FORT COLLINS, CO / ACCESSWIRE / March 15, 2019 / Marizyme, Inc. ("Marizyme" or the "Company"), a publicly traded (OTC PINK: MRZM) company focusing on acquiring late-stage drug assets for use in the acute care space for development and commercialization, announced today that they have received FDA feedback regarding their development plan for Krillase™ (MB102) in pediatric stroke. In preparation for initiating development activities for MB102, Marizyme requested feedback from the FDA using a Pre-IND application for a Type B meeting request.
Key points from the FDA's feedback include the following:
- Both intra-arterial and intravenous routes of administration need to be tested pre-clinically prior to initiation of clinical studies.
- Safety pharmacology testing (CNS, respiratory and cardiovascular) can be incorporated into the pivotal GLP toxicity studies instead of being run as separate studies.
- No safety genotoxicity studies are required prior to initiating clinical studies.
- Marizyme will need to fully characterize the raw material for viral contamination and enzymatic profile.
- For the proposed clinical studies Marizyme will need to test for immunogenicity of MB102 and justification for testing a thrombolytic therapy in healthy volunteers.
Mr. Michael K. Handley, Chief Executive Officer of Marizyme, Inc., commented: "We are very pleased with the FDA feedback to our Pre-IND Type B meeting request on our Krillase™ development program for pediatric stroke. We believe we can address each of the points raised and we look forward to continuing to work closely with FDA to move into the clinic."
About Pediatric Stroke¹
Although stroke is often viewed as occurring primarily in the elderly, it also strikes infants, children, young adults and can even occur before birth. The risk of stroke in children is greatest in the first year of life, and peaks during the perinatal period (roughly the weeks before and immediately after birth). Stroke also occurs in about one of every 4,000 live births. The risk of stroke from birth through age 18 is nearly 11 per 100,000 children per year and is one of the top 10 causes of death for children. Of children surviving stroke, 50 percent to 80 percent will have permanent neurological deficits, most commonly hemiparesis or hemiplegia (total or partial paralysis on one side of the body), cognitive and sensory impairments, epilepsy, speech or communication disorders, visual disturbances, poor attention, behavioral problems and poor quality of life.
MB102 is a novel and patent pending formulation of endovascularly delivered proteases that have demonstrated the capability to quickly and safely remove clots causing ischemic blockages in human vasculature. The first indication will be ischemic stroke in pediatrics as there are currently no approved thrombolytic therapies approved for use in children suffering from ischemic stroke.
About Marizyme, Inc.
Marizyme, Inc. is a development-stage company dedicated to the commercialization of therapies that address the urgent need of higher mortality and costs in the acute care space. Specifically, Marizyme will focus its efforts on developing treatments for disease caused by thrombus (stroke, acute myocardial infarctions or AMIs and deep vein thrombosis or DVTs), and chronic wound care conditions. These conditions combine for over $26 billion dollars in potential market opportunity and are responsible for sending over millions of patients to the hospital every year in the U.S. alone.
The Company's first product candidates are derived from Krillase™ Technology, a broad intellectual property portfolio around a novel system of proteolytic enzymes. Marizyme completed the acquisition of these assets and intends to develop several product candidates that will address unmet medical needs in the acute care setting. For more information about the Company, visit www.marizyme.com.
This press release contains certain forward-looking statements, including those relating to the Company's product development, clinical and regulatory timelines, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statements that are predictive in nature. The Company has made every reasonable effort to ensure the information and assumptions on which these statements are based are current, reasonable and complete. However, a variety of factors, many of which are beyond the Company's control, affect the Company's operations, performance, business strategy and results and there can be no assurances that the Company’s actual results will not differ materially from those indicated herein. Additional written and oral forward-looking statements may be made by the Company from time to time. The Private Securities Litigation Reform Act of 1995 provides a safe-harbor for forward-looking statements. These statements may be identified by the use of forward-looking expressions, including, but not limited to, "expect," "anticipate," "intend," "plan," "believe," "estimate," "potential," "predict," "project," "should," "would" and similar expressions and the negatives of those terms. These statements relate to future events or our financial performance and involve known and unknown risks, uncertainties, and other factors which may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this presentation. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.
¹American Stroke Association FACT Sheet
Investor and Media Contact
Michael K. Handley
Chief Executive Officer
SOURCE: Marizyme, Inc.
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