A Phase 1b/2 Study of Arfolitixorin Combined With 5-fluorouracil, Oxaliplatin, and Bevacizumab in First-line Treatment of Metastatic Colorectal Cancer

This is a clinical research study taking place in Germany. Patients with colorectal cancer at a stage of the disease where metastases occur may take part in the study. A maximum of 60 people will participate in the study.
There is already a standard therapy for treatment of colorectal cancer. This therapy contains a combination of the medicines leucovorin, fluorouracil, oxaliplatin and bevacizumab.
The sponsoring company is developing the new therapy called arfolitixorin. In this study, patients with colorectal cancer will be given arfolitixorin instead of the standard treatment leucovorin. Different patients will receive treatment with different strengths (doses) of arfolitixorin. Treatment with fluorouracil, oxaliplatin and bevacizumab will also be administrated.
The researchers want to find out if arfolitixorin could have an advantage over the standard therapy with leucovorin. They also want to investigate which dose of arfolitixorin is the most optimal dose to give to other patients and also to study if arfolitixorin is safe to use.
The product being tested, arfolitixorin, like leucovorin, belongs to a group of substances called folates which are naturally occurring forms of a type of B vitamin. Folates are administered in combination with one or more chemotherapeutic agents to enhance their effect on cancer cells.
The main mechanism of action of arfolitixorin is the same as that of leucovorin when used together with fluorouracil. However, leucovorin must first be converted into the active form in the body, whereas arfolitixorin already is in the active form. Leucovorin does not work equally well in all patients. By bypassing the metabolic activation of arfolitixorin, it is assumed that arfolitixorin works in a larger number of patients and has a stronger and longer efficacy in cancer treatment together with fluorouracil.
However, the efficacy of arfolitixorin has not yet been proven, and the substance has not been approved for the treatment of colorectal cancer. To date, arfolitixorin has been tested by around 420 volunteers and patients with colorectal cancer in different clinical studies. These studies have shown that arfolitixorin is safe and potentially can be of clinical benefit in patients with colorectal cancer when used in combination with fluorouracil, oxaliplatin and bevacizumab.
In the largest clinical study completed so far, arfolitixorin was shown to be equally effective compared to standard therapy with leucovorin, but not more effective. Additional results from this study suggested that the dose of arfolitixorin given did not deliver a sufficiently high amount of active substance into the tumor. Therefore, higher doses of arfolitixorin will be tested in this study to possibly achieve a better clinical effect. Further analyses also indicated that high accuracy regarding the timing and duration of the administration of the different treatments is important to achieve better efficacy of arfolitixorin.
Based on the available data, and the risk and benefit assessments performed, the Sponsor deems that it is relevant to further investigate the safety and tolerability, as well as the efficacy of arfolitixorin when given in combination with fluorouracil, oxaliplatin and bevacizumab. The proposed study design is believed to address all the main previous findings with the purpose to increase the efficacy with a remaining safety profile.
The study is divided into two parts. In the first part, up to five different doses of arfolitixorin will be investigated to find the optimal dose (i.e. the highest and well tolerated) of arfolitixorin as well as the optimal duration time of administration.
The second part of the study will be based on the results from the first part. Two doses of arfolitixorin will be tested for safety, tolerability and anti-tumor effect. In the second part, participants will be randomly assigned to one of two dose groups using a computer program. This so-called randomization procedure is comparable to tossing a coin.
All patients that participate in the study will receive treatment with arfolitixorin (+ fluorouracil, oxaliplatin and bevacizumab) every 2 weeks. The treatment will be given as an infusion into a vein. The number of treatment administrations that will be given is not predetermined but depends on the progression of the patient's disease.The treatment will continue every 2 weeks as long as the patient benefits from the treatment.
During the study period, the patient's disease and potential response to treatment, including shrinkage of the tumor and/or improvement of symptoms, will be monitored by imaging examinations, using so-called computer tomography (CT) or magnetic resonance imaging (MRI). The patient's state of health will also be monitored by physical examinations, and laboratory tests of urine and blood, as well as assessment of any side effects.

