TissueTech Receives FDA Clearance to Proceed with Phase 1 Clinical Study using Investigational New Drug TTAX03 to Treat Facet Joint Osteoarthritis Pain

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Investigators will evaluate the dosage and safety of Cryopreserved Amniotic Membrane and Cryopreserved Umbilical Cord TTAX03 for pain relief and functional improvement of facet joint osteoarthritis in the lumbosacral region

MIAMI, March 8, 2021 /PRNewswire/ -- Amniox Medical, Inc. (Amniox), a TissueTech, Inc. company and pioneer in the clinical application of human birth tissue-based products, announced today that its parent company TissueTech had received clearance from the U.S. Food and Drug Administration (FDA) to proceed with a dosing study using its Investigational New Drug (IND) TTAX03 to treat facet joint pain resulting from Osteoarthritis (OA). This Phase 1 randomized, double-blinded, placebo-controlled, dose-finding study will include a one-year follow-up to assess TTAX03's long-term safety and potential lasting benefit.

TissueTech is currently the only human birth tissue manufacturer cleared by the FDA to proceed with an IND study for the treatment of facet OA. FDA clearance of this IND application represents one of the first steps in commercializing TTAX03-FJ as a biologic.

Investigators have already seen impressive results from earlier studies using Amniox's commercially available Cryopreserved Amniotic Membrane and Cryopreserved Umbilical Cord (CAM/CUC) particulate CLARIX® FLO to treat joint pain resulting from moderate to severe knee osteoarthritis (OA). One study, published in the October 19, 2020 issue of Orthopedic Research & Reviews, showed that after forty-two patients with moderate to severe knee OA received a single 100mg intra-articular injection of CLARIX FLO, 86% of them rated their symptoms as "very much improved" or "much-improved" within three months.

OA is an inflammation-driven disease, and as such, there has been a surge of interest in biologic therapies that might help slow OA disease progression and alleviate associated pain. TissueTech's CAM and CUC products are currently being investigated as biologics for several different indications given their long history of safe use and the known anti-inflammatory, anti-scarring, and pro-regenerative properties of birth tissue.2-5

Research shows that patients seeking pain relief for lower back pain are known to be at risk for higher rates of substance-abuse disorders, with occurrence rates of 5% to 25%.6 According to the Centers for Disease Control (CDC), in 2017, almost 57 million patients in the U.S. had at least one prescription for opioids filled or refilled. In the context of this opioid epidemic, healthcare providers face the challenge of optimizing pain management solutions that limit opioid use.

"We believe that TTAX03 will prove to be successful as a non-opioid intra-articular treatment for moderate to severe lower back pain resulting from facet joint osteoarthritis," said TissueTech President and Chief Executive Officer Amy Tseng. "We are committed to positively impacting patients' lives and think this product could provide dramatic outcomes for patients who suffer from facet joint OA. Low back pain not only affects one's quality of life but has also been shown to contribute to opioid and other substance abuse disorders. We are hopeful this product will be able to help these patients before they become dependent on such medications."

Tseng added, "We are especially proud of the fact that we are pursuing a non-opioid treatment option to support our physicians who are working diligently to reduce the number of fatal prescription-drug overdoses brought about by opioid and other substance misuse."

About Amniox Medical, Inc.

Amniox Medical, Inc., a TissueTech, Inc. company, is a leader in the clinical application of human birth tissue-based products (amniotic membrane & umbilical cord) processed using TissueTech's proprietary CRYOTEK® cryopreservation technology. Established in 2011, Amniox serves an unmet need for better surgical and therapeutic outcomes for chronic and complex wounds, orthopedics, sports medicine, spine, urology, gynecology, plastics, and general surgery. Connect with Amniox on our Website, Facebook, LinkedIn, and Twitter.

About TissueTech, Inc.

TissueTech, Inc., the parent company of Amniox Medical, Inc. and Bio-Tissue, Inc., is a scientific and market leader in regenerative medicine. TissueTech manufactures a broad range of ocular, surgical, wound care, and soft tissue products marketed under these subsidiaries. Since its inception, clinicians have performed more than 600,000 human implants of the company's products and published more than 380 peer-reviewed studies supporting its platform technology. TissueTech is committed to an unwavering integrity culture that places our patients' safety and clinical outcomes above all else. Learn more at https://tissuetech.com/.

  1. Arthritis Care Res (Hoboken). 2016 Dec; 68(12): 1743–1750. Published online 2016 Nov 3. doi: 10.1002/acr.22897 PMCID: PMC5319385 NIHMSID: NIHMS775448.

  2. Liu J, Sheha H, Fu Y, Liang L, Tseng SC. Update on Amniotic Membrane 357 Transplantation. Expert Rev Ophthalmol. 2010;5(5):645-661 358.

  3. Tseng SC, Espana EM, Kawakita T, et al. How Does Amniotic Membrane Work? Ocul 359 Surf. 2004;2(3):177-187 360

  4. Tighe S, Mead OG, Lee A, Tseng SCG. Basic Science Review of Birth Tissue Uses in 361 Ophthalmology. Taiwan J Ophthalmol. 2020;10(1):3-12 362.

  5. Huddleston HP, Cohn MR, Haunschild ED, Wong SE, Farr J, Yanke AB. Amniotic 363 Product Treatments: Clinical and Basic Science Evidence. Curr Rev Musculoskelet Med. 364 2020;13(2):148-154.

  6. Lall MP. Opioid therapy for chronic low back pain: prescribing considerations for advanced practice registered nurses. J Neurosci Nurs. 2014;46(6):361-366; quiz E1-2. DOI: 10.1097/JNN.0000000000000093.

Bio-Tissue, Inc., a TissueTech, Inc. company and pioneer in the clinical application of human birth tissue-based products, announced today that its parent company TissueTech had received clearance from the U.S. Food and Drug Administration (FDA) to proceed with a Phase 2 study using morselized Cryopreserved Amniotic Membrane (CAM) and Cryopreserved Umbilical Cord (CUC) Investigational New Drug (IND) TTBT01. (PRNewsfoto/Bio-Tissue, Inc.)
Bio-Tissue, Inc., a TissueTech, Inc. company and pioneer in the clinical application of human birth tissue-based products, announced today that its parent company TissueTech had received clearance from the U.S. Food and Drug Administration (FDA) to proceed with a Phase 2 study using morselized Cryopreserved Amniotic Membrane (CAM) and Cryopreserved Umbilical Cord (CUC) Investigational New Drug (IND) TTBT01. (PRNewsfoto/Bio-Tissue, Inc.)
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SOURCE Amniox Medical, Inc.