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 (Date of earliest event reported) July 23, 2015
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) | (IRS Employer Identification No.) |
1275 West Washington Street, Suite 104, Tempe, Arizona | 85281 | |||
(Address of principal executive offices) | (Zip Code) |
(602) 286-5520
Registrant's telephone number, including area code
________________________________________________________________________________
(Former name or former address, if changed since last report)
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): |
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[ ] | 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 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 July 23, 2015, Capstone Therapeutics Corp. (the "Company") and its joint venture affiliate,LipimetiX Development, Inc., issued a press release announcing a patent application for Novel, More Potent Chimeric APO E Mimetic Peptides. A copy of the press release is attached hereto as Exhibit 99.1 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
Press Release dated July 23, 2015
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
CAPSTONE THERAPEUTICS CORP. |
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Date: July 23, 2015 |
/s/ JOHN M. HOLLIMAN, III John M. Holliman, III Executive Chairman and CEO |
EXHIBIT 99.1
TEMPE, Ariz., July 23, 2015 (GLOBE NEWSWIRE) -- Capstone Therapeutics Corp. (OTCQB:CAPS) ("the Company") and its joint venture affiliate, LipimetiX Development, Inc. ("JV"), announced today the conversion of a provisional U.S. Patent application claiming novel, more potent analogs of its lead peptide, AEM-28. The JV has supported research by Dr. G.M. Anantharamaiah at the University of Alabama, Birmingham ("UAB") to identify novel analogs of AEM-28 that demonstrate greater efficacy than the parent peptide and provide new composition of matter patent protection. One of the new, chimeric Apo E mimetic peptides (AEM-28-14), tested in multiple, validated animal models, demonstrates up to 400% greater cholesterol lowering efficacy and a several fold increase in the NOAEL (No Observed Adverse Effect Level) dose, a primary indicator of drug tolerability. The combination of enhanced efficacy and toleration potentially increases the therapeutic window (the range for delivering a safe and efficacious dose) significantly over previous analogs of AEM-28.
Dennis Goldberg, Ph.D., President of LipimetiX, stated: "We believe that the profound cholesterol lowering effect of a single injection of AEM-28-14, accompanied by the enhanced toleration, will allow us to expand upon the statistically-significant VLDL cholesterol and triglyceride reductions seen in our recently completed AEM-28 human clinical studies. Subject to funding, the JV plans to begin development of AEM-28-14 for cholesterol and triglyceride reduction in patients refractory to available therapeutic modalities."
Chimeric Apolipoprotein E Mimetic Peptides
Apolipoprotein E (Apo E) is in a class of protein that occurs throughout the body. Apo E is essential for the normal metabolism of cholesterol and triglycerides. After a meal, the postprandial (or post-meal) lipid load is packaged in lipoproteins and secreted into the blood stream. Apo E targets cholesterol and triglyceride rich lipoproteins to specific receptors in the liver, decreasing the levels in the blood. Elevated plasma cholesterol and triglycerides are independent risk factors for atherosclerosis, the buildup of cholesterol rich lesions and plaques in the arteries. Atherosclerosis is the major cause of cardiovascular disease, peripheral artery disease and cerebral artery disease, and can cause heart attack, loss of limbs and stroke. Defective lipid metabolism also plays an important role in the development of adult onset diabetes mellitus (Type 2 diabetes), and diabetics are particularly vulnerable to atherosclerosis, heart and peripheral artery diseases.
The UAB scientists patented the first chimeric Apo E mimetic peptide in 1999, reducing the 299 amino acid native Apo E into a 28 amino acid, dual domain peptide that can be delivered therapeutically. One domain inserts into a lipoprotein surface and the second domain binds to the Apo E receptors in the liver. In 2010, our JV's founding scientist, Dr. Dennis Goldberg, obtained worldwide right to patents for Apo E mimetic peptides from the UAB Research Foundation ("UABRF"). The JV has an Exclusive License Agreement with the University of Alabama at Birmingham Research Foundation for AEM-28 and its analogs.
AEM-28-02 was the first of the new generation chimeric Apo E peptides discovered, resulting in a provisional patent filing in July 2014. AEM-28-02 was found to be approximately 30% more potent (as tested in multiple animal models) than the parent molecule, AEM-28. AEM-28-14 is the most potent of the newly-discovered chimeric Apo E mimetic peptides. As shown in the attached figures, a single 50 ug injection of AEM-28-14 decreased cholesterol 98% in Apo E null mice. The rapid reduction of cholesterol was well tolerated, with no observed adverse effects. Cholesterol remained 35% below baseline at 24 hours.
Charts accompanying this release are available at http://media.globenewswire.com/cache/7986/file/35810.pdf
Subject to continued favorable study results and funding availability, the JV may pursue regulatory approval of AEM-28-14 as treatment for Homozygous Familial Hypercholesterolemia, Acute Hypertriglyceridemic Pancreatitis and other orphan indications in hyperlipidemia. The JV may, in the future, possibly explore additional indications for its family of Apo E mimetic peptides including Acute Coronary Syndrome, Peripheral Artery Disease and other vascular diseases associated with Type 2 Diabetes and Metabolic Syndrome.
About Capstone Therapeutics
Capstone Therapeutics is a biotechnology company committed to developing novel therapeutic peptides aimed at helping patients with under-served medical conditions. The Company is focused on development and commercialization of Chimeric Apo E Mimetic Peptides through the LipimetiX Development, Inc., joint venture.
Capstone's corporate headquarters are in Tempe, Arizona. For more information, please visit the Company's website: www.capstonethx.com. For more information on LipimetiX Development, please visit the JV's website: www.lipimetix.com.
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 involve risks and uncertainties that could cause actual results to differ materially from predicted results. These risks include the factors discussed in our Form 10-K for the fiscal year ended December 31, 2014, and other documents we file with the U.S. 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: Investor Relations (602) 286-5250 investorinquiries@capstonethx.com