DelMar Pharmaceuticals announced the closing of a $9 million offering of common stock and warrants which was led by leading healthcare dedicated institutional investors.
"Our recent financing enables us to remain on-track to initiate the pivotal Phase 3 clinical trial of VAL-083 in refractory GBM,” Jeffrey Bacha DelMar's chairman & CEO said. “This milestone, combined with VAL-083's recent scientific advancements form the foundation for this molecule to serve as a platform asset addressing unmet medical needs in a broad range of tumor types including GBM, non-small cell lung cancer, ovarian cancer and other solid tumors both as a single agent and as a key component of combination therapy regimens."
During the quarter, the company made advancements for VAL-03 as a treatment for GBM patients whose tumors express features, such as high expression of the enzyme MGMT, that make their cancer resistant to, or unlikely to, respond to currently available therapy. Accomplishments achieved included submitting a protocol to the FDA for a pivotal, 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 (Temodar) and bevacizumab (Avastin). The company also announced a collaboration with PRA Health Sciences (PRA) as the contract research organization to oversee and manage the company's pivotal VAL-083 STAR-3 GBM clinical trial. PRA Health Sciences is one of the world's leading global contract research organizations, 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, and approximately 13,000 employees worldwide.
During the period, the company also continued enrolling its Phase 2 clinical study of VAL-083 in patients with MGMT-unmethylated GBM at first recurrence/progression prior to bevacizumab (Avastin) exposure in collaboration with the University of Texas MD Anderson Cancer Center. Additionally, DelMar received ethics committee approval, retained a contract research organization, and submitted an application to the China Office of Human Genetic Resources Authority (OHGRA) to allow for initiation of the company's planned Phase 2 clinical trial in newly diagnosed patients with MGMT-unmethylated GBM at Sun Yat Sen University in Guangzhou, China. DelMar also entered into a sponsored research agreement with Duke University to evaluate VAL-083 as a front-line treatment for newly diagnosed patients with GBM.
DelMar also continued to present research results supporting the potential of VAL-083 in the treatment of a range of cancers, including GBM, at leading scientific conferences. The company presented data supporting the effectiveness of VAL-083 against chemotherapy-resistant ovarian cancers at the 11th Biennial Ovarian Cancer Research Symposium. Additionally, data was presented indicating that VAL-083 offers potential therapeutic alternatives in difficult-to-treat pediatric brain tumors – Advances in Pediatric Research: From Mechanisms and Models to Treatment and Survivorship. In April, new non-clinical data supporting the differentiation of VAL-083 in the treatment of lung cancer was presented at the American Association for Cancer Research's (AACR) annual meeting. And in May, the company presented new research at the 5th Quadrennial Meeting of the World Federation of Neuro-Oncology Societies demonstrating that VAL-083 circumvents both of the primary mechanisms correlated to chemoresistance to temozolomide, the current standard of care in the treatment of GBM.