Healthcare Professionals

Glioblastoma

Malignant gliomas are the most common primary malignant brain tumors, with glioblastoma multiforme (GBM) associated with the worst prognosis. Although GBM is a rare tumor with an incidence of 3.23 cases per 100,000 individuals worldwide, it is still a deadly disease, with a 5 year survival rate of only 6.8%.¹ Patients typically have a median overall survival of 19.2 – 23.8 months from diagnosis.²
More than 250,000 new cases of primary malignant brain tumors are diagnosed annually worldwide, 77% of which are gliomas.³

Treatment

The standard of care therapy is a combination of resection, radiotherapy with concurrent and adjuvant chemotherapy.⁴ However, chemotherapy and radiotherapy have still limited efficacy because of early resistance and accumulation of side effects.

The extent of glioblastoma multiforme (GBM) resection depends on the location and eloquent regions of the affected brain area. Tumors occurring in sites such as the eloquent cortex, brainstem, or basal ganglia are not amenable to surgical intervention, and these patients typically have a worse prognosis. Surgical success is limited because of the invasive growth of GBM and the difficulty of resection with an adequate margin of safety.⁵ Nevertheless, the identification and removal of all contrast-enhancing tumor tissue improves progression-free survival (PFS) and overall survival (OS).^6,7,8,9,10

GBM remains incurable due to its heterogeneity and complex pathogenesis. Further research efforts in the future will help to improve treatment options in the fight against the disease.

About Gliolan^®

Gliolan^® is indicated in adults for visualisation of malignant tissue during surgery for malignant glioma (WHO grade III and IV). Gliolan^® is taken orally by the patient prior to surgery. In combination with a specialist surgical microscope and blue light source, Gliolan^® fluoresces the malignant part of the tumour enabling the surgeon to make a distinction between malignant and normal tissue.

Gliolan^® Mode of Action

5-ALA Trials

We have a number of trials, some of which are currently recruiting patients. Please click on the trials highlighted below to be taken to the relevant information.

Please click here for IIT’s

Study Title	Sponsor	ClinicalTrials.gov ID	Status
Controlled clinical trial to evaluate the safety and efficacy of stereotactical photodynamic therapy with 5-aminolevulinic acid (Gliolan®) in recurrent glioblastoma	Universitätsklinikum Münster Albert-Schweitzer-Campus 1, Gebäude D5, 48149 Münster	NCT04469699	Recruiting
Clinical safety study on 5-Aminolevulinic acid (5-ALA) in children and adolescents with supratentorial brain tumors	Westfälische Wilhelms-Universität Münster, Schlossplatz 2, 48149 Münster	NCT04738162	Recruiting
Phase I/II dose escalation trial of radiodynamic therapy (RDT) with 5-Aminolevulinic acid in patients with first recurrence of glioblastoma	Westfälische Wilhelms-Universität Münster, Schlossplatz 2, 48149 Münster	NCT05590689	Recruiting
5-ALA A Pilot study to Evaluate the Safety and Feasibility of Sonodynamic Therapy Using the ExAblate MRI-Guided Focused Ultrasound in the Treatment of Cerebral Glioblastomas.	Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta, Via Celoria 11, 20133, Milano	NCT04845919	Recruiting

Gliolan^® is used widely around the world.

Gliolan^® SPC Gliolan^® Patient Information Leaflet

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Further information

For further information, please click on the most relevant link below.

Europe USA

Contact

photonamic GmbH & Co. KG
Eggerstedter Weg 12 ,
25421 Pinneberg,
Germany

https://en.photonamic.de/

Tel: +49 4101 785 39 09

Enquire

References

Pellerino, A., Caccese, M., Padovan, M. et al. Epidemiology, risk factors, and prognostic factors of gliomas. Clin Transl Imaging 10, 467–475 (2022).
Tesileanu CMS, Dirven L, Wijnenga MMJ et al (2020) Survival of diffuse astrocytic glioma, IDH1/2 wildtype, with molecular features of glioblastoma, WHO grade IV: a confirmation of the cIMPACT-NOW criteria. Neuro Oncol 22(4):515–523.
Walsh KM, Ohgaki H, Wrensch MR. Epidemiology. Handb Clin Neurol. 2016;134:3-18. doi: 10.1016/B978-0-12-802997-8.00001-3. PMID: 26948345.
Michael Weller, Martin van den Bent, Matthias Preusser et al.: EANO guidelines on the diagnosis and treatment of diffuse gliomas of adulthood. In: Nature Reviews Clinical Oncology. Band 18, Nr. 3, März 2021, ISSN 1759-4774, S. 170–186
Claes A et al. Diffuse glioma growth: A guerilla war. Acta Neuropathol 2007;114(5):443-458.
Gerritsen, J.K.W.; Broekman, M.L.D.; De Vleeschouwer, S.; Schucht, P.; Nahed, B.V.; Berger, M.S.; Vincent, A.J.P.E. Safe Surgery for Glioblastoma: Recent Advances and Modern Challenges. Neurooncol. Pract. 2022, 9, 364–379
Stummer, W.; Pichlmeier, U.; Meinel, T.; Wiestler, O.D.; Zanella, F.; Reulen, H.-J. ALA-Glioma Study Group Fluorescence-Guided Surgery with 5-Aminolevulinic Acid for Resection of Malignant Glioma: A Randomised Controlled Multicentre Phase III Trial. Lancet Oncol. 2006, 7, 392–401.
Kiesel, B.; Wadiura, L.I.; Mischkulnig, M.; Makolli, J.; Sperl, V.; Borkovec, M.; Freund, J.; Lang, A.; Millesi, M.; Berghoff, A.S.; et al. Efficacy, Outcome, and Safety of Elderly Patients with Glioblastoma in the 5-ALA Era: Single Center Experience of More Than 10 Years. Cancers 2021, 13, 6119.
Baig Mirza, A.; Christodoulides, I.; Lavrador, J.P.; Giamouriadis, A.; Vastani, A.; Boardman, T.; Ahmed, R.; Norman, I.; Murphy, C.; Devi, S.; et al. 5-Aminolevulinic Acid-Guided Resection Improves the Overall Survival of Patients with Glioblastoma—A Comparative Cohort Study of 343 Patients. Neuro-Oncology Adv. 2021, 3,
Roder C, Stummer W, Coburger J, Scherer M, Haas P, von der Brelie C, Kamp MA, Löhr M, Hamisch CA, Skardelly M, Scholz T, Schipmann S, Rathert J, Brand CM, Pala A, Ernemann U, Stockhammer F, Gerlach R, Kremer P, Goldbrunner R, Ernestus RI, Sabel M, Rohde V, Tabatabai G, Martus P, Bisdas S, Ganslandt O, Unterberg A, Wirtz CR, Tatagiba M. Intraoperative MRI-Guided Resection Is Not Superior to 5-Aminolevulinic Acid Guidance in Newly Diagnosed Glioblastoma: A Prospective Controlled Multicenter Clinical Trial. J Clin Oncol. 2023 Dec 20;41(36):5512-5523.

Compound	Indications	Territory	ClinicalTrials.gov ID	Status
5-ALA	FGS - Glioblastoma	EU	NCT00241670
5-ALA	FGS - Meningioma	US	NCT04305470	Ongoing
5-ALA	FGS - Breast Cancer	US, CA	NCT04815083	Recruiting
5-ALA	FGS - Ovarian Cancer	US	NCT05804370	Recruiting
5-ALA	PDT - Glioblastoma	EU	NCT03897491	Recruiting

FGS – Fluorescence Guided Surgery PDT – Photodynamic Therapy

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