Start Date10 Apr 2025

Sponsor / Collaborator

Isofol Medical AB

NCT04126655

/ Unknown statusPhase 1/2IIT

A Randomised Phase II Study Investigating Two Doses of Arfolitixorin Compared to Calciumfolinate Together With 5- Fluorouracil on TS Inhibition in Tumour and Adjacent Hepatic Tissue for Patients With Liver Metastases From Colorectal Cancer

A study that is blinded to the patient and the investigator where the combination of Arfolitixorin + 5-FU is compared to Calciumfolinate + 5-FU. The patients will be randomised and will receive the above described combination as IV bolus injections, peroperatively in conjuction with collection of the first tissue sample.
A low dose (30 mg) and a high dose (120) mg of Arfolitixorin will be used in order to investigate the relation between dose of Arfolitixorin and TS-inhibition.

Start Date05 Feb 2020

Sponsor / Collaborator

Region Västra Götaland

[+1]

NCT03750786

/ CompletedPhase 3

A Randomized, Multicenter, Parallel-group, Phase III Study to Compare the Efficacy of Arfolitixorin Versus Leucovorin in Combination With 5 Fluorouracil, Oxaliplatin, and Bevacizumab in Patients With Advanced Colorectal Cancer

This 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 in combination with 5-fluorouracil, oxaliplatin, and bevacizumab according to modified FOLFOX-6 until PD according to RECIST 1.1 criteria.

Start Date18 Dec 2018

Sponsor / Collaborator

Isofol Medical AB

100 Clinical Results associated with Arfolitixorin

100 Translational Medicine associated with Arfolitixorin

100 Patents (Medical) associated with Arfolitixorin

Literatures (Medical) associated with Arfolitixorin

01 Jan 2026·Cancer treatment and research communications

Deoxyuridine as a surrogate marker of thymidylate synthase inhibition contributes to a multivariable model predicting 5-FU/LV response in metastatic colorectal cancer

Article

Author: Odin, Elisabeth ; Gustavsson, Bengt ; Wettergren, Yvonne ; Carlsson, Göran

BACKGROUND:

Colorectal cancer (CRC) chemotherapy is based on 5-fluorouracil (5-FU) and the folate leucovorin (LV). The active metabolites of these compounds, 5-fluorodeoxyuridine monophosphate (FdUMP) and 5,10-methylenetetrahydrofolate (5,10-MeTHF), form an inhibitory complex with thymidylate synthase (TS) resulting in elevated deoxyuridine (dUr) levels. In contrast to LV, natural 5,10-MeTHF (arfolitixorin, ARF) participates directly in the complex. Pyridoxal 5'-phosphate (PLP) potentially boosts 5-FU/LV (FLV)-based chemotherapy.

OBJECTIVE:

The study explored the correlation between dUr levels in tumor homogenates and tumor response, and assessed the impact of LV and ARF, combined with FdUMP and optionally PLP, on dUr levels.

PATIENTS AND METHODS:

Sixty-seven patients with metastatic CRC receiving first-line FLV-based chemotherapy and exhibiting either tumor response or disease progression were included. Tumor homogenates were prepared from snap-frozen primary tumors, and the dUr level was analyzed using LC-MS/MS. Fit modelling was used to predict the effect of explanatory variables on tumor response.

RESULTS:

Significantly higher dUr levels were observed after the addition of ARF compared to LV. dUr levels correlated positively with ARF, but not with LV, dosage. Adding PLP to LV increased dUr levels in 43% of homogenates but levels remained lower than those achieved with ARF alone. The baseline dUr level, together with the variables tumor location, BMI, and chemotherapy regimen were predictive for tumor response.

