On September 29, 2019 Isofol Medical AB (publ), (Nasdaq First North Premier: ISOFOL), reported a poster presentation on the ongoing global Phase 3 AGENT clinical study in patients with metastatic colorectal cancer (mCRC) (Press release, Isofol Medical, SEP 29, 2019, View Source [SID1234539897]). The poster will be presented at the 2019 European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress, which is being held from September 27 to October 1, 2019, in Barcelona, Spain.
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Details on the presentation are as follows:
Title: Open label phase III study of arfolitixorin vs leucovorin in mFOLFOX-6 for first-line treatment of metastatic colorectal cancer: AGENT
Presentation Number: 664TiP
Presentation Time: 12 p.m. – 1 p.m. CEST
Presentation Date: September 29, 2019
Speaker: Prof Sebastian Stintzing
Session Name: Poster Display session
Location: Poster Area (Hall 4), Fira Gran Via, Barcelona, Spain
Link to the abstract and poster >>
The poster presentation is highlighting the trial design and execution to date of the AGENT study. The primary endpoint for the AGENT study is overall response rate (ORR) and key secondary endpoints include progression free survival (PFS) and duration of response (DoR). This is a randomized, multicenter, parallel-group, Phase 3 study to compare the efficacy of arfolitixorin versus leucovorin (LV) in patients with mCRC treated with 5-fluorouracil (5-FU), oxaliplatin, and bevacizumab. Patients will be randomized in a 1:1 ratio to either the investigational arm or the comparator arm. The study target is to randomize 440 patients in 18 months. An adaptive study design includes the possibility to increase the sample size to 660 patients which aim is to strengthen the statistical power for PFS. An interim analysis will be conducted after 330 patients have performed their 16 weeks scan and evaluated by the Data and Safety Monitoring Board (DSMB) who will advice the company about the sample size increase. Learn more about the global Phase 3 trial at clinicaltrials.gov.
For further information, please contact
Isofol Medical AB (publ)
Roger Tell, SVP, Chief Medical Officer
Email: [email protected]
Phone: +46 (0) 760 293 911
Investor Relations
LifeSci Advisors
Hans Herklots
E-mail: [email protected]
Phone: +41 79 598 7149
Media
LifeSci Public Relations
Alison Chen
E-mail: [email protected]
Phone: +1 646 876 4932
Certified Adviser
FNCA Sweden AB
E-mail: [email protected]
Phone: +46 8 528 003 99
About arfolitixorin
Arfolitixorin is Isofol’s proprietary drug candidate being developed to increase the efficacy of standard of care chemotherapy for advanced colorectal cancer. The drug candidate is currently being studied in a global Phase 3 clinical trial, AGENT. 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.