On March 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 it has exceeded 50% enrollment in the adjuvant arm of the Company’s ongoing Phase 2 clinical study investigating adjuvant treatment (pre-temozolomide — or TMZ – maintenance therapy) of MGMT-unmethylated glioblastoma multiforme (GBM) with VAL-083 (Press release, DelMar Pharmaceuticals, MAR 4, 2020, View Source [SID1234555175]). The 24-patient, open label study arm has now enrolled 14 patients and continues to enroll at an encouraging rate.
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The adjuvant arm of the Phase 2 study of VAL-083 being conducted at the MD Anderson Cancer Center (MDACC) is designed to enroll up to 24 newly-diagnosed patients who have undergone surgery and chemoradiation with TMZ but will now receive VAL-083 in place of standard of care TMZ for adjuvant therapy.
"The pace of enrollment for the adjuvant arm of the study has been very encouraging and we hope to see both that arm, and the recurrent arm continue to enroll patients steadily. We will continue to provide updates as they become available," commented Saiid Zarrabian, DelMar’s Chief Executive Officer. "In the meantime, having completed enrollment of our first-line study, we continue to anticipate an initial data readout before the end of August 2020."
The Company’s second study arm being conducted at MDACC is the recurrent trial arm, which is enrolling patients 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, 68 recurrent patients have been enrolled in the recurrent arm. DelMar is actively enrolling patients for both trial arms of the clinical study at MDACC.
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: