MiMedx Files With The FDA To Initiate The Company's Investigational New Drug Phase II Clinical Trial For Osteoarthritis Of The Knee
Published: Sep 19, 2017
MARIETTA, Ga., Sept. 19, 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 filed with the Food and Drug Administration (FDA) to initiate its Investigational New Drug (IND) Phase 2 clinical trial for osteoarthritis of the knee.
The osteoarthritis clinical trial will study MiMedx's AmnioFix® Injectable in a Phase 2, prospective, double-blinded, randomized controlled trial of the micronized dehydrated human amnion/chorion membrane (dHACM) injection as compared to saline placebo injection in the treatment of knee osteoarthritis. The Company expects patient enrollment to commence by the end of the year.
The trial will enroll approximately 318 study patients with a diagnosis of knee osteoarthritis defined as Grade 1 to 3 on the Kellgren Lawrence grading scale. The IND Phase 2 clinical study objective is to determine the safety and effectiveness of AmnioFix Injectable as compared to the 0.9% Sodium Chloride USP placebo injection control for the treatment of knee osteoarthritic pain.
The filed primary efficacy endpoint of this study 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. The Western Ontario and McMaster Universities (WOMAC) scores will be one of the study's secondary endpoints measured at 30, 60, 90 and 180 days.
Osteoarthritis of the knee is an extremely common occurrence in older patients, where it represents the biggest cause of disability and reduction of activity in patients over the age of 50. There are 14 million individuals in the U.S. who have symptomatic knee osteoarthritis and there were 7.8 million knee joint pain injections in the U.S. in 2015. Common medical treatment options include injectable medications such as corticosteroid; other injections such as hyaluronic acid (HA) and platelet rich plasma (PRP); and surgery, such as knee arthroscopy and knee replacement. Randomized trials have shown that corticosteroid injections may present short-term relief to patients with the condition, but unfortunately, the condition tends to recur, and complications may occur, such as systemic hyperglycemia, septic arthritis, and joint degradation. Clinicians generally agree that a lifetime limit of 2-3 corticosteroid injections is appropriate in unresponsive patients.
HA injections may provide temporary symptomatic relief and are widely used. However, their use is not without controversy and is currently not recommended by the American Academy of Orthopedic Surgeons in their treatment guidelines. PRP preparations have been popularly deployed in the treatment of knee osteoarthritis. However, concerns exist regarding this modality, since various methods of producing the material have differing bioactivity, and there is some debate in the literature about whether or not PRP is universally effective.
Bill Taylor, President and COO, stated, "With the variability of efficacy, cost, and side effects of current treatments for osteoarthritis, other treatment options are needed. This is particularly true when chronicity begins to develop and surgery is becoming the only remaining option. We believe our PURION® Processed AmnioFix® Injectable would be an ideal treatment alternative for osteoarthritis of the knee. Studies have confirmed that the natural characteristics of amniotic membrane may provide clinical benefits in the areas of enhanced soft tissue healing and inflammation modulation."
The osteoarthritis study will be the fourth IND trial for MiMedx AmnioFix Injectable. The other three IND trials include the Plantar Fasciitis Phase 2B, Plantar Fasciitis Phase 3, and Achilles Tendonitis Phase 3 trials. MiMedx also plans to submit a Biologic License Application (BLA) to the FDA for tendonitis when the Company's Plantar Fasciitis Phase 3 trial completes.
Over 80 clinical studies documenting the efficacy and effectiveness of MiMedx allografts have been published to date. The Company's robust compendium of current clinical activity includes 28 ongoing clinical studies in various stages of development and execution, 123 clinical sites under management, and 175 physicians currently contracted for research activities. This vigorous agenda of clinical activities encompasses over 450 legal agreements and contracts for study involvement.
Parker H. "Pete" Petit, CEO, said, "There should not be any further concerns about MiMedx becoming a biopharma focused organization in an expedited fashion. We have accomplished rapid asset development in these areas over the years, and in March we disclosed to shareholders that our new strategic focus would be new therapeutic areas as a biopharma company. At that point, I did not think our level of expertise and accomplishments to date were fully appreciated. However, having two ongoing phase 3 trials and one phase 2 trial at a large number of centers will be quite an accomplishment. We have been able to very efficiently and effectively conduct our trials to this point without the assistance of a Clinical Research Organization (CRO). We expect to continue to build our staff as our demands increase. Along those lines, we will shortly announce additional very experienced biopharma executives to our staff. They will help continue our rapid development of the opportunities we have with our placenta based technology."
"We are anxious to commence the Phase 2 clinical trial and we expect the study results to be compelling. We look forward to reporting the results to the medical and investment communities," added Taylor.
MiMedx® is 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. "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 1,000,000 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 Company's belief that AmnioFix Injectable is an ideal treatment alternative for osteoarthritis of the knee and expectations that study results will be compelling. 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 results or concerns may arise from data or analysis from our clinical trials; regulatory submissions may take longer or be more difficult to complete than expected; and regulatory authorities may require additional information or further studies or may fail to approve or may delay approvals. For more detailed information on the risks and uncertainties, 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.
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SOURCE MiMedx Group, Inc.