– Data Demonstrate the Importance of Generating Extracellular Matrix During Ex-Vivo Manufacturing of Cartilage Cell Therapy –
– Ex-vivo Production of Extracellular Matrix is Critical to Biomechanical Competence and May Enable Earlier Return to Function After Treatment –
– Presence of Extracellular Matrix at Time of Implantation Improves Biomechanical Competence of Cartilage Cell Therapy Compared to Therapies with Only Cells and Scaffold –
WALTHAM, Mass., Oct. 02, 2017 (GLOBE NEWSWIRE) -- Histogenics Corporation (Histogenics) (Nasdaq:HSGX), a leading cell therapy company focused on developing and commercializing products in the musculoskeletal space, today announced the publication of a study, “In Vitro Culture Increases Mechanical Stability of Human Tissue Engineered Cartilage Constructs by Prevention of Microscale Scaffold Buckling” in the online version of the peer-reviewed Journal of Biomechanics. The study analyzes the compressive properties of engineered cartilage tissue grown with chondrocytes seeded in a porous scaffold based on work completed as part of a sponsored research agreement between Histogenics and Dr. Lawrence Bonassar of Cornell University (Cornell). The initial data were presented at the Orthopaedic Research Society annual meeting in March 2017. The lead author is Jill E. Middendorf of Cornell with support from: Lena Bartell, Itai Cohen, Ph.D. and Lawrence J. Bonassar, Ph.D. of Cornell and Sonya Shortkroff, Caroline Dugopolski, Stephen Kennedy and Joseph Siemiatkoski of Histogenics.
The goal of the study was to understand how the deposition of glycosaminoglycans (GAG), a component of the extracellular matrix (ECM), influences the microscale compressive properties of tissue engineered cartilage that was produced using a lab-scale process designed to mimic that of NeoCart®. The compressive properties were specifically analyzed by looking at localized scaffold buckling. Histogenics intends to use the results of this study to provide additional data to the U.S. Food and Drug Administration (FDA) as part of a potential Biologics License Application (BLA) for NeoCart®, subject to a successful outcome in the ongoing Phase 3 clinical trial of NeoCart.
“Our collaboration with Cornell continues to generate valuable data that further characterizes our unique mechanism of action which we intend to use to support a potential BLA filing for NeoCart. In addition, these data will be critical for future development of other candidates in the NeoCart product platform,” said Stephen Kennedy, Chief Technology Officer of Histogenics. “These data add to the strong body of evidence demonstrating that our combination of cells, scaffold and tissue engineering which produces cartilage tissue ex vivo are critical for these therapies to function properly upon implantation in the body. We believe that NeoCart is unique in exhibiting these characteristics prior to implantation and are confident that this is one of the reasons we have seen such early preliminary recovery from pain and return to function as demonstrated by the data from the Phase 1 and 2 clinical trials of NeoCart,” continued Mr. Kennedy.
The compressive properties of the tissue implants improve with increased processing time, as ECM is deposited in the scaffold pores and are highly correlated to the GAG content of the constructs. Scaffolds seeded with chondrocyte cells absent significant extracellular matrix and GAG deposition have a strong tendency to buckle or collapse, resulting in sub-optimal biomechanical properties of such cartilage tissue implants. The reported results are consistent with earlier work demonstrating that in vitro cartilage constructs, or tissue implants, produced using a process that is designed to mimic that of NeoCart exhibit mechanical properties prior to implantation approaching such properties of native cartilage. Together, these attributes may enable the early response and repair of focal cartilage lesions and these findings are consistent with data seen in patients in the Phase 1 and 2 clinical trials of NeoCart.
“Developing cartilage tissue implants with appropriate mechanical properties has been a challenge for many years. It is clear that deposition of ECM improves mechanical performance, but the mechanism behind this improvement has not been clear,” stated Dr. Lawrence Bonassar, Professor at Cornell in the Meinig School of Biomedical Engineering and the Sibley School of Mechanical and Aerospace Engineering. “These data demonstrate newly synthesized ECM reinforces the structure of porous scaffolds and greatly enhances biomechanical competence of engineered cartilage tissue,” continued Dr. Bonassar.
