Tuesday, January 05, 2021

Ayala Pharmaceuticals (AYLA)
Pivotal Desmoid Tumor Trial is Set to Initiate in H1 2021

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.

Ahu Demir, Ph. D., Biotechnology Research Analyst, Noble Capital Markets, Inc.

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Ayala receives the green light to proceed with a Phase 2/3 pivotal study for desmoid tumor. Yesterday, Ayala announced that the U.S. Food and Drug Administration (FDA) agreed to allow Ayala to proceed with a Phase 2/3 study, which can potentially be a registration-enabling pivotal trial, evaluating AL102 for the treatment of desmoid tumors.

What is next?.  The company intends to commence Phase 2/3 RINGSIDE study in adult and adolescent patients with desmoid tumors in H1 2021. RINGSIDE study will include two parts: Part 1 to enroll 36 patients assessing 3 doses of AL102 and Part 2 to use a double-blind placebo-controlled section enrolling up to 156 patients. The interim data read-out from Part 1 and dose selection is expected by ...

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