The Telix Pharmaceuticals Ltd (ASX: TLX) share price is racing higher after the company announced a new phase in its drug trials. The company confirmed it will proceed with the Phase III of ProstACT study for its TLX591 drug, a prostate cancer treatment.
The company also advised this morning that it has entered into a commercialisation and partnership agreement with DuChemBio, a leading South Korean radiopharmaceutical company.
At the time of writing, the Telix share price has surged up 5% to $4.20.
About the Phase III testing
Telix recently met with the United States Food and Drug Administration (FDA) to discuss the company’s planned Phase III ProstACT trial for TLX591. Today’s announcement is the result of that meeting.
The company advised the Phase III clinical testing will involve patients with metastatic castration-resistant prostate cancer (mCRPC), and who have disease progression following prior treatment with a novel androgen axis drug (NAAD). Based on the statistical plan presented to the FDA, this study will enroll approximately 390 patients and will start in Australia.
Telix is the process of submitting a clinical trial notification to the Australian Therapeutic Goods Administration (TGA).
The company says Australian and European sites will be added progressively during the first quarter of 2021 and, and it will also evaluate the feasibility of enrolling Chinese patients, subject to regulator consultations and requisite approval.
Telix chief medical officer, Dr Colin Hayward noted:
The valuable feedback Telix has received from our November meeting with the FDA has helped Telix to finalise the clinical development roadmap for TLX591 with respect to inclusion of US patients in ProstACT.
We appreciate the FDA’s clear guidance and feedback on our proposed study, particularly the opportunity to deploy a far more compact study design.
We expect the study will require a significantly reduced recruitment time, due to both the reduced sample size and the patient-centric randomisation scheme. We look forward to working with the agency to bring TLX591 to American patients living with metastatic prostate cancer.
Partnership with Korean company
Telix and DuChemBio also announced today the founding of the Korean Partnership for Advanced Prostate Cancer Imaging in Melbourne and Seoul.
In this partnership, Telix has granted exclusive rights to DuChemBio to commercialise TLX591-CDx for prostate cancer imaging in South Korea.
The parties will cooperate to attain a marketing authorisation for the product from the Korean Ministry of Food and Drug Safety.
Commenting on the deal, Telix CEO Christian Behrenbruch stated:
Telix’s mission is to be a leading global oncology company and South Korea is a key Asian market for our products.
We are pleased to have entered this commercialisation and partnership agreement with DuChemBio to bring this highly anticipated product to Korean men with prostate cancer.
DuChemBio has a well-deserved reputation as the number one radiopharmaceutical company in Korea and we look forward to exploring future commercial and clinical opportunities through the experience of this initial partnership.
How did the Telix share price perform in 2020
The Telix share price has gained almost 170% this year, as new developments in its various medical drugs took place. At the current share price, the company commands a market value of $1.1 billion.
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