For cancer research, volunteers are crucial for testing the potency and safety of new anti-cancer drugs. DelMar Pharmaceuticals, Inc. (DMPI) , a biopharmaceutical company focused on the development and commercialization of new cancer therapies, has been able to further and expand clinical trials of the company’s chemotherapeutic, VAL-083, thanks to the ongoing participation of volunteer patients.
DelMar has announced that their Phase II clinical study of VAL-083 in patients with refractory glioblastoma multiforme (GBM) has reached full enrollment. "We are pleased to confirm that 14 patients have now received at least one course of treatment in the Phase II expansion of this study," said Jeffrey Bacha, president & CEO of DelMar Pharmaceuticals. "The fact that we achieved full enrollment far more rapidly than projected, highlights the critical need for new therapies in the treatment of refractory GBM."
Enrollment for the expansion study began in late Q2 2015. The purpose of the expansion cohort is to gain additional information about the safety and effectiveness of VAL-083 at a 40mg/m2 dose. "Currently available treatments unfortunately fail to offer any meaningful recourse to slow tumor progression or to extend life in the majority of GBM patients," said Bacha.
Steady Progression Toward Phase II/III Studies
Positive news from the company’s clinical trials continues to unfold. Along with the expanded study and assured progression into Phase II/III studies, the company will soon present an abstract that addresses the effectiveness of VAL-0838 in treating children with brain tumors.
"Given that we have now completed enrollment in the Phase II expansion phase of our current study, we remain on track to initiate Phase II/III registration-directed studies within the next nine to twelve months,” said Bacha. “The design and timing of initiation of the registration-directed clinical trial will depend on review of the data from this clinical study and discussions with the FDA and our clinical advisors."
Through the help of volunteer patients and VAL-083’s consistently positive results, DelMar Pharmaceuticals continues to provide hope for the future of cancer treatment. "We believe,” said Bacha, “VAL-083 offers promise as a modern solution to the tremendous unmet medical need for a new therapy for GBM patients who have failed – or are unlikely to respond to – currently available treatments."
For more information about DelMar Pharmaceuticals, visit www.delmarpharma.com.
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