Findings from Four Year, Multi-Center Clinical Study on Autologous
Chondrocyte Implantation Presented, Coincide with New Product Labeling
CAMBRIDGE, Mass., July 16 /PRNewswire-FirstCall/ -- Genzyme Corporation
(Nasdaq: GENZ) announced today findings from the Study of the Treatment of
Articular Repair (STAR) which investigated the safety and effectiveness of
Carticel(R) (autologous cultured chondrocytes) in patients who had an
inadequate response to a previous knee cartilage repair procedure. This
landmark study demonstrated that autologous chondrocyte implantation
provided sustained and clinically meaningful improvements in knee function
and reductions in knee pain in this patient population with significant
limitations and knee pain at baseline. Internationally renowned orthopaedic
surgeon, Dr. Brian Cole of Rush-Presbyterian-St. Luke's Medical Center,
presented the data from the STAR study at the American Orthopaedic Society
for Sports Medicine (AOSSM) meeting yesterday in Calgary, Canada.
"This was a well done, rigorous study which provided confirmation of
our current treatment options for these types of patients," stated Dr.
Cole. "What was particularly compelling is that the study specifically
investigated the outcome of patients that were unresponsive to previous
surgical treatments. These patients had failed to receive a sustained
benefit from another surgery, yet most of them who had a Carticel implant
went on to a very good outcome."
Study Results
The study achieved its endpoints and successfully fulfills Genzyme's
final post-approval commitment to the FDA. Investigators enrolled patients
in 29 clinical centers throughout North America in this open label,
prospective 4 year study. Carticel is an autologous cell therapy used for
the repair of symptomatic cartilage lesions on the thigh bone portion of
the knee caused by acute or repetitive trauma in patients who have had an
inadequate response to a prior cartilage repair procedure.
The average patient in the study was approximately 35 years old, had a
significantly large articular cartilage lesion in their knee and rated
their pre-operative knee pain as quite severe (with a median score of 2 on
a scale of 1-10 where 0 is the most severe pain and 10 is normal). The
patient population experienced significant reductions in knee pain, as well
as improvements in function, including recreational and sports activities.
Genzyme's new Carticel labeling, announced on June 25, 2007, incorporates
the safety and efficacy data from the STAR study.
"AOSSM provided us with an excellent forum to share the results of the
STAR study with leading, national orthopaedic surgeons specializing in
sports medicine and cartilage repair," said Ann Merrifield, president of
Genzyme Biosurgery, the division that manufactures and commercializes
Carticel. "We were pleased to share the Carticel safety and efficacy data
which confirms how the product can truly make a lasting positive impact for
patients."
A Unique Cell Therapy
More than 13,000 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 has 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 studies.
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 a subsequent surgical procedure, primarily
arthroscopy, following Carticel implantation is common. The most common
reactions (>5% of patients), derived from the Study of the Treatment of
Articular Repair (STAR), include arthrofibrosis/joint adhesions, graft
overgrowth, chondromalacia or chondrosis, cartilage injury, graft
complication, meniscal lesion, graft delamination, and osteoarthritis.
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 9,000 employees in locations
spanning the globe and 2006 revenues of $3.2 billion. Genzyme has been
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,
orthopedics, 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'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.prnewswire.com/comp/113803.html/
CONTACT:
Media, Sarah Millerick, +1-617-768-6438, or
Investors, Catie Forte, +1-617-768-6881, both of Genzyme
Corporation
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