At the American Association for Cancer Research (AACR) annual meeting in Washington, D.C., the cancer drug company DelMar Pharmaceuticals (OTCQB:DMPI) unveiled interim results from a phase I/II study on its flagship drug VAL-083 as a treatment for patients with recurrent malignant glioma, or progressive secondary brain tumors. See the abstract here.
Jeffrey Bacha, President and CEO of DelMar Pharmaceuticals, was optimistic about the dose-escalation trial since the finalized results should establish VAL-083's dose-limiting toxicity (DLT), which allows the company to establish ideal dosages of VAL-083 in phase III trials.
The study is ongoing (these are interim results), although current results look promising. Cohorts 1, 2 and 3 (with 3, 4, and 1 patients assessed at this point) were completed without reaching the dose-limiting toxicity threshold, which bodes well for the safety profile of VAL-083. In addition, we saw stable disease and tumor regression in two of the seven patients enrolled thus far, which gives us encouraging (albeit limited) data supporting the notion that VAL-083 will become the go-to cancer drug for glioblastoma patients after standard treatment with angiogenesis inhibitors.
These currently include Avastin (bevacizumab) and Temodar (temozolomide), which are widely used cancer drugs that have significant limitations in their efficacy in brain tumors.
VAL-083, a bi-function DNA alkylating agent originally developed by the National Cancer Institute, is a first in class (unique) molecule that has demonstrated broad anti-tumor activity, so investors should realize that the implications of this development program are not necessarily limited to the ~$650 million glioblastoma drug market.
DelMar only became a publicly traded company at the beginning of this year which explains the liquidity in DMPI common, although it's worth noting that DelMar will be able to jump directly into phase III trials for VAL-083 after the completing of their current dose escalation trial. An NDA submission based on this data could open the company up to the ~$200 million second-line glioblastoma drug market in a few years. Ideally, we'd see an acquisition of DelMar - possibly after the release of interim Phase III results for VAL-083.
Attracting the attention of larger pharmaceutical companies can be difficult, although DelMar's management seems up to the task. One thing to be noted is that DelMar's CSO is Dr. Dennis Brown, who founded ChemGenex in 1999 - a small cancer drug developer that ultimately got acquired by Cephalon in 2011 for $230 M.
The takeaway is that DelMar still has to finish its phase I/II study, but the interim data suggests that the trial is going exceedingly well. This news could also put DMPI "on the map" for investors and potential business partners (big pharma companies) looking for small cancer drug developers that are demonstrating promise.
Lastly, we should see finalized results for VAL-083's phase I/II study in Q4 2012. If these results are as good as the results we've seen thus far, expect additional interest in DelMar. I'll stay tuned.