The Telix Pharmaceuticals Ltd (ASX: TLX) share price is rocketing higher, nearing on its all-time high of $4.80.
This follows the biotechnology company's update on its bone marrow conditioning investigational candidate, TLX66.
At the time of writing, Telix shares are selling for $4.48 apiece, up 12%.
What did Telix announce?
Investors are pushing Telix shares higher after investors digest the company's latest study results from TLX66.
In its announcement, Telix advised TLX66 has met study objectives in patients with Systemic Amyloid Light Chain Amyloidosis (AL amyloidosis).
The Targeted Radiotherapy for AL Amyloidosis (TRALA) trial is a phase I/2a study currently being conducted by Telix. The program aims to evaluate the safety and toxicity of TLX66 as the sole bone marrow conditioning agent. This is before patients with AL amyloidosis go through an autologous hematopoietic stem cell transplantation (HSCT).
A HSCT is a procedure where a patient's healthy stem cells are collected from blood or bone marrow before treatment. The stem cells are then safely stored and given back to the patient after treatment.
In total, 9 patients with AL amyloidosis were enrolled into the program and received TLX66 before undergoing autologous HSCT. The result demonstrated a favourable safety profile and was well tolerated within each study recruit. Pleasingly, the entire group was 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 7 of the patients. Of those, two were complete responses (CR) and were five partial responses (PR) within the first 100 days after transplant.
In addition, malignant plasma cells in the bone marrow reduced in 6 of the 8 evaluable patients.
The TRALA trial was sponsored by the University Hospital Southampton in Southampton, United Kingdom. The study ran across 4 different sites and the data was reviewed by the trial's Independent Data Monitoring Committee (IDMC).
Words from management
Consultant Haematologist at University Hospital Southampton and TRALA principal investigator, Dr Kim Orchard commented:
Compared to the significant toxicity profile typically experienced with conventional chemotherapy-based regimens, molecularly targeted radiation with Y-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.
Telix chief medical officer, Dr Colin Hayward added:
The results from the TRALA trial indicate that TLX66 may offer a new approach to bone marrow conditioning in patients who could benefit from HSCT such as those with AL amyloidosis, providing new hope to patients with this rare disease and with few effective treatment options.
TLX66 was well-tolerated, enabling successful engraftment of the patients' own transplanted stem cells without the need for toxic chemotherapy. With all patients remaining alive, and most not requiring further therapy, we believe these data support taking TLX66 forward into a pivotal registration program in this rare disease indication.
Telix share price summary
It's been a positive year for Telix shareholders, with the company share price rising over 200% in the past 12 months. While most of the gains occurred late last year, year-to-date performance sits around 15% higher.
On valuation grounds, Telix presides a market capitalisation of roughly $1.2 billion, with 281 million shares outstanding.