CONCLUSIONS:

The method used enables simultaneous analysis of multiple compounds within a tumor homogenate. Measuring dUr in homogenates before and after folate modulation, prior to initiation of FLV-based chemotherapy, could help predict tumor response and guide the choice between LV and ARF for optimal folate support.

04 Jan 2024·Cancer research communications

A Randomized Phase III Study of Arfolitixorin versus Leucovorin with 5-Fluorouracil, Oxaliplatin, and Bevacizumab for First-Line Treatment of Metastatic Colorectal Cancer: The AGENT Trial

Article

Author: Papadimitriou, Christos ; Gibbs, Peter ; Stintzing, Sebastian ; Prager, Gerald W ; Yoshino, Takayuki ; Nygren, Peter ; de Gramont, Aimery ; Tell, Roger ; Lenz, Heinz-Josef ; Jonker, Derek J ; Tabernero, Josep

Abstract:

Purpose::

Suboptimal treatment outcomes with 5-fluorouracil (5-FU)/folate, the standard of care for metastatic colorectal cancer (mCRC), have generated interest in optimizing the folate. Arfolitixorin ([6R]-5,10-methylene-tetrahydrofolate) is an immediately active folate and may improve outcomes over the existing standard of care (leucovorin).

Experimental Design::

AGENT was a randomized, phase III study (NCT03750786). Patients with mCRC were randomized to arfolitixorin (120 mg/m2 given as two intravenous bolus doses of 60 mg/m2) or leucovorin (400 mg/m2 given as a single intravenous infusion) plus 5-FU, oxaliplatin, and bevacizumab. Assessments were performed every 8 weeks. The primary endpoint was the superiority of arfolitixorin for overall response rate (ORR).

Results::

Between February 2019 and April 2021, 490 patients were randomized (245 to each arm). After a median follow-up of 266 days, the primary endpoint of superiority for ORR was not achieved (48.2% for arfolitixorin vs. 49.4% for leucovorin, Psuperiority = 0.57). Outcomes were not achieved for median progression-free survival (PFS; 12.8 and 11.6 months, P = 0.38), median duration of response (12.2 and 12.9 months, P = 0.40), and median overall survival (23.8 and 28.0 months, P = 0.78). The proportion of patients with an adverse event of grade ≥3 severity was similar between arms (68.7% and 67.2%, respectively), as was quality of life. BRAF mutations and MTHFD2 expression were both associated with a lower PFS with arfolitixorin.

Conclusions::

The study failed to demonstrate clinical benefit of arfolitixorin (120 mg/m2) over leucovorin. However, it provides some useful insights from the first-line treatment setting, including the effect of gene expression on outcomes.

Significance::

This phase III study compared arfolitixorin, a direct-acting folate, with leucovorin in FOLFOX plus bevacizumab in mCRC. Arfolitixorin (120 mg/m2) did not improve the ORR, potentially indicating a suboptimal dose.

01 Oct 2022·ESMO open

A phase I/II study of arfolitixorin and 5-fluorouracil in combination with oxaliplatin (plus or minus bevacizumab) or irinotecan in metastatic colorectal cancer

Article

Author: Koumarianou, A ; Kentepozidis, N ; Papadimitriou, C ; Carlsson, G ; Brændengen, M ; Guren, T K ; Mavroudis, D ; Skintemo, L ; Pfeiffer, P ; Katsaounis, P ; Taflin, H ; Tell, R ; Haux, J

BACKGROUND:

5-fluorouracil (5-FU) combined with a folate remains an essential treatment component for metastatic colorectal cancer (mCRC). Leucovorin is the folate most often used, but requires intracellular conversion to a reduced folate, and has high pharmacokinetic variability and limited bioavailability in patients with low folate pathway gene expression. Arfolitixorin is an immediately active form of folate, [6R]-5,10-methylenetetrahydrofolate ([6R]-MTHF), and may improve outcomes.

