OrthoLogic Announces Results of Preliminary Interim Analysis of Phase 2b Clinical Trial of Chrysalin(R) (TP508) in Fracture Rep
29 Agosto 2006 - 4:00PM
PR Newswire (US)
TEMPE, Ariz., Aug. 29 /PRNewswire-FirstCall/ -- OrthoLogic Corp.
(NASDAQ:OLGC) today announced results of an interim analysis of
data from its Phase 2b dose-ranging clinical trial of the novel
synthetic peptide Chrysalin(R) (TP508) in unstable, displaced
distal radius (wrist) fractures. Study Description This was a
prospective, double-blind, randomized, placebo-controlled Phase 2b
multi-site, five-arm dose-response study. The five arms correspond
to Chrysalin dosages of 0 (placebo), 1, 3, 10, and 30 ug. Two
hundred seventy-four subjects were enrolled at the time enrollment
was interrupted, of whom 240 were evaluable. The study was designed
to evaluate the safety and efficacy of these doses of Chrysalin on
the rate of healing in adult subjects with unstable and/or
displaced distal radius fractures. Subjects were randomized to
receive a single 1 mL percutaneous injection of Chrysalin at one of
the above doses, administered into the fracture site under
fluoroscopic guidance. Subjects were evaluated post-surgery at
weeks 1-8, 10, 12, 26 and 52. The primary efficacy endpoint was
time to removal of all rigid immobilization used to stabilize the
fracture, defined as the time elapsed 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. 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 incidence of treatment-emergent adverse events. Study
Results In the dataset of 240 subjects as a group that were
evaluable in the Phase 2b interim analysis, treatment with
Chrysalin did not demonstrate benefit compared to placebo in the
primary efficacy endpoint of time to removal of immobilization.
Individual findings of efficacy in secondary endpoints, including
radiographic healing, were not seen in this interim analysis.
Further, no dose response relationship was observed. The trial met
the pre-specified safety endpoint by demonstrating no significant
difference in the incidence of adverse events between the Chrysalin
and placebo groups. Based on these results, the Company has
terminated the study with no further recruitment of subjects. The
interim analysis will continue, and any significant findings will
be disclosed as appropriate. "We interrupted enrollment in the
Phase 2b clinical trial in mid-March 2006 in order to perform the
interim analysis of subjects enrolled to that date," commented
Randolph C. Steer, MD, Ph.D., President of OrthoLogic. "This trial
was not powered at the interim analysis stage to detect
statistically significant differences among dose cohorts regarding
the efficacy of Chrysalin. We had hoped to discern a dose response
curve through this trial design." Dr. Steer continued: "We intend
to proceed with our planned approach to the U.S. and European
regulatory authorities to discuss pathways forward for TP508 in
fracture repair." About OrthoLogic OrthoLogic is a biotechnology
company committed to developing a pipeline of novel therapeutic
peptides and other molecules aimed at helping patients with
under-served medical conditions. The Company is focused on the
development and commercialization of two product platforms:
Chrysalin(R) (TP508) and AZX100. Chrysalin, the Company's novel
synthetic 23-amino acid peptide, is being studied 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 bone and tissue repair. The Company owns exclusive
worldwide rights to Chrysalin. AZX100 is a novel synthetic 24-amino
acid peptide in pre-clinical development, one 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 evaluated for commercially significant medical
applications, such as the treatment of vasospasm associated with
subarachnoid hemorrhage, the prevention of keloid scarring and the
treatment of asthma. OrthoLogic has an exclusive worldwide license
to AZX100. OrthoLogic's corporate headquarters are in Tempe,
Arizona. For more information, please visit the Company's website:
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
pre-clinical or clinical testing; unfavorable outcomes in our
pre-clinical 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: 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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