LifeSciences BC > Uncategorized > DelMar Pharmaceuticals to Present Updated Phase II Safety and Efficacy Data on VAL-083 in Refractory Glioblastoma Multiforme

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DelMar Pharmaceuticals to Present Updated Phase II Safety and Efficacy Data on VAL-083 in Refractory Glioblastoma Multiforme

November 09, 2015 – DelMar Pharmaceuticals Inc.

Data to be presented at the 20th Annual Scientific Meeting and Education Day of the Society for Neuro-Oncology
VANCOUVER, British Columbia and MENLO PARK, Calif., Nov. 9, 2015 /PRNewswire/ — DelMar Pharmaceuticals, Inc. (OTCQX: DMPI) (“DelMar” and the “Company”), a biopharmaceutical company focused on the development and commercialization of new cancer therapies, announced today that its abstract entitled, “Phase I/II study of Dianhydrogalactitol (VAL-083) In Patients With Recurrent Malignant Glioma,” was accepted for poster presentation at the 20th Annual Scientific Meeting and Education Day of the Society for Neuro-Oncology being held November 19 – 22, 2015, in San Antonio, Texas.

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The poster presentation will include an update on the Company’s fully enrolled 14-patient expansion cohort from its Phase II clinical study of VAL-083 (dianhydrogalactitol) in refractory glioblastoma multiforme (GBM). Patients enrolled in the GBM trial have failed both front-line therapy with temozolomide and second-line Avastin and, in most cases, one or more salvage therapies.
DelMar recently completed enrollment in the Phase II study and confirmed 40mg/m2 as the maximum tolerated dose (MTD) for advancement into registration-directed Phase II/III clinical trials in GBM.

The Company previously presented data from the Phase I dose-escalation portion of its multicenter Phase I/II clinical study with VAL-083 in patients with recurrent GBM in which dose limiting toxicity was observed at 50mg/m2/day, no drug-related severe adverse events were reported, and myelosuppression was mild at doses <40mg/m2/day.
Additionally, data on a sub-group analysis for patients receiving up to 5 mg/m2 daily x 3 every 21 days (low dose) versus those patients receiving 30mg/m2 or 40mg/m2 (therapeutic dose) of VAL-083 from the clinical trial were also previously presented. The sub-group analysis supports a dose-dependent and clinically meaningful survival benefit in GBM patients whose tumors had progressed following standard treatment with temozolomide, radiotherapy, bevacizumab and a range of salvage therapies.

DelMar’s abstract has been published online in the 2015 abstract supplement to the Society for Neuro-Oncology’s official journal, Neuro-Oncology, at http://neuro-oncology.oxfordjournals.org/.

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 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 announced the completion of enrollment in a Phase II clinical trial of VAL-083 in refractory GBM. 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.

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.

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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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