Capstone Therapeutics (Nasdaq:CAPS)
(the
"Company") today announced that the final results from its
AZX100 Phase 2a pilot clinical trial in surgical (trocar site)
scarring confirmed the early signal of effect observed in the
interim analysis previously announced. The Company plans to
continue its efforts to secure a clinical development partner and
move AZX100 toward additional trials in dermal scarring.
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 (length, width, elevation
and volume).
Analytical History
As reported by the Company on December 14, 2010, a limited
seven-month interim analysis of the Phase 2a pilot surgical (trocar
site) scarring trial (the "Original Analysis") showed a favorable
safety profile and revealed multiple signals of AZX100 efficacy,
more often within the 3.0 mg trocar sites than within sites
receiving 10.0 mg. Within this analysis - which focused on
objective measurements of the trocar site scars based on high
resolution 3-dimensional digital photography - most AZX100
treatment effect at 3.0 mg was seen at time points earlier than
Month 7; e.g., Scar Total Volume at Month 3 (p = 0.047) and Scar
Length at Month 5 (p = 0.034).
As announced by the Company on April 4, 2011, the size and
complexity of the study data set forced a delay in reporting final
results. Among the subjective, "mixed" and objective metrics
selected for this trial (POSAS, VAS and high-resolution digital
photography, respectively), only the objective metrics utilizing 3D
photographic imaging and mapping detected a therapeutic
effect. Furthermore, certain challenges were encountered in
confirming within the final data set (the "Final Analysis") the
imaging results and interim "signal" obtained from the Original
Analysis, due largely to the small size and healing qualities of
the trocar site scars.
The Final Analysis incorporates data obtained from a complete
review of all objective metrics, with imaging and mapping
techniques consistently applied.
Final Results
- The early signal of AZX100 effect was observed in objective
measurements of the trocar site scars based on high resolution
3-dimensional digital photography. For example, significantly
smaller scars as measured by total volume were seen at Month 3 in
the AZX100 treatment groups for both 3.0 mg (p = 0.0094) and 10.0
mg (p = 0.033). P-values for this metric at Month 12 were 0.56
and 0.66 for the 3.0 mg and 10.0 mg treatment groups
respectively.
- An examination of scar histology at Month 12 – measuring
collagen density, maturity and orientation – also revealed a signal
of efficacy for AZX100 at 3.0 mg (significant or nearly significant
improvements in all three tests of 3.0 mg AZX100 vs. placebo); this
was not observed in the histological tests of 10.0 mg AZX100.
- The primary efficacy endpoint was the Month 12 score on the
subjective POSAS. This trial did not meet the study objective
of demonstrating statistically-significant efficacy based on
differences in this scale between AZX100 (3.0 mg or 10.0 mg) and
placebo at Month 12.
- Secondary endpoints including earlier monthly POSAS and VAS
scores showed no meaningful benefit of AZX100 treatment.
- The safety profile of AZX100 was deemed favorable.
Commentary
"We are pleased that the final results of this pilot clinical
study have confirmed the favorable safety profile of AZX100 and
disclosed a statistically significant signal of an early positive
effect for AZX100 in trocar site scars," said Randolph C. Steer,
MD, PhD, President of Capstone Therapeutics. "With these
latest results, the AZX100 efficacy signal previously seen in
keloid scars has now been established in trocar site
scars. These results were obtained at AZX100 doses and
administration schedules that may not be optimal, which indicates
an opportunity to amplify this early signal through additional
studies."
"We believe the implications of these results for an AZX100
partnering event in dermal scarring are favorable," said Jock
Holliman, Executive Chairman of Capstone. "Our efforts aimed
at partnering will continue. While there are no guarantees
that an arrangement will be reached, we remain optimistic regarding
the prospects for AZX100 in dermal scarring."
Capstone Therapeutics to Host AZX100 Clinical Update
Teleconference
Capstone will host a conference call and webcast on Thursday,
April 28, 2011 at 9:00am EDT / 8:00am CDT / 6:00am
MST/PDT. The call may be accessed at 877-303-9204 (U.S.),
760-536-5225 (outside U.S.); accompanying slides may be viewed on
the Investors section of the Company's website,
www.capstonethx.com. A replay will be available beginning
April 28, 2011 at 12:00 noon EDT until midnight, May 1, 2011 and
may be accessed at 800-642-1687 (U.S.), 706-645-9291 (outside U.S.)
with conference ID 63370938.
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
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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