The full peer-reviewed publication will be available in the Investor Relations section of the Histogenics website at www.ir.histogenics.com once the final article is released for publication.
NeoCart is a cartilage-like, tissue engineered implant created from a patient’s own cartilage cells. 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. The patient’s cells are multiplied in Histogenics’ laboratory and then infused into a proprietary scaffold to allow them to organize and function like cartilage cells. 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. As a result, NeoCart is the only product in development or on the market with a one-year primary superiority endpoint as compared to the standard of care. NeoCart is currently in a Phase 3 clinical trial that 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 at one year post implantation against the current standard of care, microfracture. Histogenics completed enrollment in the Phase 3 clinical trial in the second quarter of 2017, is conducting the trial under a SPA with the FDA and expects to report topline data in the third quarter of 2018. NeoCart is not approved for sale in any jurisdiction. For more information, please visit www.neocartimplant.com.
About Histogenics Corporation
Histogenics is a leading cell therapy company developing and commercializing novel tissue therapies that may offer more rapid and durable recoveries for patients with pain and loss of function due to musculoskeletal conditions. Histogenics’ regenerative medicine platform combines expertise in cell processing, scaffolding, tissue engineering and bioadhesives to create tissue ex-vivo. Histogenics’ first investigational product candidate, NeoCart is designed to treat cartilage defects in the knee. Histogenics recently completed enrollment of its NeoCart Phase 3 clinical trial and expects to report top-line data in the third quarter of 2018. There are more than 500,000 or more knee cartilage procedures in the United States each year, with many healthy active adults avoiding treatment as they seek other alternatives. Left untreated, even a small cartilage defect can expand in size and progress to debilitating osteoarthritis, ultimately necessitating a joint replacement procedure. Osteoarthritis is more common in adults over the age of 50, but the condition and precursors of the condition can be observed much earlier, and cartilage damage is believed to be one of the leading contributors of this disease. For more information, please visit www.histogenics.com.
Various statements in this release are “forward-looking statements” under the securities laws. Words such as, but not limited to, “anticipate,” “believe,” “can,” “could,” “expect,” “estimate,” “design,” “goal,” “intend,” “may,” “might,” “objective,” “plan,” “predict,” “project,” “target,” “likely,” “should,” “will,” and “would,” or the negative of these terms and similar expressions or words, identify forward-looking statements. Forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties.
Important factors that could cause actual results to differ materially from those reflected in Histogenics’ forward-looking statements include, among others: the timing and success of Histogenics’ NeoCart Phase 3 clinical trial, including, without limitation, possible delays in generating the data from the trial; the ability to obtain and maintain regulatory approval of NeoCart or any product candidates, and the labeling for any approved products; the scope, progress, expansion, and costs of developing and commercializing Histogenics’ product candidates; the ability to obtain and maintain regulatory approval regarding the comparability of critical NeoCart raw materials following our technology transfer and manufacturing location transition; the size and growth of the potential markets for Histogenics’ product candidates and the ability to serve those markets; Histogenics’ expectations regarding its expenses and revenue; and other factors that are described in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Histogenics’ Annual Report on Form 10-K for the year ended December 31, 2016 and Quarterly Report on Form 10-Q for the quarter ended June 30, 2017, which are on file with the Securities and Exchange Commission (SEC) and available on the SEC’s website at www.sec.gov. In addition to the risks described above and in Histogenics’ annual report on Form 10-K and quarterly reports on Form 10-Q, current reports on Form 8-K and other filings with the SEC, other unknown or unpredictable factors also could affect Histogenics’ results.
There can be no assurance that the actual results or developments anticipated by Histogenics will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Histogenics. Therefore, no assurance can be given that the outcomes stated in such forward-looking statements and estimates will be achieved.
All written and verbal forward-looking statements attributable to Histogenics or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements contained or referred to herein. Histogenics cautions investors not to rely too heavily on the forward-looking statements Histogenics makes or that are made on its behalf. The information in this release is provided only as of the date of this release, and Histogenics undertakes no obligation, and specifically declines any obligation, to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.
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