On October 13, 2016 DelMar Pharmaceuticals, Inc. (NASDAQ: DMPI) ("DelMar" and the "Company"), a biopharmaceutical company focused on the development and commercialization of new cancer therapies, reported that the Company and its research collaborators have been invited to present data regarding the progress of VAL-083 at the following upcoming peer-reviewed scientific conferences (Press release, DelMar Pharmaceuticals, OCT 13, 2016, View Source [SID:SID1234515794]).
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European Association of NeuroOncology (EANO) Annual Meeting (Heidelberg, Germany Oct. 12 – 16, 2016);
AACR DNA Repair: Tumor Development and Therapeutic Response (Montreal, Canada Nov. 2 – 5, 2016);
AACR New Horizons in Cancer Research: Delivering Cures through Cancer Research (Shanghai, China Nov. 2 – 4, 2016);
Society for NeuroOncology Annual Meeting and CNS Anti-Cancer Drug Development Conference (Scottsdale, USA Nov. 16 – 20, 2016);
EORTC-NCI-AACR Molecular Targets and Cancer Therapeutics Symposium (Munich, Germany Nov 29 – Dec. 2, 2016); and
IASLC 17th World Congress on Lung Cancer (Vienna, Austria Dec. 4 – 7, 2016).
"We are pleased to accept these invitations to present new data at these prestigious peer-reviewed meetings," said Jeffrey Bacha, DelMar’s chairman & CEO. "Data presented at these global meetings will highlight the continued success of our strategy to leverage historical clinical validation from prior NCI-sponsored research with a modern understanding of VAL-083’s unique anti-cancer mechanism."
VAL-083 is a "first-in-class," small-molecule chemotherapeutic. In more than 40 Phase I and II clinical studies sponsored by the U.S. National Cancer Institute, VAL-083 demonstrated clinical activity against a range of cancers including lung, brain, cervical, ovarian tumors and leukemia both as a single-agent and in combination with other treatments.
"Taken together, these data support VAL-083’s potential to address unmet medical needs in major cancer indications for patients whose tumors have failed, or exhibit features that make them resistant or unlikely to respond to, current standard-of-care chemotherapy," added Mr. Bacha.
Details of DelMar’s upcoming scientific meeting presentations are as follows:
EANO 2016. On October 15, 2016, DelMar and its collaborators from the University of British Columbia will present an abstract entitled: "Dianhydrogalactitol (VAL-083) causes bifunctional alkylation leading to irreparable DNA double-strand breaks, S/G2 phase cell-cycle arrest and tumor cell death in an MGMT independent manner offering a unique treatment paradigm for GBM."
AACR DNA Repair: Tumor Development & Therapeutic Response Conference. On Friday November 4, 2016, DelMar and its collaborators from the University of British Columbia Prostate Cancer Research Center will present an abstract entitled: "Dissecting the Molecular Mechanism of Dianhydrogalactitol (VAL-083) in Cancer Treatment."
AACR New Horizons in Cancer Research: Delivering Cures through Cancer Research. On Friday November 4, 2016, DelMar and its collaborators from the University of Texas MD Anderson Cancer Center and the University of British Columbia will present an abstract entitled: "Assessment of dianhydrogalactitol in the treatment of relapsed or refractory non-small cell lung cancer."
Society for NeuroOncology Annual Meeting and CNS Anti-Cancer Drug Development Conference.
On Thursday November 17, 2016, DelMar will deliver an oral address on the unique mechanism of VAL-083 and its potential as a new treatment for central nervous system tumors including GBM and medulloblastoma during the "Drug Targets and the CNS Micro-Environment" session.
On Saturday November 19, 2016, DelMar and its collaborators from the University of British Columbia, UCSF and the Luxemburg Institute of Health will present an abstract entitled: "Molecular mechanisms of dianhydrogalactitol (VAL-083) in GBM treatment"
On Friday November 18, 2016, DelMar will present an abstract entitled: "Clinical trials of VAL-083 in patients with chemo-resistant glioblastoma"
EORTC-NCI-AACR. On Thursday December 1, 2016, DelMar and its collaborators from the University of British Columbia, UCSF, and the Luxemburg Institute of Health will present an abstract entitled: "Molecular mechanisms of dianhydrogalactitol (VAL-083) in overcoming GBM chemo-resistance"
IASCL World Congress on Lung Cancer. On Wednesday December 7, 2016, DelMar and its collaborators from MD Anderson, the Shanghai Cancer Center and the University of British Columbia will present an abstract entitled: "Assessment of Dianhydrogalactitol (VAL-083) in the Treatment of Relapsed or Refractory Non-Small Cell Lung Cancer"
About VAL-083
VAL-083 is a "first-in-class," small-molecule chemotherapeutic. In more than 40 Phase I and II clinical studies sponsored by the U.S. National Cancer Institute, VAL-083 demonstrated clinical activity against a range of cancers including lung, brain, cervical, ovarian tumors and leukemia both as a single-agent and in combination with other treatments.
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.
The Company has completed a successful end of Phase II meeting with the US FDA and plans to advance VAL-083 into a pivotal clinical trial for GBM patients following bevacizumab failure. DelMar presented data from its Phase I/II clinical trial in refractory GBM at the 2016 American Association of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual meeting demonstrating that the median survival of 22 patients receiving an assumed therapeutic dose of VAL-083 (≥20mg/m2) was 8.35 months following bevacizumab (Avastin) failure compared to published literature where survival of approximately two to five months has been reported.
DelMar’s advanced development program will feature a single multi-center randomized Phase III study measuring survival outcomes compared to a "physicians’ choice" control, which, if successful, would serve as the basis for a New Drug Application (NDA) submission for VAL-083. The control arm will consist of a limited number of salvage chemotherapies currently utilized in the treatment of Avastin-failed GBM. The final pivotal trial design will be confirmed with the FDA following further discussions with the Company’s clinical advisors.
In addition to the pivotal trial, DelMar also plans to initiate two separate Phase II clinical trials in earlier-stage GBM patients.
In collaboration with the University of Texas MD Anderson Cancer Center: A non-comparative, biomarker-driven, Phase II study to determine if treatment of MGMT-unmethylated recurrent GBM with VAL-083 or CCNU improves overall survival at 9 months, compared to historical control in bevacizumab naïve patients. (clinicaltrials.gov identifier: NCT02717962)
In collaboration with Sun-Yat Sen University and Guangxi Wuzhou Pharmaceutical (Group) Co.: A single arm Phase II clinical trial to confirm the tolerability of DelMar’s dosing regimen in combination with radiotherapy (XRT) and to explore the activity of VAL-083 in newly diagnosed MGMT-unmethylated GBM patients whose tumors are known to express high levels of MGMT.
DelMar believes that data from these clinical trials, if successful, will form the basis of a new paradigm in the treatment for all GBM patients who fail, or whose tumors exhibit features that make them unlikely to respond to currently available chemotherapy.
In addition to its clinical research in GBM, DelMar believes that its research supports a unique mechanism of action for VAL-083 and that these data support the potential of VAL-083 as a new chemotherapy that may offer improved outcomes in the treatment of GBM and other solid tumors in patients whose tumors have failed or exhibit features that make them resistant to or unlikely to respond to current standard-of-care chemotherapy.
The company and its collaborators from the University of Texas MD Anderson Cancer Center recently presented data at the 11th Biennial Ovarian Cancer Research Symposium demonstrating that VAL-083 was able to overcome cisplatin-resistance in ovarian cancer cell lines with known p53 mutations and displays synergy with both cisplatin and AstraZeneca’s PARP inhibitor Olaparib against ovarian cancer in vitro.