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Compassionate use refers to a permission granted to a doctor to use of a new, unapproved drug to treat a seriously ill patient. The permission is typically given to an individual patient or a hospital department. The principle is that it will be considered unethically not to make the drug available to the doctor for treating the patient. Revenue from compassionate use sales will most often not create any profit. It might still be important for FluoGuide as it could enhance the learning and the usability of the product. It will be a stepwise process that will be considered once the ongoing phase I/II clinical trial has been reported to the authorities, meaning after 2H-21.
Prof. Andreas Kjær is heading a research group with 40+ people working with imaging and diagnostics within cancer. Over the years, he has produced a substantial amount of scientific results (>500 research articles) and innovations (16 patents). Curasight was created many years ago in 2013, and long before FluoGuide. Curasight develops PET tracers and with these PET tracers, Curasight has conducted clinical trials including scans of more than 400 patients and through that we gained an in-depth understanding of uPAR expression in several human cancer patient populations. FluoGuide was created based on this knowledge combined with the evolving field of image-guided surgery.
Whereas Curasight develops PET tracer-based diagnostics of different human cancers and therapy based on radiation, FluoGuide develops fluorescent image-guidance of surgery.
A PET tracer (link) emit a low dose radiation that is detected by an external PET scanner. PET tracers cannot be used to guide surgery in real-time (radioactive and low resolution). A fluorophore targeted product emits light that is detected by eyes or cameras. Fluorophore targeted products cannot be used as whole body diagnostics (only visible 1-3 cm into the tissue). Accordingly, there is no overlap of the fields of the two technologies or products the two companies are based on.
Treatment of cancer in general and glioblastoma in particular, are treated with combination therapy, i.e. combination of surgery, radiation therapy and chemotherapy. Accordingly, the technologies of FluoGuide and Curasight are expected to work in synergy.
FluoGuide share can be found using the ISIN codes (Share: DK0061123312; TO1: DK0061138773).
FG001 contains a molecule with fluorescent properties (a fluorophore). Fluorophores absorb light of a specific wavelength and re-emit light of a longer wavelength. Typically, a laser will create the light and a camera will detect the re-emitted light. Lasers and camera are built into microscope, robotic surgery equipment and endoscopes, and available today at the surgery rooms with the specifications needed for FG001.
The price of FG001 will depend on the clinical benefit it provides to patients, hospitals and society, and the extent to which we manage to demonstrate this. Thus, the results of the clinical phase I/II trial for FG001 in patients with glioblastoma undergoing surgery will give the first indication of the magnitude of benefit FG001 provides to these patients.
Yes. FG001 is a medical product (drug) per definition and there are clear guidelines for medical products. Interactions with the regulatory agencies, such as FDA and EMA, are nevertheless important during the development. This shall secure that the specific issues related to FG001 and guiding of cancer surgery are discussed with the regulatory agencies during the development of FG001. The overall aim is to secure that new important products are brought to patients safely and quickly.
Post-surgery pathohistological examination is the golden standard and is a good measure for the surgical success. The pathologist investigates if the margins of the removed tissue contain cancer (termed ‘positive margins’) or the margins are clear of cancer (‘negative margins’). A surgical success is removal of all local cancer plus minimally normal tissue with a cancer free (‘negative’) margin. For glioblastoma specifically is post-surgery MRI the golden standard.
We anticipate developing 2-3 uPAR target products to guide surgery to fully explore its potential. Every time we initiate development of a new product, we have to invest to secure adequate manufacturing followed by a full toxicological testing program before human trials. The decision regarding the number of products to develop has to be balanced against the additional value it provides to patients and shareholders. We are generating data for an informed decision in mid 2021.
As previously communicated in our IPO prospectus, the costs to bring FG001 to market will require more capital than we currently have in our possession. Our vision is to create a company that fully utilizes the potential of uPAR target guided oncological surgery to the benefit of patients. Possible financing options include: Commercial partnerships, grants or issuing shares. We will always evaluate how we can create long term value to our shareholders and help cancer patients in the best possible way. So far, we have managed to create ample value to shareholders while perusing our vision of maximizing outcome in oncology surgery.