PATIENTS AND METHODS:

This open-label, multicenter, phase I/II study in patients with mCRC (NCT02244632) assessed the tolerability and efficacy of first- or second-line arfolitixorin (30, 60, 120, or 240 mg/m² intravenous) with 5-FU alone, or in combination with oxaliplatin (plus or minus bevacizumab) or irinotecan, every 14 days. Safety, efficacy, and pharmacokinetics were assessed before and after four cycles (8 weeks) of treatment.

RESULTS:

In 105 treated patients, investigators reported 583 adverse events (AEs) in 86 patients (81.9%), and 256 AEs (43.9%) were potentially related to arfolitixorin and 5-FU. Dose adjustments were required in 16 patients (15.2%). At 8 weeks, 9 out of 57 patients assessed for efficacy achieved an objective response (15.8%), and all 9 achieved a partial response. Six of these nine patients had received arfolitixorin as a first-line treatment. A further 33 patients (57.9%) achieved stable disease. Pharmacokinetics were assessed in 35 patients. The average t_max was 10 min, and area under the plasma concentration-time curve from time 0 to 1 h increased linearly between 30 and 240 mg/m². No accumulation was observed for [6R]-MTHF following repeated administration, and there were no major pharmacokinetic differences between cycle 1 and cycle 4 at any dose.

CONCLUSIONS:

Arfolitixorin is a well-tolerated moderator of 5-FU activity. It is suitable for further investigation in mCRC and has the potential to improve treatment outcomes in patients with low folate pathway gene expression. Arfolitixorin can easily be incorporated into current standard of care, requiring minimal changes to chemotherapy regimens.

News (Medical) associated with Arfolitixorin

28 Nov 2022

·www.prnewswire.com

CEO Ulf Jungnelius to leave Isofol Medical on June 1, 2023

GOTHENBURG, Sweden, Nov. 28, 2022 /PRNewswire/ -- Isofol Medical AB (publ) (Nasdaq Stockholm: ISOFOL), announced today that Chief Executive Officer Dr. Ulf Jungnelius M.D. and Isofol's Board of Directors have agreed that Ulf will step down as CEO of Isofol on June 1, 2023. Isofol's Board of Directors will take a decision regarding a new CEO once the company's future has been determined. The information in the press release is intended for investors. Dr. Ulf Jungnelius M.D. and Isofol have agreed that Ulf will leave his position as CEO of Isofol Medical on June 1, 2023. Until then he will be fully focused in leading Isofol as it completes the closure of the AGENT and to assess possible future paths forward for the Company. "As CEO, Ulf brought a valuable know-how and ability to oversee a large phase III clinical trial in oncology. We would like to thank Ulf for his hard work and dedication in taking the AGENT study to conclusive although disappointing results," said Jan Törnell, Chairman of Isofol Board of Directors. "Drug development is always a high-risk enterprise, but competent teams and dedicated shareholders are needed to make progress in fighting cancer. I would like to thank Isofol's shareholders, staff and board for their trust and confidence in allowing me to lead Isofol's effective and decisive completed phase III study," said Ulf Jungnelius. For further information, please contact Jan Törnell, chairman of the board E-mail: [email protected] Isofol Medical AB (publ) Jarl Ulf Jungnelius, M.D., CEO E-mail: [email protected] Telephone: +46 709-16 89 55 This is information that Isofol Medical AB is obliged to make public pursuant to the EU Market Abuse Regulation. This information was submitted for publication, through the agency of the contact person set out above, at 17:55 CET on November 28, 2022. About Isofol Medical AB (publ) Isofol Medical AB (publ) is a clinical-stage biotechnology company that is developing and improving the current standard treatment for patients suffering from cancer by increasing treatment efficacy through the use of cytostatics. Isofol is focused on developing a drug for first-line treatment of advanced colorectal cancer (mCRC) and is trying to improve the current clinical practice by realizing the full strength of 5-FU with the addition of arfolitixorin. Isofol has an exclusive global licensing agreement with Merck & Cie in Schaffhausen, Germany to develop and commercialize arfolitixorin in oncology. Isofol Medical AB (publ) is traded on Nasdaq Stockholm. The following files are available for download: SOURCE Isofol Medical AB (publ)

