[{"orgOrder":0,"company":"Isofol Medical","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"The First Patient Included in Australia in Isofol\\'s Phase 3 AGENT Study","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"SWEDEN","productType":"Small molecule","productStatus":"Approved","date":"January 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"Isofol Medical","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"The First Patient Included in Japan in Isofol\\'s Phase 3 AGENT Study","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"SWEDEN","productType":"Small molecule","productStatus":"New Molecular Entity","date":"February 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"Isofol Medical","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Isofol's Drug Candidate Arfolitixorin Receives Additional Clinical Patent Approval in the United States","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"SWEDEN","productType":"Small molecule","productStatus":"New Molecular Entity","date":"May 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"Isofol Medical","sponsor":"Solasia Pharma KK","pharmaFlowCategory":"D","amount":"$100.0 million","upfrontCash":"Undisclosed","newsHeadline":"Isofol Enters Licensing Agreement with Solasia to Develop and Commercialize Arfolitixorin in Japan","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"SWEDEN","productType":"Small molecule","productStatus":"New Molecular Entity","date":"August 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"Isofol Medical","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Strengthened Patent Protection for Arfolitixorin in Japan","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"SWEDEN","productType":"Small molecule","productStatus":"New Molecular Entity","date":"September 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"Isofol Medical","sponsor":"PALADIN LABS","pharmaFlowCategory":"D","amount":"$100.0 million","upfrontCash":"$103.0 million","newsHeadline":"Isofol Announces Licensing Agreement for Paladin Labs Inc. 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Find Clinical Drug Pipeline Developments & Deals by Isofol Medical
In AGENT study, patients with non-resectable mCRC treated with arfolitixorin in combination with 5-FU, oxaliplatin and bevacizumab did not achieve a statistically significant overall response rate of ≥ 10% as compared to patients treated with the standard of care.
Progression-free survival (PFS) was approximately 12.8 months for the arfolitixorin arm and 11.6 months for the control arm, with a P-value of 0.76. Data for this endpoint is not final but it is not deemed to change significantly moving forward.
As the key active metabolite of the widely used folate-based drugs, arfolitixorin can potentially benefit all patients with advanced colorectal cancer, as it does not require complicated metabolic activation to become effective.
Arfox (Arfolitixorin), is the first and only immediately active folate being developed to increase the efficacy of standard of care chemotherapy for advanced colorectal cancer.
As the first and only pure form of the folate ([6R]-MTHF) that increases 5FU-cytotoxicity, arfolitixorin is currently being evaluated in the global pivotal Phase III AGENT study used for treatment of patients with metastatic colorectal cancer (mCRC).
The patent application that will be granted includes a dose regimen involving two or more injections of arfolitixorin in combination with 5-fluorouracil (5-FU).
The iDSMB has recommended continuation of the global Phase III AGENT study with 440 patients, in accordance with the study design for the drug candidate, arfolitixorin. Isofol expects the top line results for the AGENT study to be available during H1 2022.
The abstract present results from the Phase I/IIa ISO-CC-005 study which shows a correlation between clinical benefit and gene expression of the folate pathway in patients with metastatic colorectal cancer treated with 5-FU-based chemotherapy in combination with arfolitixorin.
Isofol’s drug candidate, arfolitixorin, is evaluated for treatment of patients with first-line metastatic colorectal cancer (mCRC). The AGENT study is currently being conducted in the U.S., Canada, Europe, Australia and Japan at more than 90 clinics.
The license agreement is initially focused on the development and commercialization of arfolitixorin as first-line treatment for metastatic colorectal cancer (mCRC) patients in Japan, which is projected to be the second largest addressable patient market for arfolitixorin.
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