SAN DIEGO, Jan. 29, 2020 /PRNewswire/ -- DelMar
Pharmaceuticals, Inc. (Nasdaq: DMPI) ("DelMar" or the
"Company"), a biopharmaceutical company focused on the development
of new solid tumor cancer therapies, today announced the
publication of previously released interim clinical data in the
February 2020 issue of peer-reviewed
journal, Glioma. The article highlights results from
the first 22 patients of the Company's 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 article can be accessed
online via
http://www.jglioma.com/article.asp?issn=2589-6113;year=2019;volume=2;issue=4;spage=167;epage=173;aulast=Guo.
In the article, which was co-authored by lead investigator
Professor Zhong-ping Chen of Sun
Yat-sen University Cancer Center (SYSUCC) in Guangzhou, China, where the study is currently
being conducted, of the 22 patients who had completed at least one
cycle of treatment as of that date, median progression-free
survival (PFS) with VAL-083 as reported was 9.9 months (confidence
interval, or CI, 7.3-12.0 months). For the 18 patients
initially receiving the intended treatment dose (30
mg/m2/day on days 1, 2 and 3 of a 21-day cycle) median
PFS as reported was 10.4 months (CI 6.0-12.0 months). While this is
not a head-to-head trial, historically, temozolomide (TMZ) has been
demonstrated to have 6.9 months PFS in unmethylated GBM
patients.
"This publication represents an important additional validation
of VAL-083 as a first-line treatment. Given that an external
panel of experts reviewed both the protocol and the interim data
and were willing to publish based on the results and inclusive of
the fact that the data came from a study originating in
China. This publication is from a world-renowned journal and
we believe it demonstrates the potential to achieve one of the
first new treatments for GBM in many years. We look forward
to providing continued updates on the development of VAL-083 as
they become available," commented Saiid
Zarrabian, DelMar's Chief Executive Officer.
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. In the publication, authors outlined the two parts of
the study. The first is a dose escalation and induction
format to enroll up to ten patients to receive VAL-083 at 20, 30 or
40 mg/m2/day for three days every 21 days concurrently
with standard radiation and VAL-083 for up to eight additional
cycles. The second part of the study is an expansion phase to
enroll up to 20 additional patients. The publication
highlighted the first 23 patients enrolled, 14 of whom had been
treated in the expansion phase.
Myelosuppression was the most common adverse event in the
patients assessed, and pharmacokinetic assessments indicated that
the levels of VAL-083 were as high in the cerebrospinal fluid as in
plasma two hours after infusion.
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 & neck) in
U.S. clinical trials sponsored by the National Cancer Institute
(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.