The Telix Pharmaceuticals Ltd (ASX: TLX) share price will be in focus today after the company announced its prostate cancer therapy has been approved for stage III clinical trials.
Shares in the company closed last session trading at $3.94.
The biopharmaceutical company's prostate cancer therapy, TLX591, has been approved for a stage III trial by the Human Research Ethics Committee and the Australian Therapeutic Goods Administration.
TLX591 is designed to help treat those with metastatic prostate cancer.
Let's take a closer look at the news Telix released this morning.
Image source: Getty images
New stage III clinical trial
Telix shares will be on watch this morning after the company announced it's now able to begin a phase III clinical trial of its targeted therapy in patients with advanced metastatic castrate-resistant prostate cancer.
The phase III clinical trial, named ProstACT, will be an international, multi-centre, randomised controlled trial.
Those involved in the trial will be patients with prostate specific membrane antigen- (PSMA) expressing metastatic castrate-resistant prostate cancer. TLX591 is said to use PSMA as a target for the therapy.
The ProstACT trial will involve around 390 patients, selected by imaging with Telix's imaging technique, Illuccix.
The trial will compare standard of care therapies with the same therapies combined with TLX591.
The trial's primary endpoint is progression-free survival, with its secondary endpoints including overall survival and quality-of-life assessments.
Telix has begun initiating sites for the Australian ProstACT trial. It will add more sites during the second half of 2021, subject to necessary approvals.
According to Telix, prostate cancer is the second most common cancer in men. Around 1.4 million men were diagnosed with prostate cancer last year. Telicx stated the rate of diagnosis is improving, with the highest number of new prostate cancer cases found in the United States, Europe, Australia and New Zealand.
Commentary from management
Telix CEO Dr Christian Behrenbruch commented on the trial's approval, saying:
The commencement of the ProstACT Phase III study for TLX591 marks a major corporate milestone for Telix that brings the company a step closer to delivering on a major unmet medical need for treatment options in this patient population… TLX591 has demonstrated promising and competitive clinical potential that we believe warrants further confirmation in this second-line disease setting. It is also noteworthy that Telix's differentiated approach to integrating molecular imaging with PET alongside therapy, enables a comparatively streamlined study that we believe will support efficient patient enrolment and study execution.
Telix Pharmaceuticals share price snapshot
Investors will be hoping today's news provides a boost for Telix Pharmaceuticals shares. Currently, the Telix share price is 1.75% lower than it was at the start of 2021. Although, the company's shares have gained around 162% over the last 12 months.
The company has a market capitalisation of around $1.1 billion, with approximately 281 million shares outstanding.
