VANCOUVER, British Columbia and MENLO PARK, Calif., May 31, 2014 /PRNewswire/ -- DelMar Pharmaceuticals, Inc. (OTCQB: DMPI) ("DelMar") announced the presentation of interim clinical data from the company's ongoing clinical trial with VAL-083 in refractory glioblastoma multiforme (GBM) during the Central Nervous System Tumor Session at the 50th Annual Meeting of the American Society of Clinical Oncology (ASCO), which is being held at the McCormick Place Convention Center in Chicago.
In summary, DelMar reported that:
- To date, one of two GBM patients in cohort 6 (30 mg/m2) exhibited stable disease after one cycle of treatment. Outcomes analysis of cohorts 6 and 7 are ongoing.
- No drug-related serious adverse events have been detected, and maximum tolerated dose (MTD) has not been reached at doses up to 30 mg/m2. Enrollment and evaluation of Cohort 7 (40mg/m2) is ongoing.
- Pharmacokinetics are linear and consistent with previous published data suggesting that concentrations of VAL-083 being obtained are effective against glioma cell lines in vitro.
In earlier cohorts, DelMar reported that two patients exhibited a response (stable disease or partial response) with a maximum response of 28 cycles (84 weeks) and improved clinical signs prior to discontinuing due to adverse events unrelated to study.
DelMar has also presented data demonstrating that the cytotoxic activity of VAL-083 is independent of MGMT, the enzyme believed to cause resistance to the current front-line therapy in the treatment of GBM.
If the MTD is not reached in cohort 7, DelMar would be prepared to file a protocol amendment with the FDA to allow dosing beyond 40mg/m2.
"We continue to be enthusiastic with the progress of VAL-083 as we advance toward doses which will be taken forward into registration-directed clinical trials," said Jeffrey Bacha, president & CEO of DelMar Pharmaceuticals. "We believe that our data, combined with historical data from the National Cancer Institute demonstrating activity in the treatment of GBM, position VAL-083 as a promising new treatment option for GBM patients who have failed other available therapies."
VAL-083 represents a first-in-class, small-molecule chemotherapeutic with a unique mechanism of action. In more than 40 Phase 1 and 2 clinical studies sponsored by the U.S. National Cancer Institute (NCI), VAL-083 demonstrated promising activity against a number of cancers including lung, brain, cervical, ovarian tumors and leukemia. VAL-083 is approved in China for the treatment of chronic myelogenous leukemia and lung cancer and has received orphan drug designation in Europe and the United States for the treatment of gliomas. DelMar previously presented in vitro data demonstrating that VAL-083's unique mechanism of action is unaffected by the expression of MGMT, a DNA repair enzyme that causes chemotherapy resistance to Temodar® (temozolomide). Temodar is currently the standard front-line therapy for the treatment of glioblastoma multiforme (GBM), the most common and aggressive form of brain cancer. DelMar believes that these data, in conjunction with VAL-083's historical activity, establish the drug's potential to provide a viable treatment option for patients suffering from refractory and newly diagnosed GBM.
About the Phase I/II VAL-083 Dose Escalation Trial
DelMar's Phase I/II study is an open-label, single arm dose-escalation study designed to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of VAL-083 in patients with recurrent GBM. The study is currently enrolling at three clinical sites in the United States: The University of California, San Francisco (UCSF); The Sarah Cannon Cancer Research Institute (SCRI) in Nashville, TN and the SCRI affiliate site at the Florida Cancer Specialists in Sarasota, FL.
The primary endpoint of the current portion of the study is to determine a modernized dosing regimen for advancement to registration-directed clinical trials. Tumor volume is assessed during the study based on RANO criteria after every second cycle and patients exhibiting any evidence of continued progression at any time during the study are discontinued, but cycle 1 toxicity is captured for MTD determination. Patients enrolled present with refractory progressive GBM and a dire prognosis. All GBM patients enrolled to date have failed front-line temozolomide, and all except one had failed second-line bevacizumab therapy.
Patients in the trial must have been previously treated for GBM with surgery and/or radiation and must have failed both Avastin® and Temodar, unless either or both are contra-indicated. Subject to continued progress, DelMar anticipates completing the dose-escalation portion of its current clinical trial in mid-2014. The goal of the dose-escalation portion of the trial is to determine an appropriate dosing regimen for advancement into future registration-directed trials.
Further information regarding DelMar's clinical trial can be found at http://www.clinicaltrials.gov/ct2/show/NCT01478178?term=val-083&rank=1
About Glioblastoma Multiforme (GBM)
Glioblastoma multiforme (GBM) is the most common and most malignant form of brain cancer. Approximately 15,000 people are diagnosed with glioblastoma each year in the United States, with similar incidence in Europe. Standard of care is surgery, followed by radiation therapy or combined radiation therapy and chemotherapy with temozolomide.
GBM has a poor prognosis and only modest improvements in therapy have been made over the past 25 years. Median survival for newly diagnosed patients is less than two years, and approximately 60 percent of GBM patients treated with the standard front-line temozolomide regimen experience tumor progression within one year. Patients who fail the currently approved therapies have limited treatment options and a very poor prognosis, with a median survival of three to six months.
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 recurrent 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 press release 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.