|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
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...
Dec. 11, 2016 09:00 AM EST Reads: 617
"MathFreeOn.com is a line coding platform for engineers and scientists. When they want to solve an engineering problem and they have to use software - they have to pay a lot of money for licenses - but with MathFreeOn you don't have to pay a lot of money. Just go to our site and write the code and you can check the result right away," explained Simon Lee, CMO of MathFreeOn, in this SYS-CON.tv interview at 19th Cloud Expo, held November 1-3, 2016, at the Santa Clara Convention Center in Santa Cla...
Dec. 11, 2016 08:45 AM EST Reads: 567
Enterprise IT has been in the era of Hybrid Cloud for some time now. But it seems most conversations about Hybrid are focused on integrating AWS, Microsoft Azure, or Google ECM into existing on-premises systems. Where is all the Private Cloud? What do technology providers need to do to make their offerings more compelling? How should enterprise IT executives and buyers define their focus, needs, and roadmap, and communicate that clearly to the providers?
Dec. 11, 2016 08:00 AM EST Reads: 803
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, Dave McCarthy, Director of Products at Bsquare Corporation; Alan Williamson, Principal...
Dec. 11, 2016 07:30 AM EST Reads: 776
Video experiences should be unique and exciting! But that doesn’t mean you need to patch all the pieces yourself. Users demand rich and engaging experiences and new ways to connect with you. But creating robust video applications at scale can be complicated, time-consuming and expensive. In his session at @ThingsExpo, Zohar Babin, Vice President of Platform, Ecosystem and Community at Kaltura, discussed how VPaaS enables you to move fast, creating scalable video experiences that reach your aud...
Dec. 11, 2016 07:00 AM EST Reads: 497
Get deep visibility into the performance of your databases and expert advice for performance optimization and tuning. You can't get application performance without database performance. Give everyone on the team a comprehensive view of how every aspect of the system affects performance across SQL database operations, host server and OS, virtualization resources and storage I/O. Quickly find bottlenecks and troubleshoot complex problems.
Dec. 11, 2016 06:45 AM EST Reads: 2,324
President Obama recently announced the launch of a new national awareness campaign to "encourage more Americans to move beyond passwords – adding an extra layer of security like a fingerprint or codes sent to your cellphone." The shift from single passwords to multi-factor authentication couldn’t be timelier or more strategic. This session will focus on why passwords alone are no longer effective, and why the time to act is now. In his session at 19th Cloud Expo, Chris Webber, security strateg...
Dec. 11, 2016 05:45 AM EST Reads: 745
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...
Dec. 11, 2016 05:30 AM EST Reads: 750
"We are an all-flash array storage provider but our focus has been on VM-aware storage specifically for virtualized applications," stated Dhiraj Sehgal of Tintri in this SYS-CON.tv interview at 19th Cloud Expo, held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.
Dec. 11, 2016 05:00 AM EST Reads: 1,191
"We are a leader in the market space called network visibility solutions - it enables monitoring tools and Big Data analysis to access the data and be able to see the performance," explained Shay Morag, VP of Sales and Marketing at Niagara Networks, in this SYS-CON.tv interview at 19th Cloud Expo, held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.
Dec. 11, 2016 04:45 AM EST Reads: 682
Whether your IoT service is connecting cars, homes, appliances, wearable, cameras or other devices, one question hangs in the balance – how do you actually make money from this service? The ability to turn your IoT service into profit requires the ability to create a monetization strategy that is flexible, scalable and working for you in real-time. It must be a transparent, smoothly implemented strategy that all stakeholders – from customers to the board – will be able to understand and comprehe...
Dec. 11, 2016 04:30 AM EST Reads: 884
More and more brands have jumped on the IoT bandwagon. We have an excess of wearables – activity trackers, smartwatches, smart glasses and sneakers, and more that track seemingly endless datapoints. However, most consumers have no idea what “IoT” means. Creating more wearables that track data shouldn't be the aim of brands; delivering meaningful, tangible relevance to their users should be. We're in a period in which the IoT pendulum is still swinging. Initially, it swung toward "smart for smart...
Dec. 11, 2016 03:30 AM EST Reads: 1,176
Complete Internet of Things (IoT) embedded device security is not just about the device but involves the entire product’s identity, data and control integrity, and services traversing the cloud. A device can no longer be looked at as an island; it is a part of a system. In fact, given the cross-domain interactions enabled by IoT it could be a part of many systems. Also, depending on where the device is deployed, for example, in the office building versus a factory floor or oil field, security ha...
Dec. 11, 2016 03:00 AM EST Reads: 816
An IoT product’s log files speak volumes about what’s happening with your products in the field, pinpointing current and potential issues, and enabling you to predict failures and save millions of dollars in inventory. But until recently, no one knew how to listen. In his session at @ThingsExpo, Dan Gettens, Chief Research Officer at OnProcess, discussed recent research by Massachusetts Institute of Technology and OnProcess Technology, where MIT created a new, breakthrough analytics model for s...
Dec. 11, 2016 02:45 AM EST Reads: 926
In IT, we sometimes coin terms for things before we know exactly what they are and how they’ll be used. The resulting terms may capture a common set of aspirations and goals – as “cloud” did broadly for on-demand, self-service, and flexible computing. But such a term can also lump together diverse and even competing practices, technologies, and priorities to the point where important distinctions are glossed over and lost.
Dec. 11, 2016 02:45 AM EST Reads: 1,808