VANCOUVER, British Columbia and
MENLO PARK, Calif., July 31, 2019 /PRNewswire/ -- DelMar
Pharmaceuticals, Inc. (NASDAQ: DMPI) ("DelMar" or the
"Company"), a biopharmaceutical company focused on the development
of novel cancer therapies, today announces it has achieved
two-thirds enrollment in its ongoing Phase 2 clinical study
investigating the first-line treatment of VAL-083 with radiation
therapy in newly-diagnosed MGMT-unmethylated 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.
"While treating glioblastoma patients with an unmethylated MGMT
promoter is particularly challenging, we have been encouraged by
the enhanced levels of tumor shrinkage observed to date following
treatment with VAL-083 in combination with radiation," 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. "Having
reached this two-thirds enrollment point, we look forward to seeing
further results corroborating the preliminary data we've received,
which does appear to support the premise that VAL-083 may provide
an additional and valuable treatment option for these
difficult-to-treat patient conditions."
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 temozolomide (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.
"This first line study continues to enroll at a consistent pace,
and we look forward to completing enrollment in this very important
patient population. Once complete, we believe that the data from
this study may provide additional support for the advancement of
the adjuvant setting trial at MD Anderson Cancer Center, as well as
to potentially support a future US study for utilization of VAL-083
as a first-line therapy for newly-diagnosed patients with an
unmethylated MGMT gene promoter," commented Saiid Zarrabian, DelMar's Chief Executive
Officer. "In the meantime, we are very proud to be advancing all
three of our Phase 2 programs for VAL-083, including the two-arm
trial being conducted at MD Anderson Cancer Center in Texas for patients with recurrent GBM and
those who have undergone surgery and chemoradiation with TMZ but
will now receive VAL-083 in place of standard of care TMZ for
adjuvant therapy. We look forward to continuing to provide updates
on the progress of all three patient populations."
The company recently announced the initiation of an adjuvant arm
to the MD Anderson study to provide early disease data on
VAL-083. This arm 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. This arm is in addition to a trial arm treating
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, and 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.
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 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. 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.
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.