Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today
announces it has submitted a New Drug Application (NDA) to the
United States (U.S.) Food and Drug Administration (FDA) for
TLX101-CDx, (Pixclara™1, 18F-floretyrosine or 18F-FET), an
investigational PET2 agent for the characterization of progressive
or recurrent glioma (brain cancer) from treatment related changes
in both adult and pediatric patients.
Given the potential to address significant unmet
medical need, Pixclara™1 has been granted Orphan Drug3 and Fast
Track4 designation by the FDA, which facilitates expedited review
and closer consultation with the agency during the review process.
FET PET (Pixclara™1) is already included in international clinical
practice guidelines for the imaging of gliomas5, however there is
currently no FDA-approved targeted amino acid PET agent for adult
and pediatric brain cancer imaging commercially available in the
U.S.
There is a critical unmet need to improve the
diagnosis and management of glioma, particularly in the
post-treatment setting. With low survival rates and the need to
make rapid decisions, precision imaging is paramount. Subject to
regulatory approval, Pixclara™1 has the potential to address this
need, enabling patients to receive greater clarity in their
diagnosis and treatment decision making. Pixclara™1 is also being
developed as the “companion” theranostic imaging agent for TLX101,
Telix’s investigational neuro-oncology drug candidate, which
targets the same amino acid transporter mechanism with therapeutic
targeted radiation.
Kevin Richardson, Chief Executive Officer, Telix
Precision Medicine, stated, “Gliomas are the most common primary
brain tumors of the central nervous system. Conventional imaging
with MRI6 often yields inconclusive results in characterizing
recurrent disease and therefore delays time-sensitive decision
making4. Limitations of conventional imaging techniques include the
lack of biological specificity, dependency on blood-brain barrier
disruption, and an inherent inability to differentiate between
tumor progression or treatment-related causes7. Telix’s filing of
this NDA for Pixclara™1 is an important milestone, reflecting our
commitment to improved and accessible neuro-oncology imaging in the
U.S., and taking us one step closer to commercial availability in
2025, subject to FDA approval.”
About TLX101-CDx
TLX101-CDx (Pixclara™1) is a PET imaging agent,
which has been granted fast track and orphan drug designations by
the FDA as an imaging agent for the characterization of glioma.
TLX101-CDx targets membrane transport proteins known as LAT1 and
LAT28. This enables TLX101-CDx to be potentially utilized as a
companion diagnostic agent to TLX101 (4-L-[131I]
iodo-phenylalanine, or 131I-IPA), Telix’s LAT1-targeting
investigational glioblastoma (GBM) therapy, currently under
investigation in the IPAX-29 and IPAX-Linz10 studies.
About gliomas in the U.S.
Gliomas are very diffusely infiltrative tumours
that affect the surrounding brain tissue. They are the most common
form of central nervous system (CNS) neoplasm that originates from
glial cells, accounting for approximately 30% of all brain and CNS
tumours and 80% of all malignant brain tumours11. In the U.S.,
there are six cases of gliomas diagnosed per 100,000 people every
year. GBM is a high-grade glioma and the most common and aggressive
form of primary brain cancer, with approximately 22,000 new cases
diagnosed annually in the U.S.12. The mainstay of treatment
for GBM comprises surgical resection, followed by combined
radiotherapy and chemotherapy. Despite such treatment, recurrence
occurs in almost all patients13, with an expected survival duration
of 12-15 months from diagnosis14.
About Telix
Pharmaceuticals Limited
Telix is a biopharmaceutical company focused on
the development and commercialization of diagnostic and therapeutic
radiopharmaceuticals and associated medical devices. Telix is
headquartered in Melbourne, Australia, with international
operations in the United States, Europe (Belgium and Switzerland),
and Japan. Telix is developing a portfolio of clinical and
commercial stage products that aims to address significant unmet
medical needs in oncology and rare diseases. Telix is listed on the
Australian Securities Exchange (ASX: TLX).
Telix’s lead imaging product, gallium-68 (68Ga)
gozetotide injection (also known as 68Ga PSMA-11 and marketed under
the brand name Illuccix®), has been approved by the U.S. Food and
Drug Administration (FDA)15, by the Australian Therapeutic Goods
Administration (TGA) 16, and by Health Canada17. No other Telix
product has received a marketing authorization in any
jurisdiction.
Visit www.telixpharma.com for further
information about Telix, including details of the latest share
price, announcements made to the ASX, investor and analyst
presentations, news releases, event details and other publications
that may be of interest. You can also follow Telix on X and
LinkedIn.
Telix Investor Relations
Ms. Kyahn WilliamsonTelix Pharmaceuticals
LimitedSVP Investor Relations and Corporate CommunicationsEmail:
kyahn.williamson@telixpharma.com
This announcement has been authorized for release by the Telix
Pharmaceuticals Limited Disclosure Committee on behalf of the
Board.
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©2024 Telix Pharmaceuticals Limited. The Telix
Pharmaceuticals®, Illuccix® and Pixclara™ names and logos are
trademarks of Telix Pharmaceuticals Limited and its affiliates –
all rights reserved. Pixclara trade name is subject to final
regulatory approval.
1 Brand name subject to final regulatory approval.2 Positron
emission tomography.3 Telix ASX disclosure 6 October 2020.4 Telix
ASX disclosure 16 April 2024. Fast Track is a process designed to
facilitate the development, and expedite the review of drugs to
treat serious conditions and fill an unmet medical need. The
purpose is to get important new drugs to the patient earlier. More:
https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track5
Joint European Association of Nuclear Medicine//European
Association of Neurooncology/Response Assessment in Neurooncology
practice guidelines/Society for Nuclear Medicine and Molecular
Imaging procedure standards for the clinical use of PET imaging in
gliomas.6 Magnetic resonance imaging.7 Smith NJ et al. J Nucl Med.
2023.8 Large amino acid transporters 1 and 2.9 Telix media release
8 August 2023. ClinicalTrials.gov ID: NCT05450744.10 Telix
media release 22 November 2022.11 Goodenberger et al. Cancer Genet.
2012.12 Ostrom 2022, CBTRUS (Central Brain Tumor Registry of the
United States) Statistical Report.13 Park et al. Journal of
Clinical Oncology. 2010.14 Ostrom et al. Neuro
Oncol. 2018.15 Telix ASX disclosure 20 December 2021.16 Telix
ASX disclosure 2 November 2021.17 Telix ASX disclosure 14 October
2022.