Ayala Pharmaceuticals Announces Continuation of RINGSIDE Phase 2/3 Study in Desmoid Tumors Following Recommendation of Independent Data Monitoring Committee
Ayala Pharmaceuticals (OTCQX: ADXS) announced positive interim results from its Phase 2/3 RINGSIDE study for AL102, an investigational drug for desmoid tumors. The Independent Data Monitoring Committee (IDMC) recommended continuing the study without modifications, allowing for global patient enrollment in Phase 3. The primary endpoint is progression-free survival (PFS), with key secondary measures including objective response rate (ORR). The company plans to present updated Phase 2 data at a medical meeting in 2023. AL102 aims to address an urgent medical need as no FDA-approved systemic therapies currently exist for progressive desmoid tumors.
- IDMC recommends continuation of Phase 2/3 RINGSIDE study without modifications.
- Global enrollment for Phase 3 segment of RINGSIDE is underway.
- AL102 has the potential to be a best-in-class treatment option for desmoid tumors.
- None.
Registration-enabling Phase 3 segment of RINGSIDE is enrolling patients globally
Updated data on AL102 Phase 2 segment of RINGSIDE are planned for presentation at a medical meeting in 2023
REHOVOT, Israel and MONMOUTH JUNCTION, N.J., March 03, 2023 (GLOBE NEWSWIRE) -- Ayala Pharmaceuticals, Inc. (OTCQX: ADXS), a clinical-stage oncology company, today announced that the Independent Data Monitoring Committee (IDMC) for its Phase 2/3 RINGSIDE study evaluating investigational new drug AL102 in desmoid tumors conducted a prespecified periodic review of data from the study and recommended that the study continue without modifications.
“We thank the IDMC members for their work and guidance and are pleased with their recommendation to continue RINGSIDE with no changes,” said Ken Berlin, President and CEO of Ayala. “This recommendation was made based on the analysis of recently updated data from the Phase 2 segment of RINGSIDE. We have commenced enrollment in the Phase 3 segment of RINGSIDE on a worldwide basis. In addition, patients from Phase 2 have the opportunity to continue treatment in the open label extension in Phase 3. We believe that once-daily AL102 has best-in-class potential and are excited about its potential use in desmoid tumors. If approved, we believe it will be a valuable addition to the future therapeutic armamentarium in this underserved indication.”
Andres Gutierrez, M.D. Ph.D., EVP and Chief Medical Officer of Ayala, stated, “The IDMC is looking forward to reviewing the long term-safety profile of AL102 from the open label extension of Phase 2 and has also agreed to the proposed plans for analysis and reporting of results in the ongoing Phase 3 segment of the study. We plan to present these recently updated data from the Phase 2 segment of RINGSIDE at an upcoming medical meeting in 2023.”
Phase 3 of RINGSIDE is a double-blind, placebo-controlled, clinical trial enrolling up to 156 patients with progressive disease, comparing AL102 at 1.2 mg once-daily to placebo. The primary endpoint for Phase 3 is progression-free survival (PFS) with secondary endpoints including objective response rate (ORR), duration of response (DOR), tumor volume reduction, and patient-reported Quality of Life (QOL) measures. For more information on the RINGSIDE Phase 2/3 study of AL102 for the treatment of desmoid tumors, please visit ClinicalTrials.gov and reference Identifier NCT04871282 (RINGSIDE).
About Desmoid Tumors
Desmoid tumors, also called aggressive fibromatosis or desmoid-type fibromatosis, are rare connective tissue tumors that typically arise in the upper and lower extremities, abdominal wall, head and neck area, mesenteric root, and chest wall, or other parts of the body. Desmoid tumors do not metastasize, but often aggressively infiltrate neurovascular structures and vital organs. People living with desmoid tumors are often limited in their daily life due to chronic pain, functional deficits, general decrease in their quality of life and organ dysfunction. Desmoid tumors have an annual incidence of approximately 1,700 patients in the United States and typically occur in patients between the ages of 15 and 60 years. They are most commonly diagnosed in young adults between 30-40 years of age and are more prevalent in females. Today, surgery is no longer regarded as the cornerstone treatment of desmoid tumors due to surgical morbidity and a high rate of recurrence post-surgery. There are currently no FDA-approved systemic therapies for the treatment of unresectable, recurrent or progressive desmoid tumors.
About Ayala Pharmaceuticals, Inc.
Ayala Pharmaceuticals, Inc. is a clinical-stage oncology company primarily focused on developing and commercializing small molecule therapeutics for people living with rare tumors and aggressive cancers and is also developing proprietary Lm-based antigen delivery products for patients suffering from more common cancers. The Company’s lead candidates under development are the oral gamma secretase inhibitor, AL102, for desmoid tumors; ADXS-504, a Lm-based therapy for early-stage prostate cancer; and the intravenous gamma secretase inhibitor, AL101, for adenoid cystic carcinoma. AL102 has received Fast Track Designation from the U.S. FDA and is currently in the Phase 3 segment of a pivotal study for patients with desmoid tumors (RINGSIDE). For more information, visit www.ayalapharma.com.
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