On May 3, 2023 Reprocell USA, a CRO, reported that it has been awarded a contract to provide support for Lantern Pharma’s Phase 2 clinical trial entitled "A Study of LP-300 With Carboplatin and Pemetrexed in Never Smokers with Advanced Lung Adenocarcinoma (HARMONIC)" (Press release, Lantern Pharma, MAY 3, 2023, View Source [SID1234630948]). The Harmonic study is being conducted to determine clinical advantages for Lantern Pharma’s investigational new drug LP-300 in combination with carboplatin and pemetrexed in patients who are never smokers with lung adenocarcinoma and have relapsed after treatment with tyrosine kinase inhibitors (TKIs).
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"We are excited to select Reprocell to support our Phase 2 Harmonic trial for never smokers with advanced non-small cell lung cancer," stated Reggie Ewesuedo, M.D., M.Sc., MBA, Lantern’s VP of Clinical Development. "Reprocell has an excellent and proven track record of processing and storing clinical trial samples and we are confident that this partnership will further the advancement of the Harmonic trial."
Reprocell will produce Specimen Collection Kits, process patient samples and store biomaterial from patients in this study. Additionally, Reprocell will provide isolation of cell free DNA from plasma, genomic DNA and/or RNA from the buffy coat fraction, and archive pathology FFPEs and associated H&E-stained slides from selected patients. These services are routine procedures utilized at Reprocell and will be performed at the conclusion of specimen collection and processing. Reprocell will retain all biomaterials and pathology materials on-site until required by Lantern Pharma later.
"We are pleased to support Lantern Pharma in the Harmonic clinical trial. We believe that our capabilities in building kits, managing shipments to and from clinical sites and processing the bio samples will help Lantern Pharma in successfully conducting this trial," said Rama Modali, CEO, REPROCELL USA.
About the Harmonic Trial
The Harmonic trial (NCT05456256) is a Phase 2 clinical trial that is assessing 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 with advanced non-small cell lung cancer (NSCLC). The study has been designed as a 90 patient trial with approximately 2/3rds of the patients receiving LP-300 with chemotherapy and the remaining 1/3rd receiving chemotherapy alone. Lantern has activated 5 clinical trial sites, across 12 locations in the US including Gabrail Cancer Center, Northwest Oncology, New York Cancer and Blood Specialists, Texas Oncology, and Cancer and Blood Specialty Clinic. The first patient in the trial was recently dosed and there are multiple additional potential patients that have been pre-screened and are being monitored for possible enrollment.
In a previous multi-center Phase 3 clinical trial, a subset of never smoker NSCLC patients who received LP-300 with chemotherapy showed increased overall and two-year survival of 91% and 125%, respectively, compared to patients who only received chemotherapy. In addition, LP-300 has been administered in multiple clinical trials to more than 1,000 people and has been generally well tolerated. Additional information on the Harmonic trial can be found at the Harmonic clinical trial website, on ClinicalTrials.gov, or on the first-of-its-kind Harmonic trial iPhone app, which is focused on education & awareness for never smoker NSCLC patients and the NSCLC community.