Cancer therapy-focused biopharma firm DelMar Pharmaceuticals has signed an agreement with contract research organization PRA Health Sciences that will see the two companies work together in the Phase 3 trials of DelMar’s treatment for glioblastoma multiform (GBM) patients.
The therapy, VAL-083 is a “first-in-class,” small-molecule chemotherapeutic. It 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.
GBM is the most common and aggressive primary brain cancer. The current standard of care includes surgery, radiation, and treatment with temozolomide (TMZ), however, nearly all tumors recur and the prognosis for recurrent GBM is dismal. Most GBM tumors have unmethylated promoter status for MGMT.
“We have been working with PRA for quite some time in preparing for VAL-083’s Phase 3 study in GBM,” said Jeffrey Bacha, chairman and chief executive officer of DelMar Pharmaceuticals. “Given our recent $9 million 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.”
PRA is a global contract research organizations, by revenue, providing outsourced clinical development services to the biotechnology and pharmaceutical industries. PRA’s global clinical development platform includes more than 70 offices across North America, Europe, Asia, Latin America, South Africa, Australia and the Middle East,
According to Delmar, VAL-083 readily crosses the blood-brain barrier and accumulates in brain tumor tissue. The company’s recent Phase 1/2 clinical trial in recurrent GBM patients failing both TMZ and bevacizumab, suggested that VAL-083 offers clinically meaningful survival benefits for patients with recurrent GBM.
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.