Published on June 24, 2020
SAN DIEGO, June 24, 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 received a $500,000 loan from the National Brain Tumor Society (NBTS) and the National Foundation for Cancer Research (NFCR) to support VAL-083’s preparation forparticipation in the Global Coalition for Adaptive Research’s (GCAR) sponsored trial, Glioblastoma (GBM) Adaptive Global Innovative Learning Environment (GBM AGILE) study. On June 4, 2020, the Company announced that VAL-083, its “first-in-class,” small-molecule chemotherapeutic with a novel mechanism of action, was selected by GCAR as the third investigational therapy to participate in GBM AGILE, in which the compounds will be simultaneously evaluated across multiple international trial sites of which 25 are currently activated. DelMar intends to utilize GBM AGILE, which is an adaptive registration clinical trial, to serve as the basis for VAL-083’s new drug application submission and registration.
“It means a great deal to all of us involved with VAL-083’s development to receive support from the National Brain Tumor Society and the National Foundation for Cancer Research as these organizations are two of the leading advocacy and funding partners for GBM AGILE,” commented Saiid Zarrabian, Chief Executive Officer of DelMar Pharmaceuticals. “This funding is an important milestone as it enables us to accelerate VAL-083’s participation in GBM AGILE, which is expected to reduce VAL-083’s pivotal trial completion and regulatory submission timeline by up to 18 months.”
GBM AGILE is an international effort in newly diagnosed and recurrent GBM, utilizing an FDA approved master protocol to evaluate multiple therapies against a common control arm. As an approved registrational study, positive results from the VAL-083 arm of GBM AGILE are expected to be utilized to file for FDA approval. This study employs a cost-efficient, seamless phase 2/3 adaptive trial design with a Stage 1 learning and adapting phase and a Stage 2 expansion and confirmation phase. The effort is led by top-tier key opinion leaders in the GBM field and has the collective support of an international group of more than 130 clinicians, researchers, biostatisticians, imagers, pathologists, leaders from government and industry, and patient advocates. GCAR, a 501(c)(3) organization, is the international trial sponsor, and provides financial support for the program infrastructure, as well as trial oversight and management. Comprised of the world’s foremost clinical, translational, and basic science investigators, GCAR strives to support the development of novel treatments to fight against rare and deadly diseases like GBM where patient prognosis is poor and treatment options are limited.
“We are supporting the inclusion of VAL-083 in the GBM AGILE adaptive clinical trial platform as it is consistent with our mission to support research for, and ultimately enable delivery of, effective treatments to patients with brain tumors. We are particularly pleased to lend our support to VAL-083 given the significant unmet medical need that exists for patients with GBM,” commented David Arons, Chief Executive Officer of the National Brain Tumor Society.
Sujuan Ba, President & Chief Executive Officer of the National Foundation for Cancer Research added, “We are dedicated to facilitating the development of therapies for all cancers, and are pleased to lend our support to VAL-083’s participation in GBM AGILE. We are very hopeful that the knowledge established from VAL-083 in GBM AGILE can be insightful for other cancers – giving patients hope for treatments that are best suited for their care.”
“We are delighted to help bring together our key strategic partners, NBTS, NFCR, and DelMarPharmaceuticals,” shared Faramarz Yousefzadeh, GCAR Board Chairman. “We believe this is a model for collaboration – aiding small pharma to test promising new drugs in GBM AGILE.”
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 the National Foundation for Cancer Research
The NFCR is a 501(c)(3) nonprofit organization that provides scientists in the lab the funding they need to make game-changing discoveries in cancer treatments, detection, prevention and ultimately, a cure. NFCR has distinguished itself in the cancer research sector by emphasizing long-term, transformative research often overlooked by other major funding sources. With the help of more than 5.2 million individual donors over the last 47 years, NFCR has delivered more than $380 million in funding to public education and cancer research leading to several important, life-saving discoveries.
About the National Brain Tumor Society
The NBTS unrelentingly invests in, mobilizes, and unites the community to discover a cure, deliver effective treatments, and advocate for patients and care partners. It is in the unique position to affect change across the drug development, policy and legislative, research, and clinical trial systems at all levels. NBTS doesn’t focus on a single method or approach to defeating brain tumors. It drives a multi-faceted and thoughtful approach to aggressively influence and fund strategic research and discovery, as well as advocate for public policy changes, in order to achieve the greatest impact, results, and progress for brain tumor patients.
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 GBM AGILE, the status of the Company’s clinical trials, the reporting of the results and the impact of the COVID-19 pandemic. 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 impact of the COVID-19 pandemic on the Company’s operations and clinical trials, 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.