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TITLE: Patients Treated with Genzyme Tissue Repair's Carticel™ Show Long-Term Improvement
DATE: February 3, 1999
Orthopedic surgeons reported that 85 percent of patients treated with Genzyme
Tissue Repair's (Nasdaq:GENZL) Carticel(TM) autologous cultured chondrocytes to
repair damaged cartilage on the thigh-bone part of the knee showed improvement
in four key measures three years after therapy.
This result is revealed in the fifth report of the company's Cartilage Repair
Registry, which chronicles the progress of patients treated with Carticel, a
treatment that employs a proprietary process to grow a patient's own cartilage
to repair certain types of knee cartilage damage. Previous reports of the
registry had shown improvement at two years after surgery. The fifth report is
the first to include data from patients three years after surgery.
"We are very pleased with the growing consensus in the orthopedic community
about the important role of Carticel in treating patients," commented Tim
Surgenor, president, Genzyme Tissue Repair. "The data presented in this
registry report is consistent with the FDA approved labeling of Carticel and
will help build that consensus."
The registry data are scheduled to be presented February 5th by Bert
Mandelbaum,M.D. of the Santa Monica Orthopedic and Sports Medicine Group at a
symposium during the annual meeting of the American Academy of Orthopedic
Surgeons in Anaheim. In a recent publication, "Articular Cartilage Lesions of
the Knee" in The American Journal of Sports Medicine, Dr. Mandelbaum describes
a treatment algorithm for patients with cartilage defects which highlights the
use of Carticel.
The fifth registry report included data collected on 40 patients at the
36-month follow-up visit, 220 patients at the 24-month follow-up visit, and 588
patients at the 12-month follow-up visit, over four key measures: clinician
and patient evaluations of overall knee condition, patient reports of symptoms,
such as pain and swelling, and knee examination results.
The clinician and patient evaluations of overall knee condition were scored
using a modified Cincinnati knee scoring system, a rating method widely
recognized by orthopedic surgeons. Under that system, a score of 2 represents
poor condition, 4 is fair, 6 is good, 8 is very good, and 10 is excellent.
Patients with poor to fair ratings had significant to moderate limitations in
daily activities and were not able to participate in sports. Patients who were
rated good had no limitations in daily activities and could participate in
sports with compensation for limitations. Patients rated as very good could
participate in sports with only a few limitations, and patients rated as
excellent were able to participate in whatever sport they wished to with no
problem.
Among 40 patients with 36-month data, clinician and patient evaluations using
the Cincinnati scale increased from averages of 3.1 and 3.0 before treatment
to 6.8 and 6.6 at 36 months after treatment. There was essentially no
difference between the averages reported at 36, 24, and 12 months for this
group of patients in either the clinician or patient evaluation, indicating
that improvements noted at 12 months were sustained at 36 months.
On a scale where zero represents severe symptoms and 10 indicates no symptoms,
patients reported that 36 months after surgery pain improved by an average
of 3.2 points, swelling improved by an average of 3.6 points, partial giving
way of the knee improved by an average of 2.7 points, and full giving way of
the knee improved by an average of 2.2 points. With symptoms, as with overall
knee condition, there was little difference between the results at 12 months
and those at 36 months indicating that improvement was sustained.
Knee examinations revealed major decreases in joint line pain and effusion, and
increases in range of motion, at 12, 24 and 36 months, compared to examinations
done prior to treatment. The percentage of knees with joint line pain upon
clinical examination decreased from 84 percent before surgery to 32 percent at
36 months. The percentage with effusion – swelling measured by the surgeon's
examination – decreased from 81 percent of knees before treatment to 19 percent
at 36 months after treatment.
Data from the report also show that of all patients treated with Carticel
worldwide as of November 1998, 90 percent reported no complications, and
5 percent reported an adverse event determined by the treating surgeon to be
at least possibly related to Carticel. The cumulative incidence of treatment
failure was estimated to be 3.2 percent at 24 months and 4.7 percent at
36 months. A treatment failure occurs if another surgical procedure – either
a reimplantation of Carticel or a procedure that violates the subchondral
bone – is done on the defect, or if there has been a complete removal of the
Carticel graft.
Since the start of the registry, 91 percent of patients have reported no
additional surgical procedures following implantation of Carticel. The majority
of operations following Carticel implantation were minor and were performed
using an arthroscope.
Almost all of the patients in the registry were between the ages of 15 and 55.
During the five years prior to treatment, 71 percent of the patients had
undergone at least one procedure on the treated knee. Fifty-nine percent of
these patients had previously undergone at least one surgical procedure for
the treatment of articular injuries in the past five years.
Forty-nine percent of the knees underwent a previous procedure in which the
surgeon trimmed the edge of the defect, and 28 percent had undergone abrasion,
drilling, or microfracture, which have been widely regarded as the standards of
care.
The most frequent adverse events reported in the registry include adhesions and
overgrown tissue at the cartilage repair site and loosening of the Carticel
graft.
The data reported in the registry are observational in nature. The observed
changes may be due, at least in part, to factors other than the autologous
chondrocyte implantation procedure.
The registry is not a controlled clinical study. Patient participation is
voluntary. In addition, the report does not contain arthroscopic and
histological data, but Genzyme Tissue Repair is conducting two randomized,
controlled clinical studies and will report follow-up data on patients three
years and five years after treatment. These two studies will include
arthroscopic and histological evaluations.
Carticel was licensed by the U.S. Food and Drug Administration in August 1997,
for the repair of defects on the femoral condyle, or thigh-bone part of the
knee.
Members of the registry's independent advisory panel are Jon E. Browne, M.D.,
clinical associate professor, University of Missouri at Kansas City and
University of Kansas, and director, Orthopedic Sports Medicine Fellowship
Program, University of Missouri at Kansas City; Christoph Erggelet, M.D., Ph.D.,
Department of Orthopedics, University of Freiburg, Freiburg, Germany;
Freddie Fu, M.D., chairman, Department of Orthopedic Surgery, University of
Pittsburgh; Bert R. Mandelbaum, M.D., Santa Monica Orthopedic and Sports
Medicine Group, and director of fellowship, Santa Monica Orthopedic and Sports
Medicine Group, Santa Monica, Calif.; Lyle J. Micheli, M.D., director, Division
of Sports Medicine, Children's Hospital, and associate clinical professor,
Harvard Medical School, Boston; and J. Bruce Moseley Jr., M.D., Baylor Sports
Medicine Institute, Baylor College of Medicine, Houston.
Genzyme Tissue Repair is a leading developer of biological products for the
treatment of orthopedic injuries such as cartilage damage, and severe burns.
It is a division of Genzyme Corp. and has its own common stock intended to
reflect its value and track its performance.
This press release is a summary of a comprehensive report. Reporters and
investors who would like to see the full report may obtain a copy by calling
Genzyme's Corporate Communications Department at 617-374-7335. Surgeons can
get the report from Genzyme Tissue Repair at 1-800-453-6948 or 617-494-8484.
This press release contains forward-looking statements about the impact of the
registry data on market consensus regarding the use of Carticel. Actual
results may differ materially depending on many factors, including without
limitation actual results of sales and marketing efforts, market acceptance
of Carticel, levels of reimbursement approvals, and the competitive environment
for treatments for cartilage damage.
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Please call Genzyme's Corporate Communications department at
1-617-252-7570 for additional information. |
