Histogenics Corporation (NASDAQ:HSGX), a regenerative medicine company focused on developing and commercializing products in the musculoskeletal space, announced that as of October 24, 2016 it had enrolled 183, or approximately three-quarters, of the 245 patients required to complete enrollment of its ongoing NeoCart Phase 3 clinical trial. This trial is being conducted under a Special Protocol Assessment (SPA) with the United States Food and Drug Administration (FDA).
“The enrollment strategies we implemented last year continue to result in increased patient enrollment in our ongoing NeoCart Phase 3 clinical trial. With enrollment approximately 75% complete and tracking ahead of our expectations, we are now counting down the number of patients required to complete enrollment and turning our focus to the generation and availability of the one-year superiority data and a BLA submission to the FDA shortly thereafter,” stated Adam Gridley, Chief Executive Officer of Histogenics. “Having recently completed a financing aimed at funding Histogenics through our top-line data read-out in mid-2018, we believe we are well positioned to execute on our operating plans to bring this important therapy to market, if approved,” continued Mr. Gridley.
The Phase 3 clinical trial is designed to evaluate the safety and efficacy of NeoCart as a first-line therapy for full thickness knee cartilage defects in skeletally mature adults ages 18 to 59 and to show superiority of NeoCart against the current standard of care, microfracture. NeoCart is a tissue-engineered cartilage implant created from a patient’s own cells. The patient’s cells are multiplied in Histogenics’ laboratory and then infused into a proprietary scaffold to allow them to function like native cartilage. Before NeoCart is shipped to the surgeon for implantation, the cell and scaffold construct undergoes a bioengineering process that is designed to mimic a joint so that the implant, upon placement in the knee with a proprietary bioadhesive, is primed to begin functioning like healthy cartilage. Histogenics believes that these attributes may offer patients a more rapid recovery and a more durable treatment option, if approved, than other products and procedures, either on the market or in development.
About Histogenics Corporation
Histogenics is a leading regenerative medicine company developing and commercializing products in the musculoskeletal segment of the marketplace. Histogenics’ regenerative medicine platform combines expertise in cell processing, scaffolding, tissue engineering, bioadhesives and growth factors to provide solutions to treat musculoskeletal-related conditions. Histogenics’ first investigational product candidate, NeoCart, is currently in Phase 3 clinical development. NeoCart is an autologous cell therapy designed to treat cartilage defects in the knee using the patient’s own cells. Knee cartilage defects represent a significant opportunity in the United States, with an estimated 500,000 or more applicable procedures each year. NeoCart is designed to exhibit characteristics of articular, hyaline cartilage prior to and upon implantation into the knee and therefore does not rely on the body to make new cartilage, characteristics not exhibited in other current treatment options. For more information, please visit www.histogenics.com.
