DelMar Pharmaceuticals has been developing its lead product candidate, VAL-083, as a chemotherapy for cancer. Specifically, VAL-083 would be used in the treatment of glioblastoma multiforme (GBM), the most common form of a fatal and aggressive brain cancer. VAL-083 is a very different drug from other cancer medications. It avoids the repair activities that enable tumor cells to impede the impact of chemotherapy.
As a result, DelMar has an upcoming phase III trial in refractory GBM and two additional phase II studies anticipated to begin this year. VAL-083 will also be tested in the treatment of solid tumors and lung cancer, with phase I and II trials anticipated in 2017, the report stated. The report was signed by Robert LeBoyer, research analyst at Aegis, who added that Aegis expects DelMar Pharmaceuticals “to be driven” by these trials.
In its report, Aegis said that the phase III study is expected in late 1Q17 and should take place at major medicine centers, aiding enrollment. Further, it said that the Food & Drug Administration (FDA) believes that only one phase III study will be required for VAL-083, following its assessment of the results of completed phase I and II studies.
In 2016, DelMar completed its phase I/II trials of VAL-083, the report stated, and then met with the FDA. The FDA agreed that only one phase III trial would be necessary, because the company would then use a 505(b)(2) regulatory pathway. Aegis notes that this was a ‘significant development’, which may mean phase III results as early as 2019 ahead of approval in 2020.
On January 9, 2017, DelMar Pharmaceuticals received an increase in funding of up to CDN$413,000 from the National Research Council of Canada Industrial Research Assistance Program (NCR-IRAP) to support ongoing research of VAL-083 (http://dtn.fm/iWzk2). In conjunction with the BC Cancer Agency, Vancouver Prostate Centre and the University of British Columbia, research will continue, DelMar Pharmaceuticals announced.
“We are very pleased with NCR-IRAP’s continued support of our non-clinical research of our lead product candidate VAL-083,” Jeffrey Bacha, chairman and CEO of DelMar Pharmaceuticals, noted in the news release.
In its most recent 10-Q filing, DelMar Pharmaceuticals reported cash and cash equivalents of $4,799,033 (http://dtn.fm/5qecY). For the quarter ended June 30, 2016, the company reported to the SEC that it had raised $7.2 million from the sale of convertible preferred stock.
For more information, visit www.DelMarPharma.com
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