Appoint Drs. David Reardon, Timothy Cloughesy, and Nicholas Butowski
VANCOUVER, British Columbia and MENLO PARK, Calif., May 20, 2019 /PRNewswire/ -- DelMar Pharmaceuticals, Inc. (DMPI) ("DelMar" or the "Company"), a biopharmaceutical company focused on the development and commercialization of new cancer therapies, announced today the appointments of three additional world-class neuro-oncologists to its Scientific Advisory Board (SAB).
- Dr. David Reardon, clinical director of the Center for Neuro-Oncology at the Dana-Farber Cancer Institute and a Professor of Medicine at the Harvard Medical School
- Dr. Timothy Cloughesy, professor of neurology at the David Geffen School of Medicine at the University of California, Los Angeles and a member of the UCLA Brain Research Institute and Jonsson Comprehensive Cancer Center
- Dr. Nicholas Butowski, a neuro-oncologist practicing at UCSF Medical Center in San Francisco, CA, and director of translational research in neuro-oncology and a researcher at the Brain Tumor Center
These new advisors join existing SAB members Dr. John de Groot, Chairman, ad interim of the Department of Neuro-Oncology at MD Anderson Cancer Center and Dr. Napoleone Ferrara, world renowned scientist and Distinguished Professor of Pathology and a Distinguished Adjunct Professor of Ophthalmology and Pharmacology at the University of California, San Diego. Dr. Ferrara will serve as Chairman of DelMar's SAB.
"It is a pleasure to welcome these world class neuro-oncology experts to the Scientific Advisory Board as we further the development of VAL-083, our platform asset in treating GBM, and possibly a range of cancers in the future," commented Saiid Zarrabian, DelMar's Chief Executive Officer. "Given our two ongoing Phase II clinical trials for MGMT-unmethylated GBM, bolstering our SAB with neuro-oncology-dedicated thought leaders is particularly timely as we begin to plan the advancement of our GBM programs towards potential Phase III execution."
Brief profiles of Drs. Reardon, Butowski and Cloughesy are as follows:
Dr. David Reardon serves as clinical director of the Center for Neuro-Oncology at the Dana-Farber Cancer Institute and is a Professor of Medicine at the Harvard Medical School. Dr. Reardon previously served as associate deputy director of the Preston Robert Tisch Brain Tumor Center at Duke University. He completed his residency at the Johns Hopkins Hospital and a fellowship at the University of Michigan. His expertise includes the design and implementation of clinical trials for neuro-oncology and the preclinical evaluation of promising therapeutics. His work includes evaluation of innovative clinical therapeutics with particular focus on immune therapeutics. Dr. Reardon has published over 200 peer-reviewed manuscripts and received the R. Wayne Rundles Award for Excellence in Cancer Research.
Dr. Timothy Cloughesy is a professor of neurology at the David Geffen School of Medicine at the University of California, Los Angeles and a member of the UCLA Brain Research Institute and Jonsson Comprehensive Cancer Center. He also serves as the director of UCLA's Neuro-Oncology Program, co-director of the UCLA Brain Tumor Center, and the director of the Henry Singleton Brain Cancer Research Program. Dr. Cloughesy's research includes therapeutic, imaging, translational and basic investigations. His experience with clinical trials includes therapeutic approaches such as small molecule inhibitors, antibodies, antibody drug conjugates, chemotherapies, vaccines, viral gene transfer, and immune check point therapies. He has experience in leadership roles for first in human, PK/PD, and more traditional Phase I through Phase III studies. His focus on clinical trials in brain cancer involves novel clinical trial design, incorporation of biomarkers, and development of new biomarkers. He provided principal leadership for the accelerated approval and the conversion to full approval of the drug bevacizumab for recurrent glioblastoma. Dr. Cloughesy received his B.A. degree with honors from the University of California, Santa Barbara, and his M.D. from Tulane University. He completed his neurology residency and fellowships in clinical neurophysiology at University of California, Los Angeles. Dr. Cloughesy is board certified in neurology and clinical neurophysiology and has the UCNS Neuro-Oncology Certification.
