e-Therapeutics' ETS2101 enters phase I clinical...

e-Therapeutics' ETS2101 enters phase I clinical trial in brain cancer

e-Therapeutics plc

e-Therapeutics plc (AIM: ETX) announces the start of the first clinical trial evaluating its compound ETS2101 as a treatment for cancer. The phase I trial is enrolling patients with primary brain cancer (glioma) or cancer that has spread to the brain from other sites.

Led by Professor Santosh Kesari, MD, PhD, director of neuro-oncology at the UC San Diego Moores Cancer Center in La Jolla, California, the trial will enrol up to 24 patients. Successive cohorts of patients will receive increasing doses of ETS2101. The primary objective is to evaluate safety and determine an appropriate dose for phase II development. Secondary objectives include initial assessment of the drug’s activity, detailed study of its distribution within the brain and investigation of potential biomarkers of response. First findings are expected in late 2012 and final results during 2013.

“ETS2101 represents a novel approach to the treatment of cancer based on the new science of network pharmacology,” said Kesari. “We have seen encouraging results with this drug in our own laboratory and are excited that we can now offer it to patients in a clinical trial.”

e-Therapeutics’ Development Director, Steve Self, said: “Advancing ETS2101 into trials was one of our key goals following last year’s refinancing and refocusing of our business. We look forward with interest to seeing the first results from the clinic.”

The brain cancer trial is one of two studies in the phase I programme for ETS2101. A second, larger trial will start shortly in the UK and will evaluate the drug in patients with a wide variety of tumour types. The decision to support a focused brain cancer trial in parallel with a broader phase I study reflects the particularly interesting data obtained from work with glioma cell lines and the ability of ETS2101, unlike many current cancer drugs, to cross the blood-brain barrier.

About ETS2101

ETS2101 (dexanabinol) is a synthetic cannabinoid previously studied in trauma patients. Its anti-cancer potential was identified by e-Therapeutics’ network pharmacology platform. This revealed the drug’s potential to overcome cancer cells’ ability to evade apoptosis – the suicide mechanism that is normally triggered if cells become dysfunctional – through impact on the network of proteins controlling the process. Preclinical work has provided empirical evidence that the drug induces apoptosis in cancer cells and has demonstrated broad activity against cancer cell lines. Findings of particular interest in experiments with brain cancer lines led the Company to support early evaluation of the drug in this setting in parallel with a broader phase I cancer study.

About the ETS2101 study in brain cancer

Further details of the trial will be available shortly at www.clinicaltrials.gov

About brain cancers

According to the American Brain Tumor Association, just over 24,000 patients will be diagnosed with a primary malignant brain tumour during 2012 in the US alone. Some 80% of primary malignant brain tumours are gliomas, a broad term which includes all tumours arising from the supportive tissue of the brain. Secondary brain cancers arise when cancer in other tissues spreads (metastasises) to the brain: an estimated 98,000—170,000 cases occur each year in the US, with metastases to the brain seen in 24-45% of all cancer patients.

About UC San Diego Moores Cancer Center

UC San Diego Moores Cancer Center is home to nearly 350 medical and radiation oncologists, cancer surgeons, and researchers. It is one of only 41 National Cancer Institute-designated comprehensive cancer centres in the United States, a rare honour distinguishing exceptionally high achievement in research, clinical care, education and community outreach and partnerships. For more information, visit www.cancer.ucsd.edu. Specific information about Professor Santosh Kesari and his work can be found at www.kesarilab.ucsd.edu/Pages/default.aspx

About e-Therapeutics

e-Therapeutics is an AIM-listed biotechnology company with a proprietary platform in network pharmacology, an innovative new approach to drug discovery based on advances in network science and chemical biology. The Company’s discovery activity is focused in cancer and degenerative diseases of the nervous system and its development effort on three clinical candidates spanning cancer, psychiatric disorders and infectious diseases. e-Therapeutics is based at sites in Oxford and Newcastle, UK. For more information about the Company please visit www.etherapeutics.co.uk.

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