MicroRNA clinical trial : MiraDx, a Los Angeles-based molecular genetics company, has initiated patient enrollment in collaboration with UCLA for the non-tumor based microRNA biomarker-driven clinical trial for KRAS-variant positive HPV-positive head and neck cancer patients (HNSCC).
The clinical trial will randomly group 70 patients to receive the current standard of care (radiation plus cisplatin) or radiation, cisplatin and ERBITUX (cetuximab), an epidermal growth factor receptor (EGFR) antagonist, to study the differences in overall survival.
The intention of the microRNA clinical trial is for further confirmation of the data from a previously held phase 3 randomized study for HNSCC patients with RTOG 0522 (NCT00265941), which was previously analyzed by MiraDx. The phase 3 trial demonstrated that the subgroup of patients with the KRAS-variant who were administered with ERBITUX in combination with radiation and cisplatin had improved overall survival by a significant extent.
Dr. Joanne Weidhaas – Chair of MiraDx and David Geffen School of Medicine Head of Translational Research, Department of Radiation Oncology, commenting on the microRNA clinical trial, said: “This trial is groundbreaking in that it will further validate that there are powerful biomarkers in regions of DNA, previously considered ‘junk’ DNA, which can predict improved survival when certain targeted agents, such as cetuximab, are added to radiation.
“Our goal is to continue to prove that these types of microRNA mutations can enable clinicians to more accurately identify individuals who will benefit from specific therapeutic combinations, to truly individualize cancer therapies in meaningful ways to improve patient survival.”
The clinical trial is likely to begin enrolling patients having locally advanced HNSCC this month. The microRNA clinical trial is expected to last about a couple of years with an interim analysis to be released after year one.
Patients will be recruited for the microRNA clinical trial from across the US with enrollment to commence at UCLA and potentially expand to other clinical trial sites.
According to MiraDx, the KRAS-variant is an inherited genetic marker designed for predicting cancer risk and also unique response to cancer therapies. The molecular genetics company said that a number of studies have shown already that the KRAS-variant is predictive across cancer types, functional, and actionable.