Copenhagen, Denmark, November 8, 2022 – FluoGuide A/S (“FluoGuide” or the “Company”) is pleased to report that the first large-scale batch for its lead product FG001 has been successfully manufactured for Phase III clinical development.
FluoGuide has successfully collaborated with its supplier PolyPeptide since the very first synthesis of API FG001 (Active Pharmaceutical Ingredient). FG001 is a clinical development project launched in 2020 for the novel treatment for aggressive brain cancer. A first large-scale batch has now been successfully manufactured by PolyPeptide for Phase III clinical development.
For pivotal phase III clinical trials, FluoGuide with the support of PolyPeptide has expanded the manufacture of FG001 to commercial scale. As part of the clinical process, FluoGuide now provides for three commercial-scale validation batches to be documented and included in the registration dossier for commercial approval.
The success of the first phase III batch is therefore an important step for the preparation of possible phase III trials and the commercialization of FG001.
Morten AlbrechtsenCEO FluoGuide says “The completion of the first large-scale GMP batch is an important milestone for our lead product FG001, as it paves the way for the next clinical steps and brings us closer to commercialization”.
Neil ThompsonGlobal Director of Sales and Marketing, Polypeptide says: “We are grateful to have the opportunity to work with FluoGuide on the very innovative FG001 project and congratulate the whole team for reaching this milestone.”
For more information, please contact:
+45 24 25 62 66
Svensk Kapitalmarknadsgransking AB
PolyPeptide is a concentrate Contract development and manufacturing organization (CDMO) for active pharmaceutical ingredients based on peptides and oligonucleotides. By supporting its clients mainly in the pharmaceutical and biotechnology industry, it contributes to the health of millions of patients around the world. PolyPeptide offers products and services from preclinical to commercial stages, including generics. Its pipeline of active custom projects reflects the opportunities presented by new drug therapies in development to combat common and rare diseases. Dating back to 1952, PolyPeptide today operates a global network of six GMP certified facilities in Europethe WE and India with approximately 1,200 employees in mid-2022. Shares of Polypeptide (SIX: PPGN) are listed SIX Swiss Stock Exchange. For more information, please visit polypeptide.com.
FluoGuide’s main objective is to maximize surgical results in oncology. The Company’s lead product, FG001, is designed to improve surgical precision by illuminating cancer cells intraoperatively. The improved accuracy enabled by FluoGuide’s has a double advantage: it both reduces the frequency of local post-operative recurrences and reduces surgical sequelae. Ultimately, the improved accuracy will increase a patient’s chances of achieving a full cure and reduce system-wide healthcare costs. The Company has demonstrated the efficacy of F001 as well as its good tolerance and safety in the ongoing proof-of-concept clinical study (phase I/II) in patients with high-grade glioma undergoing surgery. FluoGuide decided to explore FG001 in three other serious cancer indications, namely lung, head and neck, meningioma and low-grade glioma. FluoGuide is listed on Nasdaq First North Sweden under the symbol “FLUO”.
For more information on the company’s uPAR technology platform and our pipeline, please visit our homepage www.fluoguide.com
This project received funding from of the European Union Horizon 2020 research and innovation program under grant agreement n° 954904.
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