VANCOUVER, British Columbia and MENLO PARK, Calif., March 20, 2014 /PRNewswire/ -- DelMar Pharmaceuticals, Inc. (OTCQB: DMPI) ("DelMar" and "DelMar Pharma") provided an update as of the quarter ended December 31, 2013 and a summary of progress toward the Company's goals for the year. DelMar also announced an investor conference call to take place today at 1 pm 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.
VAL-083 is a first-in-class small-molecule chemotherapy that was studied in more than 40 historical human clinical trials sponsored by the National Cancer Institutes (NCI) in the United States. Historical data suggests that VAL-083 has activity against a broad range of tumor types, including glioblastoma multiforme (GBM) the most common and aggressive form of brain cancer.
Approximately 15,000 new cases of GBM are diagnosed in the USA each year. Standard front-line treatment consists of surgical resection, radiotherapy, and chemotherapy with temozolomide (Temodar®). A majority of patients fail to achieve a response to front-line therapy and median time to recurrence after standard therapy is 6.9 months. Patients with recurrent GBM may receive bevacizumab (Avastin®) as second-line therapy; however, nearly half of those patients initially diagnosed will fail both front-line and second-line therapy. These patients have limited treatment options and a very poor prognosis.
Based on the unique cytotoxic mechanism of VAL-083, we believe that it may offer a new treatment option for patients who fail today's standard GBM therapies. To this aim, we are currently conducting a Phase I/II dose-escalation trial designed to assess the safety and preliminary efficacy of our lead product candidate, VAL-083, for the treatment of refractory GBM.
The goal of our current clinical trial is to establish the optimal VAL-083 dosing regimen for both safety and efficacy in a U.S.-based refractory GBM patient population. This dose would then be advanced into registration directed clinical trials.
In November 2013, we presented interim data at the 18th Annual Society for NeuroOncology (SNO) meeting. The results reported to date have shown promising drug activity and we believe that VAL-083 represents a potential new treatment option for brain tumor patients who have failed or are unlikely to benefit from today's standard of care.
We recently initiated the sixth cohort (30mg/m2) in our refractory GBM clinical trial. To date, no dose limiting toxicity has been observed. At this dose, we are delivering a higher drug concentration and higher exposure compared to the regimen employed in previous NCI-sponsored clinical trials. We plan to present the next interim data on April 9, 2014 at the American Association for Cancer Research (AACR) Annual meeting.
We are exploring VAL-083 in new indications and unlocking the commercial potential for VAL-083 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 November 2013, we presented initial in vivo data supporting the potential utility of VAL-083 in the context of platinum-based chemotherapy. Platinum-based chemotherapy regimens are an important component of cancer therapy for many tumor types including lung cancer. We believe that these newly reported data support the potential to unlock a significant potential for VAL-083 in the modern treatment of lung cancer.
We are continuing our efforts to secure a sales and marketing partner for VAL-083 in China. Our goal is to establish a sales and marketing relationship that will provide DelMar with revenue from sales in the China market.
We completed our fiscal year on budget.
As of December 31, 2013 our working capital balance was $4.1 million, which is in line with our expectations. 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 options for funding to finance our research and development operations beyond that date.
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/.
We are continuing to implement our business plan.
Our business model focuses on identifying well-validated clinical and commercial-stage compounds and establishing a scientific rationale for development in modern orphan cancer indications where an unmet medical need remains. We are researching and advancing VAL-083 in multiple indications while conducting our research and development activities in a timely and capital-efficient manner. In addition, we are assessing strategies for an up-listing to the NYSEMKT or NASDAQ at the earliest available opportunity.
The DelMar Pharma team is proud to have the continued support for our mission to develop and commercialize proven 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
Del Mar 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.
For further information, please visit www.delmarpharma.com
SOURCE DelMar Pharmaceuticals, Inc.