SAN DIEGO, June 22, 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 positive
interim data from its two Phase 2 trials of VAL-083 for the
treatment of glioblastoma multiforme (GBM) demonstrating improved
outcomes over current standard of care as both a first-line
treatment and for recurrent GBM. The data, presented in two posters
at the 2020 American Association for Cancer Research Virtual Annual
Meeting II, support the Company's planned participation in the
Global Coalition for Adaptive Research's (GCAR) Glioblastoma
Adaptive Global Innovative Learning Environment (GBM AGILE)
clinical trial. DelMar previously announced its invitation from
GCAR to participate in the selective GBM AGILE study. This pivotal
study, with its robust trial design, industry leading partners, and
strong regulatory endorsement, is intended to serve as the basis
for VAL-083's new drug application (NDA) submission and
registration.
Dr. John de Groot, Chairman of
the Department of Oncology at MD Anderson Cancer Center and planned
Principal Investigator for the VAL-083 arm of the GCAR GBM AGILE
registration study, noted, "These data continue to demonstrate an
improvement over the historical outcomes of standard therapy and
validate VAL-083's inclusion in a more robust setting as part of
the GBM AGILE study. In MD Anderson's Glioblastoma Moon Shots
Program, we are looking to create giant leaps to help patients with
GBM where treatment options are limited. It is our hope that
VAL-083 may serve as an important new therapy to help physicians
and patients dramatically reduce mortality and suffering due to
this deadly cancer. We continue to be encouraged by these results
and are excited by the opportunity to collaborate with DelMar and
GCAR to further explore the potential of VAL-083."
Interim outcomes included:
Poster #CT273 - "Phase 2 study of dianhydrogalactitol
(VAL-083) in patients with newly diagnosed MGMT-unmethylated
glioblastoma"
Results:
- For the 25 patients initially receiving the treatment dose that
will be carried forward in the GBM AGILE pivotal study (30
mg/m2/day on days 1, 2 and 3 of a 21-day cycle) median
progression-free survival (PFS) was reported to be 8.7 months
(confidence interval, or CI 6.0-12.0 months) as of the May 15, 2020 cut-off date.
- Overall PFS (n=29) with VAL-083 was 8.7 months (CI 6.4-11.2
months).
- While not a head-to-head trial, historically temozolomide
(TMZ), the standard of care, has been demonstrated to have 6.9
months PFS in newly_diagnosed unmethylated GBM patients.
The open-label Phase 2 study in newly-diagnosed unmethylated GBM
is being conducted at Sun Yat-sen University Cancer Center in
China. The Company announced full
enrollment of the study on February 19,
2020.
Poster #CT272 - "Phase 2 study of dianhydrogalactitol
(VAL-083) in patients with MGMT-unmethylated bevacizumab-naïve
glioblastoma in the recurrent of adjuvant setting"
Results:
- In recurrent GBM, for the 37 patients initially receiving the
intended treatment dose that will be carried forward in the GBM
AGILE pivotal study (30 mg/m2/day on days 1, 2 and 3 of
a 21-day cycle), median overall survival (mOS) is currently 8.5
months (CI 5.7-14.3 months) as of the May
28, 2020 cut-off date.
- Overall mOS for the 72 patients who have completed at least one
cycle of treatment was 7.1 months (CI 5.8-9.9 months).
- While this is not a head-to-head trial, historically lomustine,
which is the most commonly used chemotherapy for these patients,
has demonstrated a mOS of 7.2 months in recurrent unmethylated GBM
patients.
- In the adjuvant setting, patients receive VAL-083 as adjuvant
therapy following treatment with radiation and TMZ. As of the data
cut-off date of May 28, 2020, 19
evaluable subjects have completed at least one 21-day cycle of
treatment, with a total of 25 subjects enrolled. Enrollment for
this arm was initiated in July 2019,
and all 25 subjects enrolled to-date were alive at the data cut-off
date.
- Based on encouraging outcomes, the Company plans to increase
the adjuvant arm from the originally planned 24 patients to include
up to 12 additional patients.
The open-label Phase 2 study in recurrent and adjuvant
unmethylated GBM is being conducted at M.D. Anderson Cancer Center
in Houston.
Dr. Barbara O'Brien, Principal
Investigator, commented, "These results continue to demonstrate the
promise of VAL-083, along with a very favorable safety profile in
both the adjuvant and recurrent settings. Further, we are excited
to be able to add additional patients to the adjuvant arm of the
study, which has received great interest from patients, and has
enrolled faster than predicted. VAL-083 is well tolerated by these
patients and extending the study provides an opportunity for
patients to have access to this important trial for
glioblastoma."
Similar to prior experience with VAL-083, myelosuppression has
been the most common adverse event observed. Three subjects
experienced a serious adverse event (SAE), possibly related to
VAL-083 in the newly-diagnosed group, while 10 subjects have
experienced a possibly drug-related SAE in the recurrent group, and
one patient has experienced a possibly drug-related SAE in the
adjuvant group as of the relevant data cut-off dates.
Saiid Zarrabian, CEO of DelMar
Pharmaceuticals, added, "We continue to be encouraged with
the interim outcomes for both of our ongoing Phase 2 trials of
VAL-083 in GBM. With the support of these findings, we have
commenced preparations for VAL-083's participation in the GCAR
pivotal GBM AGILE study. We look forward to reporting top-line
results for the newly diagnosed Phase 2 study in the third quarter
of 2020 and providing additional updates on both studies at the
Society for Neuro-Oncology Annual Scientific Meeting in
November 2020."
ABOUT DELMAR PHARMACEUTICALS
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, DelMar identifies
biomarkers to personalize new therapies in indications where
patients are failing, or are unable to tolerate, standard-of-care
treatments.
DelMar'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 National Cancer Institute
(NCI). Based on DelMar's internal research programs and these prior
NCI-sponsored clinical studies, DelMar 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 GBM AGILE study,
the status of the Company's clinical trials, the reporting of the
results and the impact of the COVID-19 pandemic. 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 impact
of the COVID-19 pandemic on the Company's operations and clinical
trials, 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.
