Large Outcome Studies Reported at AAOS Annual Meeting Support Longterm
Clinical Duration
CAMBRIDGE, Mass., March 10 /PRNewswire-FirstCall/ -- Genzyme Corp.
(Nasdaq: GENZ), today announced findings from a large, multicenter,
observational study that investigated the long-term durability of
Carticel(R) (autologous cultured chondrocytes) in patients who had pain and
functional impairment from defects in the articular cartilage of their
knee. These findings revealed that almost 90 percent of patients treated
with Carticel who experienced improvement in knee function at an early
follow-up, sustained their improvement for up to almost 10 years. The data
were presented at this week's American Academy of Orthopaedic Surgeons'
(AAOS) annual meeting in San Fransisco.
"We knew that autologous chondrocyte implantation (ACI) worked for
select patients, but did it last?" said Allen Anderson, MD, (Nashville, TN)
a leading orthopaedic surgeon in the field of sports medicine who presented
the data at the medical meeting. "These data suggest that the ACI technique
not only works, but when it works, the results will last for a long time.
Similar results of long term durability had been previously reported by
Lars Peterson, M.D., but this multicenter experience suggests that
sustainable results can be reproduced by others."
Study Results
The objectives of the study were to determine if a patient's
improvement assessed at an early timepoint, defined as 1 to 5 years (mean
4.6 years) after Carticel implantation, could be sustained at a much later
time point defined as 6 to 10 years (mean 9.2 years).
Seventy-two patients were enrolled from 35 different centers across the
US. All patients enrolled had low functional scores (overall condition
score of 3.4 points on the Modified Cincinnati Knee Rating System).
Patients were young (mean age of 37 years) and had moderate to large
lesions (mean lesion size of 4.3 cm2) on the femoral chondyles (Lateral
Femoral Chondyle, Medial Femoral Chondyle and Trochlea) and most patients
had undergone at least one previous treatment for their cartilage injury.
At their early follow-up, 75 percent of all patients experienced
significant improvement in their knee function (mean improvement of 4.3 in
overall condition). Of those patients, 87 percent sustained improvement at
the later follow-up time point.
"Long-term durability of Carticel had not been evaluated in the United
States and there was a critical need to determine if Carticel patients
experienced sustained improvement," said Leanna M. Caron, vice president
and general manager of Genzyme Biosurgery, the division that manufactures
and commercializes Carticel. "This study demonstrates both the durability
and value of Carticel and leads the field to conclude that a vast majority
of this patient population maintained improvement years following their
initial procedure."
Also at the AAOS meeting, a separate study conducted at the Brigham and
Women's Hospital in Boston, Mass., Dr. Tom Minas reported the findings of a
study that compared the results of ACI following a marrow stimulation
technique versus no significant treatment (including simple debridement)
performed on the same cartilage defect. The results indicate that marrow
stimulation techniques may compromise the successful outcome of future ACI.
Investigators collected data from 329 consecutive patients treated with
Carticel for large and multiple defects (4.8 cm2 per lesion and 8.7 cm2 per
patient) and had at least two years follow-up. They concluded that patients
who had a previous marrow stimulation technique and were subsequently
treated with ACI were three times more likely to fail than patients who had
not undergone a marrow stimulation technique prior to treatment with ACI.
"The data show that in this patient population marrow stimulation
techniques like microfracture are not benign and can compromise a patient's
ability to benefit from a subsequent treatment with ACI, effectively
limiting their future treatment options," said Tom Minas, MD, an
internationally renowned orthopaedic surgeon for his extensive work in the
field of Cartilage Repair and principal investigator in this study.
"Orthopaedic surgeons should reconsider using marrow stimulation techniques
as first-line treatment for patients with larger chondral lesions. These
techniques should be reserved for patients with smaller defects, in younger
patients, where a good result is more predictable."
A Unique Cell Therapy
More than 14,000 patients in the United States have had Carticel
implants. Carticel is used by orthopaedic surgeons to treat patients who
have clinically significant articular cartilage lesions on the thigh bone
part of the knee caused by acute or repetitive trauma that have not
responded to a prior cartilage repair procedure. Carticel should only be
used in conjunction with debridement, placement of a periosteal flap and
rehabilitation. The independent contributions of the autologous cultured
chondrocytes and other components of the therapy to outcome are unknown.
Carticel employs a unique process to grow a patient's own cartilage cells
for implantation to correct certain types of damage. The treatment starts
when an orthopaedic surgeon trained in the use of Carticel provides Genzyme
with a biopsy of healthy cartilage taken from a patient's knee in an
arthroscopic procedure. Technicians at Genzyme's cell culture laboratory in
Cambridge, MA, use proprietary methods to grow millions of cells from this
biopsy. The cells are then delivered to the hospital, where the surgeon
implants them into the patient's knee defect in a surgical procedure.
