Phosphagenics Limited Receives Ethics Approval To Commence Topical Phase 2 TPM®/Oxycodone Patch Trial
8 December 2014, Melbourne: Australian drug delivery company, Phosphagenics Limited (ASX: POH; OTCQX:PPGNY), has received ethics approval to commence a proof of concept Phase 2 trial in Australia for its TPM®/Oxycodone patch.
As indicated in the November 2014 newsletter, the trial will examine the effectiveness of the patch to reduce pain in patients suffering from post-herpetic neuralgia (PHN) by delivering oxycodone topically with little systemic exposure.
PHN is a well-accepted neuropathic pain model. The US FDA has commonly granted orphan drug status to drugs being developed to treat PHN. The grant of orphan status would have very positive implications for the Company by reducing the time, the number of patients and the expense required to obtain US FDA regulatory approval of the patch.
While several studies have demonstrated that inflammation in peripheral tissues causes the up-regulation of opioid receptors, opioids delivered into the skin via a patch have never before been successfully applied to treat peripheral pain, including neuropathic pain, in humans. Positive results in this trial will open up new market opportunities and indications for oxycodone.
Phosphagenics has demonstrated that TPM® can transport oxycodone across intact skin in a rodent model and act directly on inflamed tissue to provide local pain relief. This work will be submitted this month for peer-reviewed publication.
Dr Paul Gavin, CSO of Phosphagenics, said, “It is very exciting to get our first opioid patch into formal Phase 2 pain studies, especially as we are trialing a new application for this existing drug. Clearly, an opioid product with little or no systemic delivery that greatly reduces most of the common adverse side effects caused by opioids while providing localised pain relief would be a unique and extremely valuable product.”
About PHN and Neuropathic Pain
Neuropathic pain is caused by lesion or disease of the somatosensory nervous system. There are many causes of neuropathic pain, including diabetes, cancer, infectious diseases, multiple sclerosis, stroke and many other diseases.
According to IMS Health Disease Insights 2014, sales of the key products to treat neuropathic pain in the US alone were approximately US$4 billion in 2013. Its findings also suggest that, while the US has an extremely large prevalence of neuropathic pain, only about 25% is treated with pharmaceutical agents. This opens up a significant commercial opportunity for the entry of new therapies such as the Company’s TPM®/Oxycodone patch.
PHN, one of the many causes of neuropathic pain, is triggered by a complication of the herpes zoster virus, commonly called shingles. It affects the nerve endings in the skin and is accompanied by burning or stabbing chronic pain. If the TPM®/Oxycodone patch is shown to effectively reduce pain caused by PHN, it is very likely to be effective in treating many other neuropathic pain conditions, especially those where topical treatment could provide a therapeutic advantage (e.g., diabetic peripheral neuropathy, HIV induced neuropathy).
Enquiries
Harry Rosen
Chief Executive Officer
Phosphagenics Limited
+61 3 9565 1119
David Segal
Investor Relations Manager
Phosphagenics Limited
+61 3 9565 1103
Rudi Michelson
Monsoon Communications
+61 3 9620 3333
About Phosphagenics
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.
Forward-looking Statements
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.
www.phosphagenics.com
www.bioelixia.com
Monsoon Communications
Level 12 15 William Street
Melbourne VIC 3000
p: 03 9620 3333
e: info@monsoon.com.au
w: www.monsoon.com.au
Help employers find you! Check out all the jobs and post your resume.
PHN is a well-accepted neuropathic pain model. The US FDA has commonly granted orphan drug status to drugs being developed to treat PHN. The grant of orphan status would have very positive implications for the Company by reducing the time, the number of patients and the expense required to obtain US FDA regulatory approval of the patch.
While several studies have demonstrated that inflammation in peripheral tissues causes the up-regulation of opioid receptors, opioids delivered into the skin via a patch have never before been successfully applied to treat peripheral pain, including neuropathic pain, in humans. Positive results in this trial will open up new market opportunities and indications for oxycodone.
Phosphagenics has demonstrated that TPM® can transport oxycodone across intact skin in a rodent model and act directly on inflamed tissue to provide local pain relief. This work will be submitted this month for peer-reviewed publication.
Dr Paul Gavin, CSO of Phosphagenics, said, “It is very exciting to get our first opioid patch into formal Phase 2 pain studies, especially as we are trialing a new application for this existing drug. Clearly, an opioid product with little or no systemic delivery that greatly reduces most of the common adverse side effects caused by opioids while providing localised pain relief would be a unique and extremely valuable product.”
About PHN and Neuropathic Pain
Neuropathic pain is caused by lesion or disease of the somatosensory nervous system. There are many causes of neuropathic pain, including diabetes, cancer, infectious diseases, multiple sclerosis, stroke and many other diseases.
According to IMS Health Disease Insights 2014, sales of the key products to treat neuropathic pain in the US alone were approximately US$4 billion in 2013. Its findings also suggest that, while the US has an extremely large prevalence of neuropathic pain, only about 25% is treated with pharmaceutical agents. This opens up a significant commercial opportunity for the entry of new therapies such as the Company’s TPM®/Oxycodone patch.
PHN, one of the many causes of neuropathic pain, is triggered by a complication of the herpes zoster virus, commonly called shingles. It affects the nerve endings in the skin and is accompanied by burning or stabbing chronic pain. If the TPM®/Oxycodone patch is shown to effectively reduce pain caused by PHN, it is very likely to be effective in treating many other neuropathic pain conditions, especially those where topical treatment could provide a therapeutic advantage (e.g., diabetic peripheral neuropathy, HIV induced neuropathy).
Enquiries
Harry Rosen
Chief Executive Officer
Phosphagenics Limited
+61 3 9565 1119
David Segal
Investor Relations Manager
Phosphagenics Limited
+61 3 9565 1103
Rudi Michelson
Monsoon Communications
+61 3 9620 3333
About Phosphagenics
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.
Forward-looking Statements
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.
www.phosphagenics.com
www.bioelixia.com
Monsoon Communications
Level 12 15 William Street
Melbourne VIC 3000
p: 03 9620 3333
e: info@monsoon.com.au
w: www.monsoon.com.au
Help employers find you! Check out all the jobs and post your resume.