CAPS plunges 52.38% on unfavorable AZX100 Phase 2a pilot clinical trial results

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 epicstockpicks.com is for information purposes only, and is neither a solicitation to buy nor an offer to sell securities. Epicstockpicks.com does expect that investors will buy and sell securities based on information assembled and presented herein. EpicStockPicks.com will not be responsible in any way for or accept any liability for any losses arising from an investor's reliance on or use of information obtained from our website or emails. PLEASE always do your own due diligence, and consult your financial advisor.
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