Posted on November 10th, 2015
by Jeffrey Bacha
Hello and welcome to my inaugural blog. This is the first of what I hope to be many posts regarding exciting developments in the cancer field as well as the progress of my company, DelMar Pharmaceuticals Inc. (OTCQX: DMPI), as we work toward new therapies for cancer sufferers who have few or no viable treatment options.
Cancer remains a disease that strikes fear by its very mention. Nearly everyone reading this blog will have a family member who is currently suffering or has died from cancer.
We also know from the lay press and scientific papers that this is a very exciting time in the cancer field. We have seen dramatic improvements in treatment and, now more than ever, researchers and clinicians are making strides toward potential cures for many tumor types.
Unfortunately, far too many types of cancer have been left behind in these strides and remain a deadly scourge for many patients and their families. DelMar was founded to develop and commercialize new therapies for cancer patients who have failed or are unlikely to respond to currently available treatments.
In founding DelMar, our premise was that there are existing medicines that could prove valuable in the treatment of cancer patients suffering from a lack of viable treatment options. Of course, so called “drug re-profiling” is not a new concept; companies and researchers have long been looking at drugs that were approved for one use in the treatment of an unrelated disease.
What differentiated our thought was: What if there are proven cancer medicines that had been passed over, not commercialized or fallen out of favor in this era of targeted therapies that could solve unmet medical needs in the treatment of cancer today?
Armed with this question, DelMar co-founder and Chief Scientific Officer, Dennis Brown, researched the archives of the United States Cancer Institutes (NCI) and identified a short-list of drug candidates with demonstrated promising Phase II activity in the treatment of one-or-more cancers that had not advanced to commercialization.
By harnessing modern biological tools, we can now develop a robust understanding of how such “discarded” drug candidates attack the tumor and use that knowledge to target therapy to specific cancer niches that have been underserved by modern therapy. Since clinical activity has already been established, we believe this approach will reduce technical risk, reduce cost and shorten development times!
Importantly, our team has done this before. DelMar’s predecessor company, Chemgenex, employed this strategy to develop an “old drug” as a new treatment for a rare form of leukemia that fails to respond to modern therapy. That drug was approved by the FDA in 2012 and has provided a new therapeutic option for a group of patients who previously had none.
When Chemgenex was acquired in 2011, key members of the team stuck together, picked up the next drug of interest and reformed as DelMar Pharmaceuticals – the address in Menlo Park, CA is even the same.
I was truly honored to be invited to lead a cohesive team with a proven track record and with a near obvious chance of success. It is a real dream-come-true.
DelMar’s lead drug candidate, VAL-083, demonstrated clinical activity against a range of tumor types, including lung, brain, cervical, ovarian and hematologic (blood) cancers in prior NCI-sponsored human clinical trials.
What caught our attention was VAL-083’s activity against a type of cancer called glioblastoma multiforme (GBM). GBM is the most common and aggressive form of brain cancer, with roughly 15,000 new cases each year in the United States. Current treatment options can provide benefit for some patients, there is currently no cure and unfortunately, most patients fail to respond to treatment and the majority of patients die from the disease within 18 months from diagnosis.
The current standard of treatment for GBM patients typically includes surgery to remove as much of the tumor as possible (debulking), which is then followed by front-line treatment consisting of radiotherapy and chemotherapy with Temodar (temozolomide). Avastin (bevacizumab) is approved in the United States to treat patients who have failed standard front-line therapy, but has not been proven to impact patient survival.
Based on clues from NCI-sponsored research and our own work, we knew that VAL-083 targets the tumor’s DNA differently than Temodar. It is also known that high-expression of a DNA repair enzyme called O6-DNA methylguanine methyl-transferase (MGMT) is correlated with poor patient outcomes because it causes resistance to Temodar and other therapies with a similar mechanism. Since VAL-083 is different, we have been able to demonstrate that VAL-083 retains tumor killing ability in the presence of MGMT. This understanding of the uniqueness of VAL-083’s mechanism combined with historical evidence of clinical activity in the treatment of GBM represents a potential paradigm shift for the majority of patients who fail or are unlikely to respond to currently available treatments.
Armed with this hope, we initiated clinical trials to investigate VAL-083 as a potential treatment for GBM patients who had failed both Temodar and Avastin. There is currently no available therapy for these patients. We’ve completed a Phase I trial and observed a promising dose-dependent trend in survival improvement as we advanced to higher doses. The median overall survival for patients receiving higher doses of VAL-083 was about 9 months compared to about 5 months in patients who received a sub-therapeutic dose.
Based on the safety profile observed in the Phase I dose escalation portion of our clinical trial, we selected a dose for evaluation in advanced clinical studies earlier this year. We recently announced that we have completed enrollment in a Phase II study, the results of which will be used to inform the study design of our registration-directed (Phase II/III) clinical trials which are expected to commence in 2016.
We have now also begun applying this strategy of leveraging historical clinical data with modern biological science to explore VAL-083 in additional indications such as non-small cell lung cancer and ovarian cancer.
We anticipate presenting interim results of our ongoing research at scientific meetings during the remainder of 2015 and into 2016. I look forward to sharing our further advancements and updating you on the journey toward delivering new treatment options for patients have failed or are unlikely to respond to modern therapy.
Forward Looking Statements
Any statements contained in this blog 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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