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Isofol Medical AB (SE:ISOFOL)
:ISOFOL
Arfolitixorin (Arfox + Bevacizumab)
Metastatic Colorectal Cancer (Mcrc)
Phase I/II
Recruiting
A Clinical Study of Arfolitixorin in Patients With mCRC
Mar 25, 2025
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Leucovorin, Arfolitixorin
Colo-Rectal Cancer
Phase III
Completed
A Study to Compare the Efficacy of Arfolitixorin Versus Leucovorin in Combination With 5 Fluorouracil, Oxaliplatin, and Bevacizumab in Patients With Advanced Colorectal Cancer
Nov 19, 2018
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Modufolin (Arfolitixorin)
Phase I Study In Healthy Volunteers To Evaluate Ecg Effect
Phase I
Completed
Study Evaluating ECG Effects, Safety, Tolerability and Pharmacokinetics of Single Doses of Modufolin (Arfolitixorin) in Healthy Volunteers Tetrahydrofolate in Healthy Male Volunteers
Jun 22, 2017
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Bevacizumab, Fluorouracil, Oxaliplatin, Irinotecan, Modufolin (Arfolitixorin)
Colorectal Neoplasm
Phase I/II
Completed
Modufolin (Arfolitixorin) in Combination With 5-Fluorouracil Alone or Together With Oxaliplatin or Irinotecan in Colorectal Cancer
Sep 17, 2014
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Calcium Folinate, [6R] 5,10-Methylenetetrahydrofolate (Arfolitixorin)
Osteosarcoma
Phase I/II
Completed
Investigation of [6R] 5,10-methylenetetrahydrofolate (Arfolitixorin) as Rescue Therapy for Osteosarcoma Patients Treated With HDMTX.
Nov 05, 2013
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6R-Mthf (Arfolitixorin) 200 Mg/M2, Levoleucovorin 200 Mg/M2, 6R-Mthf (Arfolitixorin) 60 Mg/M2, Levoleucovorin 60 Mg/M2
Colonic Neoplasms
Phase I/II
Completed
PK/PD Investigation of Modufolin (Arfolitixorin) in Plasma, Tumor and Adjacent Mucosa Adjacent Mucosa in Patients With Colon Cancer
Sep 05, 2012
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Pemetrexed, [6R] 5,10-Methylenetetrahydrofolate (Arfolitixorin)
Rectal Cancer
Phase I/II
Completed
An Extended Feasibility Phase I/II Study of Methylenetetrahydrofolate (Arfolitixorin) and Pemetrexed Single Agent, Given as Neoadjuvant Treatment in Patients With Resectable Rectal Cancer
May 25, 2011
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FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases:
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does Isofol Medical AB (ISOFOL) have in its pipeline
ISOFOL is currently developing the following drugs: Arfolitixorin (Arfox + Bevacizumab), Leucovorin, Arfolitixorin, Modufolin (Arfolitixorin). These drug candidates are in various stages of clinical development as the company works toward FDA approval.