DelMar Pharmaceuticals Expands GBM Clinical Trial with Fifth Clinical Trial Site Added in Denver, Colorado
- Sarah Cannon Cancer Research Center, Denver, CO, now open for recruitment of patients in Phase I/II Multicenter Study of VAL-083 for Recurrent Malignant Glioma -
VANCOUVER, British Columbia and MENLO PARK, Calif., July 20, 2015 /PRNewswire/ -- DelMar Pharmaceuticals, Inc. (OTCQX: DMPI) ("DelMar" and the "Company"), a biopharmaceutical company focused on developing and commercializing proven cancer therapies in new orphan drug indications, today announced that the Sarah Cannon Cancer Research Center at HealthOne, Denver, CO has been added as a clinical trial site for the ongoing, multicenter Phase I/II study of VAL-083 in patients with refractory glioblastoma multiforme (GBM), the most common and deadly form of human brain cancer.
"This fifth clinical site greatly adds to our recruitment bandwidth as part of our strategy to increase patient access as we continue with the expansion phase of our Phase I/II GBM clinical trial. Our goal is to complete the expansion phase and advance VAL-083 into registration-directed Phase II/III clinical trials for refractory glioblastoma in the timeliest manner possible," said Jeffrey Bacha, president & CEO of DelMar Pharmaceuticals.
Sarah Cannon Research Institute (SCRI) is the research arm of HCA's global cancer enterprise, Sarah Cannon. SCRI's Denver site is directed by Gerald Falchook, M.D., M.S. Dr. Falchook completed his oncology training at MD Anderson Cancer Center, where he also served as a faculty member for six years developing investigator-initiated clinical trials as well as collaborating with pharma/biotech industry partners to bring promising new drugs to cancer patients.
"Expanding our collaboration with SCRI provides access to leading oncologists to support the development of VAL-083 as a novel cancer chemotherapy and will enable more rapid patient enrollment to our GBM clinical trial by accessing SCRI's large network of patients," added Mr. Bacha.
DelMar's multicenter Phase I/II study with VAL-083 is ongoing in patients with recurrent GBM. The clinical trial is an open-label, single arm, safety and tolerability dose-escalation study utilizing a standard dose escalation design, until the maximum tolerated dose (MTD) or the maximum specified dose has been reached. Eligible GBM inclusion criteria requires previous treatment with surgery and/or radiation, if appropriate. Eligible GBM patients must have failed both Avastin® (bevacizumab) and Temodar® (temozolomide) unless either of these therapies was contraindicated. (ClinicalTrials.gov Identifier NCT01478178).
Recently DelMar presented interim data from this ongoing study in GBM at the American Association of Clinical Oncology (ASCO) Annual meeting. The Company confirmed the completion of the Phase I dose-escalation portion of the trial and presented data supporting a dose response trend: Patients receiving a dose ≥30mg/m2 had a median survival of 9.0 months vs. 4.4 months at doses <10mg/m2. DelMar also confirmed the initiation of a 14-patient Phase II expansion cohort at a dose of 40mg/m2. The purpose of the Phase II expansion cohort is to gain additional information about the safety and efficacy of VAL-083 at the 40mg/m2 dose prior to advancement into registration-directed Phase II/III clinical trials.
DelMar is also enrolling patients in the trial at four other oncology centers of excellence: The Mayo Clinic Cancer Center in Rochester, MN, The Brain Tumor Center at University of California, San Francisco (UCSF),.; The Sarah Cannon Cancer Research Center in Nashville, TN.; The Sarah Cannon Research Institute affiliate site at the Florida Cancer Specialist Research Institute in Sarasota, FL.; and. More information on the VAL-083 Phase I/II clinical trial in GBM may be found at http://www.delmarpharma.com/GBM_clinical_trial/.
VAL-083 is a "first-in-class", small-molecule chemotherapeutic. In more than 40 Phase 1 and 2 clinical studies sponsored by the U.S. National Cancer Institute, VAL-083 demonstrated safety and efficacy in treating 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 U.S. for the treatment of gliomas.
DelMar is currently studying VAL-083 in a multi-center Phase I/II clinical trial for patients with refractory glioblastoma multiforme (GBM) in accordance with the protocol that has been filed with the U.S. Food and Drug Administration (FDA). As a potential treatment for glioblastoma, VAL-083's mechanism of action appears to be unaffected by the expression of MGMT, a DNA repair enzyme that causes chemotherapy resistance to front-line treatment with Temodar® (temozolomide).
About DelMar Pharmaceuticals, Inc.
DelMar Pharmaceuticals, Inc. was founded to develop and commercialize proven cancer therapies in new orphan drug indications where patients are failing or have become intolerable to modern targeted or biologic treatments. The Company's lead drug in development, VAL-083, is currently undergoing clinical trials in the U.S. as a potential treatment for refractory glioblastoma multiforme. VAL-083 has been extensively studied by U.S. National Cancer Institute, 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 that could provide improved treatment options for patients.
For further information, please visit http://delmarpharma.com/; or contact DelMar Pharmaceuticals Investor Relations: firstname.lastname@example.org / (604) 629-5989. Follow us on Twitter @DelMarPharma or Facebook.com/delmarpharma. Investor Relations Counsel: Amato & Partners LLC.
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.
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SOURCE DelMar Pharmaceuticals, Inc.
Released July 20, 2015