On December 9, 2019 Samus Therapeutics, Inc. ("Samus" or the "Company"), a privately held, Boston-based, biopharmaceutical company developing epichaperome inhibitors to intervene in pathological processes and initiate the degradation of disease-associated proteins, reported a poster presentation addressing the Company’s Phase 1 study evaluating orally administered PU-H71 with ruxolitinib in patients with myelofibrosis no longer fully responsive to orally administered ruxolitinib (Press release, Samus Therapeutics, DEC 9, 2019, View Source [SID1234552162]). The poster is being presented today at the American Society of Hematology (ASH) (Free ASH Whitepaper) 2019 Annual Meeting in Orlando.
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"Preclinical data show us that the activity of mutated JAK2 is tightly regulated by epichaperomes, a complex network of proteins which forms under cellular stress, such as in cancer, and nucleates on heat shock protein 90," commented Barbara Wallner, Chief Scientific Officer of Samus Therapeutics. "PU-H71 offers a novel approach to address frontline treatment of myelofibrosis in combination to potentially improve outcomes."
The combination multicenter Phase 1b study is designed to assess the safety, tolerability, pharmacodynamics, and preliminary efficacy of orally administered PU-H71 in myelofibrosis, for which the U.S. Food and Drug Administration granted Orphan Drug designation in 2018. The study will enroll patients who have active disease and have been receiving ruxolitinib therapy for at least 3 months. The study employs a standard 3+3 dose escalation design beginning with 50 mg/day of PU-H71 to determine the maximum tolerated dose (MTD). Enrollment in the study is now ongoing in the United States.
"Early study of intravenously administered PU-H71 in myelofibrosis in combination with ruxolitinib identified a safe and tolerable dose and we redirected our efforts to oral administration," said Dick Bagley, President and Interim Chief Executive Officer of Samus Therapeutics. "We believe that the combination of PU-H71 and ruxolitinib could deliver added clinical benefit in this extraordinarily difficult to treat hematological malignancy."
Details for the ASH (Free ASH Whitepaper) 2019 presentation are as follows:
Title: Phase 1b Study of the Epichaperome Inhibitor PU-H71 Administered Orally with Ruxolitinib Continuation for the Treatment of Patients with Myelofibrosis
Lead author: Dr. Naveen Pemmaraju, Associate Professor, Department of Leukemia, MD Anderson Cancer Center
Paper #: 4178
Session: 634. Myeloproliferative Syndromes: Clinical: Poster III
Date and Time: Monday, December 9, 2019; 6:00 PM-8:00 PM ET
Location: Orange County Convention Center, Hall B