October 13, 2014 I Smith & Nephew (LSE: SN, NYSE: SNN), the global medical technology business, announces top-line results from a Phase 3 study of HP802-247, a living cell spray-on therapy designed to work with the body’s own cells to stimulate healing of venous leg ulcers (“VLUs”). HP802-247 did not meet the primary endpoint, namely a statistically significant improvement in healing over placebo, in a randomized, double-blind, vehicle-controlled study in North America.
The result reported today is headline data. A full analysis of the efficacy data and study methodology is underway and will be completed in the coming months. A second Phase 3 study in the European Union, which is expected to report in 2016, will continue while the programme analysis is completed.
Olivier Bohuon, Chief Executive Officer of Smith & Nephew, commented:
“A thorough assessment is underway to determine why the preliminary results of the first Phase 3 study are inconsistent with the strongly positive Phase 2a/2b results. While this is an unexpected and disappointing development with this one product, we remain excited by the prospects for advanced wound bioactives as unique treatments for unmet patient needs.”
Background to the study
HP802-247 is an allogenic living cell bio-formulation of irradiated keratinocytes and fibroblasts in a human fibrin suspension.
In June 2011 HP802-247 delivered positive data from a Phase 2b clinical trial, demonstrating that the compound met both its primary and secondary endpoints in the treatment of VLUs. The compound entered Phase 3 trials for this indication in North America in September 2012.
The North American study measured complete wound closure over a 12-week period in patients treated with HP802-247 plus standard care compression versus treatment with placebo plus compression. It was a randomized, double-blind study involving subjects 18 years of age and older with VLUs of at least six weeks but not more than 24 months duration.
About Smith & Nephew
Smith & Nephew is a global medical technology business dedicated to helping healthcare professionals improve people’s lives. With leadership positions in Orthopaedic Reconstruction, Advanced Wound Management,Sports Medicine and Trauma & Extremities, Smith & Nephew has around 14,000 employees and a presence in more than 90 countries. Annual sales in 2013 were more than $4.3 billion. Smith & Nephew is a member of the FTSE100 (LSE: SN, NYSE: SNN).
SOURCE: Smith & Nephew
Post Views: 217
October 13, 2014 I Smith & Nephew (LSE: SN, NYSE: SNN), the global medical technology business, announces top-line results from a Phase 3 study of HP802-247, a living cell spray-on therapy designed to work with the body’s own cells to stimulate healing of venous leg ulcers (“VLUs”). HP802-247 did not meet the primary endpoint, namely a statistically significant improvement in healing over placebo, in a randomized, double-blind, vehicle-controlled study in North America.
The result reported today is headline data. A full analysis of the efficacy data and study methodology is underway and will be completed in the coming months. A second Phase 3 study in the European Union, which is expected to report in 2016, will continue while the programme analysis is completed.
Olivier Bohuon, Chief Executive Officer of Smith & Nephew, commented:
“A thorough assessment is underway to determine why the preliminary results of the first Phase 3 study are inconsistent with the strongly positive Phase 2a/2b results. While this is an unexpected and disappointing development with this one product, we remain excited by the prospects for advanced wound bioactives as unique treatments for unmet patient needs.”
Background to the study
HP802-247 is an allogenic living cell bio-formulation of irradiated keratinocytes and fibroblasts in a human fibrin suspension.
In June 2011 HP802-247 delivered positive data from a Phase 2b clinical trial, demonstrating that the compound met both its primary and secondary endpoints in the treatment of VLUs. The compound entered Phase 3 trials for this indication in North America in September 2012.
The North American study measured complete wound closure over a 12-week period in patients treated with HP802-247 plus standard care compression versus treatment with placebo plus compression. It was a randomized, double-blind study involving subjects 18 years of age and older with VLUs of at least six weeks but not more than 24 months duration.
About Smith & Nephew
Smith & Nephew is a global medical technology business dedicated to helping healthcare professionals improve people’s lives. With leadership positions in Orthopaedic Reconstruction, Advanced Wound Management,Sports Medicine and Trauma & Extremities, Smith & Nephew has around 14,000 employees and a presence in more than 90 countries. Annual sales in 2013 were more than $4.3 billion. Smith & Nephew is a member of the FTSE100 (LSE: SN, NYSE: SNN).
SOURCE: Smith & Nephew
Post Views: 217
