MiMedx Enrolls First Patients in Phase 3 Trial Of AmnioFix Injectable in Patients with Recalcitrant Plantar Fasciitis Pain.
M2 PHARMA-January 19, 2018-MiMedx Enrolls First Patients in Phase 3 Trial Of AmnioFix Injectable in Patients with Recalcitrant Plantar Fasciitis Pain
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- Marietta, Georgia-based regenerative biomaterial products and bioimplants specialist MiMedx Group, Inc. (NASDAQ: MDXG) has randomised and enrolled the first patients in the Phase 3 investigational new drug clinical trial to assess the safety and efficacy of AmnioFix Injectable in patients with recalcitrant plantar fasciitis pain, the company said.
This prospective, double blinded, randomized controlled trial will enroll approximately 164 patients at 15 centres. Patients will be randomised 1: 1 into two treatment groups; a single injection of saline (placebo control) or a single injection of 40mg of AmnioFix Injectable.
The primary efficacy endpoint is the change in Visual Analog Scale score between baseline and day 90, expressed as the difference in means between the two groups.
The primary safety endpoint is the incidence of adverse events, serious adverse events, and unanticipated adverse events during the first 180 days post injection in the AmnioFix Injectable group versus the placebo-controlled group.
Following the conclusion of this trial, MiMedx intends to file a biologic license application with the US Food and Drug Administration for AmnioFix Injectable to treat moderate to severe plantar fasciitis pain that has failed conservative treatment for at least 30 days.
MiMedx is developing and marketing regenerative biologics utilizing human placental tissue allografts with patent-protected processes for multiple sectors of healthcare.
The company's proprietary processing methodology employs aseptic processing techniques in addition to terminal sterilization. MiMedx has supplied over 900,000 allografts to date for application in the wound care, burn, surgical, orthopedic, spine, sports medicine, ophthalmic and dental sectors of healthcare.
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|Date:||Jan 19, 2018|
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