Health Science North Research Institute (HSNRI) is that the centre a global clinical trial that could help refine breast cancer treatment and help doctors more accurately treat the disease, cutting down on time, money spent and ultimately save lives.
Earlier in June, HSNRI scientist and Laurentian University professor Dr. Amadeo Parissenti announced the institute will be part of a Breast Cancer Response Evaluation for Individualized Therapy (BREVITY) clinical trial to validate the use of the RNA Disruption Assay™ (RDA™) tool for treatment and management of breast cancer in North America and Europe. The trial has been designed with help from opinion leaders in breast oncology and funded by Rna Diagnositcs, Inc., for which Dr. Parissenti serves as chief scientific officer.
“A tool like this is needed because we want to make sure the patient is getting the most effective treatment without putting them through too much harsh procedures like chemotherapy if they don't work,” he said in an interview. “This will help medical professionals determine much faster if the treatment is working. If it isn't they can stop and consider other options. If it is, it can help determine how fast it's working, predict if or when the tumor will die completely with greater accuracy and plan treatment accordingly.”
Dr. Parissenti described the tool as a way for medical professionals to better track the effects of medical treatments like radiation and chemotherapy on a tumor by taking a biopsy sample from one week up to three weeks after a single cycle of chemotherapy is administered to a patient.
Currently patients can be given six to eight cycles of chemotherapy to up to half a year, depending on the tolerance of a patient before tumors are tested to determine if chemotherapy is working.
The tool works by measuring how fast RNA in a tumor degrades from chemotherapy, RNA, he explained, is derived from DNA and determines if a cell can live. Chemotherapy will degrade RNA of cancer tumors that respond to treatment, he said.
“What surprised us is we noticed that after chemotherapy there was no change in the tumor's RNA, meaning it was viable and chemotherapy wasn't having an effect on it,” he said. “But those that do have a really great survival benefit from chemotherapy. It's really important to sort out who is responding to chemotherapy and who isn't, so we can take those who aren't responding and consider other options. That could be surgery, radiation or other drugs.”
The clinical trial will include more than 500 patients with invasive breast cancer, scheduled to receive neoadjuvant chemotherapy (drug treatment prior to surgery), in 40 centers across Europe and North America, including Sudbury’s Northeast Cancer Centre. RDA is a diagnostic test measuring tumor response 14 days after the first cycle of treatment during neoadjuvant chemotherapy. It is expected to become a critical tool for managing response-guided therapy.
He explained the concern many patients and medical professionals have beyond death is chemotherapy can have serious consequences later in life, like cognitive problems, infections infertility and even trigger secondary cancers. The tool will help track progress, or lack therof, to help plan the progress of treatment and predict outcomes with greater accuracy and sidestep some of the side effects for those who aren't responding to chemotherapy.
“We only want to deliver such a potent treatment to those who are getting a benefit from it,” he said.
The trials are expected to take about two years and are double blind.
Roll out and marketing of the tool is happening in two phases. The parent company, Rna Diagnostics president and CEO Jeremy Bridge-Cook explained phase one will include two subphases, a training set phase, where they are using the tool to test 115 patients, then have 500 patients in phase two, known as the validation phase.
“From phase one, we will have valuable data to begin commercialization, which will allow us to sell the tests to doctors, what we call “early adopters,” and pharmaceutical companies who are conducting clinical trials and want to incorporate RDA into their clinical trial in some way,” he said. “After that, we can more to phase two, where we will announce our results at a major international breast cancer conference, which will be the triggering event for full globalization.”
The data they will collect will allow them to apply to reimburse private and public payers in the countries they will be selling this tool to.
“Successful marketing and commercialization has two components, one is to obtain reimbursement from various payers, the other is to use use relationships with key opinion leaders to generate support for the incorporation of RDA for a new standard of care to optimize the use of chemotherapy.”
Both Bridge-Cook and Dr. Parissenti said they are thankful to the research institute for their help in helping to develop the tool and use it in clinical trials in the north. Dr. Parissenti explained Health Sciences North provided all the equipment, infrastructure, laboratory, etc., for the study.
“Health Sciences North is continuing to support the company because we are just moving into space in the new Walford Building, so we are very excited about it,” he said. “It's excellent for security, we know who is coming in and out of the doors and the lab. It's actually helping us meet accreditation standards because plan to use that laboratory to provide diagnostic services, ultimately, in the future.”