SAN DIEGO, June 24, 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 it has
received a $500,000 loan from the
National Brain Tumor Society (NBTS) and the National Foundation for
Cancer Research (NFCR) to support VAL-083's preparation
for participation in the Global Coalition for
Adaptive Research's (GCAR) sponsored trial, Glioblastoma (GBM)
Adaptive Global Innovative Learning Environment (GBM AGILE) study.
On June 4, 2020, the Company
announced that VAL-083, its "first-in-class," small-molecule
chemotherapeutic with a novel mechanism of action, was selected by
GCAR as the third investigational therapy to participate in GBM
AGILE, in which the compounds will be simultaneously evaluated
across multiple international trial sites of which 25 are currently
activated. DelMar intends to utilize GBM AGILE, which is an
adaptive registration clinical trial, to serve as the basis for
VAL-083's new drug application submission and registration.
"It means a great deal to all of us involved with VAL-083's
development to receive support from the National Brain Tumor
Society and the National Foundation for Cancer Research as these
organizations are two of the leading advocacy and funding partners
for GBM AGILE," commented Saiid
Zarrabian, Chief Executive Officer of DelMar
Pharmaceuticals. "This funding is an important milestone as it
enables us to accelerate VAL-083's participation in GBM AGILE,
which is expected to reduce VAL-083's pivotal trial completion
and regulatory submission timeline by up to 18 months."
GBM AGILE is an international effort in newly diagnosed and
recurrent GBM, utilizing an FDA approved master protocol to
evaluate multiple therapies against a common control arm. As an
approved registrational study, positive results from the VAL-083
arm of GBM AGILE are expected to be utilized to file for FDA
approval. This study employs a
cost-efficient, seamless phase 2/3 adaptive trial design with
a Stage 1 learning and adapting phase and a Stage 2 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, a 501(c)(3)
organization, is the international trial sponsor, and provides
financial support for the program infrastructure, as well as trial
oversight and management. Comprised of 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 are supporting the inclusion of VAL-083 in the GBM AGILE
adaptive clinical trial platform as it is consistent with our
mission to support research for, and ultimately enable delivery of,
effective treatments to patients with brain tumors. We are
particularly pleased to lend our support to VAL-083 given the
significant unmet medical need that exists for patients with GBM,"
commented David Arons, Chief
Executive Officer of the National Brain Tumor Society.
Sujuan Ba, President & Chief
Executive Officer of the National Foundation for Cancer Research
added, "We are dedicated to facilitating the development of
therapies for all cancers, and are pleased to lend our support to
VAL-083's participation in GBM AGILE. We are very hopeful that the
knowledge established from VAL-083 in GBM AGILE can be insightful
for other cancers – giving patients hope for treatments that are
best suited for their care."
"We are delighted to help bring together our key strategic
partners, NBTS, NFCR, and DelMar Pharmaceuticals,"
shared Faramarz Yousefzadeh, GCAR
Board Chairman. "We believe this is a model for collaboration –
aiding small pharma to test promising new drugs in GBM
AGILE."
About VAL-083
VAL-083 (dianhydrogalactitol) is a "first-in-class",
bifunctional DNA-targeting agent that introduces inter-strand DNA
cross-links at the N7-position of guanine leading to DNA
double-strand breaks and cancer cell death. VAL-083 has
demonstrated clinical activity against a range of cancers including
GBM and ovarian cancer in historical clinical trials sponsored by
the U.S. National Cancer Institute (NCI). DelMar has demonstrated
that VAL-083's anti-tumor activity is unaffected by common
mechanisms of chemoresistance, including MGMT, in cancer cell
models and animal studies. Further details regarding these
studies can be found at:
http://www.delmarpharma.com/scientific-publications.html.
About the National Foundation for Cancer Research
The NFCR is a 501(c)(3) nonprofit organization that provides
scientists in the lab the funding they need to make game-changing
discoveries in cancer treatments, detection, prevention and
ultimately, a cure. NFCR has distinguished itself in the cancer
research sector by emphasizing long-term, transformative
research often overlooked by other major funding sources. With
the help of more than 5.2 million individual donors over the last
47 years, NFCR has delivered more than $380 million in funding to
public education and cancer research leading to several important,
life-saving discoveries.
About the National Brain Tumor Society
The NBTS unrelentingly invests in, mobilizes, and unites the
community to discover a cure, deliver effective treatments, and
advocate for patients and care partners. It is in the unique
position to affect change across the drug development, policy and
legislative, research, and clinical trial systems at all levels.
NBTS doesn't focus on a single method or approach to defeating
brain tumors. It drives a multi-faceted and thoughtful approach to
aggressively influence and fund strategic research and discovery,
as well as advocate for public policy changes, in order to achieve
the greatest impact, results, and progress for brain tumor
patients.
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 and neck) in
U.S. clinical trials sponsored by the 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 GBM AGILE, 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.
