BELTSVILLE, Md., May 3, 2023 /PRNewswire/ -- Reprocell
USA, a CRO, 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)". 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).
"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.
About Lantern Pharma
Lantern Pharma (NASDAQ: LTRN) is a clinical-stage
oncology-focused biopharmaceutical company leveraging its
proprietary RADR® AI and machine learning platform to
discover biomarker signatures that identify patients most likely to
respond to its pipeline of genomically-targeted therapeutics. By
targeting drugs to patients whose genomic profile identifies them
as having the highest probability of benefiting from the drug,
Lantern's approach represents the potential to deliver
best-in-class outcomes. For more information, please visit the
company's website at www.lanternpharma.com.
About REPROCELL USA
REPROCELL provides services and reagents to support the entire
drug discovery pathway. BioServe-brand biorepository and molecular
services provide researchers with human tissue samples and services
to support a wide variety of research and development, as well as
provide a starting point for stem cell
research. Stemgent-brand stem cell products and services,
along with REPROCELL brand differentiated cells and reagents,
enable researchers to bring the power of stem cells to bear on
human disease. Alvetex-brand 3D culture products provide a
physiologically relevant environment for cells that mimic the in
vitro situation. Biopta-brand human tissue assays provide
pharmaceutical companies with physiologically relevant information
on human tissue prior to clinical trials. REPROCELL, founded
in 2002, is based in Yokohama,
Japan and has laboratories in Beltsville, MD, USA, Glasgow, UK and Hyderabad, India to support global research
efforts.
For more information please visit www.REPROCELL.com or call
301-470-3362
Logo -
https://mma.prnewswire.com/media/1798779/REPROCELL_Logo.jpg
View original
content:https://www.prnewswire.co.uk/news-releases/lantern-pharma-selects-reprocell-usa-to-provide-support-for-the-phase-2-harmonic-clinical-trial-301812328.html