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Marizyme, Inc.'s MB102 Product To Initially Focus On Pediatric Stroke Market -- Spotlight Growth

Sacramento, CA, March 28, 2019 (GLOBE NEWSWIRE) -- via NEWMEDIAWIRE -- Spotlight Growth has published new content on Marizyme, Inc. ("Marizyme" or the "Company") (OTC Pink: MRZM), a biotechnology company focused on its clinically-tested and patented use of protease therapeutic platform called Krillase. Clinical testing and research have shown Krillase to be a treatment for acute ischemic stroke, myocardial infarction, deep-vein thrombosis, wound/burn care, and more. Krillase is classified as a Class III medical device in Europe for the treatment of chronic wounds. 

The financial article and video provide an overview of Marizyme, the Krillase platform, latest news, and further analysis. 

International Alliance of Pediatric Stroke: Stroke a “Top Ten” Leading Cause of Death in Children 

The truth is that stroke can impact people of all ages and backgrounds. Commonly misconstrued as an illness that primarily impacts the elderly, stroke can occur in young adults, children, infants, and even prior to birth. In fact, there are two key categories of pediatric stroke: perinatal and childhood. 

Perinatal refers to the time period between the last 18 weeks of gestation through the first thirty days of life. Childhood stroke occurs in youth aged 1 month to 18 years. 

In fact, according to the International Alliance of Pediatric Stroke (IAPS), stroke is a “top ten” leading cause of death in children. Furthermore, 60% of children that do survive a stroke “will have permanent neurological deficits, most commonly hemiparesis or hemiplegia,” according to the IAPS. 

Furthermore, the National Stroke Association says that stroke occurs in roughly 1 out of 4,000 live births and the risk of stroke until age 18 is almost 11 out of 100,000 per year. 

Despite pediatric stroke’s prevalence and high medical need, there are currently no FDA-approved treatments for the condition. 

MRZM: Initial MB102 Treatment Application To Focus On Pediatric Stroke

Marizyme currently has a Krillase-derived treatment pipeline consisting of four different applications. The company’s MB102 product is specifically for the treatment of ischemic stroke using Krillase. Management sees a major opportunity in initially focusing MB102’s development and testing on the pediatric stroke market, due to its high medical need and lack of currently available treatments. 

On March 15, 2019, Marizyme announced that it had received feedback from the FDA from a Pre-IND application for a Type B meeting request. The FDA’s feedback provided strong guidance and expectations for Marizyme, which will help the company develop proper procedures and game plan for the MB102 product. Here are the key points Marizyme provided from the FDA’s feedback:

  • 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 more information on Marizyme, please visit: http://marizyme.com and http://spotlightgrowth.com/index.php/2019/03/25/this-company-is-working-on-a-novel-thrombolytic-therapy-for-pediatric-stroke/ and https://youtu.be/AheZ3Qsk2yI

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Matt Rego
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mrego@spotlightgrowth.com