Vericel Reports Three-Year Follow-Up Results From Phase 3 SUMMIT Extension Study of MACI(TM) Implant
March 25 2015 - 7:30AM
Vericel Corporation (Nasdaq:VCEL), a leading developer of
patient-specific expanded cellular therapies for the treatment of
severe diseases and conditions, today reported that positive
results from the three-year extension of the Phase 3 SUMMIT study
with MACI™ (matrix-applied characterized autologous cultured
chondrocytes) were presented at the annual meeting of the American
Association of Orthopedic Surgeons in Las Vegas. In a poster
presentation (number P169) entitled "SUMMIT Trial: Matrix-induced
Autologous Chondrocyte Implant versus Microfracture at 3 Years,"
Professor Mats Brittberg, Cartilage Research Unit, University of
Gothenburg, Sweden, and colleagues reported that patients followed
for three years following treatment with MACI had consistent
results as those reported previously in the two-year SUMMIT trial.
In the open-label, multi-center Phase 3 SUMMIT study, 144
patients with symptomatic articular cartilage defects in the knee
were randomized to receive treatment with MACI implant or
microfracture bone marrow stimulation (MFX) and followed for two
years. The study found that treatment with MACI was clinically
and statistically significantly better than MFX, with similar
structural repair tissue and safety. The SUMMIT study
concluded that "MACI offers a more efficacious alternative than MFX
with a similar safety profile for the treatment of symptomatic
articular cartilage defects of the knee."1
In the SUMMIT Extension trial, 128 patients (men and women aged
18 to 55) from the original SUMMIT study continue to be
followed. The co-primary endpoints of the extension study are
change in knee injury and osteoarthritis outcome (KOOS) pain and
function scores at year 3, the same primary endpoint from the
two-year SUMMIT trial. Patients treated with MACI versus MFX
continue to show a statistically significant improvement from
baseline in the co-primary endpoint of KOOS pain and function at
year 3 (p = 0.046) with higher responder rates in the MACI group
(81.5%) than in the MFX group (66.7%). Patients treated with
MACI versus MFX also showed significant improvement in knee-related
quality of life and other measures. The authors concluded that
"the co-primary endpoints of pain and function showed significant
improvement with MACI, which was statistically significantly better
than with MFX." The incidences of treatment emergent adverse
events and serious adverse events were similar between treatment
groups at year 3 and no unexpected safety findings were
reported.
David Recker, M.D., Vericel's chief medical officer, stated:
"These findings appear to support the positive risk-benefit profile
of MACI implantation in patients who require knee cartilage repair
surgery that was first demonstrated in the pivotal Phase 3 SUMMIT
study. We are extremely encouraged by the favorable clinical
and efficacy of MACI compared to MFX after 3 years of
follow-up."
1 D. Saris et al., "Matrix-Applied Characterized Autologous
Cultured Chondrocytes Versus Microfracture; Two-Year Follow-up of a
Prospective Randomized Trial," The American Journal of Sports
Medicine, Vol. 42, No. 6, April 2014
About MACI
MACI is a third-generation autologous chondrocyte implantation
(ACI) product for the treatment of focal chondral cartilage defects
in the knee. MACI has been approved but is not currently marketed
in Europe and is a Phase 3 product candidate in the United
States. The pivotal clinical trial supporting MACI registration in
Europe (Superiority of MACI Implant to Microfracture Treatment, or
SUMMIT) demonstrated a statistically significant and clinically
meaningful improvement in the co-primary endpoint of pain and
function for those patients treated with a MACI implant compared to
microfracture, the previous standard of care. MACI has the
potential advantages of a shorter, less-invasive surgical procedure
and faster recovery period than current biological treatments for
knee cartilage repair. Vericel plans to meet with the FDA this
year to discuss the requirements for registration of MACI in the
United States.
About Vericel Corporation
Vericel Corporation (formerly Aastrom Biosciences, Inc.) is a
leader in developing patient-specific expanded cellular therapies
for use in the treatment of patients with severe diseases and
conditions. The company markets two autologous cell therapy
products in the U.S.: Carticel® (autologous cultured chondrocytes),
an autologous chondrocyte implant for the treatment of cartilage
defects in the knee, and Epicel® (cultured epidermal autografts), a
permanent skin replacement for the treatment of patients with
deep-dermal or full-thickness burns comprising greater than or
equal to 30% of total body surface area. Vericel is also
developing MACI™, a third-generation autologous chondrocyte implant
for the treatment of cartilage defects in the knee, and
ixmyelocel-T, a patient-specific multicellular therapy for the
treatment of advanced heart failure due to ischemic dilated
cardiomyopathy. For more information, please visit the
company's website at www.vcel.com.
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our products and growth in revenues, intended product development,
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CONTACT: Chad Rubin
The Trout Group
crubin@troutgroup.com
(646) 378-2947
Lee Stern
The Trout Group
lstern@troutgroup.com
(646) 378-2922
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