On August 27, 2019 DelMar Pharmaceuticals, Inc. (NASDAQ: DMPI) ("DelMar" or the "Company"), a biopharmaceutical company focused on the development of novel cancer therapies, reported that the Company anticipates that its current cash position, which includes the $6.7 million in net proceeds from the underwritten offering completed August 16, 2019, will be sufficient to complete enrollment in all three patient groups of its two ongoing Phase 2 clinical trials for its lead compound, VAL-083, which the Company believes will occur by the fourth quarter of calendar year 2020 (Press release, DelMar Pharmaceuticals, AUG 27, 2019, View Source [SID1234539011]).
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"To date, we have had steady enrollment in our two Phase 2 trials, and believe that with the additional capital from our recent financing, we will be in the position to complete enrollment of our Phase 2 clinical trial in China for first-line treatment with radiation for newly diagnosed MGMT-unmethylated GBM patients, as well as both arms of our Phase 2 trial with MD Anderson Cancer Center (MDACC) – one for patients with recurrent disease and one for newly diagnosed patients who have undergone chemoradiation with temozolomide, but will now receive VAL-083 as adjuvant therapy," commented Saiid Zarrabian, president and CEO of DelMar. "We believe the complete enrollment of both of these trials is an important inflection point for the Company and we are grateful to now have the capital to reach that milestone. In the meantime, we expect to provide updates on one or more of these open-label Phase 2 GBM trials at the Society of Neuro-Oncology meeting November 20-24, the American Academy of Cancer Research in April 2020 and the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) in May 2020."
The Company’s Phase 2 trial in China is a single-arm, open-label study testing VAL-083 in combination with standard radiotherapy in GBM patients who have an unmethylated promoter of the methylguanine DNA-methyltransferase (MGMT) gene. The clinical trial in newly-diagnosed GBM patients is designed to determine if first-line treatment with VAL-083 plus radiotherapy can provide improvements over the historical efficacy of standard of care temozolomide (TMZ) plus radiotherapy. Efficacy will be measured based on tumor response to treatment, progression-free survival, progression-free survival at six months, and overall survival compared to historical results in the target population. To date, the Company has enrolled 20 of the 30 patients required for the trial, with positive early results previously reported.
The Company is also conducting a Phase 2 trial with MDACC with one arm treating patients with recurrent disease, administering VAL-083 in patients who have been heavily pre-treated with TMZ prior to disease recurrence. The recurrent arm will allow a total of 83 patients to be enrolled. The second trial arm will 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 Company will provide enrollment and treatment updates as appropriate.
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: