DelMar Pharmaceuticals, Inc. (NASDAQ:DMPI) ("DelMar" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, today announced the publication of previously released interim clinical data in the February 2020 issue of peer-reviewed journal, Glioma. The article highlights results from the first 22 patients of the Company's ongoing Phase 2 clinical study investigating the first-line treatment of VAL-083 with radiation therapy in newly-diagnosed, MGMT-unmethylated glioblastoma multiforme (GBM). The article can be accessed online via http://www.jglioma.com/article.asp?issn=2589-6113;year=2019;volume=2;issue=4;spage=167;epage=173;aulast=Guo.
In the article, which was co-authored by lead investigator Professor Zhong-ping Chen of Sun Yat-sen University Cancer Center (SYSUCC) in Guangzhou, China, where the study is currently being conducted, of the 22 patients who had completed at least one cycle of treatment as of that date, median progression-free survival (PFS) with VAL-083 as reported was 9.9 months (confidence interval, or CI, 7.3-12.0 months). For the 18 patients initially receiving the intended treatment dose (30 mg/m2/day on days 1, 2 and 3 of a 21-day cycle) median PFS as reported was 10.4 months (CI 6.0-12.0 months). While this is not a head-to-head trial, historically, temozolomide (TMZ) has been demonstrated to have 6.9 months PFS in unmethylated GBM patients.
"This publication represents an important additional validation of VAL-083 as a first-line treatment. Given that an external panel of experts reviewed both the protocol and the interim data and were willing to publish based on the results and inclusive of the fact that the data came from a study originating in China. This publication is from a world-renowned journal and we believe it demonstrates the potential to achieve one of the first new treatments for GBM in many years. We look forward to providing continued updates on the development of VAL-083 as they become available," commented Saiid Zarrabian, DelMar's Chief Executive Officer.
The Phase 2 trial 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 TMZ plus radiotherapy. In the publication, authors outlined the two parts of the study. The first is a dose escalation and induction format to enroll up to ten patients to receive VAL-083 at 20, 30 or 40 mg/m2/day for three days every 21 days concurrently with standard radiation and VAL-083 for up to eight additional cycles. The second part of the study is an expansion phase to enroll up to 20 additional patients. The publication highlighted the first 23 patients enrolled, 14 of whom had been treated in the expansion phase.
Myelosuppression was the most common adverse event in the patients assessed, and pharmacokinetic assessments indicated that the levels of VAL-083 were as high in the cerebrospinal fluid as in plasma two hours after infusion.