11/01/2017 21:05:00

Histogenics Announces Publication of MRI Data From NeoCart® Phase 1 and Phase 2 Clinical Trials in the American Journal of Sports Medicine

– Data demonstrate significant improvement in cartilage quality over first 24 months after treatment, with stabilization and maturation thereafter out to 60 months – 

– Improvements in cartilage quality were accompanied by consistent and statistically significant improvements in patient reported clinical outcomes as early as 3 to 6 months after implantation – 

– Data underscore potential to provide a faster and more durable recovery for patients with cartilage defects in the knee –

WALTHAM, Mass., Jan. 11, 2017 (GLOBE NEWSWIRE) -- Histogenics Corporation (Histogenics) (Nasdaq:HSGX), a regenerative medicine company focused on developing and commercializing products in the musculoskeletal space, today announced the online publication in the January 2017 issue of the American Journal of Sports Medicine of a peer-reviewed publication entitled Magnetic Resonance Imaging Characterization and Clinical Outcomes After NeoCart Surgical Therapy as a Primary Reparative Treatment for Knee Cartilage Injuries.  The lead investigator is Dr. Dennis Crawford MD, PhD with support from other investigators including Devon E. Anderson, PhD, Riley J. Williams III, MD, Thomas M. DeBerardino, MD, Dean C. Taylor, MD, C. Benjamin Ma, MD, and Marie S. Kane, MS.  The publication analyzes magnetic resonance imaging (MRI) data through 60 months follow up from the Phase 1 and 2 clinical trials of NeoCart for the repair of articular cartilage injuries in the knee. 

29 patients with symptomatic full thickness cartilage lesions of the distal femoral condyle were treated with NeoCart in the Phase 1 and Phase 2 clinical trials and pooled for this analysis.  Safety and efficacy were evaluated prospectively by MRI and patient reported outcomes (PROs) through a 60-month follow-up period, with 21 patients evaluable at the final time point.  Qualitative MRI metrics were quantified according to modified magnetic resonance observation of cartilage repair tissue (MOCART) criteria, with an additional evaluation of repair tissue signal intensity.  The NeoCart patients were followed over 52 ± 15.5 (median=60) months.  

MOCART analyses indicated significant improvement (p<0.001) in the cartilage quality from 3 to 24 months, with stabilization and maturation from 24 to 60 months.  In addition, longitudinal MRI analysis demonstrated NeoCart repair tissue to be durable and evolve over time.  Changes in imaging measures over time corresponded with improvement in clinical measures, with maximum benefits experienced at 24-months.  Results from the two studies indicate that NeoCart is a safe and effective treatment for articular cartilage lesions through 5-year follow-up.  In addition, the Phase 1 and 2 NeoCart PROs when compared to baseline demonstrated statistically significant improvements on virtually all of the pain and functional endpoints, as early as 3 to 6 months, with sustained outcomes through 5 years.

“We are very pleased with the results of the clinical trials conducted to date and want to thank our investigators and patients for their participation.  We believe this is an area in need of a better alternative for patients who are seeking new options to repair cartilage defects that potentially offer both a more rapid recovery and durable response over time with fewer repeat surgeries,” stated Gloria Matthews, Chief Medical Officer of Histogenics.  “We believe the MRI data, while limited in the number of patients, provide additional confirmatory evidence of previously reported clinical efficacy outcomes, and demonstrate the potential benefits to patients with cartilage defects.  We are looking forward to the availability of additional data from the continuing development of this promising treatment alternative,” continued Dr. Matthews.

The demonstrated rapid maturation of cartilage as evidenced by the MRI data from the Phase 1 and Phase 2 clinical trials is consistent with biomechanical data recently presented by Histogenics and Cornell University that showed that in vitro cartilage constructs, or tissue implants, produced using a process that is designed to mimic that of NeoCart exhibited mechanical properties prior to implantation that were similar to that of native cartilage.  These results suggest that the maturation of tissue-engineered cartilage implants, such as NeoCart, leads to improved mechanical properties prior to implantation and may result in a more rapid recovery and return to function for patients suffering from cartilage defects.

“We believe the data from these two clinical trials are compelling and provide further evidence that NeoCart implants may provide an improved alternative for patients with knee cartilage defects,” stated, Dr. Dennis Crawford, Department of Orthopaedics & Rehabilitation, Oregon Health & Science University.  “The NeoCart implants appear to improve knee function and quality of life two years after surgery with maintenance through five years,” continued Dr. Crawford.

The full publication is hosted on the Histogenics website and can be found at:  http://ir.histogenics.com/phoenix.zhtml?c=252477&p=irol-presentations.

About NeoCart

NeoCart is a cartilage-like, tissue engineered implant created from a patient’s own cartilage cells.  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.  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 against the current standard of care, microfracture.  Histogenics is conducting the trial under a Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration (FDA) and expects to complete enrollment in this trial by the end of the second quarter of 2017.

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.

Forward-Looking Statements

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 enrolling the NeoCart Phase 3 clinical 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, 2015 and Quarterly Reports on Form 10-Q for the quarters ended March 31, 2016, June 30, 2016 and September 30, 2016 which are on file with the SEC and available on the SEC’s website at www.sec.gov.  Additional factors may be set forth in those sections of Histogenics’ Annual Report on Form 10-K for the year ended December 31, 2016, to be filed with the SEC in the first quarter of 2017.  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. 

Contact:

Investor Relations

Tel: +1 (781) 547-7909

InvestorRelations@histogenics.com

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