– 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
–
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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