On April 16, 2018 DelMar Pharmaceuticals, Inc. (NASDAQ: DMPI) ("DelMar" or the "Company"), a biopharmaceutical company focused on the development and commercialization of new cancer therapies, reported four poster presentations being delivered at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) ("AACR") annual meeting (Press release, DelMar Pharmaceuticals, APR 16, 2018, View Source [SID1234525448]).
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On Sunday, April 15, 2018, DelMar presented a poster showing preclinical data demonstrating that VAL-083, a first-in-class small molecule chemotherapeutic, may be beneficial, either as a single-agent, or as part of combination therapy regimens, for difficult-to-treat, or resistant, pediatric high-grade gliomas, including diffuse intrinsic pontine glioma ("DIPG"). DIPG is a rare, inoperable childhood brain tumor with very poor prognosis and a bleak survival outlook. In a poster entitled, "Dianhydrogalactitol (VAL-083) has the potential to overcome major challenges in the treatment of DIPG," VAL-083 is shown to be active as a single-agent and synergistic with AZD1775, a Wee1 inhibitor, against DIPG cell lines with varying genetic profiles, including p53 and H3.3/H3.1 K27M mutations.
Today, DelMar will be presenting a poster showing preclinical data demonstrating that the combination of VAL-083 and PARP inhibitors may be an effective therapeutic approach for the treatment of cancer. The data show that VAL-083 can synergize PARP inhibitors in both a BRACA-proficient and –deficient setting. Multiple PARP inhibitors are currently approved for the treatment of recurrent breast and ovarian cancer. DelMar also presented data in this poster further demonstrating that VAL-083 is active as a single-agent against platinum-resistant ovarian cancer.
"These important data continue to support the broad potential of VAL-083 to provide a new treatment option against a range of cancers," said Saiid Zarrabian, DelMar’s interim president and chief executive officer. "Our ongoing clinical trials in MGMT-unmethylated GBM and planned trial in platinum-resistant ovarian cancer continue to leverage insights gained through more than 40 Phase 1 and Phase 2 clinical trials sponsored by the U.S. National Cancer Institute."
DelMar will present an update on two ongoing clinical trials for MGMT-unmethylated GBM tomorrow, Tuesday April 17, 2018:
A Phase 2 clinical trial of VAL-083 in patients with MGMT-unmethylated, bevacizumab (Avastin)-naïve recurrent glioblastoma, currently being conducted in collaboration with the University of Texas MD Anderson Cancer Center; and
A Phase 1-2 clinical trial of VAL-083 in combination with radiotherapy in patients with newly diagnosed MGMT-unmethylated GBM, currently being conducted in collaboration with Sun Yat-sen University Cancer Center.
DelMar’s poster presentations can be viewed on the company’s website at:
View Source
About VAL-083
VAL-083 (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:
View Source.
VAL-083 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. VAL-083 has been granted fast-track status for the treatment of recurrent GBM by the US FDA.