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MELBOURNE, Australia and SOUTHAMPTON, United Kingdom, May 25, 2021 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces that the Company’s bone marrow conditioning investigational candidate TLX66 (90Y-besilesomab) has met study objectives, demonstrating the initial safety profile in patients with Systemic Amyloid Light Chain Amyloidosis (AL amyloidosis).
The TRALA trial (Targeted Radiotherapy for AL Amyloidosis) is a Phase I/IIa trial to evaluate the safety and toxicity of TLX66 as the sole bone marrow conditioning agent prior to autologous hematopoietic stem cell transplantation (HSCT) in patients with AL amyloidosis.1 The TRALA trial was sponsored by University Hospital Southampton in Southampton U.K. and run across four centres: Southampton, University College Hospital London, Royal Free Hospital London, and Queen Elizabeth Hospital Birmingham. All study data were reviewed by the trial’s Independent Data Monitoring Committee (IDMC).
In total, nine patients with AL amyloidosis were enrolled into the TRALA trial and received TLX66 as the sole bone marrow conditioning agent prior to undergoing autologous HSCT. TLX66 demonstrated a favourable safety profile and was well tolerated in all nine patients, each of whom completed the trial. All patients (100%) were successfully engrafted following bone marrow conditioning with TLX66 and autologous HSCT without any chemotherapy. Disease response as measured by fall in clonal free light chains (FLC) was seen in seven out of the nine patients, with two complete responses (CR) and five partial responses (PR) within the first 100 days post-transplant. In two of the patients achieving PR, the clonal FLC continued to fall, with one patient achieving CR subsequently with no further treatment. In addition, reduction in the measurable malignant plasma cells in the bone marrow was seen in six of eight evaluable patients. All patients remain alive at a median follow-up of 31 months (range 14 – 57 months).
Consultant Hematologist at University Hospital Southampton and TRALA principal investigator Dr. Kim Orchard stated, “We are highly encouraged by the safety and tolerability that 90Y-besilesomab has demonstrated as a single agent bone marrow conditioning approach in patients with AL amyloidosis. Compared to the significant toxicity profile typically experienced with conventional chemotherapy-based regimens, molecularly targeted radiation with 90Y-besilesomab demonstrated a very benign toxicity profile, which may in turn enable a considerably greater proportion of patients with AL amyloidosis to undergo life prolonging stem cell transplantation. The very low toxicity but with demonstrable responses is very encouraging.”