OrthoLogic Announces Results of Phase 3 Clinical Trial of Chrysalin(R) (TP508) in Fracture Repair
15 Mars 2006 - 1:00PM
PR Newswire (US)
TEMPE, Ariz., March 15 /PRNewswire-FirstCall/ -- OrthoLogic Corp.
(NASDAQ:OLGC) today announced results of an analysis of topline
data from its Phase 3 clinical trial of the novel synthetic peptide
Chrysalin(R) (TP508) in unstable, displaced distal radius (wrist)
fractures. Treatment with 10ug Chrysalin did not demonstrate a
statistically significant benefit compared to placebo in the
primary efficacy endpoint of time to removal of immobilization. A
secondary endpoint, radiographic evidence of time to radial
cortical bridging, showed a statistically significant benefit for
Chrysalin-treated subjects (p = 0.049). This benefit mirrored
findings from the Phase 1/2 clinical trial that provided part of
the foundation for the Phase 3 study. No difference was observed
between Chrysalin treatment and placebo in the other secondary
endpoints. The trial met the pre-specified safety endpoint by
demonstrating no significant difference in adverse event rates
between the Chrysalin and placebo groups. "We will be conducting a
full examination of these results in order to guide our program
going forward, including a planned interim analysis of results from
the ongoing Phase 2b dose ranging trial of Chrysalin in distal
radius fractures, which includes a 30ug dose," commented James M.
Pusey, MD, President and CEO of OrthoLogic. The Company expects to
communicate results of its interim analysis during the third
quarter of 2006. Study Description The study was a prospective,
double-blind, randomized, placebo-controlled Phase 3 clinical trial
designed to evaluate the safety of Chrysalin and its efficacy
regarding the rate of healing in adult subjects with unstable
and/or displaced distal radius fractures. Subjects were randomized
to receive a single 1mL percutaneous injection of Chrysalin at 10
ug or placebo administered into the fracture site under
fluoroscopic guidance. Five hundred three subjects were enrolled at
27 active centers in the United States. Subjects were evaluated
post-surgery at weeks 1-8, 10, 12, 26 and 52. The primary efficacy
endpoint was time to removal of all immobilization, defined as the
elapsed time between the date of fracture surgery and the first
study visit at which the investigator, based on clinical and
radiographic assessments of healing, removed all rigid
immobilization hardware used to stabilize the fracture. Secondary
efficacy endpoints included: * Time to clinical and radiographic
bone healing * Assessment of the fractured wrist range of motion
and grip strength relative to the contralateral limb * Clinical
outcomes as measured by the Patient Rated Wrist Evaluation
questionnaire Safety was measured as the proportion of subjects
with treatment-emergent adverse events. Conference Call The Company
will host a live conference call and Web cast today at 9:00am EST
to discuss these results. The conference call may be accessed by
dialing 866-831-5605 for domestic callers and 617-213-8851 for
international callers and providing the passcode 38024735. The Web
cast may be accessed by visiting the Investor Relations section of
the Company's Web site, http://www.orthologic.com/, and will be
available for 30 days. A replay of the call will be available
beginning March 15, 2006, at 11:00am EST until March 29, 2006. To
access the replay, please dial 888-286-8010 for domestic callers
and 617-801-6888 for international callers and provide the access
code 12355097. About OrthoLogic OrthoLogic is a biotechnology
company focused on the development and commercialization of the
novel synthetic peptide Chrysalin(R) (TP508) in two lead
indications, both of which represent areas of significant unmet
medical need -- fracture repair and diabetic foot ulcer healing.
Based on the Company's pioneering scientific research of the
natural healing cascade, OrthoLogic has become a leading company
focused on tissue and bone repair. The Company owns exclusive
worldwide rights for Chrysalin. OrthoLogic is committed to
developing a pipeline of novel peptides and other molecules aimed
at helping patients with equally under-served conditions. The
Company has an exclusive worldwide license to the novel
pre-clinical 24-amino acid peptide AZX100, the first of a new class
of compounds in the field of smooth muscle relaxation called
Intracellular Actin Relaxing Molecules, or ICARMs(TM). AZX100 is
currently being investigated for medically and commercially
significant applications, such as the treatment of vasospasm
associated with subarachnoid hemorrhage, the prevention of keloid
scarring and the treatment of asthma. OrthoLogic's corporate
headquarters are in Tempe, Arizona. For more information, please
visit the Company's Web site: http://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 product candidates; and other factors
discussed in our Form 10-K for the fiscal year ended December 31,
2005, and other documents we file with the Securities and Exchange
Commission. DATASOURCE: OrthoLogic Corp. CONTACT: Media, Lauren
Tortorete of Biosector 2, +1-212-845-5622, , for OrthoLogic Corp.;
or Investors, Melanie Friedman of Stern Investor Relations, Inc.,
+1-212-362-1200, , for OrthoLogic Corp. Web site:
http://www.orthologic.com/
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