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Telix Pharmaceuticals (ASX:TLX) has announced its receipt of fast track status from the US FDA within the approvals chain for the assessment of Telix’s PET-scan brain cancer imaging agent Pixclara.
The company is focusing particularly on gliomas in the brain – a tumour that forms from glial cells acting abnormally. Glial cells help connect neurons in the brain, making ‘glioma’ and ‘brain cancer’ effectively interchangeable.
Fast track status does not guarantee eventual commercialisation approval from the United States’ food and drug regulator but does ensure a relatively faster progression through the bureaucratic ecosystem.
Pixclara – F-floretyrosine (or, F-FET) – is designed for injection into the human body before a PET scan. Imaging agents are, in pub language, lightly radioactive materials that ‘show up’ on scanners, allowing a high-definition scan of the internal anatomy of a patient.
Telix noted on Wednesday its fast track status win is due to a relative lack of treatment viability in glioma patients.
“With low survival rates and the need to make rapid decisions, precision imaging is paramount,” Telix wrote on Wednesday.
“Pixclara is also being developed as the “companion” theranostic imaging agent for TLX101, Telix’s investigational neuro-oncology drug candidate,” the company added.
Management further outlined the dire situation most patients face at present.
“Gliomas are the most common primary brain tumours of the central nervous system. Conventional imaging with MRI6 often yields inconclusive results in characterising recurrent disease and therefore delays time-sensitive decision making,” Telix CEO Kevin Richardson said.
“Limitations of conventional imaging techniques include the lack of biological specificity, dependency on blood-brain barrier disruption, and an inherent inability to differentiate between tumour progression or treatment-related causes.”
TLX last traded at $19.97.
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