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Details:
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.
Lead Product(s): Arfolitixorin,Fluorouracil,Oxaliplatin
Therapeutic Area: Oncology Product Name: Modufolin
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 25, 2022
Details:
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.
Lead Product(s): Arfolitixorin,Fluorouracil,Oxaliplatin
Therapeutic Area: Oncology Product Name: Modufolin
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 07, 2022
Details:
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.
Lead Product(s): Arfolitixorin,Fluorouracil,Oxaliplatin
Therapeutic Area: Oncology Product Name: Arfox
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 22, 2022
Details:
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.
Lead Product(s): Arfolitixorin,Fluorouracil,Oxaliplatin
Therapeutic Area: Oncology Product Name: Arfox
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 03, 2021
Details:
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).
Lead Product(s): Arfolitixorin,Fluorouracil,Oxaliplatin
Therapeutic Area: Oncology Product Name: Arfox
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 23, 2021
Details:
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).
Lead Product(s): Arfolitixorin,Fluorouracil,Oxaliplatin
Therapeutic Area: Oncology Product Name: Arfox
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 22, 2021
Details:
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.
Lead Product(s): Arfolitixorin,Fluorouracil,Oxaliplatin
Therapeutic Area: Oncology Product Name: Arfox
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 19, 2021
Details:
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.
Lead Product(s): Arfolitixorin,Fluorouracil
Therapeutic Area: Oncology Product Name: Modufolin
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 15, 2021
Details:
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.
Lead Product(s): Arfolitixorin,Oxaliplatin,Fluorouracil
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 09, 2020
Details:
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.
Lead Product(s): Arfolitixorin,Oxaliplatin,Fluorouracil
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: PALADIN LABS
Deal Size: $100.0 million Upfront Cash: $103.0 million
Deal Type: Licensing Agreement November 02, 2020
Details:
Company has further strengthened its position in the second largest market for treatment of mCRC by obtaining two new patent grants for arfolitixorin in Japan.
Lead Product(s): Arfolitixorin,Oxaliplatin,Fluorouracil
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 01, 2020
Details:
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.
Lead Product(s): Arfolitixorin,Oxaliplatin,Fluorouracil
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Solasia Pharma KK
Deal Size: $100.0 million Upfront Cash: Undisclosed
Deal Type: Licensing Agreement August 13, 2020
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