On March 7, 2016 Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in Hematology and Oncology, reported that the Company has initiated the planned Phase 2 clinical study for Poziotinib, its novel pan-HER inhibitor (Press release, Spectrum Pharmaceuticals, MAR 7, 2016, View Source [SID:1234509387]). The Phase 2 trial is an open-label study that will enroll approximately 70 patients with HER2-positive metastatic breast cancer, who have failed at least two prior HER2-directed therapies. Schedule your 30 min Free 1stOncology Demo! "We believe Poziotinib has the potential to be the best in class pan-HER inhibitor," said Rajesh C. Shrotriya, MD, Chairman and Chief Executive Officer of Spectrum Pharmaceuticals. "The U.S. Phase 2 trial was designed on learnings from Hanmi’s Phase 1 studies as well as the ongoing Phase 2 breast cancer trial in Korea. The target market for HER2-positive agents is large, and we are encouraged by early data showing that Poziotinib could potentially be another treatment option for patients."
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Poziotinib is a novel, oral pan-HER inhibitor that irreversibly blocks signaling through the Epidermal Growth Factor Receptor (EGFR, HER) Family of tyrosine-kinase receptors, including HER1 (erbB1; EGFR), HER2 (erbB2), and HER4 (erbB4), and importantly, also HER receptor mutations; this, in turn, leads to the inhibition of the proliferation of tumor cells that overexpress these receptors. Mutations or overexpression/amplification of EGFR family receptors have been associated with a number of different cancers, including non-small cell lung cancer (NSCLC), breast cancer, gastric cancer, etc. Currently, Poziotinib is being investigated by Hanmi in several mid-stage trials in different solid tumor indications including HER2-positive breast cancer. (Phase 2 sponsored by National OncoVenture, a funding initiative by the Korean government’s National Cancer Center).