On June 24, 2020 DelMar Pharmaceuticals, Inc. (Nasdaq: DMPI) ("DelMar" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies reported 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 for participation in the Global Coalition for Adaptive Research’s (GCAR) sponsored trial, Glioblastoma (GBM) Adaptive Global Innovative Learning Environment (GBM AGILE) study (Press release, DelMar Pharmaceuticals, JUN 24, 2020, View Source [SID1234561442]). 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.
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"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 DelMar Pharmaceuticals," 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."
About VAL-083
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: