GOTHENBURG, Sweden, July 15, 2019 – Isofol Medical AB (publ), (Nasdaq First North Premier: ISOFOL), today announced the outcome of an advisory board meeting held to discuss the current status and ongoing strategy for the development of arfolitixorin, the company’s proprietary drug candidate being studied in the global pivotal Phase 3 AGENT study for advanced colorectal cancer. Arfolitixorin has the potential to significantly broaden and optimize the use of chemotherapy regimens containing fluorouracil (5-FU) for the treatment of metastatic colorectal cancer. The meeting, held during the 2019 American Society Of Clinical Oncology (ASCO) Annual Meeting in Chicago, was chaired by Heinz-Josef Lenz (USA) and attended by a global panel of colorectal cancer experts including Sebastien Stintzing (Germany), Sabine Tejpar (Belgium), Takayuki Yoshino (Japan), Howard Hochster (USA), John Marshall (USA), Tanios Bekaii-Saab (USA) and Josep Tabernero (Spain).
“The meeting provided us exactly the analysis and confirmation we needed at this critical stage to ensure we can continue to optimize the development of arfolitixorin and its future application in treating cancers,” said Anders Rabbe, chief executive officer of Isofol. “We gave the advisors a clear opportunity to review and analyze the current status of and future development plans for arfolitixorin. The data is still developing, but we believe, and the advisory board agrees, that we are progressing toward a strong target product profile with promise to provide a key new agent in the battle against colorectal cancer. We now have a substantiated and refined plan for our clinical path forward.”
Sven Erickson, chief commercial officer of Isofol, added, “We are very grateful for the support and advice given to us by the expert advisors. A key activity we will engage in on a consistent basis is to actively communicate to clinicians everywhere the unique and differentiated mode of action of arfolitixorin. The advisors agreed with us that arfolitixorin could potentially be widely adopted by medical oncologists due to the strong need to treat more patients more efficiently, provide better outcome and reduce patient complications.”
Heinz-Josef Lenz, MD, Professor of Medicine at Keck School of Medicine of University of Southern California (USC) and J. Terrence Lanni Chair in Gastrointestinal Cancer Research at USC Norris Comprehensive Cancer Center stated, “Isofol is making progress in drug development and arfolitixorin is a promising new compound that could improve the effectiveness of treatment of advanced colorectal cancer. We all await the potentially pivotal data that may emerge from the AGENT study in mid-2020, that could make arfolitixorin an important choice in colorectal cancer treatment.”
The AGENT study is a multicenter, randomized, controlled study with blinded independent review of tumor response. Top-line data from the study is expected in 2021 (ISO-CC-007, NCT03750786).
For further information, please contact
Isofol Medical AB (publ)
Anders Rabbe, CEO
Phone: +46 (0)707 646 500
Phone: +41 79 598 7149
LifeSci Public Relations
Phone: +1 646 876 4932
FNCA Sweden AB
Phone: +46 (0)8 528 003 99
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.
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 (publ) is traded on the Nasdaq First North Premier. Certified Adviser is FNCA Sweden AB.