REHOVOT, Israel and MONMOUTH JUNCTION, N.J. - Ayala Pharmaceuticals, Inc. (OTCQX: ADXS), a clinical-stage oncology company, has announced the completion of patient enrollment for its Phase 3 RINGSIDE study, which is evaluating the efficacy of the drug AL102 in treating desmoid tumors. This marks a significant milestone for the company, with a total of 156 patients enrolled in the study.
The RINGSIDE study is a double-blind, multi-center trial focusing on patients with progressive desmoid tumors. Participants are randomized to receive either a 1.2 mg dose of AL102 once daily or a placebo. The primary goal of the study is to measure progression-free survival (PFS), with secondary endpoints including objective response rate (ORR), duration of response (DOR), and patient-reported Quality of Life (QOL) measures.
Kenneth Berlin, President and CEO of Ayala Pharmaceuticals, expressed gratitude for the high level of enthusiasm from clinical trial investigators, support staff, and patients, which enabled the study to reach this stage several months ahead of schedule. The completion of enrollment is seen as a crucial step towards offering patients and physicians a new once-daily treatment option for desmoid tumors.
The RINGSIDE study is designed to support a New Drug Application (NDA) for AL102 in desmoid tumors. The Phase 3 segment follows the Phase 2 part of the study, which evaluated the efficacy, safety, tolerability, and tumor volume reduction of AL102 in a smaller group of patients.
In addition to its work on desmoid tumors, Ayala Pharmaceuticals is also developing treatments for other rare tumors and aggressive cancers. The company's lead candidates include AL102 and aspacytarabine (BST-236), which is being investigated for the treatment of acute myeloid leukemia (AML).
The news comes on the heels of a February 6, 2024 announcement that Ayala entered into an agreement with Immunome (Nasdaq:IMNM) for the acquisition of certain assets related to AL102 and another drug candidate, AL101.
The information for this article is based on a press release statement from Ayala Pharmaceuticals.
InvestingPro Insights
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