DelMar Pharmaceuticals said Tuesday that 17 of the first 20 enrolled patients have received at least their first assessment, and nine have been assessed as having achieved a complete response (CR) (9/17, or 53%), seven have been assessed with stable disease (SD), (7/17, or 41%), while nine has been assessed as disease progression (PD) (1/17, or 6%).
The company said that two patients have not been enrolled long enough to receive their first assessment and one patient died before their first assessment. Furthermore, 16 of the 20 patients enrolled (80%) were still alive as of the August 1, 2019 data cut-off date.
Dr. David Reardon, clinical director of the Center for Neuro-Oncology at the Dana-Farber Cancer Institute, and Dr. John de Groot, Professor and Chairman ad interim in the Department of Neuro-Oncology at The University of Texas MD Anderson Cancer Center (MDACC), agree that patients need something better, and they feel that VAL-083 has some promise and potential.
Dr. Reardon said: “For a tumor such as GBM, which is intrinsically infiltrative and destructive in the brain, stabilization of disease is an important achievement.”
Professor Zhong-ping Chen, the study’s principal investigator, said: “We are pleased to be leading this Phase 2 trial for first-line GBM treatment with DelMar, and are encouraged by the enhanced levels of tumor shrinkage and the complete responses we are observing after treatment with VAL-083 in combination with radiation. These preliminary data appear to support the premise that VAL-083 has the potential to provide a valuable treatment option for these patients. We look forward to completing full enrollment in the study as soon as possible.”
The company noted this Phase 2 trial which is being conducted at SYSUCC in Guangzhou, China, and in collaboration with Guangxi Wuzhou Pharmaceutical Company, is designed to enroll up to 30 patients to determine whether first-line therapy with VAL-083 treatment improves progression free survival (PFS).
Saiid Zarrabian, DelMar’s president and chief executive officer, said: “We continue to be encouraged by these early results and look forward to the completion of enrollment for our two, late-stage, Phase 2 studies. These results support our optimism that VAL-083 may provide a better treatment option than currently available treatments.”