Full Press Release Details
Presents Positive Interim Results from VAL-083
Study in MGMT-unmethylated Recurrent GBM at The Society
for NeuroOncology Annual Meeting
of recurrent GBM patients treated to date achieved stable disease as measured by magnetic resonance imaging (MRI)
British Columbia and MENLO PARK, Calif., November 21, 2017 /PRNewswire/ - - DelMar Pharmaceuticals, Inc. (NASDAQ: DMPI)
("DelMar" or the "Company"), a biopharmaceutical company focused on the development of new cancer therapies,
today provided an overview of three scientific posters presented at the 22nd Annual Meeting and Education Day of the Society for
Neuro-Oncology (SNO) held on November 16-19, 2017 in San Francisco, CA.
reported that 93% of patients enrolled were alive at the time of the analysis and 40% of patients enrolled were reported to have
achieved stable disease as assessed by MRI following treatment with VAL-083 as a single agent. "While it is too early to
interpret overall survival results from this study, the substantial disease control observed to date in the treatment recurrent
GBM, an aggressive tumor that can double in size within 6-8 weeks, is an important and positive observation at this stage,"
said Mr. Saiid Zarrabian, DelMar's Interim Chief Executive Officer.
promising early observations from our ongoing Phase 2 clinical trial of VAL-083 as a potential new treatment option for MGMT-unmethylated
GBM are also supported by extensive preclinical research into VAL-083's unique mechanism of action," added Mr. Zarrabian.
"Based on these recent data, we believe VAL-083 represents a potential solution for some of the most important unmet medical
needs in the treatment of GBM and other central nervous system tumors."
provided an update on the company's ongoing Phase 2 clinical studies in a poster entitled "Clinical Trials with
dianhydrogalactitol (VAL-083) in MGMT-unmethylated Glioblastoma", which is being conducted in collaboration with The
University of Texas MD Anderson Cancer Center. This trial is designed to enroll up to 48 patients to determine if VAL-083 treatment
improves overall survival compared to historical reference control.
Company also provided an overview of the design a separate Phase 2 clinical trial of VAL-083 for newly diagnosed MGMT-unmethylated
GBM patients on this poster. In this trial, which was recently initiated at Sun Yat-Sen University Cancer Center, patients will
be treated with VAL-083 plus radiotherapy as an alternative to standard-of-care temozolomide plus radiation in the front-line
setting. The trial is designed to enroll up to 30 patients with MGMT-unmethylated GBM to determine if VAL-083 treatment improves
progression free survival (PFS) compared to a historical reference control. This trial is being supported though DelMar's
collaboration with Guangxi Wuzhou Pharmaceutical (Group) Co., Ltd.
addition, DelMar also presented two additional pre-clinical posters during the conference:
| The Distinct Cytotoxic Mechanism of Dianhydrogalactitol (VAL-083) Overcomes Chemoresistance and Provides New Opportunities for Combination Therapy in the Treatment of Glioblastoma. | ||
| VAL-083 induces potent anti-cancer activity against treatment-resistant cells from glioblastoma, lung, prostate and ovarian tumors through a distinct mechanism of action. Cancer cells treated with VAL-083 exhibit persistent DNA double-strand breaks and activation of the homologous DNA repair (HR) system. Activation of the HR system is an indicator of VAL-083's unique anti-tumor activity. | ||
| When combined with topoisomerase or PARP inhibitors, the treatment effect of VAL-083 is increased in a synergistic or super-additive manner. Taken together, these data support the broad potential of VAL-083 as a new treatment against a wide range of cancers both as a single agent and in combination with other established cancer therapies. |
| Dianhydrogalactitol (VAL-083) Overcomes Chemoresistance in Pediatric Malignant Brain Tumors and Displays Synergy with Topoisomerase Inhibitors | ||
| Pediatric high-grade glioma (HGG) and medulloblastoma are aggressive childhood brain tumors with a high incidence of recurrence and very few patients achieve long-term survival. VAL-083 demostrates potent activity as a single agent against both chemo-resistant pediatric HGG and medulloblastoma independent of p53 status. DelMar also reported that VAL-083 potentiates radiotherapy and exhibits synergy when used in combination with topoisomerase inhibitors, two regimens commonly used in the treatment of childhood brain tumors. |
continue to be highly enthusiastic about the potential of VAL-083 as a novel treatment for cancer patients who have limited or
no treatment options", added Mr. Zarrabian. "The excellent work performed by our world class academic research collaborators
and our in-house team presented at the SNO meeting showcases VAL-083's potential both as a single agent and as a component
of combination therapeutic regimens."
poster presentations can be viewed in their entirety on DelMar's website at http://www.delmarpharma.com/scientific-publications.html
(dianhydrogalactitol) is a "first-in-class", DNA-targeting agent that introduces interstrand 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 in
vitro. Further details regarding these studies can be found at http://www.delmarpharma.com/scientific-publications.html.
has been granted an orphan drug designation by the U.S. FDA Office of Orphan Products for the treatment of glioma, medulloblastoma
and ovarian cancer, and in Europe for the treatment of malignant gliomas.
DelMar Pharmaceuticals, Inc.
Pharmaceuticals 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 have become resistant to modern targeted or biologic
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 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 across multiple oncology indications to solve significant unmet medical
is also 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. DelMar also recently announced the
allowance of a separate IND for VAL-083 as a potential treatment for platinum-resistant ovarian cancer.
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
further information, please visit http://delmarpharma.com/; or contact DelMar Pharmaceuticals Investor Relations: ir@delmarpharma.com
with the Company on Twitter, LinkedIn, Facebook, and Google+.
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 our filings with the SEC, including, our current reports on Form 8-K.