DelMar Pharmaceuticals, Inc. ($DMPI) continues to lead the fight against cancer with their anti-cancer drug’s continued and consistent positive performance. The Vancouver-based company announced updated data from the fully enrolled 14-patient expansion cohort of the Company's ongoing Phase II clinical study of VAL-083 in refractory glioblastoma multiforme (GBM).
The data was presented at the 20th Annual Scientific Meeting and Education Day of the Society for Neuro-Oncology in a poster entitled, "Phase I/II study of Dianhydrogalactitol (VAL-083) in Patients with Recurrent Malignant Glioma." Updates regarding the study, being conducted at the Sarah Cannon Research Institute, the Mayo Clinic, and UCSF Medical Center, include:
● 14 patients have been enrolled in the Phase II expansion cohort and all patients have received at least one cycle of treatment to date.
● Safety observations in the Phase II expansion cohort to date are consistent with the Phase I dose-escalation cohort. Generally, observed myelosuppression is mild (Grade 1), with the exception of one patient.
● One subject previously treated with CCNU developed Grade 4 thrombocytopenia suggesting patients with prior nitrosourea treatment who may exhibit higher susceptibility to thrombocytopenia. The inclusion criteria were modified to account for this observation.
● A Kaplan Meyer survival estimate based on interim analysis of patients enrolled in the Phase II expansion cohort is consistent with observations made in the Phase I dose-escalation portion of the study. This preliminary interim analysis suggests a potentially meaningful survival benefit in this population following treatment with VAL-083 at doses >30 mg/m2/d in comparison to published reports for the same refractory GBM population.
"The interim survival data from the Phase II expansion cohort is highly promising and consistent with our observations from the Phase I dose-escalation portion of the trial," stated Jeffrey Bacha, CEO of DelMar. "A Kaplan Meyer survival estimate, based on these preliminary interim data, projects a greater than 9-month median survival in refractory GBM patients whose tumors have recurred following both front-line therapy with temozolomide and second-line bevacizumab (Avastin®) treatment."
DelMar has made a number of significant strides with its anti-cancer drug, VAL-083, a first-in-class, small-molecule chemotherapeutic. Currently, VAL-083 is used to treat chronic myelogenous leukemia lung cancer in China, and is currently undergoing clinical trials in the US. Furthermore, the anti-cancer drug has shown promising results in the treatment of other cancers, such asbrain tumorsand non-small celllung cancer.
"Additionally, we have continued to demonstrate that the cytotoxic mechanism of VAL-083 is distinct from other chemotherapies used in the treatment of cancer,” said Bacha. “We can leverage this new understanding of how VAL-083 attacks the tumor with clinical trial data from previously conducted Phase I and Phase II NCI-sponsored clinical trials that validates VAL-083's clinical activity against a range of tumor-types to address modern unmet medical needs in the treatment of cancer."
In their mission to develop and commercialize new cancer therapies, DelMar Pharmaceuticals’ VAL-083 continues to bring the hope of an effective cancer treatment to fruition. "These results continue to support the potential of VAL-083 to address the significant unmet medical need for these patients who currently have no approved therapeutic options," said Bacha.
Equities.com had the opportunity to interview Jeffrey Bacha, President and CEO of DelMar Pharmaceuticals. The interview can be watchedhere. For more information about DelMar Pharmaceuticals, visitwww.delmarpharma.com.
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