DelMar Pharmaceuticals announced an agreement with PRA Health Sciences to conduct the Phase 3 trial of VAL-083 in recurrent glioblastoma multiforme (GBM).
"We have been working with PRA for quite some time in preparing for VAL-083's Phase 3 study in GBM," Jeffrey Bacha, chairman and chief executive officer of DelMar Pharmaceuticals said. "Given our recent $9M financing, we have the resources to facilitate the initiation of our pivotal Phase 3 study of VAL-083 as a single agent treatment for GBM patients who have failed both temozolomide (Temodar™) and bevacizumab (Avastin™), for whom there is no currently approved therapy. We are delighted to formally engage with a CRO of the caliber and reputation of PRA to run this Phase 3 study of a treatment for a cancer indication in which there is an utmost medical need in the eyes of oncologists and the FDA."
Since 2000, PRA has performed approximately 3,500 clinical trials worldwide and has worked on more than 100 marketed drugs across several therapeutic areas. Additionally, PRA has participated in the pivotal or supportive trials that led to U.S. Food and Drug Administration or international regulatory approval of more than 70 drugs.
VAL-083 is a "first-in-class," small-molecule chemotherapeutic that demonstrated clinical activity against a range of cancers including GBM in historical clinical trials sponsored by the U.S. National Cancer Institutes (NCI). DelMar has demonstrated that VAL-083's anti-tumor activity against GBM is unaffected by the expression of MGMT and MMR in vitro.
VAL-083 has received an orphan drug designation in Europe for the treatment of malignant gliomas and the U.S. FDA Office of Orphan Products has granted an orphan designation to VAL-083 for the treatment of glioma, medulloblastoma and ovarian cancer. Based on historic clinical trials run by the NCI, the modern Phase 1/2 dose finding trial run by DelMar in GBM (ASCO 2016), and recent guidance from the FDA, the company has embarked on Phase 2 or 3 trials for VAL-083 across recurrent and newly diagnosed GBM. DelMar has announced plans to advance VAL-083 into a controlled Phase 3 Study in Temozolomide-Avastin Recurrent GBM ("STAR-3") to evaluate overall survival versus salvage chemotherapy for GBM patients who have previously failed both temozolomide and bevacizumab (Avastin) and for whom there exists no approved treatment option; a Phase 2 trial (with MD Anderson Cancer Center) in first recurrence GBM patients prior to bevacizumab therapy is currently enrolling; and a separate international Phase 2 trial for newly diagnosed MGMT-unmethylated GBM is planned. DelMar believes that data from its clinical trials, if successful, will form the basis of a new treatment paradigm for the vast majority of GBM patients whose tumors exhibit features that make them unlikely to respond to currently available therapies.
GBM is the most common and aggressive primary brain cancer. Current standard of care includes surgery, radiation and treatment with temozolomide (TMZ). Most GBM tumors have unmethylated promoter status for MGMT. Second-line treatment with anti-angiogenic agent bevacizumab has not improved overall survival (OS) and 5-year survival is less than 3%.