VANCOUVER, British Columbia and
MENLO PARK, Calif., Aug. 13, 2019 /PRNewswire/ -- DelMar
Pharmaceuticals, Inc. (NASDAQ: DMPI) ("DelMar" or the
"Company"), a biopharmaceutical company focused on the development
of novel cancer therapies, provided an update on the first 20
patients enrolled in its ongoing Phase 2 clinical study
investigating the first-line treatment of VAL-083 in combination
with radiation therapy in newly-diagnosed, MGMT-unmethylated
GBM.
As of August 1, 2019, 17 of the
first 20 enrolled patients have received at least their first
assessment (two patients have not been enrolled long enough to
receive their first assessment and one patient died before their
first assessment). "Best Overall Response" for these patients per
investigator assessment were:
- Nine have been assessed as having achieved a complete response
(CR) (9/17, or 53%)
- Seven have been assessed with stable disease (SD), (7/17, or
41%)
- One has been assessed as disease progression (PD) (1/17, or
6%)
Importantly, 16 of the 20 patients enrolled (80%) were still
alive as of the August 1, 2019 data
cut-off date. The Company recently announced the enrollment
of the 20th patient into this trial.
Dr. David Reardon, clinical
director of the Center for Neuro-Oncology at the Dana-Farber Cancer
Institute and Professor of Medicine at the Harvard Medical School, and Dr. John de Groot, Professor and Chairman ad interim
in the Department of Neuro-Oncology at The University of Texas MD Anderson Cancer Center
(MDACC), are considered key opinion leaders in the brain cancer
field and currently serve as DelMar Scientific Advisory Board
members. Dr. Reardon commented, "Both John and I agree that
we desperately need something better to offer our patients and we
feel that VAL-083 has some promise and potential."
Dr. Reardon added, "For a tumor such as GBM, which is
intrinsically infiltrative and destructive in the brain,
stabilization of disease is an important achievement."
Professor Zhong-ping Chen, Founder Chairman of the Department of
Neurosurgery/Neuro-oncology at Sun Yat-sen University Cancer Center
(SYSUCC), who is the study's principal investigator, stated, "We
are pleased to be leading this Phase 2 trial for first-line GBM
treatment with DelMar, and are encouraged by the enhanced levels of
tumor shrinkage and the complete responses we are observing after
treatment with VAL-083 in combination with radiation. These
preliminary data appear to support the premise that VAL-083 has the
potential to provide a valuable treatment option for these
patients. We look forward to completing full enrollment in the
study as soon as possible."
This Phase 2 trial which is being conducted at 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. Of the 20 patients
enrolled, 17 (85%) have received their two-month (post-third cycle)
MRI and investigator assessment, 13 (65%) have received their
five-month MRI and investigator assessment, and seven (35%) have
received their eight-month MRI and investigator assessment. Two
patients (10%) have not been on the study long enough to reach
their first assessment, and one patient (5%) died before their
first assessment. Assessments are based on the trial
investigator's clinical and radiologic assessment, according to the
Response Assessment in NeuroOncology (RANO) criteria.
Saiid Zarrabian, DelMar's
president and chief executive officer, noted, "We continue to be
encouraged by these early results and look forward to the
completion of enrollment for our two, late-stage, Phase 2 studies.
These results support our optimism that VAL-083 may provide a
better treatment option than currently available treatments."
This 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. 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.
The Company also recently announced the initiation of an
adjuvant arm to the MDACC 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
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.
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.