World News: 15:04 GMT Friday 9th November 2018. [Gradalis, Inc. via Globe Newswire via SPi World News]
DALLAS, Nov. 09, 2018 (GLOBE NEWSWIRE) -- Gradalis, Inc., a clinical-stage immunotherapy company developing investigational treatments for individuals suffering from multiple cancer indications, presented initial data from its Phase 2 trial for Ewing’s sarcoma at the 2018 Annual Meeting of Children’s Oncology Group (COG).
This is a two-part open-label, non-randomized, single-arm Phase 2 study in patients with recurrent or refractory Ewing’s Sarcoma. Part 2 of the study was established in order to assess safety and efficacy of Temozolomide / Irinotecan in combination with Vigil. All patients included in the study signed informed consent for tissue procurement treatment on the study according to the requirements of each individual institution.
All eight patients had histologically confirmed Ewing’s Sarcoma. The mean age was 24 years (range: 12-46 years). All patients were heavily pretreated and failed treatment with Temozolomide and Irinotecan previously, with a mean of 5 lines of systemic treatments prior to study enrollment.
Historical progression-free survival for patients in second relapse (or greater) Ewing’s Sarcoma is 3 months or less. The median progression-free survival of the patients enrolled was 8.2 months.
The combination of Vigil, Irinotecan and Temozolomide in third-line or greater Ewing’s Sarcoma demonstrated favorable safety profile with limited treatment-related toxicities.
For more information about these clinical trials, please visit .
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Media and Investor Inquiries: Walter ChenVice President – Corporate DevelopmentGradalis, Inc. 214-442-8100
Globe Newswire: 15:04 GMT Friday 9th November 2018
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