ORH-2014 was demonstrated to be bioavailable and well-tolerated in all doses of 5, 10, and 15 mg taken orally once daily
Completed Phase 1 study demonstrated that ORH-2014 achieved the required target exposure at a dose of 15 mg once daily
Data support a dose of 15 mg can be used for future late phase trials in frontline therapy in patients with low risk acute promyelocytic leukemia (APL) and other malignancies
ORH-2014 has been granted Orphan Drug Designation by the Food and Drug Administration (FDA) and the European Medicines Agency (EMA)
Orsenix has gained alignment with the FDA to proceed with a single registration study for approval of ORH-2014 for the treatment of patients with newly diagnosed APL, assuming favorable regulatory review
WILMINGTON, DE / ACCESSWIRE / June 18, 2019 / Orsenix, LLC., a clinical stage biotech company committed to transforming cancer treatment with innovative, safe oral therapies today announced the final results from a multicenter Phase 1 study of ORH-2014, a patented, capsule form of arsenic trioxide (ATO) administered orally to patients with advanced hematologic malignancies, were presented at the.24th Congress of the European Hematology Association in Amsterdam on Saturday, June 15, 2019 by Farhad Ravandi-MD, principal investigator from MD Anderson Cancer Center. (Poster Board; Abstract PS1037)
The poster presentation titled: "Final Report: Clinical Study of Oral Arsenic Trioxide Capsule Formulation, ORH-2014, Demonstrating High Bioavailability, Good Safety and Tolerability in Patients with Advanced Hematologic Disorders" summarized the final pharmacokinetics and safety results of the Phase 1 study of ORH-2014 at doses of 5 mg, 10 mg, and 15 mg. ORH-2014 demonstrated high bioavailability as well as a favorable safety and tolerability taken orally once a day. The daily administration yielded no dose limiting toxicities up to a dose of 15 mg in patients with advanced hematologic malignancies who had relapsed from prior treatments. The most common drug-related AEs (observed in ≥3 (25%) of patients) were nausea, diarrhea, and headache, which were mild and moderate. There was a transient grade 3, QT prolongation observed in one (8.3%) patient attributed to both ORH-2014 5 mg and fluorofloxacine (Levaquin®); ORH-2014 Cmax and AUC for total arsenic were dose-proportional, and exposure (Cmax, AUC0-24) was similar to IV ATO at the approved dose. Based on the final results of this Phase 1 study, the recommended dose of ORH-2014 for future studies is 15mg once a day. ORH-2014 is anticipated to offer an oral treatment approach for patients newly diagnosed with APL as well as the opportunity for clinicians to explore the full potential of ATO to treat other malignancies, such as Acute Myeloid Leukemia, Myelodysplastic Syndromes, Myelofibrosis and Glioblastoma.
"ORH-2014 provides a potential advancement in the treatment of patients with newly diagnosed APL by removing the cumbersome, burden of daily intravenous infusions and allowing patients to maintain a better quality of life," said Farhad Ravadi- MD, Janiece and Stephen A. Lasher Professor of Medicine and Chief of Section of Developmental Therapeutics in the Department of Leukemia at the University of Texas , M. D. Anderson Cancer Center. "If approved and shown to be at least equivalent to IV ATO pls ATRA (all-trans retinoic acid), ORH-2014 daily oral dosing with oral ATRA provides an "all oral" unique treatment option for these patients. We look forward to further characterizing the full therapeutic profile of ORH-2014 in the planned registration study in APL."
"We are pleased with the support of leading clinical experts and the Food and Drug Administration for ORH-2014 as we work to advance this oral therapy into a registrational pivotal trial in APL later this year," said Adriann Sax, Chief Executive Officer of Orsenix. "Our mission is to transform cancer treatment with innovative oral therapies that give patients the freedom to live their everyday lives and to further explore the full potential of ORH-2014 to treat other malignancies where clinical efficacy of ATO has been documented."
About Orsenix LLC
Founded in 2014 by respected discovery scientist, Kris Vaddi PhD, Orsenix is a clinical stage biotech company committed to transforming cancer treatment with innovative, safe oral therapies that give patients the freedom to live their everyday lives. The Company's current pipeline is focused on furthering the development and commercialization of ORH-2014, a novel, patented oral capsule of arsenic trioxide (ATO). Orsenix is located in Wilmington, Delaware. For more information, please visit www.orsenix.com.
CONTACT:
Investor Relations:
Barbara Ryan
[email protected]
Orsenix:
Adriann Sax
Chief Executive Officer
[email protected]
SOURCE: Orsenix LLC