Corporate Banner
Satellite Banner
Scientific Community
Become a Member | Sign in
Home>News>This Article

Spinifex Announces Start of Phase 2 Proof-of-Concept Trial of EMA401 in CIPN

Published: Monday, December 10, 2012
Last Updated: Monday, December 10, 2012
Bookmark and Share
50 patients are expected to be enrolled into the trial.

Spinifex Pharmaceuticals has announced 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 has 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.

EMA 401 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.

Further Information
Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 2,800+ scientific posters on ePosters
  • More than 4,000+ scientific videos on LabTube
  • 35 community eNewsletters

Sign In

Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.

Scientific News
New Tech Vastly Improves CRISPR/Cas9 Accuracy
A new CRISPR/Cas9 technology developed by scientists at UMass Medical School is precise enough to surgically edit DNA at nearly any genomic location, while avoiding potentially harmful off-target changes typically seen in standard CRISPR gene editing techniques.
New Class of RNA Tumor Suppressors Identified
Two short, “housekeeping” RNA molecules block cancer growth by binding to an important cancer-associated protein called KRAS. More than a quarter of all human cancers are missing these RNAs.
Biologists Induce Flatworms to Grow Heads and Brains of Other Species
Findings shed light on role of a new kind of epigenetic signaling in evolution, could yield clues for understanding birth defects and regeneration.
Turning up the Tap on Microbes Leads to Better Protein Patenting
Mining millions of proteins could become faster and easier with a new technique that may also transform the enzyme-catalyst industry, according to University of California, Davis, researchers.
Mathematical Model Forecasts the Path of Breast Cancer
Chances of survival depend on which organs breast cancer tumors colonize first.
Exploring the Causes of Cancer
Queen's research to understand the regulation of a cell surface protein involved in cancer.
Ancient Viral Molecules Essential for Human Development
Genetic material from ancient viral infections is critical to human development, according to researchers at the Stanford University School of Medicine.
Tardigrade's Are DNA Master Thieves
Tardigrades, nearly microscopic animals that can survive the harshest of environments, including outer space, hold the record for the animal that has the most foreign DNA.
The Secret Behind the Power of Bacterial Sex
Migration between different communities of bacteria is the key to the type of gene transfer that can lead to the spread of traits such as antibiotic resistance, according to researchers at Oxford University.
Farming’s in Their DNA
Ancient genomes reveal natural selection in action.
Skyscraper Banner

Skyscraper Banner
Go to LabTube
Go to eposters
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
2,800+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,000+ scientific videos