OrthoLogic Announces Publication of Preclinical Data on Fracture Repair; Data Offers Further Insight into Chrysalin's Mechanism
June 16 2005 - 7:00AM
Business Wire
OrthoLogic Corp. (Nasdaq:OLGC), today announced the publication of
a key preclinical study in support of the ongoing Chrysalin (TP508)
fracture repair program. This preclinical study, published in the
current volume of Journal of Orthopaedic Research, the official
publication of the Orthopedic Research Society, was conducted as
collaboration among researchers led by Dr. Joseph Lane of the
Hospital for Special Surgery in New York, Dr. Xinmin Li of the
University of Chicago and Dr. James Ryaby, chief scientific officer
of OrthoLogic. This study tested the hypothesis whether Chrysalin
injected into an experimental fracture would upregulate genes that
control the inflammatory phase of fracture repair, and whether this
would result in an earlier appearance of new vasculature into the
fracture callus. Specifically, this study used Affymetrix
genomescale profiling to link early gene expression changes to
fracture histology and bone strength changes. The first stage of
this study showed that treatment of fractures with Chrysalin
accelerated fracture repair as demonstrated by mechanical testing
analysis, which measures the strength of the healing fracture. The
second stage used blinded histological analysis to quantify the
amount of new blood vessels in the healing fracture callus. The
results showed Chrysalin-treated fracture callus had a significant
increase in blood vessels relative to the controls. The final stage
of this study used genome array analysis to assess changes in
specific gene expression upon Chrysalin treatment. This gene array
analysis showed that Chrysalin induced expression of inflammatory
response modifiers and angiogenesis-related genes. The study's
conclusion states: "Chrysalin promotes fracture repair through a
mechanism that involves an increased induction of a number of
growth factors, enhanced expression of inflammatory mediators and
angiogenesis-related genes." "We believe studies such as these are
critical for developing peptide-based therapeutics such as
Chrysalin, and follow-up studies are underway to expand upon these
results," said Dr. Ryaby. "These studies will be used to educate
physicians on the mechanism of action of Chrysalin and provide
additional evidence of Chrysalin's mechanism of action for other
indications in orthopedic, dermal and cardiovascular tissue
repair." About Chrysalin(R) Chrysalin (TP508) is a 23-amino acid
peptide that represents the receptor-binding domain of the human
thrombin molecule, the naturally occurring agent responsible for
blood clotting and initiating many of the cellular events
responsible for repair in both soft tissue and bone. All cells
contain high-affinity thrombin receptors, which led to the
hypothesis that thrombin did more than form blood clots after
wounding. It was discovered that thrombin acted as a signaling
molecule to initiate the early stages of tissue repair. The basis
for the development of Chrysalin started in 1985, when a class of
synthetic peptides was developed representing a specific
receptor-binding domain of thrombin that activates specific
wound-healing signals. Drugs based on the Chrysalin peptide can be
used to mimic part of the thrombin response without stimulating the
events associated with blood clotting and therefore have the
potential to accelerate the natural cascade of healing events.
About OrthoLogic Corp. OrthoLogic is a drug-development company
focused on commercializing several potential therapeutics
comprising the Chrysalin(R) Product Platform, a series of product
candidates aimed at treating traumatic and chronic orthopedic
indications in bone and soft tissue as well as cardiovascular
repair and wound healing. All of these potential products are based
on the Chrysalin synthetic peptide, also known as TP508. OrthoLogic
owns an exclusive license for all worldwide medical indications for
the peptide, and is actively pursuing five orthopedic indications
for Chrysalin. These include fracture repair and spine fusion,
which are in human clinical trials, and cartilage defect repair,
which is in late-stage preclinical trials. Ligament and tendon
repair indications are in the preclinical studies stage. In
non-orthopedic areas, a human clinical trial for chronic diabetic
ulcers has been completed. OrthoLogic's product development
pipeline also includes Chrysalin-based product candidates for
dental bone formation and myocardial revascularization. For more
information, please visit the company's Web site:
www.orthologic.com. Statements in this press release or otherwise
attributable to OrthoLogic regarding our business that are not
historical facts are made pursuant to the safe harbor provisions of
the Private Securities Litigation Reform Act of 1995. These
forward-looking statements, which include the timing and
acceptability of FDA filings and the efficacy and marketability of
potential products, involve risks and uncertainties that could
cause actual results to differ materially from predicted results.
These risks include: delays in obtaining or inability to obtain
FDA, institutional review board or other regulatory approvals of
preclinical or clinical testing; unfavorable outcomes in our
preclinical and clinical testing; the development by others of
competing technologies and therapeutics that may have greater
efficacy or lower cost; delays in obtaining or inability to obtain
FDA or other necessary regulatory approval of our products; our
inability to successfully and cost effectively develop or outsource
manufacturing and marketing of any products we are able to bring to
market; changes in FDA or other regulations that affect our ability
to obtain regulatory approval of our products, increase our
manufacturing costs or limit our ability to market our products;
our possible need for additional capital in the future to fund the
continued development of our Chrysalin Product Platform; and other
factors discussed in our Form 10-K for the fiscal year ended
December 31, 2004 our Form 10-Q for the quarter ended March 30,
2005, and other documents we file with the Securities and Exchange
Commission.
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