Phase 3Executive ChangeLicense out/in

25 Nov 2022

·www.prnewswire.com

Final data from the AGENT study confirms topline results

GOTHENBURG, Sweden, Nov. 25, 2022 /PRNewswire/ -- Isofol Medical AB (publ) (Nasdaq Stockholm: ISOFOL), announced today that analysis of the AGENT study's final data confirmed topline results presented on August 3, 2022. Moreover, no predictive gene expressions for clinical response could be identified. Isofol is continuing its efforts to terminate the AGENT study in line with applicable ethical and regulatory requirements, complete the final study report for submission to regulatory agencies and prepare a manuscript for a scientific publication. Isofol is in parallel continuing to investigate possible future paths forward for the company. The information in the press release is intended for investors. On August 3, 2022, Isofol presented topline results showing that the AGENT study met neither its primary endpoint nor key secondary endpoint. Based on analysis of additional study data that Isofol obtained since then, the company can today confirm that the AGENT study's final data confirms the conclusions that were communicated in conjunction with topline results and study updates from August 31 and September 7, namely that: Neither the primary endpoint of objective response rate (ORR) nor the key secondary endpoint of progression-free survival (PFS) were met. With regards to safety data, there were no differences between the study arms with the exception of a non-statistically significant detriment in overall survival (OS) in the arfolitixorin arm. There were no significant differences in any major subgroups. There were preliminary indications that the risk of death was 11 percent greater in the experimental arm compared with the control arm. Data surrounding gene expression was also analyzed during the fourth quarter. Conclusions from this analysis did not identify any predictive biomarkers. "All in all, the final study results did not show any clinical or business value for Isofol either. We remain greatly disappointed. The company's management and board of directors will continue to diligently work together to investigate possible options for Isofol's future," said Ulf Jungnelius, CEO of Isofol. Isofol's work to terminate the AGENT study, which currently involves detailed quality control and regulatory documentation from the study sites involved, is continuing, and is estimated to be completed by the turn of the year. Isofol intends to publish key data from the study in a scientific publication to enable the medical community to fully leverage the lessons learned from the study. The preparation of a manuscript for scientific publication is ongoing and the intention is to submit it to a peer-reviewed journal in oncology during the first quarter of 2023. For further information, please contact Isofol Medical AB (publ) Jarl Ulf Jungnelius, M.D., Chief Executive Officer E-mail: [email protected] Phone: +46 (0) 709 16 89 55 Roger Tell, M.D., PhD, Chief Medical Officer E-mail: [email protected] Phone: +46 (0) 760 29 39 11 This information was submitted for publication, through the agency of the contact person set out above, at 08:30 CET on November 25, 2022. About the AGENT study The Phase III AGENT Study is the first to evaluate a meaningful alternative to the standard of care for most patients with metastatic colorectal cancer (mCRC) in 20 years and involves approximately 90 clinics in the U.S., Canada, Europe, Australia, and Japan. The Phase III randomized, controlled, multi-center study of 490 patients assessed the efficacy and safety of arfolitixorin, [6R]-5,10 methylene-THF (MTHF), compared to leucovorin, both used in combination with 5-U, oxaliplatin, and bevacizumab, in first line mCRC patients. The study was designed to show that arfolitixorin was better than leucovorin and that the results would be statistically significant. Patients were randomized in a 1:1 ratio with the primary endpoint being an overall response rate (ORR) >10 percent improvement vs. the control arm. The key secondary endpoint is a clinically meaningful positive trend in progression free survival (PFS). Other secondary endpoints include duration of response (DOR), number of curative metastasis resections, safety, and patient reported outcomes such as quality of life (QoL). Exploratory endpoints include pharmacokinetic (PK) measurements and level of gene expression of folate relevant genes in tumor cells. In the 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 (leucovorin + 5-FU, oxaliplatin and bevacizumab). About Isofol Medical AB (publ) Isofol Medical AB (publ) is a clinical-stage biotechnology company that is developing and improving the current standard treatment for patients suffering from cancer by increasing treatment efficacy through the use of cytostatics. Isofol is focused on developing a drug for first-line treatment of advanced colorectal cancer (mCRC) and is trying to improve the current clinical practice by realizing the full strength of 5-FU with the addition of arfolitixorin. Isofol has an exclusive global licensing agreement with Merck & Cie in Schaffhausen, Germany to develop and commercialize arfolitixorin in oncology. Isofol Medical AB (publ) is traded on Nasdaq Stockholm. The following files are available for download: SOURCE Isofol Medical AB (publ)

