Histogen Reports FDA Clinical Hold for Planned Phase 1/2 Trial of HST-003 for Knee Cartilage Regeneration
- Category: DNA RNA and Cells
- Published on Wednesday, 20 January 2021 10:42
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SAN DIEGO, CA, USA I January 19, 2021 I Histogen Inc. (NASDAQ: HSTO), a clinical-stage therapeutics company focused on developing potential first-in-class restorative therapeutics that ignite the body’s natural process to repair and maintain healthy biological function today announced that the U.S. Food and Drug Administration (FDA) has verbally notified the company that it has additional questions about the company’s Investigational New Drug (“IND”) application package for the planned Phase 1/2 clinical trial of HST-003, which is intended to evaluate the safety and efficacy of human extracellular matrix (hECM:HST-003) implanted within microfracture interstices and the cartilage defect in the knee to regenerate hyaline cartilage in combination with a microfracture procedure.
Histogen has not yet received the written notice of its clinical hold from the FDA, which the FDA expects to provide to the company by February 12, 2021. Based upon the verbal communication with FDA, they indicated that the clinical hold is due to pending CMC information that is required to complete their review. Histogen plans to work diligently with the FDA to seek the release of the clinical hold and provide updated guidance on any potential impact to the HST-003 program once the written notice from FDA is received.
Histogen’s human extracellular matrix, or hECM, is intended for regenerating hyaline cartilage for the treatment of articular cartilage defects with a novel malleable scaffold that stimulates the body’s own stem cells. In multiple preclinical models, HST-003 has been shown to regenerate mature cartilage and well vascularized bone, indicating therapeutic potential in the sports medicine, spinal disc repair, orthopedic, and dental areas. Studies conducted by outside experts have demonstrated that HST-003 is anti-inflammatory, angiogenic, and can stimulate the growth of stem cells in damaged areas to induce tissue regeneration. The most extensive in vivo work in animals has focused on the regeneration of new hyaline cartilage and bone in full thickness knee injuries.
Histogen Inc. is a clinical-stage therapeutics company focused on developing potential first-in-class restorative therapeutics that ignite the body’s natural process to repair and maintain healthy biological function. Histogen’s innovative technology platform utilizes cell conditioned media and extracellular matrix materials produced by hypoxia-induced multipotent cells. Histogen’s proprietary, reproducible manufacturing process provides targeted solutions across a broad range of therapeutic indications including hair growth, dermal rejuvenation, joint cartilage regeneration and spinal disk repair. For more information, please visit www.histogen.com.