SAN DIEGO, June 4, 2020 /PRNewswire/ -- DelMar
Pharmaceuticals, Inc. (Nasdaq: DMPI) ("DelMar" or the
"Company"), a biopharmaceutical company focused on the development
of new solid tumor cancer therapies, announced today the acceptance
of an invitation from the Global Coalition for Adaptive Research
(GCAR) to include VAL-083 in GCAR's Glioblastoma Adaptive Global
Innovative Learning Environment (GBM AGILE) Study, an adaptive
clinical trial platform in glioblastoma multiforme (GBM). DelMar
will utilize the GBM AGILE study to serve as the basis for
VAL-083's new drug application (NDA) submission and
registration.
"We wish to convey our gratitude to GCAR for extending an
invitation to DelMar to participate in the GBM AGILE study. We
believe that GCAR's already-approved robust adaptive trial design,
industry leading partners and clinical support vendors, as well as
strong regulatory endorsement can measurably accelerate our efforts
to bring VAL-083 to market for GBM patients who have significant
unmet medical needs," commented Saiid
Zarrabian, Chief Executive Officer of DelMar
Pharmaceuticals. "With 24 clinical sites currently enrolling
patients and with additional sites in the US, Canada, Europe and China expected to come online in the next 12
months, our participation in GBM AGILE is expected to provide a
significant time and cost savings advantage related to clinical
trial initiation. We look forward to enrolling the first patient
into the VAL-083 arm of the study which is planned for the fourth
quarter of this year."
GBM AGILE is an international effort in newly-diagnosed and
recurrent GBM, utilizing an FDA approved master protocol with
multiple drugs to be tested simultaneously and over
time against a common control arm. As an approved
registrational study, results from the VAL-083 arm of GBM AGILE are
intended to be utilized to file for FDA
approval. This study employs a
cost-efficient, adaptive trial design with a Stage 1 (Phase 2)
learning and adapting phase and a Stage 2 (Phase 3) expansion
and confirmation phase. The effort is led by top-tier key opinion
leaders in the GBM field and has the collective support of an
international group of more than 130 clinicians, researchers,
biostatisticians, imagers, pathologists, leaders from government
and industry, and patient advocates. GCAR is a 501(c)(3)
organization that functions as GBM AGILE study sponsor, and
provides financial support for the program infrastructure, as well
as general trial oversight. Comprising the world's foremost
clinical, translational, and basic science investigators, GCAR
strives to support the development of novel treatments to fight
against rare and deadly diseases like GBM where patient prognosis
is poor and treatment options are limited.
"We look forward to advancing DelMar's promising compound,
VAL-083, in GBM AGILE. This registrational study is designed to
accelerate the identification and approval of new drugs for
patients with glioblastoma, a challenging disease with limited
treatment options. We are very pleased to collaborate with
DelMar Pharmaceuticals to initiate planning for the inclusion of
VAL-083 in the trial for recurrent and newly-diagnosed GBM
patients," commented Meredith
Buxton, PhD, MPH, Chief Executive Officer of GCAR.
ABOUT GLOBAL COALITION FOR ADAPTIVE RESEARCH
GCAR is a 501(c)(3) nonprofit organization, comprised of some of
the world's foremost physicians, clinical researchers and
investigators united in expediting the discovery and development of
cures for patients with rare and deadly diseases. As its first
priority, GCAR is sponsoring GBM AGILE, an adaptive platform trial
for patients with GBM – the most common and deadliest of malignant
primary brain tumors. Key strategic partners for the GBM
AGILE study effort include the National Brain Tumor Society,
National Foundation for Cancer Research, and Asian Fund for Cancer
Research. These three nonprofit organizations are working
together to provide philanthropic support as well as assistance in
communicating with patients and families and inviting all others to
join in supporting this innovative approach to brain tumor
treatment development.
ABOUT DELMAR PHARMACEUTICALS, INC.
Located in San Diego,
California, 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 2 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.
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 AGILE study, the
status of the Company's clinical trials, the reporting of the
results and the impact of the COVID-19 pandemic. 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 impact
of the COVID-19 pandemic on the Company's operations and clinical
trials, 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,
2019, the Company's Quarterly Reports on Form 10-Q, and the
Company's Current Reports on Form 8-K.
CONTACTS:
Investors:
CORE IR
516-222-2560
ir@coreir.com
Media:
Jules
Abraham
Director of Public Relations
CORE IR
917-885-7378
julesa@coreir.com
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SOURCE DelMar Pharmaceuticals, Inc.