Globestar Therapeutics Update on Project Amethyst(TM) and Recent Financials
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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?.
