Rna Diagnostics Inc., a Canadian company with a patented platform technology providing real-time cancer therapy guidance, announced enrollment of the first patient in the BREVITY trial at the Azienda Socio-Sanitaria Territoriale di Cremona in Cremona, Italy today. BREVITY (Breast Cancer Response EValuation for Individualized TherapY) is an international prospective clinical trial to validate the RNA Disruption Assay™ (RDA™) as a tool for assessing treatment response/non-response in primary breast cancer. The trial will include 700+ patients with invasive breast cancer, scheduled to receive neoadjuvant chemotherapy, in 40 centers across North America and Europe.

“RDA has the potential to improve the way doctors treat cancer,” said Prof. Dr. Cornelia Liedtke, Chief Investigator for the BREVITY trial and Professor and Senior Consultant of Gynecology at the Breast Center Charité-Universitätsklinikum in Berlin. Dr. Liedtke is an acknowledged leader in breast cancer research in Germany. She is a member of the Breast Committee of the German Gynecological Oncology Group (AGO) that issue treatment guidelines followed by breast cancer specialists in Germany. In her role as Chief Investigator, she will ensure that BREVITY meets the highest quality standards and European and North American regulatory requirements.

RDA is a diagnostic test that measures tumor response after the 1st cycle (14-21 days) of neoadjuvant therapy (drug treatment prior to surgery). It is expected to become a critical tool for managing response-guided therapy in cancer patients. RDA consists of proprietary methods that quantify and score the degradation (disruption) of ribosomal RNA (rRNA) within tumors induced by response to a wide spectrum of chemotherapeutic and targeted drugs. RNA disruption has been shown to be an effective predictor of response/non-response and survival after neoadjuvant therapy.

“We consistently hear that oncologists need better tools to determine which patients are responding to treatment and which are not. Continuing treatment of patients with drugs that are highly toxic and extremely expensive, when the patient is not receiving any benefit, is the opposite of personalized medicine. As more targeted drugs become available to treat various cancers, determining which drug is working for which patient becomes even more critical. Assessing patient response in real-time, with the RDA test, will be an effective way to improve outcomes and manage healthcare costs. BREVITY is a significant investment for Rna Diagnostics and is critical for our commercial launch, clinician acceptance and reimbursement of RDA, so the recruitment of the first patient is an important milestone for the company.” said Dr. Jeremy Bridge-Cook, President and CEO of Rna Diagnostics.

Head of the Breast Cancer Group in Cremona and Associate Professor of Medical Oncology at University of Trieste, Prof. Daniele Generali, the Principal Investigator of BREVITY for Italy, said “BREVITY, if it meets its primary endpoint, will demonstrate the validity of the RDA test to rapidly and accurately measure the effectiveness of breast cancer treatment. It will help clinicians adopt the proper treatment strategy based on the individual response, early during therapy, leading to a concrete benefit for any single patient.”

BREVITY will include patients with all subtypes of invasive breast cancer (stage II and stage III), scheduled to receive standard of care neoadjuvant chemotherapy and targeted drugs. The primary endpoint of BREVITY is the ability of RDA to predict, at 14-21 days after initiation of chemotherapy, the absence or presence of a pathologic complete response (pCR) at surgery, a surrogate of outcome. Full patient accrual, as well as the primary endpoint of the trial, is expected to be achieved in 2020.