Phase 3License out/inClinical Result

11 Nov 2022

·www.prnewswire.com

Isofol Medical AB (publ) publishes interim report, January-September 2022

GOTHENBURG, Sweden, Nov. 11, 2022 /PRNewswire/ -- Isofol Medical AB (publ), (NASDAQ Stockholm: ISOFOL), announced today that the company's interim report for January-September 2022 is now available on the company's website, . The information in the press release is intended for investors. Third quarter, July – September 2022 Net revenue amounted to TSEK 2,907 (5,154) and other revenue to TSEK 0 (0) The result for the period amounted to TSEK -32,513 (-51,026) Earnings per share amounted to SEK -0.20 (-0.32) Cash and cash equivalents as of September 30 amounted to TSEK 234,983 (420,861) January – September 2022 Net revenue amounted to TSEK 10,940 (17,702) and other revenue to TSEK 1 (0) The result for the period amounted to TSEK -134,420 (-139,081) Earnings per share amounted to SEK -0.83 (-1.22) Significant events during the third quarter 2022 On July 26, Isofol received approval of a biomarker analysis patent. On August 3, Isofol presented the top-line results of the global pivotal phase III AGENT study. The study data revealed that the study did not achieve the primary endpoint of objective response rate (ORR) or the key secondary endpoint of progression-free survival (PFS). On August 31, Isofol announced that based on additional study data, there was no longer reason to continue with the AGENT study. The conclusions regarding primary and secondary endpoints will not be revised. Isofol's Board resolved to assess possible alternatives for the company's future. On September 7, Isofol reported additional study data that laid the groundwork for the decision to terminate the study early. In parallel with this decision, Isofol's Board will continue to investigate possible alternatives to secure the largest possible value for Isofol's shareholders. Significant events after the event of the period No significant events occurred after the end of the period. CEO´s comment: "Given the AGENT study results' low clinical and business value for Isofol, we began work during the quarter to terminate the study. This must be carried out in accordance with applicable ethical aspects and regulatory requirements. This work is extensive and will therefore require both time and resources throughout autumn 2022 and the beginning of 2023. We also took active measures to reduce costs and secure the company's financial position, which has been our utmost priority along with finding any positive outcomes in the study data and terminating the study," says CEO Ulf Jungnelius. Audiocast, November 11, at 11:00 a.m. CET In conjunction with the publication of the interim report for the third quarter of 2022, Isofol invites investors, analysts, and media to an audiocast on November 11, 2022 at 11:00 a.m. CET. The presentation will be held by Isofol´s CEO Ulf Jungnelius and CFO Gustaf Albèrt, who will present and comment the report, followed by a Q&A-session. The presentation will be held in English. Date and time November 11, 2022, at 11:00 a.m. CET Webcast link Phone number To participate via telephone, please dial one of the numbers below. SE: +46 8 50 55 83 69 UK: +44 333 300 92 68 US: +1 631 913 1422, PIN: 46897527# The presentation will also be available on Isofol's website after the broadcast: For more information, please contact Isofol Medical AB (publ) Ulf Jungnelius, M.D., CEO E-mail: [email protected] Telephone: +46 709-16 89 55 Gustaf Albèrt, CFO E-mail: [email protected] Telephone: +46 709-16 83 02 The information was submitted for publication, through the agency of the contact person set out above, at 08:00 CET, on November 11, 2022. About Isofol Medical AB (publ) Isofol Medical AB (publ) is a clinical stage biotech company that is progressing and advancing current standards of care for people living with cancer by working to improve the efficacy of the current chemotherapeutic standards of care. Isofol is focused on developing a drug for the first line treatment of metastatic colorectal cancer (mCRC) and seeks to elevate current clinical practice by unlocking the full strength of 5-FU with the addition of arfolitixorin. Isofol holds a worldwide exclusive licensing agreement with Merck & Cie, Schaffhausen, Germany to develop and commercialize arfolitixorin for use in oncology. Isofol Medical AB (publ) is traded on Nasdaq, Stockholm. The following files are available for download: SOURCE Isofol Medical AB (publ)

