On
'It means a great deal to all of us involved with VAL-083's development to receive support from the
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(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
'We are delighted to help bring together our key strategic partners, NBTS, NFCR, and
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
About the
The NFCR is a 501(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
About the
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
Located in
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
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.
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
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