LAVAL, QC, March 17 /CNW/ - BioSyntech, Inc. ("BioSyntech" or "the
Company") (TSX: BSY), a biotechnology company developing novel products in
regenerative medicine, today announced it has received positive preliminary
results from a prospectively planned six-month interim analysis of its
Canadian-European pivotal clinical trial for BST-CarGel(R). Results drawn from
a 20 subject subset of the trial indicate evidence of a positive effect of
BST-CarGel(R) treatment on cartilage structure when compared to the surgical
control. The interim analysis also showed the safety of BST-CarGel(R) to be
comparable to the control. The sole purpose of this interim analysis was to
obtain pilot data for submission to the U.S. Food and Drug Administration
(FDA) as a pilot study in support of an Investigational Device Exemption (IDE)
for a U.S. pivotal trial for this medical device.
Dr. William Stanish, Professor of Surgery at Dalhousie University in
Halifax, Nova Scotia, and Principal Investigator for the trial commented, "I
do not have access to interim analysis data, but it came as no surprise when
BioSyntech told me that the evidence for BST-CarGel(R) appears to be positive.
The fundamental science behind the product is strong and is what led me to
participate in this initiative." Dr. Stanish treated several of the subjects
included in the interim analysis.
"Evidence of a positive effect of BST-CarGel(R) on both the quantity and
quality of the regenerated cartilage tissue is important at this six month
interim point, since these parameters comprise the primary endpoints of the
study," said Claude LeDuc, CEO of BioSyntech, "These results are in line with
our published animal studies demonstrating similar positive outcomes, as well
as anecdotal data in humans treated under Health Canada's Special Access
Program. Furthermore, this data supports our belief that BST-CarGel(R) could
be a cost-effective, off-the-shelf surgical alternative that could
dramatically improve cartilage repair over traditional methods in a minimally
invasive manner. We expect to confirm safety and efficacy of BST-CarGel(R) in
the longer 12 month analysis of the entire sample population of 80 subjects."
About the Canadian-European BST-CarGel(R) trial
The ongoing BST-CarGel(R) clinical trial is a randomized, comparative
study of the treatment of focal cartilage lesions located on the medial
femoral condyle in 80 subjects (40/group) from 18 to 55 years of age.
Treatment with BST-CarGel(R) applied to a microfractured cartilage lesion
under 10 cm2, is being compared to microfracture alone applied to similar
lesions. Subjects are randomized to treatment by either BST-CarGel(R) or
microfracture, and further stratified to their lesion type, either
characterized as acute (i.e. traumatic) or chronic (i.e. degenerative). The
primary endpoint for this trial is cartilage repair at 12 months, defined
through the quantity and quality of the repair tissue measured with
quantitative magnetic resonance imaging (MRI). Secondary endpoints are safety
and knee-related pain, stiffness and function measured using the Western
Ontario and McMaster Universities (WOMAC) osteoarthritis index questionnaire.
Subject enrolment currently stands at over 50% for this pivotal trial and
extensive efforts are underway to complete enrolment in 2008.
BioSyntech is a medical device company specialized in the development,
manufacturing and commercialization of advanced biotherapeutic thermogels for
regenerative medicine (tissue repair) and therapeutic delivery. Biosyntech's
platform technology is a family of hydrogels called BST-Gel(R), some of which
are liquid at low temperature and solid at human body temperature. These gels
can be injected or applied to a specific local site and offer beneficial
properties for the local repair of damaged tissue such as cartilage, bone and
chronic wounds and provide the benefit of avoiding invasive surgery. The
Company's two lead, late-stage products, BST-CarGel(R) and BST-DermOn(TM), are
currently undergoing Canadian and European pivotal trials. For additional
information, visit www.biosyntech.com.
This press release contains forward-looking statements and information
which are subject to material risks and uncertainties. Such statements are not
historical facts and are based on the current expectations of management. You
are cautioned that such statements are subject to a multitude of risks and
uncertainties that could cause actual results, future circumstances, or events
to differ materially from those projected in the forward-looking information.
These risks include, but are not limited to, those associated with our
capacity to finance our activities, the adequacy, timing, and results of our
clinical trials, the regulatory approval process, competition, securing and
maintaining corporate alliances, market acceptance of the Company's products,
the availability of government and insurance reimbursements for the Company's
products, the strength of intellectual property, the success of research and
development programs, reliance on subcontractors and key personnel, and other
risks and uncertainties detailed from time-to-time in our filings with the
Canadian securities commissions.
Readers should not place undue reliance on the forward-looking
information, given that (i) our actual results could differ materially from a
conclusion, forecast or projection in the forward-looking information, and
(ii) certain material factors or assumptions which were applied in drawing a
conclusion or making a forecast or projection as reflected in the
forward-looking information, could prove to be inaccurate. Additional
information about (i) the material factors that could cause actual results to
differ materially from the conclusion, forecast or projection in the
forward-looking information, and (ii) the material factors or assumptions that
were applied in drawing a conclusion or making a forecast or projection as
reflected in the forward-looking information, is contained in the Company's
annual report and other documents filed from time to time with the Canadian
securities commissions which are available at www.sedar.com. These statements
speak only as of the date they are made, and we assume no obligation to revise
such statements as a result of any event, circumstance or otherwise, except in
accordance with law.
For further information:
For further information: BioSyntech Inc., Yvonne Kramer Ph.D., Sr.
Director, Corporate & Business Development, Tel: (450) 686-2437, ext. 315,
Yvonne.Kramer@biosyntech.com; The Equicom Group, Arianna Vanin, Investor
Relations, Tel: (514) 844-4680, firstname.lastname@example.org