On April 27, 2017 DelMar Pharmaceuticals (Nasdaq: DMPI) ("DelMar" and the "Company"), a biopharmaceutical company focused on the development and commercialization of new cancer therapies, reported that it will present a poster at the Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) held in Chicago, IL from June 2nd to June 6th, 2017 (Press release, DelMar Pharmaceuticals, APR 27, 2017, View Source [SID1234518707]).

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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
Glioblastoma.
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 View Source

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 (Free ASCO Whitepaper) 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).