The Phase 1/2a study ISO-CC-005 is completed
GOTHENBURG, Sweden, January 30, 2020 – Isofol Medical AB (publ) (Nasdaq First North Premier: ISOFOL), today announces that the recruitment and treatment of patients in the company's Phase 1/2a study with arfolitixorin has been completed. Totally 101 patients have been treated at 10 hospitals in the Nordic countries and Europe. The final analysis has started and study data is expected to be presented at ESMO 2020.
Ulf Jungnelius, M.D., Chief Executive Officer of Isofol, comments: “ISO-CC-005 has fulfilled its purpose by determining the dose we have chosen for further development in our Global Phase 3 AGENT study. Our focus now is taking the AGENT study in goal and submitting the results for a market approval. "
Isofol's target with the ISO-CC-005 study was to develop an effective and safe dose of arfolitixorin for continued clinical development. An expanded patient group to determine the safety profile of arfolitixorin in combination with the today's standard of care in first-line metastatic colorectal cancer, has now been conducted in accordance with protocol and the study has fulfilled its purpose and concluded.
For further information, please contact
Isofol Medical AB (publ)
Jarl Ulf Jungnelius, M.D., Chief Executive Officer
E-mail: jungnelius@isofolmedical.com
Investor Relations
LifeSci Advisors
Hans Herklots
E-mail: hherklots@lifesciadvisors.com
Phone: +41 79 598 7149
Media
LifeSci Public Relations
Alison Chen
E-mail: achen@lifescipublicrelations.com
Phone: +1 646 876 4932
Certified Adviser
FNCA Sweden AB
E-mail: info@fnca.se
Phone: +46 8 528 003 99
The information was submitted for publication, through the agency of the contact person set out above, at 08:15 CET on January 30, 2020.
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 study, 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.
About Isofol Medical AB (publ)
Isofol Medical AB (publ) is a clinical stage biotech company developing arfolitixorin to improve the efficacy of standard of care chemotherapy for advanced colorectal cancer by increasing tumor response and progression free survival. Isofol holds a worldwide exclusive license agreement with Merck KGaA, Darmstadt, Germany to develop and commercialize arfolitixorin for oncology indications. Isofol Medical AB is traded on the Nasdaq First North Premier. Certified Adviser is FNCA Sweden AB.