|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
According to Forrester Research, every business will become either a digital predator or digital prey by 2020. To avoid demise, organizations must rapidly create new sources of value in their end-to-end customer experiences. True digital predators also must break down information and process silos and extend digital transformation initiatives to empower employees with the digital resources needed to win, serve, and retain customers.
Sep. 28, 2016 09:15 PM EDT Reads: 322
As ridesharing competitors and enhanced services increase, notable changes are occurring in the transportation model. Despite the cost-effective means and flexibility of ridesharing, both drivers and users will need to be aware of the connected environment and how it will impact the ridesharing experience. In his session at @ThingsExpo, Timothy Evavold, Executive Director Automotive at Covisint, will discuss key challenges and solutions to powering a ride sharing and/or multimodal model in the a...
Sep. 28, 2016 08:30 PM EDT Reads: 425
If you’re responsible for an application that depends on the data or functionality of various IoT endpoints – either sensors or devices – your brand reputation depends on the security, reliability, and compliance of its many integrated parts. If your application fails to deliver the expected business results, your customers and partners won't care if that failure stems from the code you developed or from a component that you integrated. What can you do to ensure that the endpoints work as expect...
Sep. 28, 2016 08:30 PM EDT Reads: 1,709
In this strange new world where more and more power is drawn from business technology, companies are effectively straddling two paths on the road to innovation and transformation into digital enterprises. The first path is the heritage trail – with “legacy” technology forming the background. Here, extant technologies are transformed by core IT teams to provide more API-driven approaches. Legacy systems can restrict companies that are transitioning into digital enterprises. To truly become a lea...
Sep. 28, 2016 08:15 PM EDT Reads: 318
IoT is fundamentally transforming the auto industry, turning the vehicle into a hub for connected services, including safety, infotainment and usage-based insurance. Auto manufacturers – and businesses across all verticals – have built an entire ecosystem around the Connected Car, creating new customer touch points and revenue streams. In his session at @ThingsExpo, Macario Namie, Head of IoT Strategy at Cisco Jasper, will share real-world examples of how IoT transforms the car from a static p...
Sep. 28, 2016 07:00 PM EDT Reads: 1,625
Cloud computing is being adopted in one form or another by 94% of enterprises today. Tens of billions of new devices are being connected to The Internet of Things. And Big Data is driving this bus. An exponential increase is expected in the amount of information being processed, managed, analyzed, and acted upon by enterprise IT. This amazing is not part of some distant future - it is happening today. One report shows a 650% increase in enterprise data by 2020. Other estimates are even higher....
Sep. 28, 2016 06:45 PM EDT Reads: 4,150
From wearable activity trackers to fantasy e-sports, data and technology are transforming the way athletes train for the game and fans engage with their teams. In his session at @ThingsExpo, will present key data findings from leading sports organizations San Francisco 49ers, Orlando Magic NBA team. By utilizing data analytics these sports orgs have recognized new revenue streams, doubled its fan base and streamlined costs at its stadiums. John Paul is the CEO and Founder of VenueNext. Prior ...
Sep. 28, 2016 06:30 PM EDT Reads: 3,109
One of biggest questions about Big Data is “How do we harness all that information for business use quickly and effectively?” Geographic Information Systems (GIS) or spatial technology is about more than making maps, but adding critical context and meaning to data of all types, coming from all different channels – even sensors. In his session at @ThingsExpo, William (Bill) Meehan, director of utility solutions for Esri, will take a closer look at the current state of spatial technology and ar...
Sep. 28, 2016 06:15 PM EDT Reads: 283
The Internet of Things can drive efficiency for airlines and airports. In their session at @ThingsExpo, Shyam Varan Nath, Principal Architect with GE, and Sudip Majumder, senior director of development at Oracle, will discuss the technical details of the connected airline baggage and related social media solutions. These IoT applications will enhance travelers' journey experience and drive efficiency for the airlines and the airports. The session will include a working demo and a technical d...
Sep. 28, 2016 06:00 PM EDT Reads: 1,771
What happens when the different parts of a vehicle become smarter than the vehicle itself? As we move toward the era of smart everything, hundreds of entities in a vehicle that communicate with each other, the vehicle and external systems create a need for identity orchestration so that all entities work as a conglomerate. Much like an orchestra without a conductor, without the ability to secure, control, and connect the link between a vehicle’s head unit, devices, and systems and to manage the ...
Sep. 28, 2016 05:15 PM EDT Reads: 246
Businesses are struggling to manage the information flow and interactions between all of these new devices and things jumping on their network, and the apps and IT systems they control. The data businesses gather is only helpful if they can do something with it. In his session at @ThingsExpo, Chris Witeck, Principal Technology Strategist at Citrix, will discuss how different the impact of IoT will be for large businesses, expanding how IoT will allow large organizations to make their legacy ap...
Sep. 28, 2016 05:15 PM EDT Reads: 247
The many IoT deployments around the world are busy integrating smart devices and sensors into their enterprise IT infrastructures. Yet all of this technology – and there are an amazing number of choices – is of no use without the software to gather, communicate, and analyze the new data flows. Without software, there is no IT. In this power panel at @ThingsExpo, moderated by Conference Chair Roger Strukhoff, panelists will look at the protocols that communicate data and the emerging data analy...
Sep. 28, 2016 05:00 PM EDT Reads: 1,724
SYS-CON Events announced today that Commvault, a global leader in enterprise data protection and information management, has been named “Bronze 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. Commvault is a leading provider of data protection and information management solutions, helping companies worldwide activate their data to drive more value and business insight and to transform moder...
Sep. 28, 2016 04:30 PM EDT Reads: 2,813
Creating replica copies to tolerate a certain number of failures is easy, but very expensive at cloud-scale. Conventional RAID has lower overhead, but it is limited in the number of failures it can tolerate. And the management is like herding cats (overseeing capacity, rebuilds, migrations, and degraded performance). Download Slide Deck: ▸ Here In his general session at 18th Cloud Expo, Scott Cleland, Senior Director of Product Marketing for the HGST Cloud Infrastructure Business Unit, discusse...
Sep. 28, 2016 04:15 PM EDT Reads: 2,438
Whether they’re located in a public, private, or hybrid cloud environment, cloud technologies are constantly evolving. While the innovation is exciting, the end mission of delivering business value and rapidly producing incremental product features is paramount. In his session at @DevOpsSummit at 19th Cloud Expo, Kiran Chitturi, CTO Architect at Sungard AS, will discuss DevOps culture, its evolution of frameworks and technologies, and how it is achieving maturity. He will also cover various st...
Sep. 28, 2016 04:15 PM EDT Reads: 1,879