DelMar Pharmaceuticals Anticipates Current Cash Runway Will Provide Sufficient Capital for Full Enrollment in All Three Patient Groups in Two Phase 2 Clinical Trials
VANCOUVER, British Columbia and MENLO PARK, Calif., Aug. 27, 2019 /PRNewswire/ -- DelMar Pharmaceuticals, Inc. (NASDAQ: DMPI) ("DelMar" or the "Company"), a biopharmaceutical company focused on the development of novel cancer therapies, today announced 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.
"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 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.
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:
About DelMar Pharmaceuticals, Inc.
DelMar is focused on the development and commercialization of new therapies for cancer patients who have limited or no treatment options. By focusing on understanding tumor biology and mechanisms of treatment resistance, the Company identifies biomarkers to personalize new therapies in indications where patients are failing, or are unable to tolerate, standard-of-care treatments.
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 & neck) in U.S. clinical trials sponsored by the NCI. Based on DelMar's internal research programs and these prior NCI-sponsored clinical studies, the Company is conducting clinical trials to support the development and commercialization of VAL-083 to solve significant unmet medical needs.
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.
Further information on DelMar's clinical trials can be found on clinicaltrials.gov: https://www.clinicaltrials.gov/ct2/results?cond=&term=val-083&cntry1=&state1=&recrs
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. 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 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 SEC, including, the Company's Annual Report on Form 10-K for the year ended June 30, 2018, the Company's Quarterly Reports on Form 10-Q, and the Company's Current Reports on Form 8-K.
Director of Public Relations
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SOURCE DelMar Pharmaceuticals, Inc.
Released August 27, 2019