QSAM Biosciences provides update to shareholders on Phase 1 progress

QSAM Biosciences issued the following letter to its shareholders. “We are pleased to provide you with an update on the progress and preliminary data from our Phase 1 trial studying the safety and early signs of efficacy of CycloSam… Initial Analysis of Trial Data – First Cohort. In the first three patients dosed with the lowest radiation levels in our study, representing the first cohort of trial participants, the preliminary findings are as follows: Safety: No serious adverse events and all three patients maintained normal red and white blood cell and platelet counts within normal ranges throughout the treatment period with slight dips that quickly recovered. SUV Scores: This is a biomarker that measures metabolic rates in tumor cells. Published papers correlate this biomarker with efficacy.1 In our first patient, we measured four bone tumors and noted a 56% – 64% decrease in SUV. In patients two and three, SUV scores are variable. RECIST Scores: This is a measurement of the size of tumors before and after CycloSam administrations and accompanying CT scans; and is used in later stage trials to determine efficacy. In patients one and three, we saw no progression of tumor size at the four month follow-up. In patient two, we saw a 53% reduction in tumor size in one lesion and the second lesion completely resolved, measuring 0 mm. Pain Scores: The first two patients experienced significant pain relief and improved mobility within a week after treatment, which lasted for approximately six months. The third patient, whose cancer had metastasized to the spine from the breast, experienced moderate pain relief. This limited pain relief in patient three may be attributable to the size and particular location of the tumor in the spine… It is our goal to complete Cohort 3 by the end of the year, which will set us up to complete Phase 1 in Q1 2024. This is a few months behind our original timetable; but we believe the groundwork we have achieved over the last six months — including initiating new trial sites, qualifying a second nuclear reactor, completing several important manufacturing studies and tasks, and implementing and launching a fully-integrated digital and social media patient recruitment strategy — will help us advance more quickly into and through the critical Phase 2 efficacy trials next year. Market Opportunity and Growth of the Broader Radiopharmaceutical Sector: With respect to the market for a bone directed radiotherapeutic agent, we continue to refine and define the potential patient population and future market opportunities. In the United States, there are over 400,000 new patients diagnosed each year with metastatic bone cancer and 350,000 patient deaths…Concentrating on these specific areas of high unmet need is not only important for the well being and survival of cancer patients, but also for the pharmaceutical companies that are commercializing radiopharmaceutical drugs to treat the types of cancer that often metastasize to the bone… Furthermore, the supply chains and infrastructure supporting the use of radiopharmaceuticals – drugs that require certain specialized manufacturing processes and just-in-time delivery to the point-of-care – are rapidly expanding… We look forward to more progress in the second half of 2023, which we expect will continue to de-risk our technology and create value for our shareholders. We are confident in our team, our technology, and our ability to advance CycloSam(R) through the FDA process. Ultimately, however, our primary mission is to help the hundreds of thousands of adults and children each year suffering from bone cancer.”