CHESTER, N.J., Jan. 06, 2020 (GLOBE NEWSWIRE) --Hillstream Biopharm Inc.(“Hillstream”) today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to salinomycin based on nonclinical pharmacology data from HSB-1216 (QUATRAMER salinomycin), a new chemical entity for the treatment of small cell lung cancer. The ODD designation provides seven years of market exclusivity post approval for the HSB-1216.
“We are very excited and pleased that HSB-1216 received orphan designation from the FDA,” stated Randy Milby, Hillstream’s Chief Executive Officer. “Now is an exciting time for the development of medicines for small cell lung cancer. We believe treatment with HSB-1216 may represent a complementary approach to other potential therapies by inhibiting cancer stem cells.”
About HSB-1216 (QUATRAMER Salinomycin)
HSB-1216 is a novel formulation of salinomycin, a potent cancer stem cell inhibitor, encapsulated within QUATRAMER delivery technology. Salinomycin kills cancer stem cells by ferroptosis when iron is sequestered in the lysosomes. Salinomycin was identified as the most potent cancer stem cell (CSC) inhibitor known to-date by who or include reference. CSC represent an elusive population of tumor stem cells that are believed to reproduce and sustain cancer. HSB-1216 has shown strong effect on eliminating CSCs. The QUATRAMER salinomycin concentrates within the tumor and is a highly efficacious inhibitor of lung cancer cells. The encapsulation within the QUATRAMER enables may increase tolerability to salinomycin.