|By PR Newswire||
|August 11, 2014 07:00 AM EDT||
MELBOURNE, Australia, Aug. 11, 2014 /PRNewswire/ --
- Single dose pharmacokinetic (PK) study reproduces earlier results
- Therapeutic oxymorphone blood levels achieved in all 15 subjects
- Drug elimination indicates favourable safety profile
Australian drug delivery company, Phosphagenics Limited (the Company) (ASX: POH, OTCQX: PPGNY),announces that the first of its additional studies designed to further characterise the TPM®/Oxymorphone patch, in support of an Investigational New Drug (IND) application with the FDA has been completed. The study was conducted on 15 healthy volunteers at Linear Clinical Research's facility in Perth, it assessed additional pharmacokinetic parameters associated with the safety and elimination profile that were not addressed in the previous multiple dose Phase 1 study. The data generated will be used to help design the upcoming Phase 2 study, support the IND application and inform the eventual product label.
This single dose study unequivocally reproduced the outstanding results obtained in the previous Phase 1 study, both in terms of the oxymorphone delivery profile from the patch and the oxymorphone blood concentration in subjects.All 15 subjects achieved an oxymorphone blood concentration that was well above the minimum therapeutic blood level for the drug. The total number of subjects exposed to the TPM®/Oxymorphone patch now stands at 27 with all patients attaining therapeutic oxymorphone blood levels.
Dr Paul Gavin, Chief Scientific Officer said, "The TPM®/Oxymorphone patch has demonstrated reproducibility in two independent manufacturing and clinical trial campaigns with all subjects tested demonstrating blood concentrations equivalent to those produced by the commercially available oral dosage form. These studies clearly establish that the TPM®/Oxymorphone patch has significant potential to be a remarkable product."
"The latest study also provides new information regarding the elimination phase of oxymorphone after patch removal, an important variable in patient safety that is needed to determine the Phase 2 study design. As with any transdermal system, drug delivery ceased upon patch removal and residual drug in the body was eliminated steadily over time.This represents one of the key safety advantages of a transdermal opioid system compared to the oral dosage form. Accidental overdose (i.e. due to the application of multiple simultaneous patches) rarely occurs with a transdermal patch because of the ease of intervention (i.e. removal of the unintended patches and immediate cessation of delivery)" said Dr Gavin.
Phosphagenics' TPM®/Oxymorphone patch development program for the next 18 months was previously described at this year's Annual General Meeting and reiterated in an announcement to the market on 28 July 2014.This result represents the successful and timely completion of the first stage of additional research that was communicated to the market. Phosphagenics will shortly commence the second planned study which will compare the transdermal absorption of oxymorphone from application of the patch to different parts of the body. That study will inform the selection of appropriate sites for application of patches during Phase 2. Both characterisation studies have been designed to provide valuable information for potential licensees as well as various global regulatory bodies.
Phosphagenics expects to begin the Phase 2 trial in the USA during the first half of 2015 following the submission of an IND with the FDA.
Investor Relations Manager
MZ North America
Phosphagenics Limited is a drug delivery company that is commercialising various products within the pharmaceutical, cosmetics and animal health sectors, using its proprietary drug delivery system called TPM® (Targeted Penetration Matrix). TPM® is a patient friendly and cost effective system, based on Vitamin E, that enhances the topical or transdermal delivery of active molecules. The lead products advancing through clinical trials are oxymorphone and oxycodone patches for the relief of chronic pain.
Phosphagenics' shares are listed on the Australian Securities Exchange (POH) and its ADR -- Level 1 program in the US is with The Bank of New York Mellon (PPGNY).
Inherent Risks of Investment in Biotechnology Companies
There are a number of inherent risks associated with the development of pharmaceutical products to a marketable stage. The lengthy clinical trial process is designed to assess the safety and efficacy of a drug prior to commercialisation and a significant proportion of drugs fail one or both of these criteria. Other risks include uncertainty of patent protection and proprietary rights, whether patent applications and issued patents will offer adequate protection to enable product development, the obtaining of necessary drug regulatory authority approvals and difficulties caused by the rapid advancements in technology.
Certain statements in this announcement may contain forward-looking statements regarding Company business and the therapeutic and commercial potential of its technologies and products in development. Any statement describing Company goals, expectations, intentions or beliefs is a forward-looking statement and should be considered an at-risk statement. Such statements are subject to certain risks and uncertainties, particularly those risks or uncertainties inherent in the process of developing technology and in the process of discovering, developing and commercialising drugs that can be proven to be safe and effective for use as human therapeutics, and in the endeavour of building a business around such products and services.
SOURCE Phosphagenics Limited
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...
Mar. 26, 2017 05:15 AM EDT Reads: 6,150
In their Live Hack” presentation at 17th Cloud Expo, Stephen Coty and Paul Fletcher, Chief Security Evangelists at Alert Logic, provided the audience with a chance to see a live demonstration of the common tools cyber attackers use to attack cloud and traditional IT systems. This “Live Hack” used open source attack tools that are free and available for download by anybody. Attendees learned where to find and how to operate these tools for the purpose of testing their own IT infrastructure. The...
