow Inc.has deployed IxNetwork® to validate the company’s designs and accelerate the delivery of its proven, reliable products. Based in Montréal, NoviFlow Inc. supports network carriers, hyperscale data center operators, and enterprises seeking greater network control and flexibility, network scalability, and the capacity to handle extremely large numbers of flows, while maintaining maximum network performance. To meet these requirements, NoviFlow in...
Aug. 25, 2016 11:00 AM EDT Reads: 1,824
StarNet Communications Corp has announced the addition of three Secure Remote Desktop modules to its flagship X-Win32 PC X server. The new modules enable X-Win32 to safely tunnel the remote desktops from Linux and Unix servers to the user’s PC over encrypted SSH. Traditionally, users of PC X servers deploy the XDMCP protocol to display remote desktop environments such as the Gnome and KDE desktops on Linux servers and the CDE environment on Solaris Unix machines. XDMCP is used primarily on comp...
Aug. 25, 2016 10:30 AM EDT Reads: 479
SYS-CON Events announced today that StarNet Communications will exhibit at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. StarNet Communications’ FastX is the industry first cloud-based remote X Windows emulator. Using standard Web browsers (FireFox, Chrome, Safari, etc.) users from around the world gain highly secure access to applications and data hosted on Linux-based servers in a central data center. ...
Aug. 25, 2016 09:15 AM EDT Reads: 591
SYS-CON Events announced today that eCube Systems, a leading provider of middleware modernization, integration, and management solutions, will exhibit at @DevOpsSummit at 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. eCube Systems offers a family of middleware evolution products and services that maximize return on technology investment by leveraging existing technical equity to meet evolving business needs. ...
Aug. 25, 2016 09:00 AM EDT Reads: 492
SYS-CON Events announced today Telecom Reseller has been named “Media Sponsor” of SYS-CON's 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Telecom Reseller reports on Unified Communications, UCaaS, BPaaS for enterprise and SMBs. They report extensively on both customer premises based solutions such as IP-PBX as well as cloud based and hosted platforms.
Aug. 25, 2016 09:00 AM EDT Reads: 566
For basic one-to-one voice or video calling solutions, WebRTC has proven to be a very powerful technology. Although WebRTC’s core functionality is to provide secure, real-time p2p media streaming, leveraging native platform features and server-side components brings up new communication capabilities for web and native mobile applications, allowing for advanced multi-user use cases such as video broadcasting, conferencing, and media recording.
Aug. 25, 2016 08:45 AM EDT Reads: 2,108