REHOVOT, Israel and MONMOUTH JUNCTION, N.J., Feb. 20, 2024 (GLOBE NEWSWIRE) -- Ayala Pharmaceuticals, Inc. (OTCQX: ADXS), a clinical-stage oncology company, today announced that patient enrollment has been completed in the Phase 3 RINGSIDE study evaluating AL102 in desmoid tumors. A total of 156 patients were enrolled.

以色列REHOVOT和新泽西州MONMOUTH JUNCTION，2024年2月20日（环球通讯社）--Ayala Pharmaceuticals，Inc.（OTCQX:ADXS），一家临床阶段的肿瘤公司，今天宣布患者登记已经完成评估AL102在类胶质瘤中的3期环旁研究。共有156名患者入选。

”Completion of enrollment in RINGSIDE represents a significant milestone in the development of AL102,” said Kenneth Berlin, President and Chief Executive Officer of Ayala. “There has been a high-level of enthusiasm from clinical trial investigators, support staff, and patients during the enrollment of RINGSIDE.

Ayala总裁兼首席执行官肯尼斯·伯林（KennethBerlin）表示：“环边注册的完成代表着AL102发展的一个重要里程碑。”。“在参加比赛期间，临床试验研究人员、支持人员和患者表现出了高度的热情。

We are extremely grateful to the patients and their families, clinical investigators, operational partners and the Ayala team who have helped us achieve this important milestone several months ahead of schedule.   Completing enrollment is an important step toward our goal of providing patients and physicians with a once-daily treatment option for desmoid tumors.

We believe that AL102 has the potential to be a best-in-class gamma secretase inhibitor for this disease.” The Phase 3 segment of the RINGSIDE study is a double-blind, multi-center trial enrolling patients with progressive disease, randomized between AL102 1.2 mg dosed once daily or placebo. The primary endpoint is progression-free survival (PFS) with secondary endpoints including objective response rate (ORR), duration of response (DOR), and patient-reported Quality of Life (QOL) measures.

我们相信AL102有可能成为治疗这种疾病的最佳γ分泌酶抑制剂。”RINGSIDE研究的第3阶段是一项双盲，多中心试验，招募进行性疾病患者，随机分为每日一次服用AL102 1.2 mg或安慰剂。主要终点是无进展生存期（PFS），次要终点包括客观缓解率（ORR），缓解持续时间（DOR）和患者报告的生活质量（QOL）测量。

RINGSIDE has been designed as a registration study to support a New Drug Application (NDA) in desmoid tumors. About RINGSIDE The RINGSIDE pivotal Phase 2/3 study is a randomized global multi-center trial, with a seamless design, which allowed Ayala to continue to Phase 3 without concluding the Phase 2 .

RINGSIDE被设计为一项注册研究，以支持韧带样肿瘤的新药申请（NDA）。关于RINGSIDE RINGSIDE关键2/3期研究是一项随机的全球多中心试验，采用无缝设计，允许Ayala继续进行第3阶段而不结束第2阶段。