Thursday, February 24, 2022

Ayala Pharmaceuticals (AYLA)
Ayala Completes Phase 2/3 Trial RINGSIDE Part A and Confirms Data Milestone

Ayala Pharmaceuticals Inc clinical-stage oncology company focused on developing and commercializing small molecule therapeutics for patients suffering from rare and aggressive cancers, primarily in genetically defined patient populations. The company's current portfolio of product candidates, AL101 and AL102, targets the aberrant activation of the Notch pathway with gamma secretase inhibitors. Its product candidate, AL101, is being developed as a potent, selective, injectable small molecule gamma secretase inhibitor, or GSI. It is also developing AL101 for the treatment of T-ALL, an aggressive, rare form of T-cell specific leukemia.

Robert LeBoyer, Senior Research Analyst, Noble Capital Markets, Inc.

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First Stage of Phase 2/3 RINGSIDE Trial Completed Enrollment.  Ayala has announced that enrollment is complete for Part A of the Phase 2/3 RINGSIDE trial. This trial is testing the oral gamma-secretase inhibitor, AL102, in desmoid tumors. The data from this portion of the trial is expected to be announced in mid-2022, consistent with prior guidance.

Part A Is Designed To Determine Safety, Efficacy, and Dosing For Part B.  The first part of the RINGSIDE trial enrolled 36 patients to evaluate safety, tolerability, and changes in tumor volume by MRI scans. These data will be used to select the dose for Part B. A previous sub-study tested pharmacokinetics and found no food restrictions were needed ...

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