VANCOUVER, British Columbia and MENLO PARK, Calif., May 20, 2014 /PRNewswire/ -- DelMar Pharmaceuticals, Inc. (OTCQB: DMPI) ("DelMar" and "DelMar Pharma") provided a quarterly update and a summary of progress toward the Company's goals for the year. DelMar also announced an investor conference call to take place on Thursday June 5, 2014 at 11:30 am EDT. Details and log-in information will be posted on the website at www.delmarpharma.com in advance of the call.
Highlights from the quarter are as follows:
We Continue to Advance Our Clinical Trials with VAL-083 as a Potential New Treatment for Refractory Glioblastoma Multiforme
We recently completed the sixth cohort (30mg/m(2)) and have opened the seventh cohort (40mg/m(2)) in our refractory glioblastoma multiforme (GBM) clinical trial. To date, no dose limiting toxicity has been observed. We are now delivering nearly twice the amount of VAL-083 than was administered in previous U.S. National Cancer Institute (NCI)-sponsored clinical trials (240 mg/m(2) vs 125 mg/m(2)) in comparison to the NCI's 33-day cycle.
We presented VAL-083 interim clinical data at the American Association of Cancer Research (AACR) Annual Meeting on April 9, 2014. The interim results demonstrated that:
1) VAL-083 therapy is well tolerated; no drug-related serious adverse events have been detected in 26 patients treated to date in the current study.
2) The maximum tolerated dose (MTD) was not reached after completion of cohort 5 (20 mg/m(2)).
3) There was a dose-dependent increase in VAL-083 exposure, and this was comparable to drug-levels predicted from previous NCI-sponsored publications, which means that we can be confident in the drug levels being delivered to the tumor with our modernized dosing regimen.
The primary endpoint of this stage of DelMar's current study is to determine a modernized dosing regimen for advancement to registration-directed clinical trials. We plan to present the next interim data, which will include patients who have completed cohort 6 (30 mg/m(2)) on May 31, 2014 at the 50(th) Annual Meeting of the American Society for Clinical Oncology (ASCO). A link to our permanent ASCO abstract (#TPS2109) can be viewed by clicking here or by searching http://abstracts2.asco.org/.
We Continue to Explore the Potential Utility of VAL-083 in New Indications in an Effort to Expand the Agent's Commercial Potential in China
VAL-083 is approved in China as a treatment for both chronic myelogenous leukemia (CML) and lung cancer. Our research suggests that VAL-083 may have a valuable place in the modern treatment of CML and lung cancer, both in China and worldwide in the context of both tyrosine kinase inhibitor (TKI) sensitive and resistant tumors.
During AACR, we presented data comparing the activity of VAL-083 to standard platinum-based therapy (cisplatin) against human non-small cell lung cancer (NSCLC) cell lines A549 (TKI-sensitive) and H1975 (TKI-resistant). In the study, VAL-083 demonstrated superior safety and efficacy against both cell lines, regardless of their respective TKI sensitivities.
We believe these data establish a basis under which to conduct post-market clinical studies in order to validate the modern use of VAL-083 for the treatment of NSCLC in China, where the drug is already approved for shrinking lung cancer tumors. This endeavor could also establish a favorable proof-of-concept for the global development of VAL-083 as a potential treatment for NSCLC.
We Have Adequate Drug Supply
During the quarter we produced additional clinical supply of VAL-083 in collaboration with our Guangxi Wuzhou Pharmaceuticals, our manufacturing partner in China. This additional supply positions us to meet the needs of our ongoing clinical trials in the United States as well as planned post-market clinical activities in China. In addition, we have established a North American back-up supplier for the active pharmaceutical ingredient in order to mitigate potential future supply chain risk.
Ex-U.S. Partnering Activities Are Ongoing
We are continuing our efforts to secure a sales and marketing partner for VAL-083 in China. Our goal is to establish a relationship that will provide DelMar with revenue from VAL-083 sales in the China market. While we cannot offer concrete guidance on the timing or outcome of such discussions, we remain confident that we will establish an appropriate partnership to complement our collaboration with Guangxi Wuzhou Pharmaceuticals.
We Remain on Budget and Are Continuing to Implement Our Business Plan
As of March 31, 2014 our working capital balance was $3.3 million, which is slightly higher than expected due to the exercise of warrants for cash. Based on our operating budget, we estimate that these funds will provide us with sufficient capital to support our ongoing research and development activities through the first calendar quarter of 2015.
We continue to explore financing options to further fund our research and development programs beyond that date. One such option is to continue to work with our existing warrant holders in an effort to provide a possible source of non-dilutive capital. The potential reduction in our outstanding warrant liability is also in line with our broader goal of pursuing a senior listing for our shares, which we believe will have a positive impact on our mission to increase shareholder value.
Details of our quarterly and year-end financials can be found via the SEC Filings section of our website at: http://www.delmarpharma.com/investors/sec_filings/.
On behalf of the entire DelMar Pharma team, I thank you for your continued support of our mission to develop and commercialize proven cancer medicines for patients who have failed currently available therapy. As always, our goal remains to serve patients who have unmet clinical needs and to build value for our shareholders in the timeliest manner possible.
About DelMar Pharmaceuticals ?
DelMar Pharmaceuticals was founded in 2010 to develop and commercialize proven cancer therapies in new orphan drug indications where patients are failing modern targeted or biologic treatments. The Company's lead asset, VAL-083, is currently undergoing clinical trials in the United States as a potential treatment for refractory glioblastoma multiforme (GBM), the most common and aggressive form of brain cancer. VAL-083 benefits from extensive clinical research sponsored by the U.S. National Cancer Institute (NCI), and is currently approved for the treatment of chronic myelogenous leukemia (CML) 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.
Safe Harbor Statement
Any statements contained in this update 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. We do not undertake to update these forward-looking statements made by us.
SOURCE DelMar Pharmaceuticals, Inc.