VANCOUVER, British Columbia and MENLO PARK, Calif., April 16, 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 Mayo Clinic Cancer Center 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.
"We are very pleased to add this prestigious institution as our fourth clinical trial site and have the opportunity to collaborate with some of the world's leading oncologists as we advance VAL-083 through clinical development," stated Jeffrey Bacha, DelMar's president and CEO. "The addition significantly expands our recruitment bandwidth as we seek to advance VAL-083 into Phase II/III registration directed clinical trials as rapidly as possible."
DelMar's 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. Subjects must have failed both bevacizumab (Avastin®) and temozolomide (Temodar®), unless either of these therapies was contraindicated.
MTD is determined by treating small cohorts of patients with escalating doses of VAL-083 until a dose limiting toxicity (DLT) is observed in at least two subjects in a given cohort. Once the MTD is determined, DelMar will expand enrollment at the MTD (or other selected optimum Phase II dose) by an additional 14 patients to gather additional safety and efficacy data prior to advancing into Phase II/III registration-directed trials.
DelMar's modernized VAL-083 dosing regimen takes advantage of improved side-effect management and new knowledge of the pharmacokinetic and toxicity profile of VAL-083 to deliver doses of VAL-083 that are substantially higher than were achieved in prior GBM clinical trials sponsored by the US National Cancer Institutes (NCI).
"Our strategy to 'hit the tumor harder more often' allows us to achieve higher levels of drug at the tumor-site, which we believe will result in significant clinical benefit for GBM patients who currently have no viable treatment options," added Mr. Bacha.
DelMar is currently studying a dose of 50 mg/m2 and three patients have completed the required assessments. At this dose, one patient completed the required safety follow-up period without a DLT. The second patient in the 50 mg/m2 cohort experienced myelosuppressive DLT, defined by grade four thrombocytopenia (low platelet counts). The third patient did not experience a DLT, but did show a strong trend toward DLT, defined by Grade 3 thrombocytopenia. All symptoms of toxicity resolved rapidly and spontaneously returned to normal without concomitant medication or transfusion.
Based on the observation of one DLT in three patients, DelMar's has enrolled three additional patients in the 50 mg/m2 dose cohort prior to confirming MTD or advancing to higher doses. If a DLT is observed in any of these three patients, the highest previous safe dose – 40 mg/m2 – would be proposed as the MTD for advancement to registration-directed trials. If no further DLT is observed, DelMar may determine to continue dose escalation to 60 mg/m2. However, if continued strong trends toward DLT are observed, DelMar may cease dose-escalation and propose 50 mg/m2 as the MTD for advancement into Phase II/III registration directed clinical trials in refractory GBM.
"Based on our current enrollment and timelines, DelMar believes it is likely that we will confirm MTD during the first half of calendar 2015," concluded Mr. Bacha.
DelMar will present a formal update on its progress with its ongoing Phase I/II clinical trial at the American Association of Cancer Research (AACR) Annual Meeting during the "Clinical Trials in Progress" session being held between 8AM and noon EDT on Monday, April 20, 2015.
The VAL-083 Phase I/II clinical trial is also being conducted at three other oncology centers of excellence: The Brain Tumor Center at University of California, San Francisco (UCSF), Calif.; The Sarah Cannon Cancer Research Center in Nashville, Tenn.; and the Sarah Cannon Research Institute affiliate site at the Florida Cancer Specialist Research Institute in Sarasota, Fla. 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 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. 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). DelMar is currently studying VAL-083 in a Phase I/II clinical trial for patients with refractory glioblastoma multiforme.
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: [email protected] / (604) 629-5989 follow us on Twitter @DelMarPharma or Facebook.com/delmarpharma.
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.
SOURCE DelMar Pharmaceuticals, Inc.