BRISBANE, Australia and SAN DIEGO, Nov. 15 /PRNewswire/ -- Xenome Limited today announced it had commenced a Phase I/IIa trial of Xen2174, a new class of peptide therapeutic for the treatment of severe intractable pain.
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The trial is an open label, single blind, multicentre, single dose, dose escalating, safety and tolerability study of intrathecally administered Xen2174 in cancer patients suffering severe intractable pain. The trial will be conducted at multiple sites in Australia and undertaken under both US (FDA) and Australian (TGA) regulatory authorizations.
Xenome has based Xen2174 development strategies upon new knowledge of pain mechanisms, physicians’ patterns of clinical practice, healthcare system and patient attitudes. A distinctive advantage of Xen2174’s mechanism of action is its ability to interact with a major natural pain-relieving pathway of the human body.
“The positive Phase I safety results warrant further investigation of the potential safety and efficacy of Xen2174 in cancer pain patients, and also in the broader severe intractable pain market including neuropathic pain patients,” said Mr. Ian McRitchie, Director of Clinical Development, Xenome.
“The continued demonstration of safety and what we hope to be the first signal of human efficacy from Xen2174 will represent validation of Xenome’s underlying technology,” said Dr. Roger Drinkwater, Xenome CEO. “We believe our peptide discovery and development portal will translate advantages that are inherent in highly evolved venoms, including specificity and potency, into what we hope to show as essential clinical benefits of improved safety and efficacy in our clinical trial program.”
Hundreds of millions of people worldwide are affected by severe pain, which alters their physical and emotional well being, diminishes their quality of life, and impairs their ability to work. Only an estimated 25 percent of people with severe painful conditions are treated effectively with currently available therapeutics.
The debilitating effect of severe intractable pain on quality of life is most significant in the cancer patient population. Despite advances in the treatment of cancer, pain management remains a significant unmet need and represents a growing opportunity as cancer is increasingly viewed as a chronic disease.
Further information: Ian McRitchie Director of Clinical Development Xenome Ltd Tel: +61 7 3720 8055 E-mail: discovery@xenome.com Website: www.xenome.com About Xen2174
Xen2174, a chi conopeptides is derived from the venom of the cone snail, a marine shellfish that is abundant on the Queensland Great Barrier Reef. Xen2174 has been shown to selectively inhibit the Norepinephrine Transporter (NET) a known drug target in the central nervous system. In the spinal cord Norepinephrine (NE) is the dominant neurotransmitter activating the descending inhibitory pain pathway. Delivery of Xen2174 directly into the space around the spinal cord deposits the drug adjacent to NET so that in episodes of pain, the inhibition of NET by Xen2174 elevates the levels of NE leading to the activation of inhibitory pathways preventing pain signals from reaching the brain. In animal models of acute and chronic pain, Xen2174 has been shown to provide superior pain relief when compared to morphine. The Xen2174 program is currently supported by an AusIndustry R&D START Grant.
About Xenome
Xenome is a world leader in the discovery of novel peptides from animal venoms. Based in Brisbane, Australia, and with US business offices in San Diego, California Xenome has generated a unique expertise in peptide chemistry to translate the evolutionary advantages inherent in venom peptides into highly bioactive libraries of molecules that are now in demand by global biotechnology and pharmaceutical companies. Peptide molecules with unique chemistry and pharmacology are being used in Xenome’s drug development activities, which are focused on pain management and inflammatory disease. Xenome’s activities are supported through the continuing commitment of Queensland BioCapital Funds, the majority shareholder. http://www.xenome.com
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CONTACT: Ian McRitchie, Director of Clinical Development, Xenome Ltd, +617 3720 8055, discovery@xenome.com
Web site: http://www.xenome.com/