Mar. 26, 2017 03:30 AM EDT Reads: 7,289
SYS-CON Events announced today that IoT Now 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. IoT Now explores the evolving opportunities and challenges facing CSPs, and it passes on some lessons learned from those who have taken the first steps in next-gen IoT services.
Mar. 26, 2017 03:30 AM EDT Reads: 3,851
SYS-CON Events announced today that Interoute, owner-operator of one of Europe's largest networks and a global cloud services platform, has been named “Bronze Sponsor” of SYS-CON's 20th Cloud Expo, which will take place on June 6-8, 2017 at the Javits Center in New York, New York. Interoute is the owner-operator of one of Europe's largest networks and a global cloud services platform which encompasses 12 data centers, 14 virtual data centers and 31 colocation centers, with connections to 195 add...
Mar. 26, 2017 03:15 AM EDT Reads: 1,050
SYS-CON Events announced today that MobiDev, a client-oriented software development company, will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place June 6-8, 2017, at the Javits Center in New York City, NY, and the 21st International Cloud Expo®, which will take place October 31-November 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. MobiDev is a software company that develops and delivers turn-key mobile apps, websites, web services, and complex softw...
Mar. 26, 2017 01:45 AM EDT Reads: 3,740
DevOps is often described as a combination of technology and culture. Without both, DevOps isn't complete. However, applying the culture to outdated technology is a recipe for disaster; as response times grow and connections between teams are delayed by technology, the culture will die. A Nutanix Enterprise Cloud has many benefits that provide the needed base for a true DevOps paradigm.
Mar. 26, 2017 12:30 AM EDT Reads: 1,914
Information technology (IT) advances are transforming the way we innovate in business, thereby disrupting the old guard and their predictable status-quo. It’s creating global market turbulence. Industries are converging, and new opportunities and threats are emerging, like never before. So, how are savvy chief information officers (CIOs) leading this transition? Back in 2015, the IBM Institute for Business Value conducted a market study that included the findings from over 1,800 CIO interviews ...
Mar. 26, 2017 12:30 AM EDT Reads: 5,179
Virtualization over the past years has become a key strategy for IT to acquire multi-tenancy, increase utilization, develop elasticity and improve security. And virtual machines (VMs) are quickly becoming a main vehicle for developing and deploying applications. The introduction of containers seems to be bringing another and perhaps overlapped solution for achieving the same above-mentioned benefits. Are a container and a virtual machine fundamentally the same or different? And how? Is one techn...
Mar. 26, 2017 12:30 AM EDT Reads: 2,917
What sort of WebRTC based applications can we expect to see over the next year and beyond? One way to predict development trends is to see what sorts of applications startups are building. In his session at @ThingsExpo, Arin Sime, founder of WebRTC.ventures, will discuss the current and likely future trends in WebRTC application development based on real requests for custom applications from real customers, as well as other public sources of information,
Mar. 26, 2017 12:15 AM EDT Reads: 770
As businesses adopt functionalities in cloud computing, it’s imperative that IT operations consistently ensure cloud systems work correctly – all of the time, and to their best capabilities. In his session at @BigDataExpo, Bernd Harzog, CEO and founder of OpsDataStore, will present an industry answer to the common question, “Are you running IT operations as efficiently and as cost effectively as you need to?” He will expound on the industry issues he frequently came up against as an analyst, and...
Mar. 26, 2017 12:00 AM EDT Reads: 4,155
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...
Mar. 26, 2017 12:00 AM EDT Reads: 1,757
ChatOps is an emerging topic that has led to the wide availability of integrations between group chat and various other tools/platforms. Currently, HipChat is an extremely powerful collaboration platform due to the various ChatOps integrations that are available. However, DevOps automation can involve orchestration and complex workflows. In his session at @DevOpsSummit at 20th Cloud Expo, Himanshu Chhetri, CTO at Addteq, will cover practical examples and use cases such as self-provisioning infra...
Mar. 25, 2017 11:15 PM EDT Reads: 2,963
The financial services market is one of the most data-driven industries in the world, yet it’s bogged down by legacy CPU technologies that simply can’t keep up with the task of querying and visualizing billions of records. In his session at 20th Cloud Expo, Jared Parker, Director of Financial Services at Kinetica, will discuss how the advent of advanced in-database analytics on the GPU makes it possible to run sophisticated data science workloads on the same database that is housing the rich inf...
Mar. 25, 2017 10:45 PM EDT Reads: 3,673
For organizations that have amassed large sums of software complexity, taking a microservices approach is the first step toward DevOps and continuous improvement / development. Integrating system-level analysis with microservices makes it easier to change and add functionality to applications at any time without the increase of risk. Before you start big transformation projects or a cloud migration, make sure these changes won’t take down your entire organization.
Mar. 25, 2017 09:45 PM EDT Reads: 3,585
My team embarked on building a data lake for our sales and marketing data to better understand customer journeys. This required building a hybrid data pipeline to connect our cloud CRM with the new Hadoop Data Lake. One challenge is that IT was not in a position to provide support until we proved value and marketing did not have the experience, so we embarked on the journey ourselves within the product marketing team for our line of business within Progress. In his session at @BigDataExpo, Sum...
Mar. 25, 2017 08:45 PM EDT Reads: 2,823