- VAL-083 offers a promising solution for major unmet needs in the treatment of a variety of cancers -
- VAL-083 has potential to improve treatment options for patients with GBM, NSCLC, ovarian cancer and pediatric brain tumors -
VANCOUVER, British Columbia and MENLO PARK, Calif., Nov. 13, 2015 -- DelMar Pharmaceuticals, Inc. ($DMPI) ("DelMar" and the "Company"), a biopharmaceutical company focused on the development and commercialization of new cancer therapies, today presented data on the promising potential of VAL-083 (dianhydrogalactitol) as a solution for major unmet needs in the treatment of a variety of cancers.
"Poor outcomes due to drug-resistance remain a significant unmet clinical challenge for many cancer patients. New agents are needed to address treatment-resistant cancers," stated Jeffrey Bacha, DelMar's president and CEO. "Historical clinical data from the U.S. National Cancer Institute (NCI), along with our own preclinical and clinical trial data, all support the activity of VAL-083 against a range of tumor types via a novel mechanism of action that we believe could provide improved treatment options for patients."
DelMar's presentation summarizes the Company's data on the promising potential of VAL-083 across a range of indications. A poster entitled, "The unique mechanism of action of dianhydrogalactitol (VAL-083) may provide a new treatment option for chemo-resistant cancers," was presented at the American Association for Cancer Research (AACR) New Horizons in Cancer Research Conference: Bringing Cancer Discoveries to Patients in Shanghai, China.
DelMar's presentation highlights the Company's recent research supporting the importance of VAL-083 as a chemotherapeutic agent in the treatment of cancer where resistance to alkylation-based chemotherapy remains an unmet medical need in the modern treatment of cancer and is summarized in the poster presentation as follows:
- VAL-083 activity is independent of O6-methylguanine-DNA methyltransferase (MGMT) expression and overcomes temozolomide (TMZ)-resistance in GBM cell lines;
- VAL-083 overcomes cisplatin-resistance in ovarian cancer and NSCLC cell lines;
- VAL-083 overcomes tyrosine kinase inhibitor (TKI)-resistance in non-small cell lung cancer (NSCLC) cell lines, including H1975 with T790M mutation in EGFR;
- VAL-083 displays synergy and super-additivity with both cisplatin and oxaliplatin in NSCLC cell lines, including TKI-resistant cells in vitro and in vivo;
- VAL-083 activity is independent of p53 status than in comparison to platinum-based chemotherapy; and
- VAL-083 is active against pediatric brain tumors in vitro including high grade gliomas (HGG), GBM cancer stem cells and p53 mutated SHH medulloblastoma.
"The data presented today support expanded clinical use of VAL-083 under its current lung-cancer approval in China and also serve as the basis for global development of VAL-083 in important cancer indications such as GBM, NSCLC and ovarian cancer," added Mr. Bacha. "These data represent important steps toward realizing our vision of leveraging historical clinical data with new research into the mechanism of VAL-083 to address modern unmet medical needs in the treatment of cancer."
The poster on VAL-083's promise as new treatment option for chemo-resistant cancers may be found on DelMar's website under http://www.delmarpharma.com/scientific-publications.html.
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 is a bifunctional alkylating agent which primarily mediates cytotoxic guanine interstrand N7 DNA cross-links, separating it from other widely used DNA alkylating chemotherapeutics such as temozolomide (TMZ), nitrosoureas and platinum-based agents. Additionally, VAL-083 readily crosses the blood-brain barrier and has been demonstrated to accumulate preferentially in tumor tissue. VAL-083 is approved in China for the treatment of chronic myelogenous leukemia (CML) and lung cancer, and has received orphan drug designation in Europe and the U.S. for the treatment of malignant gliomas.
DelMar has demonstrated that VAL-083's anti-tumor activity is unaffected by the expression of MGMT, a DNA repair enzyme that is implicated in chemotherapy resistance and poor outcomes in GBM patients following standard front-line treatment with Temodar® (temozolomide).
DelMar recently completed enrollment in Phase II clinical studies with VAL-083 for refractory glioblastoma multiforme (GBM) in the United States. Patients have been enrolled at five clinical centers in the United States: Mayo Clinic (Rochester, MN); UCSF (San Francisco, CA) and three centers associated with the Sarah Cannon Cancer Research Institute (Nashville, TN, Sarasota, FL and Denver, CO).
In the Phase I dose-escalation portion of the study, VAL-083 was well tolerated at doses up to 40mg/m2 using a regimen of daily x 3 every 21 days. Adverse events were typically mild to moderate; no treatment-related serious adverse events reported at doses up to 40 mg/m2. Dose limiting toxicity (DLT) defined by thrombocytopenia (low platelet counts) was observed in two of six (33%) of patients at 50 mg/m2. Generally, DLT-related symptoms resolved rapidly and spontaneously without concomitant treatment, although one patient who presented with hemorrhoids received a platelet transfusion as a precautionary measure.
Sub-group analysis of data from the Phase I dose-escalation portion of the study suggested a dose-dependent and clinically meaningful survival benefit following treatment with VAL-083 in GBM patients whose tumors had progressed following standard treatment with temozolomide, radiotherapy, bevacizumab and a range of salvage therapies.
Patients in a low dose (≤5mg/m2) sub-group had a median survival of approximately five (5) months versus median survival of approximately nine (9) months for patients in the therapeutic dose (30mg/m2 & 40mg/m2) sub-group following initiation of VAL-083 treatment. DelMar reported increased survival at 6, 9 and 12 months following initiation of treatment with VAL-083 in the therapeutic dose sub-group compared to the low dose sub-group.
Further details can be found at http://www.delmarpharma.com/scientific-publications.html.
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 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: email@example.com / (604) 629-5989. Connect with the Company on Twitter, LinkedIn, Facebook, and Google+. Investor Relations Counsel: Amato & Partners LLC.
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