License out/inFinancial StatementPhase 3

100 Deals associated with Arfolitixorin

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KEGG	Wiki	ATC	Drug Bank
D08925	-	-	DB12676

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Adenocarcinoma of large intestine	Phase 3	United States	Isofol Medical AB	18 Dec 2018
Adenocarcinoma of large intestine	Phase 3	Japan	Isofol Medical AB	18 Dec 2018
Adenocarcinoma of large intestine	Phase 3	Australia	Isofol Medical AB	18 Dec 2018
Adenocarcinoma of large intestine	Phase 3	Austria	Isofol Medical AB	18 Dec 2018
Adenocarcinoma of large intestine	Phase 3	Canada	Isofol Medical AB	18 Dec 2018
Adenocarcinoma of large intestine	Phase 3	France	Isofol Medical AB	18 Dec 2018
Adenocarcinoma of large intestine	Phase 3	Germany	Isofol Medical AB	18 Dec 2018
Adenocarcinoma of large intestine	Phase 3	Greece	Isofol Medical AB	18 Dec 2018
Adenocarcinoma of large intestine	Phase 3	Spain	Isofol Medical AB	18 Dec 2018
Adenocarcinoma of large intestine	Phase 3	Sweden	Isofol Medical AB	18 Dec 2018

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03750786 (AGENT, ESMO_GI2024) Manual	Phase 3	Metastatic Colorectal Carcinoma First line	59	Arfolitixorin combination with 5-FU, oxaliplatin, and bevacizumab. (the Greek patient subpopulation)	nlhbiwctni(kxyasbehex) = kculstkhky xeuatwncuq (lvtkhgnjvg, 22.1 - 63.4) View more	-	29 Jun 2024
				Leucovorin combination with 5-FU, oxaliplatin, and bevacizumab. (the Greek patient subpopulation)	nlhbiwctni(kxyasbehex) = kterdgfvow xeuatwncuq (lvtkhgnjvg, 21.5 - 55.1) View more
NCT03750786 (AGENT, Pubmed) Manual	Phase 3	Metastatic Colorectal Carcinoma First line	490	Arfolitixorin	poreuolhqy(tmuspzyqev) = kfeiqyugpj nnaivcensq (hlxdmscalc ) View more	Negative	04 Jan 2024
				Leucovorin	poreuolhqy(tmuspzyqev) = ulmbeapccd nnaivcensq (hlxdmscalc ) View more
NCT03750786 (AGENT \| AGENT Trial \| AGENT Phase III, CTgov)	Phase 3	Adenocarcinoma of large intestine \| Advanced Colorectal Adenocarcinoma \| Colorectal Cancer	490	Arfolitixorin (Group A)	nahnbzardg(boodkokpdr) = xgmcpkayxq uzucfkvofv (mrowhscjfb, qghjzzmxva - kjjzaafekr) View more	-	26 Oct 2023
				Leucovorin (Group B)	nahnbzardg(boodkokpdr) = xsiwiemfoe uzucfkvofv (mrowhscjfb, ctmfanwamg - qjxtjilwdi) View more
NCT02244632 (ISO-CC-005, Pubmed) Manual	Phase 1/2	Colorectal Cancer First line	105	5-fluorouracil+oxaliplatin+bevacizumab+irinotecan+arfolitixorin	izkgonragd(hndtbpwada) = oufzwkbwbj rzotpdaeel (cuxqfsabwr ) View more	Positive	29 Sep 2022
NCT03750786 (AGENT, Corporate Publications) Manual	Phase 3	Metastatic Colorectal Carcinoma First line	490	Fluorouracil+Oxaliplatin+Bevacizumab-BVZR+arfolitixorin	ubvffbiuwg(kgxiydtofu): P-Value = 0.85 View more	Negative	07 Sep 2022
