Telix Pharmaceuticals Limited (TLX), a commercial-stage biopharmaceutical company, on Thursday presented dosimetry data from the Phase 2 OPTIMAL-PSMA trial for TLX597-Tx in treating metastatic castration-resistant prostate cancer (mCRPC).
TLX597-Tx is a small molecule, PSMA-targeting, radioligand therapy (RLT) candidate designed to treat earlier-stage prostate cancer.
The Phase 2 OPTIMAL-PSMA is an open-label, multi-center, randomized, investigator-initiated trial (IIT), led by Professor Louise Emmett to evaluate the efficacy of TLX597-Tx. Conducted on 120 men with advanced mCRPC, the study utilizes a novel dose-intensification regimen, which increases the radiation dosage delivered to cancerous lesions when the tumors are the most vulnerable to improve overall effectiveness of the treatment.
Initial dosimetry data suggests low uptake by the salivary glands and kidneys, supporting dose intensification. By reducing radiation exposure in these healthy organs, the treatment prevents unwanted side effects like xerostomia and renal toxicity. In addition to better tolerability, the drug shows higher tumor uptake levels when compared to existing PSMA RLTs.
The company is also initiating OPTIMAL-E, a Phase 2 study in androgen pathway-sensitive prostate cancer (mHSPC), and is simultaneously advancing TLX591-Tx, a radio antibody-drug conjugate (rADC) in the Phase 3 ProstACT Global trial for treating mCRPC.
TLX closed Thursday at $11.00, up 5.47%. In the overnight market, the stock is trading at $11.20, up 1.82%.
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