Capstone Therapeutics Announces Update to Timing of Release of Final Results From AZX100 Phase 2a Pilot Clinical Trial in Surgic
04 Avril 2011 - 10:05PM
Capstone Therapeutics (Nasdaq:CAPS) (the "Company") today announced
an update to the reporting schedule for twelve-month results from
its AZX100 Phase 2a pilot clinical trial in surgical (trocar site)
scarring.
Due to the size and complexity of the dataset, the report has
been delayed beyond the Company's originally-projected end-of-first
quarter 2011 announcement date.
The Company will report these results as soon as
practicable.
AZX100 Phase 2a in Surgical (Trocar Site)
Scarring
Study Description
The Company conducted a pilot Phase 2a clinical trial of AZX100
in surgical (trocar site) scarring (OL-ASCAR-03); this was a
double-blind, placebo within-patient controlled, multi-center dose
ranging study to evaluate the safety and preliminary efficacy of
AZX100 (3.0 mg or 10.0 mg versus placebo) in trocar site scars of
subjects who have undergone arthroscopic shoulder surgery. In this
trial, AZX100 (or placebo) was administered on Days 9 and 21
following surgery, with no additional dosing throughout the
remainder of the trial. One hundred fifty subjects were dosed
in the trocar site scarring trial.
Pre-specified endpoints of these studies included evaluations of
safety and efficacy of AZX100 based on the subjective primary
endpoint Patient and Observer Scar Assessment Scales (POSAS) and
objective secondary endpoints analyzed using 2D and 3D
high-resolution digital photography. These endpoints included
blinded, independently-scored Visual Analog Scales (VAS) and
objective measurements of scar dimensions.
About Capstone Therapeutics
Capstone Therapeutics is a biotechnology company committed to
developing a pipeline of novel therapeutic peptides aimed at
helping patients with under-served medical conditions. The
Company is focused on development and commercialization of two
product platforms: AZX100 and Chrysalin (rusalatide acetate or
TP508).
AZX100 is a novel synthetic 24-amino acid peptide, one of a new
class of compounds in the field of smooth muscle relaxation and
fibrosis. Based on its demonstrated effects in pre-clinical
models and safety in clinical trials, AZX100 is currently being
evaluated for commercially significant medical applications such as
the prevention or reduction of hypertrophic and keloid scarring and
treatment of pulmonary fibrosis. Capstone has an exclusive
worldwide license to AZX100.
Chrysalin, the Company's novel synthetic 23-amino acid peptide,
has been proven in multiple pre-clinical and clinical models to
stimulate cellular events leading to angiogenesis,
revascularization, and repair of dermal and musculoskeletal
tissues. It is currently being evaluated in disorders that
involve vascular endothelial dysfunction, such as acute myocardial
infarction and chronic myocardial ischemia. The Company owns
certain exclusive worldwide rights to Chrysalin.
Capstone's corporate headquarters are in Tempe,
Arizona. For more information, please visit the Company's
website: www.capstonethx.com.
The Capstone Therapeutics logo is available at
http://www.globenewswire.com/newsroom/prs/?pkgid=5429
Statements in this press release or otherwise attributable
to Capstone 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 product;
effects of the Capstone Stockholder Put Rights or ongoing Qui Tam
Litigation on our stock price, liquidity or our ability to continue
operations; effects on our stock price and liquidity if we are
unable to meet the requirements for continued listing on the Nasdaq
Capital Market; our 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, 2010, and other documents we file with the Securities
and Exchange Commission.
Editor's Note: This press release is also
available under the Investors section of the Company's website at
www.capstonethx.com.
CONTACT: Karen Struck, Investor Relations
(602) 286-5250
kstruck@capstonethx.com
Lauren Glaser --The Trout Group
(415) 392-3310
lglaser@troutgroup.com
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