SAN DIEGO, Feb. 19, 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 it has enrolled and
begun dosing the final patient in its ongoing Phase 2 clinical
study investigating the first-line treatment of VAL-083 with
radiation therapy in newly-diagnosed, MGMT-unmethylated
glioblastoma multiforme (GBM). The trial, which is
being conducted at the Sun Yat-sen University Cancer Center
(SYSUCC) in Guangzhou, China, and
in collaboration with Guangxi Wuzhou Pharmaceutical Company, is
designed to enroll up to 30 patients to determine whether
first-line therapy with VAL-083 treatment improves progression free
survival (PFS). The current standard of care is first-line
temozolomide (TMZ) with radiation.
"We are very pleased to have enrolled and started dosing our
final patient in this important study. This earlier than predicted
full enrollment is encouraging and will allow an earlier topline
data readout," commented Professor Zhong-ping Chen, founder
chairman of the Department of Neurosurgery/Neuro-oncology at Sun
Yat-sen University Cancer Center, and who is also the study's
principal investigator. "The enrollment of the final patient also
provides us the opportunity to corroborate the preliminary data
we've recently published, which supports the possibility that
VAL-083 can provide a new and valuable treatment option in this
difficult-to-treat indication."
The Phase 2 trial is a single-arm, open-label study testing
VAL-083 in combination with standard radiotherapy in GBM patients
who have an unmethylated promoter of the methylguanine
DNA-methyltransferase (MGMT) gene. The clinical trial in
newly-diagnosed GBM patients is designed to determine if first-line
treatment with VAL-083 plus radiotherapy can provide improvements
over the historical efficacy of standard of care TMZ plus
radiotherapy. Efficacy will be measured based on tumor response to
treatment, progression-free survival, progression-free survival at
six months, and overall survival compared to historical results in
the target population.
"Having completed enrollment of our first-line study ahead of
schedule, we expect to complete analysis for the topline data in
our most important Phase 2 trial for first-line GBM patients
earlier than anticipated. We are optimistic that we will
receive the initial data readout before the end of August 2020," commented Saiid Zarrabian, DelMar's Chief Executive
Officer. "In the meantime, we continue to rapidly advance our other
Phase 2 program in the adjuvant and recurrent settings for VAL-083
at MD Anderson Cancer Center and look forward to providing further
updates on the progress of our ongoing open label GBM trials at
upcoming scientific meetings."
DelMar has been monitoring the coronavirus situation in
China. Based on discussions with our principal investigator
at SYSUCC, we believe the coronavirus outbreak will not have a
significant impact on our patient treatment timeline.
In addition to the Phase 2 clinical trial in first-line
treatment, DelMar is conducting an additional two-arm Phase 2
clinical trial in GBM. The adjuvant arm, which initiated in late
2019 will enroll up to 24 newly-diagnosed patients who have
undergone surgery and chemoradiation with TMZ but will now receive
VAL-083 in place of standard of care TMZ for adjuvant therapy. The
second arm treats patients with recurrent disease, administering
VAL-083 in patients who have been heavily pre-treated with TMZ
prior to disease recurrence. The recurrent arm will allow a total
of 83 patients to be enrolled. Both arms are being conducted
at the University of Texas MD Anderson
Cancer Center.
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 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 the status of the
Company's clinical trials and the reporting of the
results. 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, 2019, the Company's
Quarterly Reports on Form 10-Q, and the Company's Current Reports
on Form 8-K.
CONTACTS:
Investors:
John
Marco
Managing Director
CORE IR
516-222-2560
johnm@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.