Curebase and Persephone Biosciences Partner in Clinical Trial of Colorectal Cancer Among Diverse Populations
January 11, 2022
SAN FRANCISCO, Jan. 11, 2022 /PRNewswire/ -- Curebase, a company committed to democratizing access to clinical studies, and Persephone Biosciences, a privately held company investigating the human microbial ecosystem's effect on therapeutic treatment, today announced a collaboration for the long-term clinical study of patients with colorectal cancer (CRC) to develop prevention strategies and better treatment options.
The decentralized clinical trial (DCT) involves collecting stool and blood specimens from 350 study volunteers with CRC, as well as 1,000 healthy people who are categorized as either low risk or high risk for the disease. A top priority of the ARGONAUT study and specifically the CRC patient arm, through a collaboration with Janssen Research & Development, LLC (Janssen), is to ensure at least half of participants are from diverse populations.
Participants who meet the entry criteria will provide two samples each of blood and stool over a six-month period. Follow-up appointments will be held at 12, 18, and 24 months to collect tumor scan results and additional updated medical data. Some trial participants will be monitored for up to eight years.
Curebase's decentralized clinical trial model ensures more diverse studies because unique populations – which typically are underrepresented in clinical trials – can be included. The company's virtual research sites also provide physicians with new and unique options to offer their patients, regardless of location. The Curebase platform empowers sponsors, CROs and physicians from practices of all sizes to conduct clinical research, including private practices, independent clinics, and large academic research sites.
"A trial of this size, in which 50% of participants are planned to comprise racial and ethnic minorities, is unprecedented in both scale and ambition," said Dr. Stephanie Culler, co-founder and chief executive officer of Persephone Biosciences. "Curebase has helped Persephone secure community study sites throughout the U.S. that meet our diversity and inclusion criteria, while at the same time providing these sites with a DCT platform and virtual staff support that makes their participation in our trial easy. Together, I believe we are well positioned to better understand the role of the gut's microbiome in patient response to cancer therapies and, just as importantly, potentially to help create more equitable treatment outcomes for patients."
Curebase and Persephone are setting up more than 30 sites across the U.S. to recruit participants for the CRC study and collect patient electronic data. Participants are being given a convenient kit for producing an at-home stool sample, along with packaging and labeling material enabling easy pickup and shipping by FedEx.
Expected to begin early this year, this clinical trial is part of ARGONAUT, a longitudinal, observational study of 4,000 patients with advanced-stage cancer and healthy individuals with varying cancer risk. Importantly, the ARGONAUT study will enroll a diverse patient population, emphasizing patients from minority groups. The data collected may be used to develop precision microbiome medicines and to identify clinically actionable cancer-specific biomarkers for guiding therapeutic decisions. In addition to CRC, ARGONAUT will study non-small cell lung cancer, triple negative breast cancer and pancreatic cancer.
The results of the ARGONAUT study aim to provide a better understanding of the gut microbiome's role in patient response to cancer therapies, which in time may lead to the development of adjuvant therapeutics or a precision medicine approach to future oncology interventions, based on prior microbiome diagnostic testing. In addition, the potential discovery of biomarkers in the microbiome could enable earlier cancer detection and intervention.
"Diversity and inclusion in clinical trials is imperative for the rapid development of treatments that can help the most people," said Curebase founder and CEO Tom Lemberg. "We're excited to work with Persephone Biosciences on this landmark study that will provide researchers and clinicians with invaluable insights into treating and preventing colorectal cancer."
About Persephone Biosciences
Persephone Biosciences is committed to harnessing the role of the human microbial ecosystem to create better and more equitable therapeutics and diagnostics, and to aid disease prevention. Persephone's technology platform is based on diverse and inclusive, population-scale, observational clinical trials in conjunction with advanced multi-omics analyses and machine learning with the aim to probe the complex interaction between microbes and the immune system. Persephone develops precision immunotherapies utilizing synthetic biology for unmet needs and more equitable treatment outcomes.
At Curebase, our mission is to bring quality medical innovations to patients faster and improve human wellbeing through more efficient clinical studies. We are proving that clinical research can be radically accelerated if we empower physicians everywhere to enroll patients in the communities where they live. By applying cutting edge clinical software and remote study management techniques to the problem, we are reinventing clinical trials and research from the ground up.