Spectrum Pharmaceuticals Submits Phase 2 Breast Cancer Protocol to FDA as Part of an Investigational New Drug (IND) Application for Poziotinib

Spectrum Pharmaceuticals

, a biotechnology company with fully integrated commercial and drug development operations with a primary focus in Hematology and Oncology, announced today the Company has submitted an IND application to the U.S. Food and Drug Administration (FDA) and plans to initiate a Phase 2 breast cancer study in the U.S. as soon as possible. "This Phase 2 study is an important step for us to solidify our registration strategy in the U.S.," said Rajesh C. Shrotriya, MD, Chairman and Chief Executive Officer of Spectrum Pharmaceuticals. "The potential target market for Poziotinib is large, and metastatic breast cancer patients continue to progress despite availability of several drugs. Poziotinib has shown promising early clinical activity in Phase 1 trials in patients who had failed multiple lines of treatment including the HER2-directed therapies, trastuzumab and lapatinib. The U.S. Phase 2 trial was designed based on learnings from Phase 1 and Hanmi's ongoing Phase 2 trials in Korea. We are planning a fast to market strategy as a single agent in parallel with the development of a broader indication using poziotinib in combination with other approved therapies for use in earlier stage disease." The Phase 2 study is planned to be an open-label study that will enroll approximately 70 patients with HER-2 positive metastatic breast cancer, who have failed at least one or more HER-2 directed therapy. The dose and schedule of oral poziotinib will be based on clinical experience from the studies in Korea, and in addition include the use of prophylactic therapies to help minimize known side-effects of HER2-directed therapies. 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 EGFR-mutant NSCLC, gastric cancer, head & neck cancer and HER2 positive breast cancer.