DelMar Pharmaceuticals Announces Second Quarter Fiscal Year 2016 Financial Results and Corporate Update

DelMar Pharmaceuticals (OTCQX:DMPI) a biopharmaceutical company focused on the development and commercialization of new cancer therapies, today announced its financial results for the second quarter of the 2016 fiscal year ending December 31, 2015. The Company also highlighted recent corporate and clinical achievements and provided an overview of expected near-term milestones.
As quoted in the press release:

RECENT CORPORATE HIGHLIGHTS

• Announced a collaboration with the University of Texas MD Anderson Cancer Center (MD Anderson) to extend and accelerate the clinical development of VAL-083 for glioblastoma multiforme (GBM) patients following first recurrence of the disease. MD Anderson will initiate a new Phase II clinical study with VAL-083 at first recurrence/progression, prior to Avastin^® (bevacizumab) exposure. Eligible patients will have recurrent GBM characterized by a high expression of MGMT, the DNA repair enzyme implicated in drug-resistance and poor patient outcomes following current front-line chemotherapy.
• Completed enrollment of the Phase II expansion cohort for the GBM study at a dose of 40mg/m². Confirmed 40mg/m² as the maximum tolerated dose (MTD) for advancement into registration directed clinical trials. This optimized dosing regimen may enhance the potential of VAL-083 to impact a patient’s tumor as well as to improve patient outcomes.
• Presented interim Phase II data at the 2015 Society for Neuro-Oncology Annual Meeting. A Kaplan Meier survival estimate, based on these preliminary interim data, projects a clinically meaningful survival benefit for refractory GBM patients whose tumors have recurred following both front-line therapy with temozolomide and second-line bevacizumab treatment.
• Presented data supporting VAL-083’s potential as a treatment for pediatric brain tumors at the American Association for Cancer Research (AACR) Advances in Pediatric Research Conference. The preclinical and clinical data support advancement of VAL-083 into a clinical study in pediatric patients with recurrent or resistant medulloblastoma (MB) and high grade gliomas (HGGs).
• Presented data indicating the promising potential of VAL-083 as a solution for major unmet needs in the treatment of a variety of cancers, including GBM, non-small cell lung cancer (NSCLC), ovarian cancer and pediatric brain tumors, at the AACR New Horizons in Cancer Research Conference.
• Announced additional data on the unique molecular mechanisms responsible for VAL-083 activity against cancer at the 2015 Canadian Cancer Research Conference. These data suggest that VAL-083’s activation of immune response pathways may represent a promising personalized medicine approach in the treatment of cancer.
• Presented positive data on the benefit of VAL-083 in combination with platinum-based chemotherapy for non-small cell lung cancer at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics. The data demonstrate that VAL-083 retains activity in chemo-resistant NSCLC tumor types and has a super-additive effect in NSCLC when used in combination with platinum-based chemotherapeutic agents.
• Presented positive preclinical data supporting the activity of VAL-083 in treatment-resistant ovarian cancer. The data support VAL-083 as a viable treatment option for patients failing platinum-based chemotherapy and demonstrates a potential benefit in combination with platinum therapy.

EXPECTED NEAR-TERM MILESTONES

• Report top-line data from the Phase II study with VAL-083 in refractory GBM in the first half of 2016;
• Engage the U.S. Food and Drug Administration (FDA) regarding the design of a proposed registration-directed Phase II/III clinical trial for VAL-083 in refractory GBM;
• Initiate registration-directed Phase II/III clinical trials for VAL-083 as a new treatment option for refractory GBM in 2016;
• Initiate the Phase II clinical study at MD Anderson with VAL-083 in patients with GBM at first recurrence/progression;
• Initiate clinical studies in newly-diagnosed GBM patients as an alternative to temozolomide in patients with high expression of MGMT;
• Initiate new clinical trials with VAL-083 in refractory NSCLC;
• Continue to pursue pre-clinical research with leading investigators to advance VAL-083 as a potential treatment for other chemo-resistant cancers including ovarian cancer and pediatric medulloblastoma;
• Maximize the value of the VAL-083 pipeline through potential partnership opportunities in high value oncology markets;
• Continue to build the Company’s intellectual property portfolio; and
• Continue to implement strategies that enable DelMar to meet qualifications to list its shares on a national stock exchange.

DelMar Pharmaceuticals CEO and Chairman, Jeffrey Bacha, stated:

The progress we continued to achieve this quarter for our VAL-083 (dianhydrogalactitol) clinical program and the consistent positive data from preclinical studies, along with the recently announced collaboration with University of Texas MD Anderson Cancer Center, not only further validates the promise of VAL-083 as a potential new treatment for chemo-resistant tumors, but also sets the stage for 2016 to be a transformational year for our Company,” stated Jeffrey Bacha, Chairman and CEO of DelMar Pharmaceuticals.
For the first half of 2016 we will focus on accomplishing several actionable milestones that will position DelMar to expand clinical development around VAL-083 and also serve to maximize shareholder value. We believe that DelMar’s recent data, combined with historical clinical validation, positions VAL-083 as a superior alternative to currently available chemotherapy for GBM patients whose tumors are characterized by high expression of MGMT. Our goal is nothing short of creating a paradigm-shift in the treatment of this horrific cancer.
We anticipate reporting top-line survival data from the Phase II expansion cohort of our refractory GBM clinical trial in the first half of 2016. Based on our observations to date, we believe that we are well positioned to advance VAL-083 into Phase II/III registration clinical trials in refractory GBM during 2016. New non-clinical data reported in 2015 continued to demonstrate VAL-083’s unique cytotoxic anti-cancer mechanism, and we anticipate leveraging these data by expanding our clinical development programs around VAL-083 also during 2016.

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