Arfolitixorin, a proprietary drug candidate being developed by clinical stage biotech company Isofol Medical to increase the efficacy of standard of care chemotherapy for advanced colorectal cancer, has received a clinical patent in the United States.
The drug candidate is currently being studied in a global Phase III clinical trial (NCT03750786) [1]
This trial is a multicenter, randomized, parallel-group, Phase III study in at least 440 patients with advanced colorectal cancer to compare the efficacy of treatment with arfolitixorin versus leucovorin (folinic acid) in combination with 5-fluorouracil (Adrucil?; Teva Generics), oxaliplatin (Eloxatin?; Sanofi Genzyme), and bevacizumab (Avastin?; Genentech/Roche) according to modified FOLFOX-6* until Progressive Disease (PD) according to the Response Evaluation Criteria in Solid Tumors (RECIST 1.1 criteria).
Folate-based drugs
Today, more than 500,000 patients in the United States, Japan and Europe, are treated with folate-based therapies annually.
While beneficial, current folate-based therapies are prodrugs that need multiple activation steps into an active metabolite to exert their actions.
In contrast, as the key active metabolite of the widely used folate-based drugs, arfolitixorin can potentially benefit patients with advanced colorectal cancer, as it does not require complicated metabolic activation to become effective.
Patent
The patent, which expires in 2038 and is the first in a series of clinical patent applications to be granted to the company, is for a method of increasing blood concentration of deoxyuridine, a blood biomarker for inhibition of tumor growth in human cancer treatment.
The granted patent, US 10,292,984, is directed towards a dose regime for the combination of arfolitixorin and 5-fluorouracil injections to cancer patients and its superior effectiveness of reducing tumor growth compared to leucovorin and 5-fluorouracil. This better effect is due to a stronger inhibition of Thymidylate Synthase (TS), a vital enzyme for the DNA synthesis and tumor growth, which can be simply measured as the increased level of the biomarker deoxyuridine in blood samples from patients.[2]
?This patent, which has been applied for world-wide, is considered of high importance for Isofol.” noted Anders Rabbe, Chief Executive Officer of Isofol Medical.
“It is a clinical patent based on data derived from clinical studies with arfolitixorin demonstrating potential superior activity for arfolitixorin and 5-fluorouracil treatment compared to today?s standard of care therapy with leucovorin and 5-fluorouracil,? he added.
Isofol Medical holds a worldwide exclusive license agreement with Merck KGaA, Darmstadt, Germany to develop and commercialize arfolitixorin for oncology indications.
References
[1] A Study to Compare the Efficacy of Arfolitixorin Versus Leucovorin in Combination With 5 Fluorouracil, Oxaliplatin, and Bevacizumab in Patients With Advanced Colorectal Cancer (AGENT) – NCT03750786.
[2] US Patent: Methods for increasing blood plasma 2′-deoxyuridine (dUrd) and thymidylate synthase inhibition [Online]
