VANCOUVER, British Columbia—Xenon Pharmaceuticals Inc. announced today that it has initiated a phase II clinical trial evaluating its novel topical XEN402 therapy for the treatment of post herpetic neuralgia (PHN).
"This is an important step forward in the development of topical XEN402," says Dr. Simon Pimstone, Xenon's president and CEO. "This is a truly unique product built on our genetic studies that showed Nav1.7 deficient humans are completely unable to feel pain. By treating pain locally at its source through Nav1.7 block, topical XEN402 could be a very effective and safe treatment option. Our preclinical data show excellent efficacy with topical XEN402 in multiple inflammatory and neuropathic pain models when compared to other topical agents and additive effects to existing oral pain treatments."
Pimstone adds that he and the rest of the company are hopeful that the product could eventually treat multiple chronic painful conditions, and add, "This progress signifies another example of Xenon transitioning its target discovery engine to human proof-of-concept trials."
XEN402 has been developed by Xenon as a topical ointment formulation and recently concluded a 21-day cumulative dose safety tolerability Phase I study in normal human volunteers. The product reportedly was well-tolerated and achieved good drug concentrations in the skin. Topical XEN402 is being developed by Xenon for painful neuropathic disorders such as PHN and targets the sodium channel sub-type Nav1.7. This target is highly expressed in sensory nerve endings and its expression has been shown to be up-regulated in chronic painful conditions such as PHN.
Dr. Paul Goldberg, Xenon's vice president of clinical development, referred to topical XEN402 as a "potentially transformative therapy as leading agents have significant side effects and often leave many patients still in pain. As such, there is a large unmet medical need for a novel analgesic that is both effective and safe. We see topical XEN402 being used both as a monotherapy and as an adjuvant agent as well."
Xenon expects to conclude the Phase II trial in the first quarter of 2011 with top-line data available in the second quarter of that year.
"This is an important step forward in the development of topical XEN402," says Dr. Simon Pimstone, Xenon's president and CEO. "This is a truly unique product built on our genetic studies that showed Nav1.7 deficient humans are completely unable to feel pain. By treating pain locally at its source through Nav1.7 block, topical XEN402 could be a very effective and safe treatment option. Our preclinical data show excellent efficacy with topical XEN402 in multiple inflammatory and neuropathic pain models when compared to other topical agents and additive effects to existing oral pain treatments."
Pimstone adds that he and the rest of the company are hopeful that the product could eventually treat multiple chronic painful conditions, and add, "This progress signifies another example of Xenon transitioning its target discovery engine to human proof-of-concept trials."
XEN402 has been developed by Xenon as a topical ointment formulation and recently concluded a 21-day cumulative dose safety tolerability Phase I study in normal human volunteers. The product reportedly was well-tolerated and achieved good drug concentrations in the skin. Topical XEN402 is being developed by Xenon for painful neuropathic disorders such as PHN and targets the sodium channel sub-type Nav1.7. This target is highly expressed in sensory nerve endings and its expression has been shown to be up-regulated in chronic painful conditions such as PHN.
Dr. Paul Goldberg, Xenon's vice president of clinical development, referred to topical XEN402 as a "potentially transformative therapy as leading agents have significant side effects and often leave many patients still in pain. As such, there is a large unmet medical need for a novel analgesic that is both effective and safe. We see topical XEN402 being used both as a monotherapy and as an adjuvant agent as well."
Xenon expects to conclude the Phase II trial in the first quarter of 2011 with top-line data available in the second quarter of that year.
