According to the American Cancer Society, 2015 saw an estimated 1,658,370 new diagnosed cancer cases and 589,430 cancer deaths in the US. With over 100 types of cancer affecting patients and families all over the world, any and all progress toward more effective treatment brings medicine closer to potentially life-saving solutions. DelMar Pharmaceuticals, Inc. (DMPI), a biopharmaceutical company that’s focused on the development and commercialization of new cancer therapies, is one company actively working towards effective treatments that could save those suffering from multiple forms of cancer.
A Groundbreaking Anti-Cancer Drug
In more than 40 Phase I and II clinical studies sponsored by the US National Cancer Institute, the company’s VAL-083, DelMar’s first-in-class, small-molecule chemotherapeutic, has demonstrated clinical activity against a range of cancers including lung, brain, cervical, ovarian tumors and leukemia both as a single-agent and in combination with other treatments. Currently, the company is moving into a Phase II clinical study of VAL-083 in patients with refractory GBM. VAL-083 is approved to treat chronic myelogenous leukemia lung cancer in China and has received orphan drug designation in Europe and the US for the treatment of malignant gliomas.
"We have made tremendous progress in executing our clinical development strategy with VAL-083 in refractory glioblastoma multiforme ("GBM") and identifying additional value drivers through non-clinical research that position us to expand our clinical development efforts into non-small cell lung cancer ("NSCLC") and other solid tumors,” said Jeffrey Bacha, president and CEO of DelMar Pharmaceuticals.
“We have completed full enrollment of the Phase II expansion cohort in our refractory GBM clinical trial. The results of this study will be the basis for advancing VAL-083 into the planned registration-directed Phase II/III trial in refractory GBM.”
GBM is a malignant adult brain tumor that can affect vision and motor skills, as well as impair cognitive functions. The prognosis for those diagnosed with GBM is dismal, with a current median survival rate of four to six months, and less than five percent survival rate in the fifth year.
"We believe,” said Bacha, “VAL-083 offers promise as a modern solution to the tremendous unmet medical need for a new therapy for GBM patients who have failed – or are unlikely to respond to – currently available treatments."
A Year of Significant Progress
In 2015, VAL-083 put DelMar front and center on the medical field’s world stage. Operational highlights include:
- Completing the enrollment of the 14-patient expansion cohort of the company’s Phase II clinical study of VAL-083 in patients with refractory GBM. Furthermore, DelMar confirmed 40mg/m2 as the maximum tolerated dose for advancement into registration-directed clinical trials.
- Reporting additional non-clinical data supporting the favorable differentiation of VAL-083 versus standard of care in the treatment of GBM, non-small cell lung cancer and other solid tumors.
- Adding the Mayo Clinic Cancer Center in Rochester, Minnesota and the Sarah Cannon Cancer Research Center at HealthOne, Denver, Colorado as a new clinical trial sites in DelMar’s ongoing, multicenter Phase I/II clinical trial study of VAL-083 in patients with refractory GBM.
- Presenting data at the American Association for Cancer Research ("AACR") - Advances in Pediatric Research: From Mechanisms and Models to Treatment and Survivorship, that indicated VAL-083’a potential therapeutic alternatives in difficult-to-treat pediatric brain tumors.
- Presenting data at AACR's Advances in Ovarian Cancer Research: Exploiting Vulnerabilities that supported the effectiveness of VAL-083 against cisplatin-resistant ovarian cancers.
- Acquiring additional capital to support drug development and research programs through a registered stock offering for gross proceeds of $2.6 million.
In addition to an already impressive list of recent achievements, the company also presented a corporate overview and provided an update on the ongoing Phase II clinical trial of VAL-083 at the SeeThruEquity Microcap Investor Forum this past November.
(Working Towards) Cancer Free in 2016
In the medical research sector, DelMar Pharmaceuticals is one of the truly innovative companies to follow. As the company moves closer in bringing VAL-083 to patients in need, DelMar is positioned to continue making positive strides in the new year with their innovative anti-cancer research and clinical trials. "I am extremely pleased with our significant achievements in recent months,” said Bacha. “DelMar is well positioned for major developments as VAL-083 advances toward registration-directed studies for refractory GBM and into clinical trials for new indications. We anticipate that the VAL-083 program will continue to produce key data during the remainder of 2015 and throughout 2016.”
For more information about DelMar Pharmaceuticals, visit www.delmarpharma.com.
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