8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C.  20549

______________________

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

_______________________

Date of Report:  December 13, 2010 (Date of earliest event reported)

CAPSTONE THERAPEUTICS CORP.

(Exact name of registrant as specified in its charter)

Delaware	000-21214	86-0585310
(State or other jurisdiction of incorporation)	(Commission File Number)	(I.R.S. Employer Identification No.)

1275 West Washington Street, Suite 101, Tempe, Arizona	85281
(Address of principal executive offices)	(Zip Code)

Registrant’s telephone number, including area code:

(602) 286-5520

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

[ ] Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

[ ] Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

[ ] Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

[ ] Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Section 7 – Regulation FD

Item 7.01.            Regulation FD Disclosure.

The information in this Current Report, including the accompanying exhibit, is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Exchange Act or otherwise subject to the liabilities of that Section.  The information in this Current Report shall not be incorporated by reference into any registration statement or other document filed pursuant to the Securities Act of 1933, as amended, or the Exchange Act, regardless of any general incorporation language contained in such filing.

           On December 8, 2010, Capstone Therapeutics Corp. announced by press release that it will host a teleconference and webcast to discuss AZX100 clinical and other data, on Tuesday, December 14, 2010 at 11:00am EST / 10:00am CST / 9:00am MST / 8:00am PST.  The teleconference may be accessed at (877) 303-9204 (U.S.), (760) 536-5225 (outside U.S.); accompanying slides can be viewed by logging onto the Investors section of the Company’s website, www.capstonethx.com.  A replay will be available beginning December 14, 2010 at 1:00pm EST until midnight December 17, 2010 and may be accessed at (800) 642-1687 (U.S.) or (706) 645-9291 (outside U.S.) with conference ID 30689632.  A cop y of the presentation “Capstone Therapeutics AZX100 Dermal Scarring Clinical Development Program December 14, 2010” is attached as Exhibit 99.1 and is incorporated by reference herein.

Section 8 – Other Events

Item 8.01             Other Events

The information in this Current Report, including the accompanying exhibit, is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section.  The information in this Current Report shall not be incorporated by reference into any registration statement or other document filed pursuant to the Securities Act of 1933, as amended, or the Exchange Act, regardless of any general incorporation language contained in such filing.

On December 13, 2010, Capstone Therapeutics Corp. issued a press release on the results of AZX100 Phase 2a Pilot Clinical Trials in Keloid and Surgical Scarring.  A copy of the press release is attached hereto as Exhibit 99.2 and is incorporated by reference.

Section 9 – Financial Statements and Exhibits

Item 9.01             Financial Statements and Exhibits.

(d)                      Exhibits

Exhibit No.          Description

99.1                       AZX100 Dermal Scarring Clinical Development Program December 14, 2010

99.2                       Press Release dated December 13, 2010

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Dated:  December 14, 2010                                                                                     CAPSTONE THERAPEUTICS CORP.

/s/ John M. Holliman, III

John M. Holliman, III

Executive Chairman

EX-99

Exhibit 99.1

1

AZX100 Dermal Scarring
Clinical Development Program
14-Dec-2010

AZX100

AZX100

2

Safe Harbor Statement

Statements in this presentation or otherwise attributable to Capstone Therapeutics
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 or 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; effects of the Capstone Stockholder Put
Right on our stock price; 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.

3

Dermal Scarring: Range of Indications

Keloid Scars

•Overgrowth of dense fibrous
tissue

•Extend beyond borders of
original wound

•Do not regress
spontaneously

•Tend to recur after excision

Hypertrophic Scars

•Red, itching, raised fibrous lesions

•Typically do not expand beyond
boundaries of initial injury

•May undergo partial spontaneous
resolution

•Common after thermal and other
injuries that involve deep dermis

Normal Scars

•Various types:

•Flat, pale

•Sunken

•Red, dark, raised

•Result from surgery, burns
acne

4

Keloid Scars

The “tough problem”

          ►Progressive growth that extends past original scar

                   ●  Invades and destroys normal skin and tissue

          ►Cause of keloid formation still not understood; several theories

                   ●  Alteration in Dermal “Environment”

                   ●  Collagen Turnover

                   ●  Genetic Immune Dysfunction

                   ●  Viral Cause or Trigger

Little new in treatment of keloids over past 20 years;
       standard treatment may involve:

           ►  Steroid injection

           ►  Radiation

           ►  Pressure

           ►  5-fluorouracil

5

What are the Goals of Phase 2a?