Dr. Nicholas Butowski is a neuro-oncologist practicing at UCSF Medical Center in San Francisco, CA. Dr. Butowski serves as director of translational research in neuro-oncology and a researcher at the Brain Tumor Center. He specializes in brain tumors, neuroimaging, cognitive and rehabilitative neurology, and complementary therapies for neurological disorders. In his research, Dr. Butowski focuses on developing treatments for primary brain tumors as well as methods to ensure good quality of life for patients and to assist them in recovering from or coping with brain injury. Dr. Butowski earned his medical degree at the University of Illinois at Chicago and completed a residency in neurology and a fellowship in neuro-oncology at UCSF. He is a member of the American Academy of Neurology, American Society of Clinical Oncology and Society for Neuro-oncology.
VAL-083 (Dianhydrogalactitol) is a novel bi-functional DNA targeting agent that rapidly induces interstrand cross-links at N7-guanine, leading to DNA double-strand breaks and ultimately cell death. VAL-083's unique cytotoxic mechanism circumvents MGMT mediated chemoresistance and differentiates it from other therapies used in the treatment of glioblastoma multiforme (GBM), including temozolomide (TMZ). This makes VAL-083 an ideal candidate to explore treating patients who are unlikely to respond to TMZ due to MGMT expression in their GBM as per the 2017 National Comprehensive Cancer Network guidelines.
VAL-083 has been granted orphan drug designations by the U.S. FDA Office of Orphan Products for the treatment of glioma, medulloblastoma and ovarian cancer, and in Europe for the treatment of malignant gliomas. VAL-083 has been granted fast-track status for the treatment of recurrent GBM by the US FDA.
About DelMar Pharmaceuticals, Inc.
DelMar is focused on the development and commercialization of new therapies for cancer patients who have limited or no treatment options. By focusing on understanding tumor biology and mechanisms of treatment resistance, the Company identifies biomarkers to personalize new therapies in indications where patients are failing, or are unable to tolerate, standard-of-care treatments.
The Company's current pipeline is based around VAL-083, a "first-in-class", small-molecule chemotherapeutic with a novel mechanism of action that has demonstrated clinical activity against a range of cancers including central nervous system, ovarian and other solid tumors (e.g. NSCLC, bladder cancer, head & neck) in U.S. clinical trials sponsored by the National Cancer Institute (NCI). Based on DelMar's internal research programs, and these prior NCI-sponsored clinical studies, the Company is conducting clinical trials to support the development and commercialization of VAL-083 to solve significant unmet medical needs.
VAL-083 is being studied in two collaborator-supported, biomarker-driven, Phase II clinical trials for MGMT-unmethylated GBM. Overcoming MGMT-mediated resistance represents a significant unmet medical need in the treatment of GBM. In addition, DelMar has announced the allowance of a separate IND for VAL-083 as a potential treatment for platinum-resistant ovarian cancer.
Further information on DelMar's clinical trials can be found on clinicaltrials.gov: https://www.clinicaltrials.gov/ct2/results?cond=&term=val-083&cntry1=&state1=&recrs
Safe Harbor Statement
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, including statements regarding the Phase 2 clinical trial discussed above and the current results and outcomes of such trial. Any forward-looking statements contained herein are based on current expectations but are subject to a number of risks and uncertainties. The factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the Company's ability to develop, market and sell products based on its technology; the expected benefits and efficacy of the Company's products and technology; the availability of substantial additional funding for the Company to continue its operations and to conduct research and development, clinical studies and future product commercialization; and, the Company's business, research, product development, regulatory approval, marketing and distribution plans and strategies. These and other factors are identified and described in more detail in the Company's filings with the SEC, including, the Company's Annual Report on Form 10-K for the year ended June 30, 2018, the Company's Quarterly Reports on Form 10-Q, and the Company's Current Reports on Form 8-K.