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Lantern Pharma Receives FDA Authorization to Initiate its Phase 2 Clinical Trial, Harmonic™, for LP-300 in Never Smokers with Non-Small Cell Lung Cancer
The Harmonic™ trial is a Phase 2 multi-center study focused on never smokers with advanced non-small cell lung cancer (NSCLC) and will begin patient
About this update from Lantern Pharma Inc.
[{"type":"text","content":"\n\nThe Harmonic™ trial is a Phase 2 multi-center study focused on never smokers with advanced non-small cell lung cancer (NSCLC) and will begin patient enrollment during Q3 2022.\n\n\nIn a previous Phase 3 multi-center clinical trial, a subset of never smoker patients with NSCLC receiving LP-300 with chemotherapy showed increased overall and two-year survival of 91% and 125%, respectively, compared to patients who received chemotherapy alone.\n\n\nIn the US in 2021 there were an estimated 24,000 to 30,000 never smoker patients diagnosed with NSCLC.\n\n\n DALLAS--(BUSINESS WIRE)--\nLantern Pharma Inc. (NASDAQ: LTRN), a clinical stage biopharmaceutical company using its proprietary RADR® artificial intelligence (\"A.I.\") and machine learning (“ML”) platform to transform the cost, pace, and timeline of oncology drug discovery and development, today announced that the Food and Drug Administration (FDA) has cleared the Company to proceed with its Phase 2 clinical trial, Harmonic™, for its investigational new drug LP-300. The Harmonic™ trial will be a 90 patient, multi-center, two arm, open-label, and randomized clinical trial evaluating LP-300 in combination with chemotherapy for never smoker patients with advanced non-small cell lung cancer (NSCLC).\n\n“The launch of the Harmonic™ trial is a major milestone for LP-300. Our team is looking forward to beginning patient enrollment during the third quarter,” said Panna Sharma, CEO and President of Lantern. “LP-300 is an innovative therapy that is being developed for never smokers with NSCLC, a unique and growing population of lung cancer patients whose cancer is genetically different from smokers with lung cancer. LP-300 will be delivered in combination with standard of care chemotherapy. Importantly, LP-300 has been well tolerated in prior clinical trials and has shown potential to protect against harmful effects of chemotherapy while also de-naturing many of the tyrosine kinase receptors through cysteine modification that are involved with NSCLC,” continued Sharma.\n\nAbout the Harmonic™ Trial and LP-300:\n\nThe Harmonic™ trial is a Phase 2 clinical trial that will assess the effect of Lantern’s investigational new drug LP-300 in combination with standard of care (SOC) chemotherapy, pemetrexed and carboplatin, on the overall and progression-free survival of never smoker patients wit...