MELBOURNE, Australia, May 2, 2023 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces first patients have been imaged in Canada with its commercially available prostate cancer imaging agent, Illuccix [kit for the preparation of gallium (68Ga) PSMA-11 for intravenous injection].
With Illuccix now available nationwide in Canada through Telix's partner Isologic Innovative Radiopharmaceuticals (Isologic), INITIO Medical Group in Burnaby, BC (INITIO) became one of the first sites to administer this novel PSMA-PET imaging agent that can help healthcare professionals diagnose the stage and spread of prostate cancer - an important step for men with this disease.
Illuccix, after radiolabeling with gallium (68Ga), is indicated for use with positron emission tomography (PET) of prostate specific membrane antigen (PSMA) positive lesions in men with prostate cancer:
- with suspected metastasis who are suitable for initial definitive therapy;
- with suspected recurrence with elevated serum prostate specific antigen (PSA) level.
Illuccix is the first PSMA-PET imaging agent to have been granted regulatory approval in Canada. Health Canada became the third regulatory body worldwide to approve Illuccix, which is also commercially available in Australia, New Zealand and the United States.
Dr. Philip Cohen, INITIO Director and Division Head, Nuclear Medicine, Lions Gate Hospital in North Vancouver said, "Nuclear isotope therapy enters a new era with the ability to see and diagnose invisible cancers based on their molecular "signature" and then target them based on the same signature. Now if we can see the cancer we can treat it, and potentially control, and eventually someday cure this terrible disease."
Andre Gagnon, President of Isologic added, "PSMA-PET is emerging as a standard of care worldwide, and it is tremendous that we can now provide Canadian physicians and their patients with this innovative new diagnostic tool via our national network, servicing 265 hospitals and clinics."
Kevin Richardson, Chief Executive Officer for Telix Americas continued, "The launch of Illuccix in Canada marks an important milestone for Telix and the ~24,000 men who will be diagnosed with prostate cancer in the country this year. Widespread availability of PSMA-PET imaging, via Telix's distribution partner Isologic, will help deliver on a significant unmet medical need for the men in Canada and their families affected by this disease."
Healthcare professionals in Canada can order Illuccix kits by email firstname.lastname@example.org or by phone 1-877-505-4711 ext 0. Unit doses can be ordered from your local radiopharmacy.
INITIO is Western Canada's only private PET/CT scan facility with over 20 years' experience, offering Rapid PET/CT and CT scans and nuclear medicine treatments with no wait list. INITIO has diagnostic scanning for cancer, cognitive impairment, and cardiac sarcoidosis, and now offers gallium-68 PSMA-PET imaging and lutetium-177 PSMA therapy for prostate cancer. With these latest additions, INITIO Medical Group reaffirms its commitment to providing the most advanced and effective treatments to patients and looks forward to the positive impact these will have on the lives of those affected by prostate cancer.
About Isologic Innovative Radiopharmaceuticals
Isologic is a Canadian radiopharmaceutical company, dedicated to nuclear medicine and radiopharmaceutical production. The head office is in Montreal, Quebec, and our sites are in Dorval, Lachine, Quebec, Toronto, Burlington, Ottawa, and Vancouver.
Isologic is the leading Canadian manufacturer of positron-emitting radiopharmaceuticals (PERs) and distributor of radiopharmaceuticals for photon emission tomography (PET). Isologic operates an internal logistics and delivery structure, which allows it to control its radioisotope autonomy.
About Telix Pharmaceuticals Limited
Telix is a biopharmaceutical company focused on the development and commercialisation of diagnostic and therapeutic radiopharmaceuticals. 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-stage products that aims to address significant unmet medical need in oncology and rare diseases. Telix is listed on the Australian Securities Exchange (ASX: TLX).
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 Twitter (@TelixPharma) and LinkedIn.
Telix's lead product, gallium-68 (68Ga) gozetotide (also known as 68Ga PSMA-11) injection, has been approved by the U.S. Food and Drug Administration (FDA), and by the Australian Therapeutic Goods Administration (TGA), and by Health Canada.
 Public Health Agency of Canada, 2021.
 Telix ASX disclosure 20 December 2021.
 Telix ASX disclosure 2 November 2021.
 Telix ASX disclosure 14 October 2022.
Illuccix is a Schedule C radiopharmaceutical product.
Click here for approved product monograph in Canada.
Telix Investor Relations
Ms. Kyahn Williamson
Telix Pharmaceuticals Limited
SVP Corporate Communications and Investor Relations
This announcement is not intended as promotion or advertising directed to any healthcare professional or other audience in any country worldwide (including Australia, United States and the United Kingdom). This announcement may include forward-looking statements that relate to anticipated future events, financial performance, plans, strategies or business developments. Forward-looking statements can generally be identified by the use of words such as "may", "expect", "intend", "plan", "estimate", "anticipate", "outlook", "forecast" and "guidance", or other similar words. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. Forward-looking statements are based on the Company's good-faith assumptions as to the financial, market, regulatory and other risks and considerations that exist and affect the Company's business and operations in the future and there can be no assurance that any of the assumptions will prove to be correct. In the context of Telix's business, forward-looking statements may include, but are not limited to, statements about: the initiation, timing, progress and results of Telix's preclinical and clinical studies, and Telix's research and development programs; Telix's ability to advance product candidates into, enrol and successfully complete, clinical studies, including multi-national clinical trials; the timing or likelihood of regulatory filings and approvals, manufacturing activities and product marketing activities; the commercialisation of Telix's product candidates, if or when they have been approved; estimates of Telix's expenses, future revenues and capital requirements; Telix's financial 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 place undue reliance on these forward-looking statements.
Except as required by applicable laws or regulations, Telix does not undertake to publicly update or review any forward-looking statements. Past performance cannot be relied on as a guide to future performance. Readers should read this announcement together with our material risks, as disclosed in our most recently filed reports with the ASX and on our website.
2023 Telix Pharmaceuticals Limited. The Telix Pharmaceuticals and Illuccix name and logo are trademarks of Telix Pharmaceuticals Limited and its affiliates (all rights reserved).