SAN DIEGO, May 5, 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
enrolled 22 patients 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 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. Additionally, in the
recurrent arm of the study, which is also being conducted at MDACC,
72 patients out of a planned 83 patients have now been enrolled.
DelMar continues to actively enroll patients in both trial arms of
the clinical study, even in light of the COVID-19 pandemic.
DelMar previously announced that it had completed full
enrollment of the planned 29 patients 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 is being conducted at the Sun Yat-sen University Cancer
Center in Guangzhou, China, and is
designed to determine whether first-line therapy with VAL-083
treatment improves progression free survival. The current standard
of care is first line TMZ with radiation.
Pending meeting formats and other unforeseen changes, DelMar
currently intends to announce additional clinical trial updates
concomitant with planned scientific poster presentations at or
around the American Society of Clinical Oncology (ASCO) ASCO20
Virtual Scientific Program May 29-31,
2020, and at or around the American Association for Cancer
Research Virtual Annual Meeting II June
22-24, 2020.
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, the impact of the COVID-19 pandemic 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 surrounding the COVID-19 pandemic, 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.
