Biotech Submits IND Application With FDA
May 04, 2021 at 13:16 PM EDT
Tuesday, May 4, 2021 Biotech Submits IND Application With FDA An Austin-based biotech firm just announced its submission of Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for the initial of a Phase 1 clinical trial of Samarium-153 DOTMP (CycloSam ® ) in patients with bone cancer. Shares of QSAM Biosciences Inc. (OTCQB:QSAM) rallied on the news. QSAM (f/k/a Q2Earth. 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. 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 high bone turn over making it an ideal agent to treat osteosarcoma, bone metastases and to perform bone marrow ablation. Sm-153 DOTMP has been cleared by the FDA under an investigator initiated IND to commence human dosing of cancer patients. Traders were bullish on the news as shares climbed up to an early session high of $0.535/share (+27.00%) following the news. This move was welcomed by long-term shareholders who have been holding on during the pullback since mid-February.