Based on Data in More Than Four Hundred Acute Promyelocytic Leukemia (APL) Patients, Arsenic Trioxide Oral Solution was Highly Effective and Safe while Reducing Treatment Burden
Arsenic Trioxide Oral Solution is Already Approved in Hong Kong for the Treatment of APL
Interactions with Applicable Health Authorities (FDA and EMA) to Align on Registration Pathway Planned in the Second Half of 2024
Randolph, NJ – June 15, 2024 – SDK Therapeutics LLC (“SDK Therapeutics”), a biotechnology company focused on developing and commercializing medicines in hematology, oncology, and rare diseases to improve the life of patients, announced today that it has entered into an agreement with American Unicorn Laboratories Limited (“AULL”), whereby SDK Therapeutics will have the exclusive right to establish supply of Arsenic Trioxide Oral Solution from AULL for North America and Europe, with the rights to product development and commercialization subject to the terms and conditions of the said agreement between SDK Therapeutics and AULL.
Intravenous arsenic trioxide is currently used to treat APL patients in the U.S. and the rest of the world except Hong Kong, where the oral liquid formulation of arsenic trioxide is approved and used. Clinical studies spearheaded by Dr. Harinder Gill have shown that complete remission rates of 100% and long-term overall and relapse-free survivals of more than 97% are obtained with oral arsenic trioxide-based frontline treatment.1,2 Additionally, there are many down sides associated with the intravenous formulation, including treatment burden and severe cardiac toxicity. Arsenic Trioxide Oral Solution represents a significant opportunity to provide patients and providers with comparable efficacy based on extensive clinical experience while offering a differentiated safety profile.
“Arsenic Trioxide Oral Solution has the potential to become the new standard of care in acute promyelocytic leukemia by addressing the significant treatment burden associated with the current formulation used in North America and Europe. We plan to leverage upon the available clinical evidence to achieving our goal of rapidly bringing this oral treatment to patients in North America and Europe. We look forward to engaging with FDA and EMA in the second half of 2024 to align on the design of an applicable registration trial.” said Stephane Berthier, PharmD., Chief Executive Officer of SDK Therapeutics.
About Acute Promyelocytic Leukemia
Acute promyelocytic leukemia (APL) accounts for approximately 5–10% of patients with acute myeloid leukemia (AML) and is characterized by the balanced translocation t(15;17) (q22;q12), resulting in the formation of PML-RARA fusion gene. The combination therapy of all-trans retinoic acid (ATRA) and arsenic trioxide (ATO) has shown to be highly effective, achieving remission rates greater than 80% in patients with APL. This combination therapy is the standard treatment for adult patients with de novo, non-high-risk APL.
A Potential New Standard-of-Care
Therapy with the Product Arsenic Trioxide is currently approved in North America and Europe only as an intravenous formulation, which imposes a significant burden on patients, requiring up to 140 two- to four- hour infusions over the course of induction and consolidation treatment.
Arsenic Trioxide Oral Solution is an oral liquid formulation of arsenic trioxide that has already been approved in Hong Kong for the treatment of patients with acute promyelocytic leukemia (APL). It has been extensively studied in over 400 APL patients, both newly diagnosed and relapsed,1-3 with long-term data demonstrating its efficacy and safety. The oral solution is administered once daily and has the potential to become the new standard of care for newly diagnosed APL patients. It offers comparable efficacy to the intravenous formulation, with the added benefits of a more convenient route of administration, reduced treatment burden on patients, improved accessibility, and lower costs to the healthcare system.
About American Unicorn Laboratories Limited
American Unicorn Laboratories Limited is a Hong Kong company engaged in the business of manufacturing various pharmaceutical products and is the manufacturer of the Arsenic Trioxide Oral Solution in Hong Kong.
1 Gill, H. et al. Oral arsenic trioxide incorporation into frontline treatment with all-trans retinoic acid and chemotherapy in newly diagnosed acute promyelocytic leukemia: A 5-year prospective study. Cancer 125, 3001-3012, doi:10.1002/cncr.32180 (2019).
2 Gill, H. et al. An Entirely Oral Regimen of Oral-Arsenic Trioxide/All-Trans Retinoic Acid/Ascorbic Acid in Newly Diagnosed Acute Promyelocytic Leukaemia (APL): Updated Results of an Ongoing Multicentre Trial. Blood 142, 157 (2023).
3 Gill, H. et al. Long-term outcome of relapsed acute promyelocytic leukemia treated with oral arsenic trioxide-based reinduction and maintenance regimens: A 15-year prospective study. Cancer 124, 2316-2326, doi:10.1002/cncr.31327 (2018).
About SDK Therapeutics LLC
SDK Therapeutics LLC is a New Jersey based biotechnology company founded in 2024 with a mission to develop and commercialize medicines in hematology, oncology, and rare diseases to improve the life of patients.
Contact: Stephane Berthier
Chief Executive Officer
+1-862-812-6042
[email protected]