MiMedx Initiates Phase III Plantar Fasciitis Clinical Trial
Published: Aug 03, 2017
MARIETTA, Ga., Aug. 2, 2017 /PRNewswire/ -- MiMedx Group, Inc. (NASDAQ: MDXG), the leading biopharmaceutical company developing and marketing regenerative and therapeutic biologics utilizing human placental tissue allografts with patent-protected processes for multiple sectors of healthcare, announced today that the Company has initiated its Phase 3 Plantar Fasciitis clinical study.
The Company submitted a formal Investigational New Drug (IND) amendment to the Food and Drug Administration (FDA) requesting the initiation of the Phase 3 trial based on the interim results of its IND Phase 2B trial for the treatment of Plantar Fasciitis. To date, the Company has received no comments or changes to the amendment filing or the Phase 3 protocol, and the Company is moving forward with the Phase 3 trial. MiMedx anticipates enrolling the first Phase 3 patient within the next 30 to 60 days.
The Phase 3 clinical study is a prospective, double-blinded, randomized controlled trial of AmnioFix Injectable as compared to a saline placebo injection in the treatment of Plantar Fasciitis on subjects that have moderate or severe pain due to Plantar Fasciitis with failed treatment for at least one month. The comparison group will be treated with a 0.9% Sodium Chloride USP placebo injection. Approximately 164 patients will be enrolled in the study with an estimated enrollment period of 18 months. The primary efficacy endpoint will be the change in Visual Analog Scale (VAS) score for patients between baseline and Day 90 expressed as the difference in means between the AmnioFix Injectable versus placebo-treated group. The primary safety endpoint will be 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-treated group.
MiMedx also reported that the Company will be hosting a webcast on Monday, August 7, 2017 beginning at 2:00 p.m. Eastern Time to discuss this study as well as the progress of the Company's numerous other clinical studies in support of its Biopharmaceutical strategy. MiMedx executives "Pete" Petit, Chairman and CEO; Bill Taylor, President and COO; Debbie Dean, Executive Vice President; Chris Cashman, EVP and Chief Commercialization Officer; and Mark Landy, Vice President Strategic Initiatives, will be presenting during the August 7th call. Also present will be Donald Fetterolf, M.D., Chief Medical Officer; Thomas Koob, PhD, Chief Scientific Officer; and other members of MiMedx senior management.
The Company expects the planned presentations to last approximately 45 minutes. After the planned presentations, the call will be open for questions and answers. The subject matter, topics and updates to be covered during the formal presentations include:
- Update of Biopharma Transition Activities
- Initiation Status of Plantar Fasciitis IND Phase 3 Study
- Update on Plantar Fasciitis IND Phase 2B Study
- Upcoming Filings for Additional IND Clinical Studies
- Plantar Fasciitis and Pain Management Commercial Update
A listen-only simulcast of the MiMedx August 7, 2017 shareholder call will be available on-line at the Company's website at www.mimedx.com beginning at 2:00 p.m. eastern time, August 7, 2017. A 30-day on-line replay will be available approximately one hour following the conclusion of the live broadcast on the Company's website at www.mimedx.com.
MiMedx® is a biopharmaceutical company developing and marketing regenerative biologics utilizing human placental tissue allografts with patent-protected processes for multiple sectors of healthcare. "Innovations in Regenerative Medicine" is the framework behind our mission to give physicians products and tissues to help the body heal itself. We process the human placental tissue utilizing our proprietary PURION® Process among other processes, to produce safe and effective allografts. MiMedx proprietary processing methodology employs aseptic processing techniques in addition to terminal sterilization. MiMedx is the leading supplier of placental tissue, having 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. For additional information, please visit www.mimedx.com.
Important Cautionary Statement
This press release includes forward-looking statements, including statements regarding the timing, results, and publication of clinical studies; and the potential safety and efficacy, and additional approved uses and markets for our products. These statements also may be identified by words such as "believe," "except," "may," "plan," "potential," "will" and similar expressions, and are based on our current beliefs and expectations. Forward-looking statements are subject to significant risks and uncertainties, and we caution investors against placing undue reliance on such statements. Actual results may differ materially from those set forth in the forward-looking statements. Among the risks and uncertainties that could cause actual results to differ materially from those indicated by such forward-looking statements include the risk that unexpected concerns may arise from additional data or analysis from our clinical trials; regulatory submissions may take longer or be more difficult to complete than expected; and that regulatory authorities may require additional information or further studies or may fail to approve or may delay approval or grant marketing approval that is different than anticipated. For more detailed information on the risks and uncertainties associated with new product development and commercialization activities, please review the Risk Factors section of our most recent annual report or quarterly report filed with the Securities and Exchange Commission. Any forward-looking statements speak only as of the date of this press release and we assume no obligation to update any forward-looking statement.
SOURCE MiMedx Group, Inc.