Safety & Tolerability

Initial Investigation of Dose &
     Administration

Analyses to Detect Any Signal or Trend of
    Efficacy

6

AZX100 Phase 2a Clinical Trials - Keloid
Scars

7

AZX100 Phase 2a Clinical Trials - Keloid Scars

Two Studies:

         ►  OL-ASCAR-04:3.0, 10.0 mg per linear cm or placebo

         ►  OL-ASCAR-05:0.3, 1.0 mg per linear cm or placebo

Objective:

         ►  Reduction or prevention of recurrence following
           keloid scar excision

Study Design:

         ►  Placebo-controlled; n = 59 in each study (118 dosed)

         ►  Two Intradermal injections

                   ●  21 ± 2 days following excision

                   ●  42 ± 2 days following excision

8

AZX100 Phase 2a Results - Keloid Scars

Summary

OL-ASCAR-04 & -05 Primary Efficacy Endpoints
     (POSAS @ Single Month 12 Time Point) Not Met

OL-ASCAR-05 Secondary Endpoints Reveal
     Multiple Signals of Efficacy Before Month 12

         ►  Consistent pattern favoring AZX100 treatment
           (1.0 mg per cm) across multiple outcomes &
           time points

         ►  With small sample size (n=19),
           signals not statistically significant

         ►  Serves as basis for next study design

Favorable Safety Profile

9

Where was AZX100 “better”?
Outcomes & Time Points at which AZX100 1.0mg/cm was “better” than placebo
(not statistically significant)

Mean Observer POSAS
      Total

         ► Months 4-7

Mean Patient POSAS
      Total

         ► Months 3-9

Mean Observer VAS

         ► Months 4-7

Mean Scar Width

         ► Months 2-6

Mean Scar Maximum
      Elevation

         ► Months 2-9

Mean Scar Mean
      Elevation

         ► Months 3-9

Mean Blinded VAS

         ► Months 3-6

AZX100 OL-ASCAR-05 - 12-Month Analysis - 1.0 mg/cm Dose Group vs. PlaceboMean Scar Width (mm) by Visit by Treatment Group

Not statistically significant;
for illustrative purposes only

10

AZX100 OL-ASCAR-05 - 12-Month Analysis - 1.0 mg/cm Dose Group vs. Placebo

Mean Scar Maximum Elevation (mm) by Visit by Treatment Group

Not statistically significant;
for illustrative purposes only

11

12

Consistent Pattern Favoring AZX100 Treatment
      (1.0 mg per cm) Across Multiple Outcomes & Time Points

          ► Small sample size (n=19); signals not statistically significant

Trend of Efficacy Observed at Earlier Time Points (Months 2-9)

          ► Mean Observer POSAS Total

          ► Mean Patient POSAS Total

          ► Mean Observer VAS

          ► Mean Scar Width

          ► Mean Scar Maximum Elevation

          ► Mean Scar Mean Elevation

          ► Mean Blinded VAS

Favorable Safety Profile

AZX100 Phase 2a Results - Keloid Scars

Conclusions

13

AZX100 Phase 2a Clinical Trials - Surgical
(Trocar Site) Scars

14

AZX100 Phase 2a Clinical Trial in
Surgical (Trocar Site) Scars

One Study:

           ► OL-ASCAR-03:3.0, 10.0 mg or placebo

Objective:

           ► Scar reduction in trocar sites

Study Design:

           ► Comparison of three trocar site scars following arthroscopic
             shoulder surgery

           ► Placebo-controlled; n = 150 dosed

           ► Two active doses per patient (intra-patient control)
             3.0 mg, 10.0 mg

           ► Placebo-only cohort (n=25)

           ► Two intradermal injections into each trocar site

                   ● 9 ± 2 days following surgery

                   ● 21 ± 2 days following surgery

15

OL-ASCAR-03:
      7-Month Interim Analysis of Selected Metrics Reveals
      Multiple Signals of Efficacy

         ► Monthly statistical tests performed:Months 3-7
          (7 outcomes x 5 months x 2 comparisons = 70 tests)

                     ● 8 tests yielded statistically significant or near significant results

                     ● 7 of these 8 favored AZX100

         Slightly more often at 3.0 mg than 10.0 mg

         Most effects earlier than Month 7

         Examples:   Scar Total Volume @ Month 3 (p = 0.047);
                                              Scar Length @ Month 5 (p = 0.034)

Favorable Safety Profile

AZX100 Phase 2a Clinical Trial in
Surgical (Trocar Site) Scars - Interim Results

16

Is AZX100 a Viable Candidate for
Clinical & Commercial Development?

Novel Mechanism

                ►Anti-fibrotic

Strong Patent Position

Phase 2a - Early Human Efficacy Trials

                ►Demonstrated Safety

                ►Observed Signal of Efficacy Across Multiple Time Points

Cost-Effective Manufacturing Process

Market Potential…

                ►Multiple Indications

                      ●Dermal Scarring; Other Fibrotic Disorders (e.g., IPF)

                ►Benefits in Scarring:“Faster / Stronger / Smaller”

                ►Large Market

                      ●22.5 Million Procedures Performed Annually in U.S. Alone

                      ●Estimated Addressable Market >$1.0 Billion

                ►Prophylactic Standard of Care in General Surgery

                ►Reimbursement for Problem Scars (Keloid)

17

Is AZX100 a Viable Candidate for
Clinical & Commercial Development?

