VANCOUVER, British Columbia and
MENLO PARK, Calif., May 20, 2019 /PRNewswire/ -- DelMar
Pharmaceuticals, Inc. (Nasdaq: 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.
About VAL-083
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
For additional information, please
visit http://delmarpharma.com/; or contact DelMar
Pharmaceuticals Investor Relations: ir@delmarpharma.com /
(604) 629-5989.
Connect with the Company
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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.
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SOURCE DelMar Pharmaceuticals, Inc.