QSAM Biosciences Inc. (QSAM) Marks Milestone with Dosing of First Patient in CycloSam Clinical Trial

  • Treating patients with primary or secondary bone cancer remains goal, says company CEO
  • Radiopharmaceuticals is a new class of drugs that delivers radiation therapy directly to cancer cells
  • QSAM is working to develop CycloSam(R) as a breakthrough therapeutic for adult and pediatric bone cancer patients

QSAM Biosciences (OTCQB: QSAM), a company developing a new class of drugs called radiopharmaceuticals, is leading the charge to evaluate a new treatment for bone cancer and other related, underserved diseases. The company’s pioneering efforts are evident as the first patient has completed treatment in the company’s clinical trial designed to study the effect of its proprietary radiopharmaceutical technology: CycloSam(R).

“This is an important milestone for QSAM,” said QSAM cofounder and CEO Douglas R. Baum (https://ibn.fm/GcD0R). “Successfully treating patients with primary or secondary bone cancer remains an area of significant unmet medical need and a goal for CycloSam(R).”

QSAM received Investigational New Drug Application (“IND”) approval from the U.S. Food and Drug Administration (“FDA”) and shortly thereafter activated its planned phase 1, open-label, dose-escalation, multicenter clinical trial. The trial will study patients who have been diagnosed with bone cancer, including cancer that has metastasized from the lung, breast or prostate, and will evaluate the safety, tolerability, dosimetry and preliminary efficacy of CycloSam.

Radiopharmaceuticals is a new class of drugs that delivers radiation therapy directly and specifically to cancer cells. “The last several years have seen an explosion of research and clinical trials testing new radiopharmaceuticals,” reports a recent National Cancer Institute (“NIH”) article (https://ibn.fm/nJsjs).

The article noted that radiation therapy was first used to treat cancer more than a century ago, with approximately one-half of all cancer patients still receiving it at some point during their treatment. “Until recently, most radiation therapy was given much as it was 100 years ago, by delivering beams of radiation from outside the body to kill tumors inside the body,” noted the NIH article, which observed that external radiation can cause collateral damage because normal tissue is radiated along with the cancerous tissue. 

“The resulting side effects of radiation therapy depend on the area of the body treated but can include loss of taste, skin changes, hair loss, diarrhea and sexual problems,” the article continued. New research and studies indicate that “targeting radiation therapy at the cellular level has the potential to reduce the risk of both short- and long-term side effects of treatment while at the same time enabling even tiny deposits of cancer cells to be killed throughout the body.”

It is this approach that QSAM focuses on with its lead drug candidate, CycloSam, which is a clinical-stage bone-seeking radiopharmaceutical designed to deliver targeted radiation safely and precisely to tumors in the bone (https://ibn.fm/ZRteN). According to the company, CycloSam delivers Samarium-153, a beta-emitting radioisotope, to areas of rapid bone formation through a superior chelant, DOTMP. The treatment is believed to provide a controlled dose of radiation directly to the tumor environment while minimizing radiation exposure to healthy tissue. The desired goal is tumor regression and increased survival of the patient, results that will be evaluated in the clinical trial process.

“Every day our teams are working toward developing CycloSam as a breakthrough therapeutic for cancer patients, both children and adults, male and female, who unfortunately still have poor options and limited long-term survival prognosis,” said Baum. “We look forward to sharing the results of this study with our shareholders and the medical community.”

For more information, visit the company’s website at www.QSAMbio.com

NOTE TO INVESTORS: The latest news and updates relating to QSAM are available in the company’s newsroom at http://ibn.fm/QSAM

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