Phase 2 trial more than 90% enrolled with enrollment continuing even in light of coronavirus pandemic
SAN DIEGO, May 5, 2020 /PRNewswire/ — DelMar Pharmaceuticals, Inc. (Nasdaq: DMPI) (“DelMar” or the “Company”), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, announced today it has enrolled 22 patients in the adjuvant arm of the Company’s ongoing Phase 2 clinical study investigating adjuvant treatment (pre-temozolomide — or TMZ — maintenance therapy) of MGMT-unmethylated glioblastoma multiforme (GBM) with VAL-083.
The adjuvant arm of the Phase 2 study of VAL-083 being conducted at the MD Anderson Cancer Center (MDACC) is designed to enroll up to 24 newly-diagnosed patients who have undergone surgery and chemoradiation with TMZ but will now receive VAL-083 in place of standard of care TMZ for adjuvant therapy. Additionally, in the recurrent arm of the study, which is also being conducted at MDACC, 72 patients out of a planned 83 patients have now been enrolled. DelMar continues to actively enroll patients in both trial arms of the clinical study, even in light of the COVID-19 pandemic.
DelMar previously announced that it had completed full enrollment of the planned 29 patients in its ongoing Phase 2 clinical study investigating the first-line treatment of VAL-083 with radiation therapy in newly-diagnosed, MGMT-unmethylated GBM. The trial is being conducted at the Sun Yat-sen University Cancer Center in Guangzhou, China, and is designed to determine whether first-line therapy with VAL-083 treatment improves progression free survival. The current standard of care is first line TMZ with radiation.
Pending meeting formats and other unforeseen changes, DelMar currently intends to announce additional clinical trial updates concomitant with planned scientific poster presentations at or around the American Society of Clinical Oncology (ASCO) ASCO20 Virtual Scientific Program May 29-31, 2020, and at or around the American Association for Cancer Research Virtual Annual Meeting II June 22-24, 2020.
VAL-083 (dianhydrogalactitol) is a “first-in-class”, bifunctional DNA-targeting agent that introduces inter-strand DNA cross-links at the N7-position of guanine leading to DNA double-strand breaks and cancer cell death. VAL-083 has demonstrated clinical activity against a range of cancers including GBM and ovarian cancer in historical clinical trials sponsored by the U.S. National Cancer Institute (NCI). DelMar has demonstrated that VAL-083’s anti-tumor activity is unaffected by common mechanisms of chemoresistance, including MGMT, in cancer cell models and animal studies. Further details regarding these studies can be found at:
About DelMar Pharmaceuticals, Inc.
Located in San Diego, California, DelMar is focused on the development and commercialization of new therapies for cancer patients who have limited or no treatment options. By focusing on understanding tumor biology and mechanisms of treatment resistance, the Company identifies biomarkers to personalize new therapies in indications where patients are failing, or are unable to tolerate, standard-of-care treatments.
The Company’s current pipeline is based around VAL-083, a “first-in-class”, small-molecule chemotherapeutic with a novel mechanism of action that has demonstrated clinical activity against a range of cancers, including central nervous system, ovarian and other solid tumors (e.g. NSCLC, bladder cancer, head and neck) in U.S. clinical trials sponsored by the NCI. Based on DelMar’s internal research programs and these prior NCI-sponsored clinical studies, the Company is conducting clinical trials to support the development and commercialization of VAL-083 to solve significant unmet medical needs.
VAL-083 is being studied in two collaborator-supported, biomarker-driven Phase 2 clinical trials for MGMT-unmethylated GBM. Overcoming MGMT-mediated resistance represents a significant unmet medical need in the treatment of GBM. In addition, DelMar has announced the allowance of a separate IND for VAL-083 as a potential treatment for platinum-resistant ovarian cancer.
Further information on DelMar’s clinical trials can be found on clinicaltrials.gov: https://www.clinicaltrials.gov/ct2/results?cond=&term=val-083&cntry1=&state1=&recrs.
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, including statements regarding the status of the Company’s clinical trials, the impact of the COVID-19 pandemic and the reporting of the results. 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 surrounding the COVID-19 pandemic, 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 the Company’s filings with the SEC, including the Company’s Annual Report on Form 10-K for the year ended June 30, 2019, the Company’s Quarterly Reports on Form 10-Q, and the Company’s Current Reports on Form 8-K.
Director of Public Relations