Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today
announces the opening of an expanded access program (EAP) in the
United States (U.S.) for TLX101-CDx (Pixclara™1, 18F-floretyrosine
or 18F-FET) an investigational positron emission tomography (PET)
agent for imaging progressive or recurrent glioma, following U.S.
Food and Drug Administration (FDA) agreement to proceed.
Amino acid PET is included in U.S. and European
clinical practice guidelines for the imaging of gliomas2, however
there is no FDA-approved targeted amino acid PET agent for brain
cancer imaging currently available in the U.S. Telix’s goal is to
make this product commercially available in the U.S., significantly
increasing patient access to this important imaging agent for both
adult and paediatric patients. The Company expects to file its New
Drug Application (NDA) for TLX101-CDx with the FDA during Q3
2024.
Patrick Wen, MD, Professor, Neurology, Harvard
Medical School and Director, Center for Neuro-Oncology, Dana-Farber
Cancer Institute, said, “Amino acid PET imaging of the brain is
increasingly used to supplement conventional imaging by MRI3, which
for many years has been the primary clinical imaging modality in
patients with glioma at all stages of disease. After treatment, MRI
has several limitations, including the lack of biological
specificity, dependency on blood-brain barrier disruption, and an
inability to differentiate between tumour progression or recurrence
from treatment-related changes. TLX101-CDx (FET-PET) shows
potential to provide a more rapid and conclusive diagnosis, inform
treatment decisions and deliver a new standard for the management
of gliomas in the U.S.”
David N. Cade, MD, Telix Chief Medical Officer,
added, “As we finalise the submission of our NDA for TLX101-CDx,
the opening of this expanded access program will enable us to
provide continued access to this investigational agent, where there
is significant unmet medical need in the U.S. Glioma is the most
common and aggressive form of primary brain cancer and we believe
TLX101-CDx has the potential to make an important difference for
U.S. glioma patients who deserve greater reliability in their
diagnosis and treatment decision making.”
Under its EAPs – sometimes also called
‘compassionate use’ – the FDA works with companies to allow access
to investigational products, outside of a clinical trial, to
patients with serious or life-threatening illnesses, for whom there
are no comparable or satisfactory alternate options.
U.S. patients, or physicians who may have
eligible patients in the U.S. can e-mail
eap-americas@telixpharma.com or complete the form here for further
information about the TLX101-CDx EAP.
Telix’s Policy on Offering Compassionate Use to
Investigational Medicines can be downloaded at the following
link.
About TLX101-CDxTLX101-CDx
(Pixclara™1) is a PET imaging agent, which has been granted fast
track4 and orphan drug5 designations by the FDA as an imaging agent
for the characterisation of glioma. TLX101-CDx targets membrane
transport proteins known as LAT1 and LAT26. This enables TLX101-CDx
to be potentially utilised 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-27 and IPAX-Linz8
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 tumours9. 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.10. The mainstay of treatment for GBM
comprises surgical resection, followed by combined radiotherapy and
chemotherapy. Despite such treatment, recurrence occurs in almost
all patients11, with an expected survival duration of 12-15 months
from diagnosis12.
About Telix
Pharmaceuticals LimitedTelix is a biopharmaceutical
company focused on the development and commercialisation of
therapeutic and diagnostic 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 FDA8, by the
Australian Therapeutic Goods Administration (TGA) 9, and by Health
Canada10. No other Telix product has received a marketing
authorisation 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
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The information contained in this announcement
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recommendation with respect to shares of Telix Pharmaceuticals
Limited (Telix) in any jurisdiction, including the United States.
No representation or warranty, express or implied, is made in
relation to the accuracy or completeness of the information
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or when they have been approved; estimates of Telix’s expenses,
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performance; developments relating to Telix’s competitors and
industry; and the pricing and reimbursement of Telix’s product
candidates, if and after they have been approved. Telix’s actual
results, performance or achievements may be materially different
from those which may be expressed or implied by such statements,
and the differences may be adverse. Accordingly, you should not
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should read this announcement together with our risk factors, as
disclosed in our most recently filed reports with the ASX or on our
website.
To the maximum extent permitted by law, Telix
disclaims any obligation or undertaking to publicly update or
revise any forward-looking statements contained in this
announcement, whether as a result of new information, future
developments or a change in expectations or assumptions.
©2024 Telix Pharmaceuticals Limited. The Telix
Pharmaceuticals®, Illuccix® and Pixclara™1 names and logos are
trademarks of Telix Pharmaceuticals Limited and its affiliates –
all rights reserved.
________________________1 Brand name subject to final regulatory
approval.2 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.3 Magnetic resonance imaging.4 Telix ASX disclosure 16
April 2024.5 Telix ASX disclosure 6 October 2020.6 Large amino acid
transporters 1 and 2.7 Telix media release 8 August 2023.
ClinicalTrials.gov ID: NCT05450744.8 Telix media release 22
November 2022.9 Goodenberger et al. Cancer Genet. 2012.10 Ostrom
2022, CBTRUS (Central Brain Tumor Registry of the United States)
Statistical Report.11 Park et al. Journal of Clinical Oncology.
2010.12 Ostrom et al. Neuro Oncol. 2018.