Lisata Therapeutics has treated the first patient in a Phase IIa clinical trial of its investigational drug LSTA1, targeting patients with newly diagnosed glioblastoma multiforme (GBM).
LSTA1 is designed to enhance the delivery of anti-cancer drugs to solid tumours by activating a novel uptake pathway.
The placebo-controlled, double-blind, randomised, proof-of-concept trial aims to evaluate LSTA1 when combined with standard of care.
The first subject for the trial was enrolled at Tartu University Hospital in Estonia. It is set to expand across multiple sites in Estonia and Latvia, with a planned enrolment of 30 patients. The randomisation will favour the LSTA1 treatment group in a 2:1 ratio.
Lisata agreed to provide both the investigational drug and funding for the trial.
The US Food and Drug Administration (FDA) previously granted LSTA1 orphan drug designation for malignant glioma.
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The company has gathered extensive non-clinical data supporting the enhanced delivery of existing and emerging anti-cancer therapies, including immunotherapies, chemotherapeutics and RNA-based therapeutics, with LSTA1.
LSTA1 has also shown promising safety, tolerability and activity in enhancing standard chemotherapy for pancreatic cancer.
The company continues to explore the drug’s potential across different solid tumours.
Lisata chief medical officer and R&D executive vice-president Kristen Buck said: “We are very pleased to announce the first patient treated in this Phase IIa study evaluating LSTA1 in patients with newly diagnosed GBM, a very aggressive brain tumour that is often fatal.
“We hold great hopes for the benefits of LSTA1 in this indication based on preclinical evidence that demonstrates LSTA1 enhances penetration through the limited permeability of the blood-brain barrier.”
In September 2023, Lisata treated the first patient in the head and neck squamous cell carcinoma cohort of the Phase IIa BOLSTER trial of LSTA1 for solid tumours.