				Fluorouracil+Oxaliplatin+Bevacizumab-BVZR+Folinic Acid
NCT02244632 (ISO-CC-005, Biospace) Manual	Phase 1/2	Colorectal Cancer BRAF mutation	31	Levofolinate Calcium+5,10-Methylenetetrahydrofolate	jtmzoclvho(qlhfzelwqb) = rtsuhwuojf gprnbjrbie (ekbqugonsu )	Positive	30 Sep 2020
NCT03203564 (CTgov)	Phase 1	-	33	Modufolin (200 mg/m2 of Modufolin®)	tuqsocvjus(eppzaqwldx) = qavnpdaqnp snraqqollf (rqubkexcxe, 2.85) View more	-	19 Mar 2020
				Modufolin (350 mg/m2 of Modufolin®)	tuqsocvjus(eppzaqwldx) = whmtxkajpf snraqqollf (rqubkexcxe, 2.84) View more
NCT01987102 (CTgov)	Phase 1/2	Osteosarcoma	18	Calcium Folinate+[6R] 5,10-methylenetetrahydrofolate (arfolitixorin) (Cohort 1)	yhgdpezmsw = brubbwlsii wailhkwqcw (fscybzkgvz, gyqxobrtcp - vcamrexzqr) View more	-	26 Jun 2019
				Calcium Folinate+[6R] 5,10-methylenetetrahydrofolate (arfolitixorin) (Cohort 2)	yhgdpezmsw = eifpqkexbv wailhkwqcw (fscybzkgvz, rmkkfutdig - oxircomkoc) View more
NCT02244632 (ISO-CC-005, ESMO2018)	Phase 1/2	Metastatic Colorectal Carcinoma	67	Arfolitixorin + 5-FU + irinotecan + oxaliplatin + bevacizumab	hbzbwctmwd(pwzjlytviu) = 27 SAEs have been reported in 13 patients, 6 of these were judged as at least possibly related to arfolitixorin. No SAE were judged as solely related to arfolitixorin. dvaprawybr (bfvlhhsnlx )	Positive	21 Oct 2018
NCT02244632 (ISO-CC-005, ASCO_GI2018)	Phase 1/2	Metastatic Colorectal Carcinoma	42	Modufolin + 5-FU + irinotecan + oxaliplatin ± bevacizumab	yemrsuvqrj(jiseuwtnwi) = 19 SAEs have been reported in 12 patients, 3 of these were judged as at least possibly related to Modufolin. No SAE were judged as solely related to Modufolin. rnximlkimm (jkxedtcxod )	Positive	26 Feb 2018

Translational Medicine

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Deal

Boost your decision using our deal data.

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Core Patent

Boost your research with our Core Patent data.

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Clinical Trial

Identify the latest clinical trials across global registries.

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Approval

Accelerate your research with the latest regulatory approval information.

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Regulation

Understand key drug designations in just a few clicks with Synapse.

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AI Agents Built for Biopharma Breakthroughs

Accelerate discovery. Empower decisions. Transform outcomes.

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Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

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Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis