VANCOUVER, British Columbia and MENLO PARK, Calif., April 25, 2017 /PRNewswire/ — DelMar Pharmaceuticals, Inc. (Nasdaq: DMPI) (“DelMar” and the “Company”), a biopharmaceutical company focused on the development and commercialization of new cancer therapies, today announced that it has entered into a three-year collaboration with Duke University to evaluate VAL-083, the Company’s platform compound, as a front-line treatment for newly diagnosed patients with glioblastoma multiforme (“GBM”).
Under the terms of the collaboration, DelMar will fund a series of pre-clinical studies to be conducted by Duke University’s Glioblastoma Drug Discovery Group to evaluate VAL-083, either alone or in combination with other agents, for activity against a range of glioblastoma subtypes (personalized drug development). The goal of the research will be to identify molecular characteristics of GBM tumors that are more likely to respond to VAL-083, and not the standard of care, temozolomide, as a front-line treatment or through combination therapies.
“VAL-083 is a promising drug that has the potential to help many GBM patients, especially the over half of GBM patients whose tumors predominantly exhibit an unmethylated MGMT promoter and do not respond to temozolomide, the current standard of care,” commented Dr. Madan Kwatra, Director of the Glioblastoma Drug Discovery Group at Duke University.
GBM is a deadly brain cancer in which the current standard of care consists of surgery followed by radiation and chemotherapy using temozolomide. However, temozolomide only works for about 40% of GBM patients that have a methylated MGMT promoter. In contrast, VAL-083 is a novel chemotherapeutic agent that has activity against GBM with both methylated and unmethylated MGMT promoters. As such, VAL-083 is a more versatile chemotherapeutic agent that may help a wider subset of GBM patients.
“We are delighted to be working with another top-tier research institute and in particular, Dr. Kwatra who is a world renowned expert in the GBM field,” stated Jeffrey Bacha, chairman and chief executive officer of DelMar Pharmaceuticals. “The efforts of his department in the coming years will greatly contribute to our goal of optimizing VAL-083 as a next generation personalized solution for a broad range of cancers.”
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.
DelMar is currently conducting a Phase 2 clinical trial in patients with MGMT-unmethylated, Bevacizumab-naive, recurrent GBM in collaboration with the University of Texas MD Anderson Cancer Center. DelMar has also announced plans to advance VAL-083 into a pivotal randomized multi-center Phase 3 clinical trial for the treatment of bevacizumab-failed GBM and into a separate international Phase 2 trial for newly diagnosed MGMT-unmethylated GBM patients.
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.
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