Carticel was the first cell therapy to be approved by the FDA. First
introduced in March of 1995, Carticel received accelerated approval from
the FDA in August of 1997 after the FDA instituted specific cell therapy
guidelines. Under accelerated approval, the FDA required Genzyme to conduct
confirmatory post-marketing clinical studies. Genzyme successfully
completed the confirmatory studies and, in June of 2007, the FDA deemed the
commitment satisfied.
To learn more about Carticel please visit http://www.carticel.com.
Cell Therapy Expertise at Genzyme
Genzyme has more than a decade of experience in developing and
manufacturing autologous cell therapy products that have been used to treat
thousands of patients. Epicel(R) (cultured epidermal autografts), a cell
therapy for treating patients with severe burns, is also manufactured by
Genzyme. Together, Carticel and Epicel represent the first such products
ever brought to market in the United States, providing Genzyme with
superior scientific and commercial expertise in this field.
About Carticel
CARTICEL is for autologous use and is indicated for the repair of
symptomatic cartilage defects of the femoral condyle (medial, lateral or
trochlea), caused by acute or repetitive trauma, in patients who have had
an inadequate response to a prior arthroscopic or other surgical repair
procedure (e.g., debridement, microfracture, drilling/abrasion
arthroplasty, or osteochondral allograft/autograft). CARTICEL should only
be used in conjunction with debridement, placement of a periosteal flap and
rehabilitation. The independent contributions of the autologous cultured
chondrocytes and other components of the therapy to outcome are unknown. It
is not indicated for the treatment of cartilage damage associated with
generalized osteoarthritis. It is not recommended for patients whose knee
meniscus has been surgically removed unless the patient has undergone
surgical reconstruction prior to or concurrent with CARTICEL implantation.
Pre-existing conditions including meniscal tears, joint instability or
malalignment of the joint should be corrected prior to or concurrent with
CARTICEL implantation. It should not be used in patients with a known
history of hypersensitivity to gentamicin, other aminoglycosides or
materials of bovine origin. CARTICEL is not routinely tested for
transmissible infectious diseases and may transmit disease to the
healthcare provider handling CARTICEL. In addition, it should not be used
in patients who have previously had cancer in the bones, cartilage, fat or
muscle of the treated limb. Use in children, patients over age 65, or in
joints other than the knee has not yet been assessed.
The occurrence of subsequent surgical procedures (SSPs), primarily
after arthroscopy, following CARTICEL implantation is common. In the Study
of the Treatment of Articular Repair (STAR), forty-nine percent (49%) of
patients underwent an SSP on the treated knee, irrespective of their
relationship to CARTICEL, during the 4-year follow-up. The most common
serious adverse events (greater than or equal to 5% of patients), derived
from STAR, include arthrofibrosis/joint adhesions, graft overgrowth,
chondromalacia or chondrosis, cartilage injury, graft complication,
meniscal lesion, graft delamination, and osteoarthritis. For more
information about Carticel, visit http://www.carticel.com.
About Genzyme
One of the world's leading biotechnology companies, Genzyme is
dedicated to making a major positive impact on the lives of people with
serious diseases. Since 1981, the company has grown from a small start-up
to a diversified enterprise with more than 9,500 employees in locations
spanning the globe and 2006 revenues of $3.2 billion. In 2007, Genzyme was
chosen to receive the National Medal of Technology, the highest honor
awarded by the President of the United States for technological innovation.
In 2006 and 2007, Genzyme was selected by FORTUNE as one of the "100 Best
Companies to Work for" in the United States.
With many established products and services helping patients in nearly
90 countries, Genzyme is a leader in the effort to develop and apply the
most advanced technologies in the life sciences. The company's products and
services are focused on rare inherited disorders, kidney disease,
orthopaedics, cancer, transplant, and diagnostic testing. Genzyme's
commitment to innovation continues today with a substantial development
program focused on these fields, as well as immune disease, infectious
disease, and other areas of unmet medical need.
GENZYME(R) and SYNVISC(R) are registered trademarks of Genzyme
Corporation SYNVISC ONE(TM) and SYNVISC-ONE(TM) are trademarks of Genzyme
Corporation
Genzyme's press releases and other company information are available at
http://www.genzyme.com and by calling Genzyme's investor information line at
1-800- 905-4369 within the United States or 1-678-999-4572 outside the
United States.
Media Contact: Investor Contact:
Sarah Millerick Catie Forte
(617) 768-6438 (617) 768-6881
SOURCE Genzyme Corporation
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Related links:
http://www.genzyme.com
http://www.carticel.com
http://www.prnewswire.com/comp/113803.html/
CONTACT:
Media: Sarah Millerick, +1-617-768-6438, or
Investor: Catie Forte, +1-617-768-6881
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