FAQ: Lantern Pharma's Subsidiary Starlight Therapeutics FDA Clearance for GBM Combination Trial
Summary
What is the significance of the FDA clearance for Starlight Therapeutics?
The FDA clearance allows Starlight Therapeutics to initiate a Phase Ib/2a clinical trial for STAR-001 in combination with spironolactone, targeting glioblastoma multiforme (GBM), a highly aggressive brain cancer with limited treatment options, potentially offering a new therapeutic avenue.
What is STAR-001 and how does it work?
STAR-001 is a brain-penetrant DNA-damaging agent designed to exploit DNA repair deficiencies through synthetic lethality, with its effect enhanced by spironolactone, which induces NER deficiency in tumor cells.
What are the Orphan Drug and Fast Track designations?
The Orphan Drug designation is for drugs treating rare diseases, and Fast Track designation is for speeding up the review of drugs to treat serious conditions and fill unmet medical needs, both of which STAR-001 has received from the FDA.
How does Lantern Pharma’s AI platform RADR® contribute to this trial?
Lantern Pharma’s AI-driven RADR® platform is used to identify optimal patient populations and accelerate development timelines, leveraging machine learning and multiomic data to enhance the drug development process.
Who is involved in this clinical trial?
The trial involves Lantern Pharma’s wholly owned subsidiary, Starlight Therapeutics, and patients with recurrent glioblastoma multiforme (GBM) at first progression, under the oversight of the FDA.
Where can I find more information about Lantern Pharma and this trial?
More information is available in the company’s newsroom at https://ibn.fm/LTRN and the full press release can be viewed at https://ibn.fm/8ndAq.
What is the goal of the Phase Ib/2a clinical trial?
The trial aims to evaluate the safety, tolerability, and preliminary efficacy of STAR-001 in combination with spironolactone for patients with recurrent glioblastoma multiforme (GBM).
Why is this trial important for GBM patients?
This trial is important because GBM is a highly aggressive brain cancer with limited treatment options, and the combination of STAR-001 with spironolactone represents a potential new treatment strategy targeting DNA repair deficiencies in tumor cells.
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