Navigation Links
Spinifex Announces Start of Phase 2 Proof-of-Concept Trial of EMA401 in Postherpetic Neuralgia

MELBOURNE, Australia, September 19, 2011 /PRNewswire/ --

Spinifex Pharmaceuticals, an Australian pain drug development company, today announced the first patients have been treated in its Phase 2 clinical trial of EMA401 in postherpetic neuralgia (PHN), a painful condition that develops in some patients following herpes zoster (shingles) and where existing therapy does not relieve pain in all individuals.

The double-blind, placebo-controlled randomised trial is being conducted at centers in five countries and the first patient was treated at the clinic of Dr. Douwe De Jong in Pretoria, South Africa. Approximately 170 patients are expected to be enrolled in total.

The trial is designed to prove the concept of the use of EMA401, an angiotensin II type 2 (AT2) receptor antagonist, in PHN and determine its safety, tolerability and pharmacokinetic profile. The primary endpoint of the trial is reduction in mean daily pain score versus placebo over the last week of 28 days of treatment. Secondary endpoints include a number of further measures of pain and quality of life.

The discovery that AT2 receptor agonists offer an innovative approach to the treatment of neuropathic and inflammatory pain was originally made by Professor Maree Smith at The University of Queensland. Having acquired the technology, Spinifex has conducted a comprehensive pre-clinical and early clinical development program. EMA401 has shown efficacy in a number of relevant models and good human safety and pharmacokinetics in Phase 1 studies.

Spinifex Pharmaceuticals CEO Tom McCarthy said: "Today marks an important new step in the development of EMA401 and of Spinifex. We have successfully applied our development expertise to take a scientific discovery through early clinical development and now into proof-of-concept trials. This is the first of three Phase 2 trials to be initiated and we look forward to confirming the promise for EMA401 we have seen in our earlier clinical and pre-clinical studies."

Dr Milton Raff (Christiaan Barnard Memorial Hospital, Cape Town, South Africa), Principal Investigator for the Study, said: "Current treatments for postherpetic neuralgia are effective in some patients but a significant proportion either don't respond to therapy and are left with debilitating symptoms or suffer significant side effects. EMA401 offers an entirely novel approach to the treatment of the condition and could represent a valuable new option in an area where there is a clear need for new medicines."

In addition to PHN, Spinifex's clinical program for EMA401 will include studies in other neuropathic pain indications including pain and hypersensitivity in peripheral nerve injury patients, and pain and hypersensitivity in cancer chemotherapy patients. The market for neuropathic pain treatments is expected to continue to increase and is projected to reach US$6.2 billion by 2017. Despite this growth, current therapy needs to be improved as a significant proportion of neuropathic pain patients don't respond to current therapy and these treatments have dose-limiting side effects. As a result, EMA401 is being developed as a potential first-in-class oral treatment for neuropathic pain and related symptoms without central nervous system side effects.

Spinifex Pharmaceuticals

Spinifex Pharmaceuticals is an Australian biotechnology company developing new drug candidates for the treatment and management of pain.

Established in 2005 and based in Melbourne, Spinifex has applied its world-class drug development capabilities to advance product candidates. Its lead product EMA401 is under development as a potential first-in-class oral treatment for neuropathic pain and related symptoms without CNS side effects. Spinifex's Phase 2 program for EMA401 will include clinical trials in a number of neuropathic pain conditions. Spinifex investors are GBS Venture Partners, Brandon Capital Partners, Uniseed and UniQuest.

For more information please contact:

Dr Tom McCarthy
CEO Spinifex Pharmaceuticals
Tel:  +61(0)3-9938-1205

Chris Gardner/Nina Enegren
Citigate Dewe Rogerson
Tel:  +44(0)20-7638-9571

SOURCE Spiniflex
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Dendreon Announces Publication of Phase 1 Study Highlighting Immunologic and Clinical Activity of Lapuleucel-T (Neuvenge(R)) in Advanced Breast Cancer Patients
2. EDAP Announces Launch of Clinical Study Combining HIFU and Chemotherapy for Localized Aggressive High Risk Prostate Cancer
3. Cephalon Announces Positive Results from a Pivotal Study of FENTORA in Opioid-tolerant Patients with Non-cancer Breakthrough Pain
4. ADVENTRX Announces Fast Track Designation Granted By the FDA For CoFactor For the Treatment of Metastatic Colorectal Cancer
5. DOV Pharmaceutical, Inc. Announces Successful Phase Ib Results for DOV 21,947
6. Phosphagenics Announces Positive Phase 1b Transdermal Insulin Clinical Trial Results
7. Xenomics Announces Implementation of its First Diagnostic Test for Acute Myeloid Leukemia Into Clinical Practice
8. Emisphere Technologies, Inc. Announces 2007 Second Quarter Financial Results
9. Amicus Therapeutics Announces Second Quarter 2007 Financial Results
10. Genta Incorporated Announces Second Quarter 2007 Financial Results and Corporate Highlights
11. MicroDose Announces Positive Results From the QDose Inhaled Insulin Glucose Clamp Study
Post Your Comments:
(Date:11/30/2015)... FRANCISCO , Nov. 30, 2015 Next ... Designers of Things (DoT ) co-located events covering ... and the Internet of Things, will draw more than ... Jose Convention Center. The events, combined show ... latest technologies. --> ...
(Date:11/30/2015)... Nov. 30, 2015   Royal Philips (NYSE: ... the industry,s first MRI guided user interface and automatic ... patients with MR Conditional implants, such as knee and ... 2015 Radiological Society of North America Annual Meeting (RSNA) ... supports diagnostic confidence of this growing patient population. ScanWise ...
(Date:11/30/2015)... 30, 2015 North America ... to grow at a CAGR of 7.6% from 2015 to 2020. ... USD 135.6 million in 2014, and is expected to grow at ... According to the new Market Research Report "North America Cardiac Output ... User (Hospitals, ambulatory care, others) - Analysis And Forecast To 2020", ...
Breaking Medicine Technology:
(Date:11/30/2015)... City, NY (PRWEB) , ... December 01, 2015 ... ... honors Dale Jones as a 2015-2016 inductee into its VIP ... leadership in education. NAPW is the nation’s leading networking organization exclusively for professional ...
(Date:11/30/2015)... Md. (PRWEB) , ... November 30, 2015 , ... ... rewarding, but also extremely stressful. At the VA Maryland Health Care System, ... care for veterans patients. “Caregivers have a difficult job. Seventy-four percent report ...
(Date:11/30/2015)... ... November 30, 2015 , ... Stress, anxiety, illness, infection or even a ... possible tumors? , Heather Spader, MD, a new pediatric neurosurgeon at Joe DiMaggio Children’s ... might point to tumors. , “Bad headaches that don’t go away, that ...
(Date:11/30/2015)... ... November 30, 2015 , ... An extensive ... is specialized and only includes chiropractic clinics in the US. , The team ... alternative health practitioner when back pain sets in. When people are experiencing back ...
(Date:11/30/2015)... Los Angeles, CA (PRWEB) , ... November 30, 2015 , ... ... such as grafts, strip harvesting and follicular unit extraction. These techniques and procedures have ... of helping patients suffering from hair loss. While Dr. Parsa Mohebi, M.D. has utilized ...
Breaking Medicine News(10 mins):