On June 4, 2020 DelMar Pharmaceuticals, Inc. (Nasdaq: DMPI) ("DelMar" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, reported the acceptance of an invitation from the Global Coalition for Adaptive Research (GCAR) to include VAL-083 in GCAR’s Glioblastoma Adaptive Global Innovative Learning Environment (GBM AGILE) Study, an adaptive clinical trial platform in glioblastoma multiforme (GBM) (Press release, DelMar Pharmaceuticals, JUN 4, 2020, View Source [SID1234560830]). DelMar will utilize the GBM AGILE study to serve as the basis for VAL-083’s new drug application (NDA) submission and registration.

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"We wish to convey our gratitude to GCAR for extending an invitation to DelMar to participate in the GBM AGILE study. We believe that GCAR’s already-approved robust adaptive trial design, industry leading partners and clinical support vendors, as well as strong regulatory endorsement can measurably accelerate our efforts to bring VAL-083 to market for GBM patients who have significant unmet medical needs," commented Saiid Zarrabian, Chief Executive Officer of DelMar Pharmaceuticals. "With 24 clinical sites currently enrolling patients and with additional sites in the US, Canada, Europe and China expected to come online in the next 12 months, our participation in GBM AGILE is expected to provide a significant time and cost savings advantage related to clinical trial initiation. We look forward to enrolling the first patient into the VAL-083 arm of the study which is planned for the fourth quarter of this year."

GBM AGILE is an international effort in newly-diagnosed and recurrent GBM, utilizing an FDA approved master protocol with multiple drugs to be tested simultaneously and over time against a common control arm. As an approved registrational study, results from the VAL-083 arm of GBM AGILE are intended to be utilized to file for FDA approval. This study employs a cost-efficient, adaptive trial design with a Stage 1 (Phase 2) learning and adapting phase and a Stage 2 (Phase 3) 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 is a 501(c)(3) organization that functions as GBM AGILE study sponsor, and provides financial support for the program infrastructure, as well as general trial oversight. Comprising 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 look forward to advancing DelMar’s promising compound, VAL-083, in GBM AGILE. This registrational study is designed to accelerate the identification and approval of new drugs for patients with glioblastoma, a challenging disease with limited treatment options. We are very pleased to collaborate with DelMar Pharmaceuticals to initiate planning for the inclusion of VAL-083 in the trial for recurrent and newly-diagnosed GBM patients," commented Meredith Buxton, PhD, MPH, Chief Executive Officer of GCAR.