Brisbane, Australia 25 September 2008: Xenome Limited (“Xenome”) announced today that it has initiated its latest clinical trial of Xen2174, a new drug for the treatment of moderate to severe pain. The phase II study is the first trial of Xen2174 for the control of acute post-operative pain and will enrol approximately 200 patients at multiple clinical sites in the US.
The study will evaluate the safety and efficacy of Xen2174 administered as a single intrathecal administration to patients undergoing unilateral bunionectomy (i.e. surgery to remove bunions on one foot). Bunionectomy is a standard and well-accepted model for the assessment of acute pain therapies.
Results from the study will be assessed against multiple safety and efficacy endpoints and will supplement the clinical data previously generated in a chronic pain setting, where Xen2174 was safe and well-tolerated across a broad range of doses and showed evidence for an analgesic effect.
“This study represents an important next step in the development of Xen2174,” stated Dr Ian Nisbet, Xenome’s CEO and managing director. “If successful, it will provide proof-of-concept in a well-accepted human model of post-surgical pain. Importantly, the study was initiated on schedule and we intend to complete it and announce the results in the second half of 2009.”
There is a significant need for improved drugs in the treatment of post-operative pain and other forms of moderate to severe pain. Severe post-operative pain is usually managed using opioid drugs such as morphine, sometimes in combination with other analgesics. While opioids are effective, they can cause side-effects such as constipation, nausea, sleepiness and, in isolated cases, the slowing or cessation of breathing. They are also addictive and subject to abuse.
Xen2174 acts to control pain via a completely different mechanism compared to opioid drugs. Early studies have shown that Xen2174 has the potential to overcome some of the disadvantages of opioids and, as a result, could provide a new treatment option for people suffering from moderate to severe pain.
Further details on the study are available at the Xenome website (www.xenome.com) and at www.clinicaltrials.gov.
Xenome is a biotechnology company focused on the discovery and development of peptide-based therapeutics. The Company's lead product, Xen2174, is a novel conopeptide analogue for the treatment of moderate to severe pain. Xen2174 is a non-competitive inhibitor of norepinephrine transporter (NET), a validated target for the management of pain.
In an international phase I/II clinical trial in cancer patients, a single intrathecal administration of Xen2174 was found to be safe and well-tolerated across a broad dose range. In addition, the study provided evidence for an analgesic effect that had a rapid onset of action and was long-lasting.
Xenome's discovery platform is based on proprietary libraries of venom peptides, analogues and mimetics. In November 2007 Xenome and Amylin Pharmaceuticals, Inc. (NASDAQ:AMLN) entered into a partnership to screen Xenome's XDiscover™ library for new drug candidates against metabolic and musculoskeletal disease targets. Both Xen2174 and the Amylin partnership leverage off Xenome's unique expertise in peptide chemistry and its ability to translate the evolutionary advantages inherent in venom peptides into highly bioactive, drug-like molecules.
Further information can be obtained from the Xenome website (www.xenome.com).
Dr Ian Nisbet
Chief Executive Officer
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