QSAM Biosciences Announces Submission of IND Application for CycloSam® with FDA
QSAM Biosciences Inc. (OTCQB: QSAM) announced the submission of an Investigational New Drug (IND) application to the FDA for a Phase 1 clinical trial of CycloSam® (Samarium-153 DOTMP) aimed at treating bone cancer. The IND submission was completed electronically and accepted for review. The study is a dose escalation and dose finding trial for various types of bone tumors. QSAM is also working with a contract research organization to recruit clinical investigators and sites, with patient enrollment expected to begin mid-year. Previous successes include FDA clearance for Osteosarcoma treatments.
- FDA accepted IND application for CycloSam® for Phase 1 clinical trial.
- Previous successful FDA-cleared IND for osteosarcoma treatments.
- Active recruitment for clinical trial investigators and sites underway.
- Expected patient enrollment to begin mid-year.
- None.
Austin, TX, May 04, 2021 (GLOBE NEWSWIRE) -- QSAM Biosciences Inc. (OTCQB: QSAM), a company developing next-generation nuclear medicines for the treatment of cancer and related diseases, announced today that it has submitted an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for the initiation of a Phase 1 clinical trial of Samarium-153 DOTMP (CycloSam®) in patients with bone cancer. The IND submission was submitted fully electronically, was compliant with all current FDA electronic document requirements, and was accepted for review by the FDA.
“This IND submission is an important accomplishment for QSAM as we continue to advance the development of CycloSam for the treatment of several types of primary and metastatic bone cancers,” stated Douglas R. Baum, the Company’s CEO and Co-Founder. “We look forward to commencing this study and additional clinical trials to demonstrate the safety and efficacy of CycloSam in patients with primary and secondary bone cancer.”
The first proposed clinical trial included in the IND is a dose escalation and dose finding study of CycloSam to treat solid tumor(s) in the bone or metastatic to the bone. A wide group of all tumors metastatic to the bone from prostate, lung, and breast cancer are proposed to be eligible for this clinical trial.
In parallel with this regulatory submission, the Company has contracted with a well-established contract research organization (CRO) and is actively recruiting investigators and clinical trial sites to participate in this study, and expects to begin enrolling patients mid-year. The FDA has already cleared an investigator-initiated IND for CycloSam for the treatment of osteosarcoma, and a second single-patient IND in 2020 for a bone marrow ablation procedure prior to stem cell transplantation.
About QSAM Biosciences:
QSAM Biosciences, Inc. holds the worldwide license for CycloSam® (Samaium-153 DOTMP), a clinical-stage novel radiopharmaceutical meant to treat different types of bone cancer and related diseases. QSAM’s initial technology is Samarium-153 DOTMP, aka CycloSam®, a clinical-staged bone targeting radiopharmaceutical developed by IsoTherapeutics Group LLC, leaders in the nuclear medicine space who also developed FDA-approved and commercially available Quadramet® (Samarium-153 EDTMP), indicated for pain palliation. CycloSam was assigned to IsoTherapeutics Group’s subsidiary, IGL Pharma, Inc.
CycloSam® has already demonstrated preliminary safety and efficacy in animal studies and a single patient FDA-cleared successful human trial performed in 2020. This nuclear technology uses low specific activity Samarium-153 (resulting in far less europium) and DOTMP, a chelator which is believed to eliminate off-target migration and targets sites of high bone turn over making it an ideal agent to treat osteosarcoma or other bone metastases. Osteosarcoma is the most common malignant bone tumor among children and adolescents. Because of its ability to deliver radiation to the skeletal system, it is also believed to be an effective agent to perform bone marrow ablation as pre-conditioning for bone marrow transplantation. This drug candidate utilizes an FDA approved radioisotope combined with a novel chelant that has demonstrated increased efficacy and decreased side effects in animal models. Further, CycloSam® utilizes a streamlined, just-in-time manufacturing process. Given these factors, management believes there is a strong pathway to commercialization.
CycloSam® is cleared by the FDA under an investigator initiated IND to commence human dosing in patients with osteosarcoma and bone metastasis. CycloSam® was also cleared by FDA and successfully used under a single-patient IND to perform bone marrow ablation prior to allogenic marrow transplantation (BMA/T) in 2020.
Legal Notice Regarding Forward-Looking Statements: This news release contains "Forward-looking Statements". These statements relate to future events or our future financial performance. These statements are only predictions and may differ materially from actual future results or events. We disclaim any intention or obligation to revise any forward-looking statements whether as a result of new information, future developments or otherwise. There are important risk factors that could cause actual results to differ from those contained in forward-looking statements, including, but not limited to our ability to fully commercialize our technology, risks associated with changes in general economic and business conditions, actions of our competitors, the extent to which we are able to develop new products and markets, the time and expense involved in such development activities, the ability to secure additional financing, the ability to consummate acquisitions and ultimately integrate them, the level of demand and market acceptance of our products, and changes in our business strategies. This is not an offering of securities and securities may not be offered or sold absent registration or an applicable exemption from the registration requirements.
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