QSAM Biosciences Inc. (QSAM)

[RandyKCMO]

BIG NEWS!! QSAM Biosciences Receives Orphan Drug Designation from FDA for CycloSam® in the Treatment of Osteosarcoma
08/18/2021

Austin, TX, Aug. 18, 2021 (GLOBE NEWSWIRE) -- QSAM Biosciences Inc. (OTCQB: QSAM), a company developing next generation nuclear medicines, including Samarium-153-DOTMP (CycloSam®), for the treatment of cancer and related diseases and conditions, announced that the U.S. Food and Drug Administration (FDA) has approved QSAM’s application for Orphan Drug Designation of CycloSam® in the treatment of patients diagnosed with osteosarcoma.

Osteosarcoma is the most common form of bone cancer in children and young adults (ages 15-39) with primary high-grade bone malignancy. Out of five patients who develop or present with metastatic osteosarcoma bone cancer, only one will survive. There have been few advancements over the last 40 years for this deadly disease, and accordingly, there is a large unmet market need for a better treatment that is more efficacious against pediatric osteosarcoma and better tolerated by patients.

“Receipt of Orphan Drug Designation is an important accomplishment for our bone cancer program and for our company. This designation further validates our data-driven approach in oncology drug development and sets the stage for additional aggressive efforts we are undertaking in pediatric and adult cancer therapies,” stated the Company’s CEO, Douglas R. Baum. “Orphan Drug Designation is designed to provide a number of benefits, most notably, seven years of market exclusivity, which complements our growing portfolio of issued patents that we expect will provide us enhanced commercial and market protections.”

Baum continued: “This orphan designation is one of several milestones we have achieved since we started last year working to bring CycloSam through the clinical trial process and ultimately, with FDA approval, to market. We are excited to advance this groundbreaking research to help patients suffering from this devastating disease where the benefits of current treatment options are very limited.”

CycloSam is believed to be a significantly improved formulation of a previously FDA approved radiopharmaceutical. This novel drug candidate utilizes both a more efficient method of isotope manufacturing and an advanced chelation technology which may potentially allow for repeated dosing of patients with bone cancer in an effort to halt or reverse tumor growth.

https://www.otcmarkets.com/stock/QSAM/news/QSAM-Biosciences-Receives-Orphan-Drug-Designation-from-FDA-for-CycloSam-in-the-Treatment-of-Osteosarcoma?id=317010