DelMar Pharmaceuticals and MD Anderson Initiate New Phase Two Clinical Trial of VAL-083 for MGMT-unmethylated Recurrent Glioblastoma Multiforme (GBM)
Study will enroll 48 MGMT-unmethylated Avastin (bevacizumab)-naïve recurrent GBM patients
VANCOUVER, British Columbia and MENLO PARK, Calif., Jan. 25, 2017 /PRNewswire/ -- DelMar Pharmaceuticals, Inc. (NASDAQ: DMPI) ("DelMar" and the "Company"), a biopharmaceutical company focused on the development and commercialization of new cancer therapies, is pleased to announce the opening of enrollment of a Phase II study of VAL-083 at the University of Texas MD Anderson Cancer Center in Houston, Texas.
The Phase II study of VAL-083 (dianhydrogalactitol) in patients with MGMT-unmethylated, Avastin (bevacizumab)-naïve recurrent glioblastoma will enroll 48 patients in a single-arm design to determine if treatment with VAL-083 improves overall survival, compared to historical control. Further information regarding the clinical trial can be found on DelMar's website and at clinicaltrials.gov (clinicaltrials.gov identifier: NCT02717962).
"This study is a keystone in our strategy to expand the development of VAL-083 to target MGMT-unmethylated GBM, a significant unmet medical need," said Jeffrey Bacha, chairman & CEO of DelMar Pharmaceuticals. "We are pleased to launch this important trial in collaboration with the University of Texas MD Anderson Cancer Center, one of the world's most respected medical centers devoted exclusively to cancer patient care, research, education and prevention."
Approximately two-thirds of newly diagnosed GBM patients have tumors with an unmethylated MGMT promoter, which is correlated with high expression of the DNA repair enzyme, MGMT. Published studies have documented that expression of MGMT is an important factor in predicting the outcome of GBM patients treated with alkylating agents such as temozolomide (TMZ), carmustine (BCNU), and lomustine (CCNU).
Patients whose tumors exhibit high expression of MGMT have a poor prognosis and significantly shorter progression free survival (PFS) and overall survival (OS) in comparison to patients with a methylated MGMT promoter and low MGMT expression. In a 2011 study of more than 800 GBM patients, those with tumors carrying the unmethylated MGMT promoter had a median overall survival of 14 months versus 21 months for those with a methylated MGMT promoter. The difference in progression-free survival – the period after treatment during which the cancer does not worsen – was 5.7 and 8.7 months, respectively.
VAL-083 is a "first-in-class," small-molecule chemotherapeutic that demonstrated clinical activity against a range of cancers including GBM in historical clinical trials sponsored by the U.S. National Cancer Institutes. DelMar has demonstrated that VAL-083's anti-tumor activity against GBM is unaffected by the expression of MGMT in vitro. 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.
DelMar has also announced plans to advance VAL-083 into a pivotal randomized multi-center Phase III clinical trial for the treatment of bevacizumab-failed GBM and into a separate international Phase II trial for newly diagnosed GBM patients with an unmethylated MGMT promoter.
"We believe that data from these upcoming 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 chemotherapy," added Mr. Bacha.
"Our data demonstrating that VAL-083's activity against GBM is independent of MGMT expression combined with VAL-083's established clinical activity against GBM from published NCI-sponsored clinical studies provides confidence to our hope that VAL-083 will give doctors and their patients a new and unique chemotherapy to address this enormous global unmet medical need."
About Glioblastoma Multiforme (GBM)
GBM is the most common and the most lethal form of glioma. Approximately 15,000 new cases of GBM are expected to be diagnosed in the United States during 2017. GBM progresses quickly and patients deteriorate rapidly. Common symptoms include headaches, seizures, nausea, weakness, paralysis and personality or cognitive changes such as loss of speech or difficulty in thinking clearly. The majority of GBM patients do not survive for more than two years following diagnosis, and the median survival in newly diagnosed patients with best available treatments is less than 15 months.
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. The Company's lead drug in development, VAL-083, is currently undergoing clinical trials in the U.S. as a potential treatment for refractory glioblastoma multiforme. VAL-083 has been extensively studied by the U.S. National Cancer Institute, 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.
For further information, please visit http://delmarpharma.com/; or contact DelMar Pharmaceuticals Investor Relations: firstname.lastname@example.org / (604) 629-5989. Connect with the Company on Twitter, LinkedIn, Facebook, and Google+.
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.
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SOURCE DelMar Pharmaceuticals, Inc.
Released January 25, 2017