DelMar Pharmaceuticals Presents Phase I/II GBM Clinical Trial Data

DelMar Pharmaceuticals (OTCQX:DMPID) presented new data from its recently completed Phase I/II clinical trial of VAL-083 (dianhydrogalactitol) at the American Society of Clinical Oncology’s (ASCO) Annual Meeting on Saturday, June 4, 2016.
As quoted in the press release:

In summary, DelMar’s presentation noted:

• VAL-083 attacks cancer cells via a unique mechanism of action which is distinct from other chemotherapies used in the treatment of glioblastoma multiforme (GBM).  Specifically, VAL-083 is active independent of MGMT, a DNA repair enzyme which is highly expressed in approximately 2/3 of GBM patients and correlated with resistance to temozolomide, the current front-line chemotherapy in the treatment of GBM.  Of patients tested in the DelMar trial, 84% exhibited high MGMT.
• Median survival of 22 patients receiving an assumed therapeutic dose of VAL-083 (≥20mg/m²) was 8.35 months, suggesting that VAL-083 may offer improved survival for GBM patients following bevacizumab (Avastin) failure in comparison to currently available salvage therapy. Median survival for VAL-083 treated patients following bevacizumab failure compared with published literature demonstrating survival of approximately three to five months with common salvage therapy regimens.
• A dose of 40 mg/m²/day VAL-083 administered on the first three days of every three week cycle is well tolerated in refractory GBM patients and has been selected for study in subsequent clinical trials.

DelMar recently announced the completion of a successful end of Phase II meeting with the US FDA and its plans to advance VAL-083 into a pivotal clinical trial for GBM patients whose tumors have recurred following front-line therapy and second line treatment with bevacizumab.
DelMar’s advanced development program will feature a single randomized Phase 3 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.

• A randomized, non-comparative, biomarker-driven, Phase 2 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)
• A single arm Phase 2 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 Pharmaceuticals Chairman and CEO, Jeffrey Bacha, stated:

This year’s ASCO meeting was an opportunity to share the aggregate of our research to date with the global cancer research community. Based on our findings related to VAL-083’s unique mechanism of action and data from our Phase I/II clinical trial we believe that VAL-083 has the potential to offer a new treatment option for cancer patients whose tumors exhibit features correlated with resistance to currently available chemotherapy.

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