RICHLAND, WA / ACCESSWIRE / March 28, 2024 / GlobeStar Therapeutics Corporation (OTC PINK:GSTC) (GSTC), is a clinical stage pharmaceutical company focused on advancing new therapies for Multiple Sclerosis (MS) and other neurological diseases, including but not limited to Rheumatoid Arthritis (RA), released on March 11, 2024 its fiscal year first quarter financials for the quarter ended 12/31/2023. The Company reported that $42,800 of cash was used in operating activities vs. $39,142 in the prior year's quarter and net loss per share is $0.00 for both periods. Operating expenses increased to $155,871 vs the prior year's quarter of $155,271.
GlobeStar is focused on efforts to obtain regulatory approvals for, and then commercialize, Project Amethyst™. Project Amethyst™ is a compound intended to treat neurodegeneration from MS, consisting of a patented custom drug cocktail of Minocycline, Fluconazole, and Atorvastatin. Each of these drugs has been approved by the FDA for separate applications. GSTC is the exclusive worldwide licensee for the all patents and patent applications relating to this compound.
GlobeStar is endeavoring to arrange financing to commence a study of the pharmacokinetic action of the three drugs, and then to initiate a clinical trial. Pharmacokinetics looks at changes in a drug after administration. A pharmacokinetic study generally requires from two weeks to eight weeks.
GlobeStar is discussing the parameters for a pharmacokinetic study with several Clinical Research Organizations (CRO's) in Europe and India. The CRO selected by GlobeStar would assist the company, SMI HealthCare LLC (SMIHC) and Advanced Innovative Partners (AIP) to develop a clinical trial plan. GlobeStar intends to seek FDA guidance in the development of that plan.
Following completion of the pharmacokinetic study, GlobeStar intends to arrange financing for SMIHC to manage an initial clinical trial in India, as well as regulatory filings, intellectual property rights filings, manufacturing, sales and distribution in India, Southeast Asia, Africa, and the Middle East. The clinical trial likely would require approximately three to six months. If results are positive, the trial would support regulatory clearance in India and potentially other countries, facilitating the Company's transition to revenues. Results also could be used to accelerate progress toward regulatory approval in the United States, though an additional trial likely would be required to obtain FDA approval.
It is anticipated that AIP will 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™.
The North American MS drug market was valued at $10.73 billion in 2022, while the global MS drug market was $22.32 billion in 2022 and is projected to reach $31.90 billion in 2030 according to Fortune Business Insights. Over 3.4 billion people are suffering from various neurological disorders and it appears the number afflicted is rising annually (Global Burden of Disease, Injuries and Risk Factors). A study by Lancet Neurology suggests that the overall burden pf neurological conditions which are measured in disability-adjusted life years-which represent the total years of healthy life lost due to disability, illness, or premature death increased by 18 percent from 1990 to 2021. The study shows that across different regions and income levels over 80 percent of neurological deaths and health loss occur in low and middle-income countries, while western and central sub-Saharan Africa faced up to five times higher rates.
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 the Project Amethyst™ patents and patent applications. For additional information see: www.globestartherapeutics.com.
NOTICE REGARDING FORWARD-LOOKING STATEMENTS
This news release contains forward-looking information within the meaning of Section27A of the Securities Act of 1933 and Section 21E 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 forth above and the company assumes no responsibility to update the information included herein for events occurring after the date hereof.
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SOURCE: GlobeStar Therapeutics Corporation
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