On July 24, 2019 DelMar Pharmaceuticals, Inc. (NASDAQ: DMPI) ("DelMar" or the "Company"), a biopharmaceutical company focused on the development of novel cancer therapies, reported that the first patient has been treated in the adjuvant (pre-temozolomide maintenance) trial arm of VAL-083’s Phase 2 study in MGMT-unmethylated glioblastoma multiforme (GBM) being conducted at the University of Texas MD Anderson Cancer Center (MDACC) (Press release, DelMar Pharmaceuticals, JUL 24, 2019, View Source [SID1234537701]). This recently-approved arm of the study will enroll up to 24 newly-diagnosed patients who have undergone surgery and chemoradiation with temozolomide (TMZ) but will now receive VAL-083 in place of standard of care TMZ for adjuvant therapy.
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"Treating patients with MGMT promoter unmethylated glioblastoma is particularly challenging," commented principal investigator Dr. Barbara O’Brien, assistant professor of Neuro-Oncology at the MD Anderson Cancer Center. "These tumors are inherently resistant to temozolomide, leaving physicians and patients without viable alternative treatments, so I’m particularly pleased that we have added this additional trial arm to our ongoing study. Better therapies are greatly needed for both newly-diagnosed and recurrent glioblastoma, and VAL-083 has so far shown a favorable safety profile and provided early, but encouraging, results from the trial that is currently underway."
This adjuvant arm, which was recently approved by the MDACC Institutional Review Board, will provide early disease data on VAL-083, in contrast to those patients enrolling in the Company’s original recurrent trial arm of the MDACC clinical study who have typically been heavily pre-treated with TMZ prior to disease recurrence. In the recurrent setting, the Company previously announced that MDACC had approved up to 35 additional patients to this recurrent GBM study at a dose of 30 mg/m2, allowing for a total of up to 83 patients to be enrolled. To date, 56 recurrent patients have been enrolled. DelMar is actively enrolling patients for both trial arms of the clinical study at MDACC.
Concurrently, the Company is conducting a Phase 2 clinical study of VAL-083 as first line treatment for GBM in combination with radiotherapy in China at the renowned Sun Yat-sen University Cancer Center for which it provided an update on June 3, 2019. This update can be accessed via the company’s website at View Source VAL-083 has been granted orphan drug designations by the U.S. FDA Office of Orphan Products for the treatment of glioma, medulloblastoma and ovarian cancer, and in Europe for the treatment of malignant gliomas. It has also been granted fast-track status for the treatment of recurrent GBM by the U.S. FDA.
"Enrolling and treating the first adjuvant patient in this study is an important milestone as it provides us with the opportunity to understand the best use for VAL-083 in the clinical setting – whether as first-line therapy along with radiation, as adjuvant therapy immediately following chemoradiation or in the recurrent setting. We firmly believe in the potential for this compound and look forward to providing an opportunity for a larger patient population to benefit from VAL-083 treatment. We look forward to providing updates on the progress of all of our clinical programs," commented Saiid Zarrabian, DelMar’s Chief Executive Officer.
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: