VANCOUVER, British Columbia and
MENLO PARK, Calif., Aug. 27, 2019 /PRNewswire/ -- DelMar
Pharmaceuticals, Inc. (NASDAQ: DMPI) ("DelMar" or the
"Company"), a biopharmaceutical company focused on the development
of novel cancer therapies, today announced that the Company
anticipates that its current cash position, which includes the
$6.7 million in net proceeds from the
underwritten offering completed August 16,
2019, will be sufficient to complete enrollment in all three
patient groups of its two ongoing Phase 2 clinical trials for its
lead compound, VAL-083, which the Company believes will occur by
the fourth quarter of calendar year 2020.
"To date, we have had steady enrollment in our two Phase 2
trials, and believe that with the additional capital from our
recent financing, we will be in the position to complete enrollment
of our Phase 2 clinical trial in China for first-line treatment with radiation
for newly diagnosed MGMT-unmethylated GBM patients, as well as both
arms of our Phase 2 trial with MD Anderson Cancer Center (MDACC) -
one for patients with recurrent disease and one for newly diagnosed
patients who have undergone chemoradiation with temozolomide, but
will now receive VAL-083 as adjuvant therapy," commented
Saiid Zarrabian, president and CEO
of DelMar. "We believe the complete enrollment of both of
these trials is an important inflection point for the Company and
we are grateful to now have the capital to reach that
milestone. In the meantime, we expect to provide updates on
one or more of these open-label Phase 2 GBM trials at the Society
of Neuro-Oncology meeting November
20-24, the American Academy of Cancer Research in
April 2020 and the American Society
of Clinical Oncology in May
2020."
The Company's Phase 2 trial in China 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. To date, the Company has
enrolled 20 of the 30 patients required for the trial, with
positive early results previously reported.
The Company is also conducting a Phase 2 trial with MDACC with
one 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. The second trial 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. The Company will
provide enrollment and treatment updates as appropriate.
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.