Corporate Banner
Satellite Banner
Biomolecular Screening
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 2,600+ scientific posters on ePosters
  • More than 3,800+ 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
Promising Drug Candidate to Treat Chronic Itch
In a new study, scientists from the Florida campus of The Scripps Research Institute (TSRI) describe a class of compounds with the potential to stop chronic itch without the adverse side effects normally associated with medicating the condition.
Are Changes to Current Colorectal Cancer Screening Guidelines Required?
Editorial suggests more research is needed to pinpoint age to end aggressive screening.
Assessing Cancer Patient Survival and Drug Sensitivity
RNA editing events another way to investigate biomarkers and therapy targets.
New Molecular Marker for Killer Cells
Cell marker enables prognosis about the course of infections.
Potential Target for Treatment of Autism
Grant of $2.4 million will support further research.
Sniffing Out Cancer
Scientists have been exploring new ways to “smell” signs of cancer by analyzing what’s in patients’ breath.
Inroads Against Leukaemia
Potential for halting disease in molecule isolated from sea sponges.
Molecular ‘Kiss Of Death’ Flags Pathogens For Destruction
Researchers have discovered that our bodies mark pathogen-containing vacuoles for destruction by using a molecule called ubiquitin, commonly known as the "kiss of death."
A New Single-Molecule Tool to Observe Enzymes at Work
A team of scientists at the University of Washington and the biotechnology company Illumina have created an innovative tool to directly detect the delicate, single-molecule interactions between DNA and enzymatic proteins.
Milestone Single-Biomolecule Imaging Technique May Advance Drug Design
The first nanometer resolved image of individual tobacco mosaic virions shows the potential of low-energy electron holography for imaging biomolecules at a single particle level; a milestone in structural biology and a potential new tool for drug design.

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
2,600+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
3,800+ scientific videos