Navigation Links
Spinifex Announces Start of Phase 2 Proof-of-Concept Trial of EMA401 in Chemotherapy-Induced Peripheral Neuropathy
Date:12/10/2012

MELBOURNE, Australia, December 10, 2012 /PRNewswire/ --

Spinifex Pharmaceuticals, an Australian pain drug development company, today announces that the first patients have been treated in its Phase 2 study of EMA401 in Chemotherapy-Induced Peripheral Neuropathy (CIPN), a painful and debilitating condition that develops in some patients receiving cancer chemotherapy.

The study is an open label biomarker study being conducted at Hammersmith Hospital, London, UK. The trial is designed to provide proof of concept of the use of EMA401, an angiotensin II type 2 (AT2) receptor antagonist, in CIPN. Approximately 50 patients are expected to be enrolled into the trial. Patients will have received either taxane or platinum chemotherapy for any cancer type.

The primary endpoint is the change in mean spontaneous pain intensity score between baseline and the last week of 28 days of dosing using the Numeric Pain Rating Scale (NPRS). A number of secondary endpoints will also be evaluated including changes in nerve characteristics in skin biopsies taken from the calf pre-treatment and after EMA401 treatment at day 29.

Spinifex recently announced positive results from its Phase 2 study of EMA401 in post-herpetic neuralgia (PHN), a neuropathic pain which follows herpes zoster (shingles) in some patients. The primary endpoint of reduction in mean daily pain score over the last week of 28 days of treatment was met, with EMA401 showing a clinically meaningful and statistically significant improvement versus placebo. In addition, a significantly greater proportion of patients on EMA401 reported a more than 30% reduction in mean pain intensity score compared to baseline, meeting a key secondary endpoint. EMA401 was also shown to be generally safe and well tolerated with no serious treatment related adverse events reported.

Despite being a large and growing market, current therapy for chronic and neuropathic pain needs to be improved as a significant proportion of 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 chronic pain, including neuropathic pain, without central nervous system side effects.

Spinifex Pharmaceuticals CEO Tom McCarthy said: "Today's announcement marks another significant step in the development of EMA401 and for Spinifex. Our recent results for EMA401 in PHN served to highlight its potential as an entirely novel approach for the treatment of neuropathic pain. We look forward to completing this study in a second key indication and to moving EMA401 further towards being an important treatment for broader chronic and neuropathic pain indications."

Lead Investigator, Professor Praveen Anand, said: "The pain associated with CIPN can be extremely debilitating and may affect the quality of life of patients for years, even when the cancer is in remission. Further, CIPN symptoms are a major reason for cancer treatments to be reduced or stopped early. The use of an AT2 receptor antagonist as a treatment for neuropathic pain is a highly innovative approach and, in addition to the strong Phase 2 results already seen by the company, my own group has undertaken non-clinical work which is highly compelling. EMA401 could represent a valuable new option for patients in an area where there is a clear need for new medicines."

As described above EMA401 is an AT2 receptor antagonist. The discovery that AT2 receptor antagonists 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 on EMA401. Spinifex continues to conduct research into the role of the AT2 receptor in nociceptive, inflammatory and neuropathic pain states and these fundamental studies support not only the EMA401 clinical program but also Spinifex's ongoing AT2 receptor antagonist drug discovery program.

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 chronic pain, including neuropathic pain, without CNS side effects. Spinifex's Phase 2 program for EMA401 includes clinical trials in a number of neuropathic pain conditions. Spinifex investors are GBS Venture Partners, Brandon Capital Partners, Uniseed and UniQuest.

http://www.spinifexpharma.com.au

For more information please contact:

Company
Dr Tom McCarthy
CEO Spinifex Pharmaceuticals
Tel: +61-(0)3-9938-1205
Email: tom.mccarthy@spinifexpharma.com.au

Media
Chris Gardner/Nina Enegren
Citigate Dewe Rogerson
Tel: +44-(0)20-7638-9571
Email: nina.enegren@citigatedr.co.uk


'/>"/>
SOURCE Spinifex Pharmaceuticals
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Seahorse Bioscience Announces Asia Mito 2012 Travel Award Winners Advancing Cell Metabolism Research
2. Blue Belt Technologies Announces Golden Jubilee National Hospital Completes Initial NavioPFS Unicondylar Knee Replacement Surgery
3. Northwest Biotherapeutics Announces Public Offering of Common Stock and Warrants, and Listing on NASDAQ
4. AcelRx Pharmaceuticals Announces Pricing of Public Offering of Common Stock
5. PTC Therapeutics Announces European Medicines Agency Validation of Marketing Authorization Application for Ataluren in Duchenne Muscular Dystrophy
6. Omeros Announces Encouraging Data from Phase 1 Clinical Trial for PDE10 Program
7. OrthoAccel Technologies, Inc. Announces Appointment of New Chief Financial Officer
8. Cerecor Announces Option to Johns Hopkins Brain Science Institute DAAO Inhibitor Platform
9. Savient Announces the Election of Robert G. Savage to its Board of Directors
10. Harrington Discovery Institute at University Hospitals Case Medical Center Announces Grant Funding to Physician-Scientists at Major Academic Medical Centers to Support New Drug Development
11. Braincells, Inc. Announces the Successful Completion of a Multiple Ascending Dose Study of BCI-838, a Group II mGluR2/3 Antagonist, and the Companys Plans for a Proof-of-Concept Study in Patients with Treatment-Resistant Depression
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:3/28/2017)... 2017 The global emerging cancer diagnostics market ... from 2016 to 2023 and reach a figure of ... is a chronic disease and is affecting a huge ... market. This report is focused on emerging cancer diagnostics ... is propelled due to factors such as: increasing number ...
(Date:3/28/2017)... 2017  Medeon Biodesign, Inc., a ... to announce that the Company led and successfully ... Inc., a San Jose, CA ... orthopedic extremity applications.  The orthopedic ... due to procedure volume growth, lifestyle influences and ...
(Date:3/28/2017)... -- "US Cancer Generics Market Outlook 2022" report gives ... analysis related to the emergence and integration of ... US. The report analyzes various clinical and non-clinical ... drugs in recent years. The introduction of generics ... for various stake holders involved US cancer drug ...
Breaking Medicine Technology:
(Date:3/28/2017)... ... March 28, 2017 , ... ... the first technology to directly address the resolution to globally reduce the harmful ... a patented compound of FDA and TTB approved ingredients that when infused into ...
(Date:3/28/2017)... ... March 28, 2017 , ... Resoundant, Inc., the developer of ... Siemens Healthineers annual customer education symposium, a world-class learning conference that offers educational ... 27 - 31, 2017 at the Atlanta Marriott Marquis in Atlanta, Georgia. , ...
(Date:3/28/2017)... ... March 29, 2017 , ... The Thyroid Secret is a ... FASCP. The program was recently launched on March 1, and Dr. Wentz discussed ... , Dr. Izabella Wentz is a licensed pharmacist and a foremost thyroid ...
(Date:3/28/2017)... Seattle, WA (PRWEB) , ... March 28, 2017 ... ... reach a 22% share of all holidays (IBT World Travel Trends Report). As ... physically challenging, include a range in temperatures, and prolonged sun exposure. In response, ...
(Date:3/28/2017)... ... March 28, 2017 , ... ... advancing the science and clinical practice of radiosurgery, announced today the publication ... multi-institutional, observational registry established to standardize data collection from patients treated with ...
Breaking Medicine News(10 mins):