The product candidate is designed to predict which patients are at high risk for developing common chemotherapy-related side effects before cancer treatment begins. Inform said it anticipates enrolling up to 1,000 patients in approximately 30 sites in the US beginning in Q4 of this year.
Carl de Moor, Inform Genomics Chief Technology Officer, explained to Outsourcing-Pharma.com that the observational pivotal study will follow patients “undergoing standard of care autologous hematopoietic stem cell transplants to determine who will develop moderate to severe oral mucositis, a very serious side effect, resulting from their conditioning regimens.
“We also will be capturing saliva samples prior to the transplant and then extract genomic information from those samples (single nucleotide polymorphisms or SNPs) that we will use in combination with clinical information to develop and validate algorithms that predict risk of oral mucositis. Ultimately, these algorithms can then be used by clinicians to understand who is at risk for oral mucositis,” he said.
Moor told Outsourcing-Pharma.com that Icon was selected after an extensive review process of multiple CROs.
“The CROs were evaluated on a number of criteria, including price, experience with observational studies, experience with the studies in autologous stem cell transplant patients, understanding of the study challenges, team chemistry, quality of the project manager, quality of operational plan, quality of pre-proposal questions, and quality of bid defense presentation, including ability to answer operational questions,” de Moor said.
He noted that the company sent the RFP (request for proposal) to five CROs, and invited three for bid defenses.
Ultimately, Icon was selected because of the strength of its team, their competitive pricing, “experience with the indication, experience in observational studies and the overall strength of the bid defense.”
In the first phase of development, the HSCT/Mucositis product candidate demonstrated that it could accurately predict a patient's risk for developing oral mucositis, the company said.
De Moor added: “Overall study timeline is approximately two years and the planned enrollment timeline is approximately 15 months, pending completion of a formal feasibility study which Icon will lead.”
In addition to this trial, Inform Genomics is also planning to run another large observational study in solid tumor patients and went through a similar CRO selection process. “For that study we selected Vector Oncology as our CRO,” de Moor said.