Several Patient Assistance Programs (PAPs), rising initiatives from governments of different countries related to cancer awareness, increasing prevalence of cancer across the globe, and rising R&D initiatives and clinical studies from various biopharmaceutical companies are growing cancer treatment options.
EpicentRx, Inc., a US based immunotherapy company focused at finding new mechanisms to outsmart cancer with minimum toxicity, reportedly announced positive outcomes from its Phase 1 G-FORCE study of RRx-001 as a first line therapy for newly diagnosed glioblastoma.
RRx-001, the company’s lead program, is a small molecule immunotherapy that focuses on the CD47 – SIRPα axis. It has been evaluated across multiple clinical trials.
GBM (glioblastoma multiforme) accounts for 15-20% of all the primary intracranial neoplasm. This disease typically leads to death within the initial 15 months after its diagnosis. 64 years is the median diagnosis age for the disease. Since agents from different drug classes were unsuccessful in clinical studies, there is an immense need for less toxic and more effective GBM therapy.
In the Phase 1 study, 18 patients that had histologically verified glioblastoma, were administered with RRx-001 plus radiotherapy along with temozolomide. After a gap of six weeks, patients in cohorts 4 to 6 received RRx-001 maintenance treatment plus temozolomide, while patients that were in cohorts 1 to 3 were given temozolomide maintenance therapy.
President and CEO at EpicentRx, Corey A. Carter, M.D., stated that patients that are detected with glioblastoma have very few treatment options and a very poor prognosis. The outcomes from this Phase 1 study and the company’s currently underway Phase 3 REPLATINUM study in SCLC (small cell lung cancer) validates RRx-001 to be a viable treatment for several cancer types.
Dr. Carter further added that the company also plans to initiate a Phase 0 RRx-001 study for GBM soon. The trial would look for further insights into action mechanisms in brain tumors prior to initiating the Phase 3 trials.
RRx-001 compound currently has an Orphan Drug Designation (ODD) from the Food and Drug Administration to treat SCLC, glioblastoma and neuroendocrine cancer.