RICHLAND, WA / ACCESSWIRE / November 2, 2023 / GlobeStar Therapeutics Corporation (OTC PINK:GSTC), (GSTC), a clinical-stage pharmaceutical company focused on advancing new therapies for Multiple Sclerosis (MS) and other neurological diseases today announced that building on its recent agreement with SMI HealthCare LLC (SMIHC) to manage an initial clinical trial, regulatory filings, intellectual property rights filings, manufacturing, sales and distribution in India, Southeast Asia, Africa, and the Middle East. Globestar has also entered into a definitive agreement with Advanced Innovative Partners (AIP) for AIP to provide advice to GlobeStar and SMIHC on the global design, strategy and execution of clinical trials, regulatory filings, intellectual property rights filings, and manufacturing for Project Amethyst™.
Project Amethyst™ is a compound intended to treat neurodegeneration from multiple sclerosis (MS). GSTC is the exclusive worldwide licensee for Project Amethyst™, including all patents and patent applications relating thereto.
James C. Katzaroff, President and CEO of GlobeStar Therapeutics Corporation stated: "I am pleased that GlobeStar and SMI Healthcare will receive advice and assistance from the superb team at AIP to further the growth of Project Amethyst™. I have known AIP's founder, Stanley Satz for many years, and have strong confidence in AIP's capabilities, relationships and wisdom."
Stanley Satz, PhD., AIP's Chairman and Chief Science officer said: "Our team has considerable experience worldwide developing and implementing clinical trials for radiopharmaceuticals and other therapies. Through our agreement with GlobeStar Therapeutics Corporation, we will have the opportunity to contribute to the refinement, approval and launch of Project Amethyst™ therapeutics that we believe will be important tools in the fight against MS."
The GlobeStar and AIP agreement has been approved by the parties' respective boards and is immediately effective. AIP will initially advise GlobeStar and SMIHC on the design and launch of an initial clinical trial in India and the associated regulatory approvals for GSTC's MS products in North America and Europe.
According to the U.S. National Institutes of Health, between 2013 and 2020, the reported incidence of MS has increased by approximately 50% in the 81 most affected countries.
Pursuant to the parties' agreement, GlobeStar retains ownership of all intellectual property rights, and final approval of Project Amethyst™, including the right to engage additional advisors and subject matter experts.For its consulting services, AIP will be paid a monthly consulting fee and bonuses, a portion of which will be deferred and will become payable only if GlobeStar secures FDA marketing approval. If AIP introduces GlobeStar or SMIHC to potential customers, or strategic partners, subject to compliance with applicable law, AIP may also become entitled to receive commissions on certain revenues or profits derived from those relationships.
GlobeStar was advised by an affiliate of SMI Group LLC in this transaction.
About GLOBESTAR THERAPEUTICS
GlobeStar Therapeutics Corporation (OTC PINK:GSTC) (GSTC)'s mission is to pioneer biotechnology in transformative therapies for the management of chronic neurodegenerative diseases. In an initial study of Project Amethyst™ in Italy of 150 volunteers, 90 between 25 and 65 years of age with MS disease and 60 healthy volunteers, the average Expanded Disability Status Scale (EDSS) score for subjects with MS dropped by at least 1.3 points for pre-treatment and an average of 4.02 points after treatment. After 45 days of treatment, all subjects reported an improvement in balance and motor control of all extremities, and most reported an improvement in bladder control. GSTC is the exclusive global licensee of Project Amethyst™ patents and patent applications. For further information, see: www.globestartherapeutics.com
About ADVANCED INNOVATIVE PARTNERS
Advanced Innovative Partners is a private clinical stage company focused on developing therapeutic and diagnostic radiopharmaceuticals for oncology, rare pediatric diseases, infectious disease and biomedical countermeasures. The company's robust nuclear medicine portfolio includes specialty pharmaceuticals enabling personalized medicine. For additional information about AIP, see: www.advancedinnovativepartners.com
About SMI HealthCare
SMI HealthCare LLC was formed by SMI Group LLC to engage in consulting and distribution services regarding healthcare products and services, with an initial focus on India and developing countries.
Founded by Kenin M. Spivak, SMI Group LLC is a privately-held Los Angeles-based group consisting of management consulting, a licensed investment bank, and a registered investment advisor. Its professionals have closed more than $50 billion of complex transactions and led multinational businesses with more than 30,000 employees. For additional information about SMI Group LLC see: www.SMIGLLC.com
NOTICE REGARDING FORWARD-LOOKING STATEMENTS
This news release contains forward-looking information within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the of the Securities Exchange Act of 1934, including statements that include the words believe, expects, anticipates, or similar expressions. Such forward-looking statements involve known and unknown risks, and other factors that may cause the actual results, performance, or achievements of the company to differ materially from those expressed or implied by such forward-looking statements. In addition, description of anyone's past success is no guarantee of future success. This news release speaks as of the date first set above and the company assumes no responsibility to update the information herein for events occurring after the date hereof.
CONTACT:
JAMES C. KATZAROFF, President and CEO
[email protected]
509.531.1671
SOURCE: GlobeStar Therapeutics Corporation