DelMar Pharmaceuticals Provides Update on VAL-083 Clinical Trial and Outlines Corporate Objectives for 2015
-- First Observation of Dose Limiting Toxicity Signals VAL-083's Potential Advancement Toward Registration Directed Clinical Trials in Refractory Glioblastoma --
VANCOUVER, British Columbia and MENLO PARK, Calif., Jan. 12, 2015 /PRNewswire/ -- DelMar Pharmaceuticals, Inc. (OTCQB: DMPI) ("DelMar", "the Company) provided an update on the Company's ongoing Phase I/II clinical trial with VAL-083 as a potential new treatment for refractory glioblastoma multiforme (GBM), the most common and aggressive form of brain cancer. In addition, DelMar outlined its corporate objectives for 2015.
Clinical Trial Update
VAL-083 is currently undergoing the dose-escalation portion of a Phase I/II clinical trial in the United States. The goal of this trial is to establish the maximum tolerated dose (MTD) of VAL-083 in a modernized dosing regimen for advancement into registration directed trials as a potential new therapy for the treatment of refractory GBM.
The DelMar dosing regimen uses a cycle of treatment on the first three days of every three weeks. DelMar believes that this modernized dosing regimen, along with improvement in management of myelosuppression in the modern era, provides for more aggressive dosing in comparison to previous clinical trials sponsored by the US National Cancer Institutes (NCI).
DelMar is currently studying a dose of 50mg/m2 and two patients have completed the required assessments. The Company's clinical protocol requires acquisition of safety data for 35 days following initial treatment with VAL-083. At this dose, one patient completed the required 35 day follow-up period without observation of a dose limiting toxicity (DLT).
The second patient in the 50mg/m2 cohort experienced myelosuppressive DLT as defined by grade four thrombocytopenia (low platelet counts). The patient's symptoms resolved rapidly and spontaneously returned to normal without concomitant medication or transfusion.
"Historically, dose limiting toxicity observed with VAL-083 was limited to myelosuppression. This result signals that we are we are nearing the end of the dose-escalation phase of our clinical trial and close to establishing the MTD that we will propose for advancement into a Phase II/III registration trial," stated Jeffrey Bacha, president & CEO of DelMar Pharmaceuticals.
MTD is determined by studying the drug in cohorts of three patients at successively higher doses until a DLT is observed in at least two of the patients in a given cohort. If a DLT is observed in only one of three subjects, the protocol stipulates that an additional three subjects would be enrolled at that dose, and if one of these additional subjects experiences a DLT, the MTD is then determined. If no DLT is observed, the trial may proceed to higher dose cohorts.
"If we observe a DLT with the third patient in the 50mg/m2 cohort, we would then propose the highest previous dose – 40mg/m2 – as the maximum tolerated dose for advancement to registration directed trials," continued Mr. Bacha.
"However, if no further DLT is observed at 50mg/m2, we may determine to continue dose escalation to a higher dose cohort. Our protocol currently allows dosing up to 60mg/m2 and our goal is to maximize the exposure of our drug to the tumor."
DelMar intends to present detailed clinical findings of this study at peer reviewed scientific meetings in 2015. The Company's most recent data presentations from the 2014 Society for NeuroOncology Annual Meeting can be found on the DelMar Pharmaceuticals website at: http://www.delmarpharma.com/products/publications/.
2015 Corporate Objectives
DelMar also outlined the Company's corporate objectives for 2015.
- Complete the dose-escalation portion of the Phase I/II clinical trial and advance VAL-083 into registration-directed clinical trials;
- Advance VAL-083 into additional indications, and seek opportunities to expand our asset base;
- Seek to access additional capital to ensure adequate funding for our research and drug development activities;
- Pursue a national exchange listing for our shares as part of our strategy to maximize shareholder value; and
- Continue to enhance our already strong intellectual property portfolio.
DelMar will present at the Biotech Showcase Conference in San Francisco on Wednesday January 14, at 1:45PM Pacific Time. The presentation will be webcast and a live link will be available on the Company's website at www.delmarpharma.com.
VAL-083 is a first-in-class, small-molecule chemotherapeutic with a unique mechanism of action. In more than 40 Phase 1 and 2 clinical studies sponsored by the National Cancer Institute, VAL-083 has shown safety and efficacy in treating a number of cancers including lung, brain, cervical, ovarian tumors and leukemia. VAL-083 is approved in China for the treatment of chronic myelogenous leukemia and lung cancer and has received orphan drug designation in Europe and the U.S. for the treatment of gliomas. As a potential treatment for glioblastoma, VAL-083's mechanism of action is unaffected by the expression of MGMT, a DNA repair enzyme that causes chemotherapy resistance to front-line treatment with Temodar® (temozolomide). DelMar is currently studying VAL-083 in a Phase 1/2 clinical trial for patients with refractory glioblastoma multiforme.
About DelMar Pharmaceuticals
DelMar Pharmaceuticals was founded in 2010 to develop and commercialize proven cancer therapies in new orphan drug indications where patients are failing modern targeted or biologic treatments. The Company's lead asset, VAL-083, is currently undergoing clinical trials in the U.S. as a potential treatment for recurrent glioblastoma multiforme (GBM), the most common and aggressive form of brain cancer. VAL-083 benefits from extensive NCI-sponsored clinical research and is currently approved for the treatment of chronic myelogenous leukemia (CML) and lung cancer in China. Published pre-clinical and clinical data suggest that VAL-083 may be active against a range of tumor types via a novel mechanism of action. DelMar's scientific presentations can be viewed on the company's website at www.delmarpharma.com.
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 our filings with the SEC, including, our current reports on Form 8-K. We do not undertake to update these forward-looking statements made by us.
For further information, please visit www.delmarpharma.com
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SOURCE DelMar Pharmaceuticals, Inc.
Released January 12, 2015