Capstone Therapeutics Announces Continuation of Second of Two AZX100 Phase 2 Clinical Trials in Keloid Scarring
12 Mai 2010 - 1:00PM
Capstone Therapeutics
(Nasdaq:CAPS) announced
today it has completed a limited analysis of a subset of data from
the second of its two ongoing AZX100 Phase 2a clinical trials in
keloid scarring. The clinical trial will continue to its
planned 12-month endpoints.
The company's goals for this analysis were to assess AZX100
ongoing safety, to evaluate the quality of the clinical trial
dataset in order to guide future studies and to determine whether
continuation of the trial would be futile from a statistical
perspective.
"We have again met our objectives for this preliminary analysis
of our second keloid trial," said Randolph C. Steer, MD, PhD,
President of Capstone Therapeutics. "Following a limited
review by our independent statistician of the safety and quality of
the dataset, we have been advised to continue the trial. The
primary endpoint is the 12-month POSAS score; we expect to report
data from this trial during 4Q2010."
The two ongoing AZX100 Phase 2 keloid clinical trials
(OL-ASCAR-04, dosing 3.0mg and 10.0mg per linear cm - continuation
announced March 2, 2010; and OL-ASCAR-05, dosing 0.3mg and 1.0mg
per linear cm – continuation announced today) are blinded,
placebo-controlled, multicenter, parallel group dose ranging
studies to evaluate the safety and preliminary efficacy of AZX100
following excision of keloid scars. The primary objective of
the studies is to evaluate the efficacy of AZX100 based on the
differences among dosage groups in Patient and Observer Scar
Assessment Scale (POSAS) scores at 12 months. Secondary
objectives include safety determination and evaluations of efficacy
via validated scar assessment scales using both 2D and 3D digital
photography. Fifty-nine subjects were dosed in each
trial. The analysis reported today examined certain metrics
from a subset of dosed subjects followed for six months
post-excision.
About Capstone Therapeutics
Capstone Therapeutics (trade name of OrthoLogic Corp.) 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,
treatment of pulmonary fibrosis and intimal
hyperplasia. 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
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 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,
2009, 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: Capstone Therapeutics
Investor Relations
Karen Struck
(602) 286-5250
kstruck@capstonethx.com
The Trout Group
Lauren Glaser
(415) 392-3310
lglaser@troutgroup.com
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