Capstone Therapeutics Corp (NASDAQ:CAPS) plunged 52.38% to trade at $0.495
after the Company announced an unfavorable twelve-month results from its two
AZX100 Phase 2a pilot clinical trials in keloid scarring. Shares of the Company
fell 53 cents and hit its new 52-week low of $0.45 on the opening of the market.
2.59 million shares of the Company exchanged hands as compared to the 3 month
average trading volume of 0.177 million shares. The Company has a market
capitalization of $20.72 million on 40.78 million shares as on the current
market prices. The Company had however shown a favorable safety profile from its
seven-month interim analysis of the Phase 2a pilot surgical (trocar site)
scarring trial, and revealed multiple signals of AZX100 efficacy. The occurrence
of the favorable results was more frequent within the 3.0 mg trocar sites than
within sites receiving 10.0 mg. Additional statistical data is yet to be
determined as the study is still ongoing. Two tests had been conducted by the
biotechnology company for the reduction or prevention of post-excision keloid
scarring. The two pilot Phase 2a clinical trials of AZX100 included OL-ASCAR-04,
with dosing at 3.0 mg or 10.0 mg per linear cm; and OL-ASCAR-05, with dosing at
0.3 mg or 1.0 mg per linear cm. In these trials, AZX100 (or placebo) was
administered 21 and 42 days following surgery, with no additional dosing
throughout the remainder of the trial. Fifty-nine subjects were dosed in each
of these two pilot keloid scarring trials. The twelve-month AZX100 Phase 2a
pilot clinical trials did not meet the study objective of demonstrating
statistically-significant efficacy based on differences in this scale between
AZX100 and placebo at the single Month 12 time point, though the trial showed a
favorable safety profile for AZX100. Secondary endpoints showed multiple signals
of AZX100 efficacy within the1.0 mg-per-linear-cm cohort, particularly at
earlier time points but no significant benefit was observed for the other AZX100
doses. The endpoints of the trials included blinded, independently-scored Visual
Analog Scales (VAS) and objective measurements of scar dimensions. Each of the
endpoints of these trials was being evaluated for its potential to guide and
inform future studies of AZX100 in dermal indications. Keloid scars are among
the most difficult dermatologic conditions to treat, and there are no
currently-approved therapeutic agents specifically indicated for these scars.
The Company believes that the clinical data of AZX100 merited its continued
development and the Company on the basis of its trial's results seeks a
collaboration partner to advance AZX100 in both surgical and keloid scar
reduction. 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). Disclaimer: The assembled information distributed by
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