Isofol’s Board of Directors decides to initiate the planning of clinical studies and will announce a strategic development plan on March 19
GOTHENBURG, Sweden, February 14, 2024 – Isofol Medical AB (publ), (Nasdaq Stockholm: ISOFOL), has been engaged in intensive strategy work since the new Board of Directors and management took office in January. The Board of Directors has decided today to prepare a new development program for arfolitixorin, with the goal of initiating new clinical studies as soon as possible. The company intends to present details of the strategic direction on March 19, along with holding an investor meeting.
The information in the press release below is intended for investors.
During the past year and the beginning of 2024, Isofol has conducted analyses of the company’s previous clinical studies along with performing several preclinical laboratory tests, which has led to an increased understanding of arfolitixorin and its posology. Overall, the current facts indicate that the value of arfolitixorin is best demonstrated in the clinic, with a different dose and administration regimen than the one used in the earlier AGENT study.
The Board of Directors has therefore decided to focus the company's efforts on initiating new clinical studies without delay. The aim is to generate data in order to maximize the potential for a future commercialization. The initial focus will be to conduct small scale trials in a time- and cost-efficient manner, powered to prove the value of arfolitixorin compared to standard of care. Planning is currently underway and further details will be announced on 19 March.
In parallel with this, Isofol continues to analyze data from the AGENT study and will perform additional laboratory studies with the primary goal of optimizing the design of the new clinical program.
As part of the strategy work, the company has established a clinical committee with external experts such as Isofol’s founder Professor Bengt Gustavsson, Professor Åke Hjalmarsson and Professor David Machover, who has led pivotal research on the combination of folates and vitamin B6.
"Our current knowledge indicates that the dose and administration regimen used in the AGENT study was suboptimal and that arfolitixorin’s efficacy potentially could be increased with an optimized posology – which is best proven in new clinical studies. Preparations of the upcoming clinical program is in full swing, and I am pleased that we have succeeded in recruiting prominent external experts to the company as advisors in the work. We look forward to presenting further details in March," says CEO Petter Segelman Lindqvist.
Invitation to investor meeting
Isofol will hold an investor meeting at 6 p.m. on March 19, at the company's head office in Gothenburg. The investor meeting will also be available to follow digitally. A registration form and more information will be published on the company's website on March 1.
For more information, please contact
Isofol Medical AB (publ)
Petter Segelman Lindqvist, CEO
E-mail: [email protected]
Phone: +46 (0) 739 60 12 56
This is information that Isofol Medical AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 12:40 CET on February 14, 2024.
About Isofol Medical AB (publ)
Isofol Medical AB (publ) is developing the drug candidate arfolitixorin with the aim of increasing the efficacy of current standard treatments for colorectal cancer and certain other tumor diseases. A Phase III study of arfolitixorin has been completed and the company is now evaluating opportunities to advance the drug candidate toward a marketing authorization application by conducting additional studies and entering potential partnerships. Isofol Medical AB (publ) is traded on Nasdaq Stockholm.