Answer:

         ► Capstone believes the AZX100
           development program in
           dermal scarring should be continued

To this end…

          ►Capstone is pursuing a pharma or biotech collaboration to
            fund development

          ►Internal planning & development programs continue

          ►Clinical Pathway Indicated

                    ●  Initiate Phase 2 dose / administration optimization studies in both
                    keloid and normal scars prior to moving to Phase 3 registration trials

18

NASDAQCM:CAPS

www.capstonethx.com

Capstone Therapeutics

1275 West Washington Street - Suite 101

Tempe, AZ85281

(602) 286-5520

EX-99

Exhibit 99.2

Capstone Therapeutics Announces Results of AZX100 Phase 2a Pilot Clinical Trials in Keloid and Surgical Scarring

TEMPE, Ariz., Dec. 13, 2010 (GLOBE NEWSWIRE) -- Capstone Therapeutics (Nasdaq:CAPS)(the "Company") announced today twelve-month results from its two AZX100 Phase 2a pilot clinical trials in keloid scarring and seven-month interim results of its ongoing AZX100 Phase 2a pilot clinical trial in surgical (trocar site) scarring.

The goals of a Phase 2a clinical trial include assessments of the safety and tolerability of the therapeutic agent being tested, initial investigation of dose and administration schedules and analyses to detect any signal or trend of efficacy in the chosen indication.

AZX100 Phase 2a in Keloid Scarring - Study Description

Keloid scars are among the most difficult dermatologic conditions to treat, and there are no currently-approved therapeutic agents specifically indicated for these scars. "Preventing development of a keloid after surgery is a real challenge. I don't know a reliable way to routinely do it," said Mark V. Dahl, MD, former President, American Academy of Dermatology and a consultant to Capstone.

Capstone conducted two pilot Phase 2a clinical trials of AZX100 in reduction or prevention of post-excision keloid scarring: 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. These were blinded, placebo-controlled, multicenter, parallel group dose ranging studies to evaluate the safety and preliminary efficacy of AZX100 following excision of keloid scars. Fifty-nine subjects were dosed in each of these two pilot keloid scarring trials.

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. Each of the endpoints of these trials was being evaluated for its potential to guide and inform future studies of AZX100 in dermal indications.

Twelve-Month Results [Click here for accompanying slides]

• The primary endpoint of the Phase 2a pilot keloid scarring trials was the Month 12 score on the subjective POSAS. The 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.
• Secondary endpoints, including earlier monthly POSAS scores, VAS scores and objective endpoints based on high resolution digital photography, showed multiple signals of AZX100 efficacy within the1.0 mg-per-linear-cm cohort, particularly at earlier time points (e.g. between Months 2 and 9, depending upon the metric.) No meaningful benefit was observed for the other AZX100 doses (0.3 mg, 3.0 mg or 10.0 mg per linear cm).
• There was a consistent pattern favoring AZX100 treatment (1.0 mg per linear cm) across multiple outcomes and time points; but, with a small sample size (n=19), these signals were not statistically significant.
• The safety profile of AZX100 was determined to be favorable.

AZX100 Phase 2a in Surgical (Trocar Site) Scarring - Study Description

The Company is also conducting - with similar outcome measures - a pilot Phase 2a clinical trial of AZX100 in surgical (trocar site) scarring (OL-ASCAR-03); this is 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 9 and 21 days following surgery, with no additional dosing throughout the remainder of the trial.

One hundred fifty subjects were dosed in the trocar site scarring trial. Twelve-month data from this study are due 1Q2011.

Seven-Month Interim Results

The limited seven-month interim analysis of the Phase 2a pilot surgical (trocar site) scarring trial 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. 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).

Because the study is ongoing, it is not yet possible to determine whether additional statistically significant effects will be observed.

Commentary

"We designed these Phase 2a pilot clinical trials to guide the future development of AZX100 in multiple scarring indications. The favorable safety profile and the observed efficacy signals support our belief that AZX100 is a viable candidate in dermal scar reduction," said Randolph C. Steer, MD, PhD, President of Capstone Therapeutics. "The pattern of AZX100 efficacy at 1.0 mg per linear cm at earlier time points that was seen in the keloid trial will assist us in future dose and administration optimization clinical trials."

"We believe the AZX100 clinical data merit its continued development," said Jock Holliman, Executive Chairman of Capstone Therapeutics. "Based on the results obtained thus far from these Phase 2a pilot clinical trials, Capstone will seek a collaboration partner to advance AZX100 in both surgical and keloid scar reduction."

Capstone Therapeutics to Host AZX100 Clinical Update Teleconference [Click here for accompanying slides]

Capstone Therapeutics will host a teleconference and webcast to discuss AZX100 clinical and other data today, Tuesday, December 14, 2010 at 11:00am EST / 10:00am CST/ 9:00am MST/ 8:00am PST. The teleconference may be accessed at (877) 303-9204 (U.S.), (760) 536-5225 (outside U.S.); accompanying slides can be viewed by logging onto the Investors section of the Company's website, www.capstonethx.com. A replay will be available beginning December 14, 2010 at 1:00pm EST until midnight December 17, 2010 and may be accessed at (800) 642-1687 (U.S.) or (706) 645-9291 (outside U.S.) with conference ID 30689632.

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 Right 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, 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

                       (415) 392-3310

                       kstruck@capstonethx.com

                      The Trout Group

                      Lauren Glaser

                      (602) 286-5250

                      lglaser@troutgroup.com