We previously reported the preliminary findings of a Phase II study (NCT00431561) confirmed its favorable safety profile and showed that OT101 can offer early disease control to R/R high-grade glioma patients at 6 months at a rate comparable to that achieved with the standard alkylating chemotherapy drug temozolomide. We are now reporting our analysis of the long-term follow-up data on the recalcitrant/resistant anaplastic astrocytoma (R/RR AA) patient subpopulation treated in the NCT00431561 study as proof of concept for the clinical utility of the Convection Enhanced Delivery of OT-101 platform (CEDOT). Notably, OT101 administered intratumorally via the CEDOT platform exhibited clinically meaningful single-agent activity and induced durable complete response (CR), partial response (PR) in more than half of the treated R/R AA patients. The median overall survival of patients receiving the CEDOT-delivered experimental therapy 1136 (95% CI:811 - 1743) days which was significantly better than the 590 (95% CI:287 - NA) days median OS (Log Rank χ2=6.5, P-value=0.011) of the TMZ-treated patient population.
“This work demonstrates superiority of OT-101 against an approved chemotherapeutic agent against AA and emphasizes our commitment to find effective new therapies for difficult-to-treat cancers,” stated Dr.
OT-101 has received orphan drug designation for glioblastoma, melanoma, and pancreatic cancer. Furthermore, FDA recently granted Rare Pediatric Designation for OT-101 against diffuse intrinsic pontine glioma (DIPG). OT-101 is also effective against coronavirus including COVID-19 and being deployed against the COVID-19 epidemic.
Mateon was created by the recent reverse merger with Oncotelic which became a wholly owned subsidiary of
The Chief Executive Officer of Mateon, Dr.
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Source: Mateon Therapeutics