SAN DIEGO, March 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 it has exceeded 50%
enrollment in the adjuvant arm of the Company's ongoing Phase 2
clinical study investigating adjuvant treatment (pre-temozolomide
-- or TMZ – maintenance therapy) of MGMT-unmethylated glioblastoma
multiforme (GBM) with VAL-083. The 24-patient, open label study arm
has now enrolled 14 patients and continues to enroll at an
encouraging rate.
The adjuvant arm of the Phase 2 study of VAL-083 being conducted
at the MD Anderson Cancer Center (MDACC) is designed to 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 pace of enrollment for the adjuvant arm of the study has
been very encouraging and we hope to see both that arm, and the
recurrent arm continue to enroll patients steadily. We will
continue to provide updates as they become available," commented
Saiid Zarrabian, DelMar's Chief
Executive Officer. "In the meantime, having completed enrollment of
our first-line study, we continue to anticipate an initial data
readout before the end of August
2020."
The Company's second study arm being conducted at MDACC is the
recurrent trial arm, which is enrolling patients who have typically
been heavily pre-treated with TMZ prior to disease
recurrence. In the recurrent setting, the Company previously
announced that MDACC had approved up to 35 additional patients to
this recurrent GBM study at a dose of 30 mg/m2, allowing
for a total of up to 83 patients to be enrolled. To-date, 68
recurrent patients have been enrolled in the recurrent arm. DelMar
is actively enrolling patients for both trial arms of the clinical
study at MDACC.
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.