DelMar to Present Poster of Clinical Research with VAL-083 in Patients with Chemo-Resistant Glioblastoma ("GBM") at ASCO Annual Meeting
VANCOUVER, British Columbia and MENLO PARK, Calif., April 27, 2017 /PRNewswire/ -- DelMar Pharmaceuticals (Nasdaq: DMPI) ("DelMar" and the "Company"), a biopharmaceutical company focused on the development and commercialization of new cancer therapies, today announced that it will present a poster at the Annual Meeting of the American Society of Clinical Oncology (ASCO) held in Chicago, IL from June 2nd to June 6th, 2017.
The following poster will be presented during the Central Nervous System Tumors Session:
| Date and Time: |
June 5th at 1:15 PM – 4:45 PM central daylight time |
| Abstract Title: |
Clinical Trials of VAL-083 in Patients With Chemo-Resistant |
| Abstract ID: |
TPS2082 |
About VAL-083
VAL-083 is a "first-in-class," small-molecule DNA-targeting agent that demonstrated clinical activity against a range of cancers including GBM in historical clinical trials sponsored by the U.S. National Cancer Institutes (NCI). DelMar has demonstrated that VAL-083's anti-tumor activity against GBM is unaffected by the expression of MGMT in vitro. High expression of MGMT in MGMT-unmethylated GBM patients is correlated with chemo-resistance and poor survival following treatment with temozolomide, the current standard-of-care. Further details can be found at http://www.delmarpharma.com/scientific-publications.html.
VAL-083 has received an orphan drug designation in Europe for the treatment of malignant gliomas and the U.S. FDA Office of Orphan Products has granted an orphan designation to VAL-083 for the treatment of glioma, medulloblastoma and ovarian cancer. Based on historic clinical trials run by NCI, the modern phase I/II dose finding trial run by DelMar in GBM (ASCO 2016), and recent guidance from the FDA, the Company is embarking on multiple phase 2 and 3 clinical trials for VAL-083 encompassing both front-line and recurrent GBM therapy.
DelMar has announced plans to advance VAL-083 into a pivotal randomized multi-center Phase 3 clinical trial for the treatment of bevacizumab-failed GBM. DelMar has also initiated a Phase 2 trial for bevacizumab-naïve recurrent MGMT-unmethylated GBM patients in collaboration with the MD Anderson Cancer Center. A separate international Phase 2 trial for newly diagnosed MGMT-unmethylated GBM will be initiated at Sun-Yat Sen University in Guangzhou China. DelMar believes that data from its clinical trials, if successful, will form the basis of a new treatment paradigm for the vast majority of GBM patients whose tumors exhibit features that make them unlikely to respond to currently available therapies. The poster at ASCO 2017 will highlight the clinical results to date and the Company's clinical trial designs for VAL-083 in GBM.
About Glioblastoma Multiforme (GBM)
GBM is the most common and aggressive primary brain cancer. Current standard of care includes surgery, radiation and treatment with temozolomide (TMZ), however nearly all tumors recur and the prognosis for recurrent GBM is dismal. Most GBM tumors have unmethylated promoter status for O6-methylguanine-DNA-methyltransferase (MGMT); a validated biomarker for TMZ-resistance. Second-line treatment with anti-angiogenic agent bevacizumab has not improved overall survival (OS) and 5-year survival is less than 3%. Dianhydrogalactitol (VAL-083) is a bi-functional alkylating agent targeting N7-Guanine and inducing interstrand DNA cross-links, double-strand breaks and cell death in GBM cell lines and GBM cancer stem cells, independent of MGMT status in vitro. VAL-083 readily crosses the blood-brain barrier and accumulates in brain tumor tissue. Our recent phase I/II clinical trial in recurrent GBM patients failing both TMZ and bevacizumab suggested that VAL-083 offers clinically meaningful survival benefits for patients with recurrent GBM and pinpointed a new dosing regimen (40 mg/m2/d on days 1, 2, and 3 of a 21-day cycle) which was well-tolerated and was selected for study in subsequent GBM trials. DelMar has initiated, or plans to initiate, three additional GBM trials, the results of which may support a new treatment paradigm in chemotherapeutic regimens for the treatment of GBM. These trials include:
| i) |
An ongoing single-arm, biomarker driven, Phase 2 study to determine if VAL-083 treatment of MGMT-unmethylated adult GBM patients at first recurrence/progression, prior to bevacizumab improves overall survival at 9 months, compared to historical control with lomustine (clinicaltrials.gov identifier: NCT02717962). |
| ii) |
A planned pivotal Phase 3 study in recurrent GBM after failing both TMZ and bevacizumab. The control arm will consist of a limited number of salvage chemotherapies currently used in bevacizumab-failed GBM. If successful, this study will serve as the basis for a New Drug Application (NDA) submission for VAL-083. |
| iii) |
A planned single arm, biomarker driven, Phase 2 study to confirm the tolerability and efficacy of VAL-083 in combination with radiotherapy in newly diagnosed MGMT-unmethylated GBM patients whose tumors are known to express high MGMT levels. (clinicaltrials.gov identifier: NCT03050736). |
About DelMar Pharmaceuticals, Inc.
DelMar Pharmaceuticals, Inc. was founded to develop and commercialize new cancer therapies in indications where patients are failing or have become intolerable to modern targeted or biologic treatments. DelMar's VAL-083 is currently undergoing clinical trials in the U.S. as a potential new therapy for GBM. VAL-083 has been extensively studied by the U.S. National Cancer Institutes, and is currently approved for the treatment of chronic myelogenous leukemia 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 that could provide improved treatment options for patients.
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.
SOURCE DelMar Pharmaceuticals, Inc.
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