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|Item 8.01.|| |
On July 5, 2022, Ayala Pharmaceuticals, Inc. announced interim data results from Part A of its ongoing RINGSIDE pivotal Phase 2/3 clinical trial evaluating AL102 in desmoid tumors. In February 2022, Part A completed enrollment of 42 patients with progressive desmoid tumors in three study arms across three doses of AL102: 1.2 mg daily, 2 mg twice weekly, and 4 mg twice weekly with initial follow up to evaluate safety, tolerability and tumor volume by MRI after 16 weeks.
As of the cut-off date of May 1, 2022, 13 patients had reached the 16-week time point of which 10 had a completed central reading of their MRI scans. Of these 10 patients, nine showed a decrease in tumor size. In addition, one patient showed an unconfirmed partial response as measured by RECIST 1.1. AL102 was observed to be well tolerated at all dose levels with no dose-limiting toxicities and no Grade 4 or 5 adverse events observed. The most common treatment-related adverse events were Grade 1 and 2 and included diarrhea, fatigue, skin rash and nausea.
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|Ayala Pharmaceuticals, Inc.|
|Date: July 5, 2022||By:|
|Roni Mamluk, Ph.D.|
|Chief Executive Officer and President|