Allarity Therapeutics Accelerates Trial Enrollment To Bring FDA-Approved Breast Cancer Treatment To European Market - Interim Results Could Be Released In Second Half Of 2023

CAMBRIDGE, MA / ACCESSWIRE / April 27, 2023 / Recently, Allarity Therapeutics, Inc. (NASDAQ:ALLR) announced plans to speed up its Phase 2 clinical trial for IXEMPRA®, the clinical-stage pharma company's metastatic breast cancer treatment. Already approved by the Food and Drug Administration (FDA) for patients in the United States, the company is sponsoring this current trial as part of its work to get IXEMPRA® and IXEMPRA-DRP® the companion diagnostic approved as a treatment in Europe. With the accelerated recruitment of patients, Allarity aims to release interim data from the trial in the second half of 2023.

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The Phase 2 Trial Combines IXEMPRA® With Allarity's Precision Diagnostic Technology

Originally developed by Bristol Myers Squibb, IXEMPRA is a small molecule targeted inhibitor of microtubules, the structures that help form the cancer cell's cytoskeleton and regulate cell growth. IXEMPRA® attaches to these microtubules to block the process of dividing and multiplying, ultimately causing the cancer cell to die. As such, it's meant to both kill existing cancer cells and slow the growth of new ones.

It was already approved by the FDA for the U.S. market in 2007, where it is marketed by its current owner R-PHARM U.S., LLC, thanks to its ability to increase progression-free survival rates and overall response rates in patients with metastatic breast cancer. Allarity owns exclusive development rights for the drug in Europe, where it is not currently approved.

What really sets the Phase 2 trial apart from others, however, is Allarity's patented Drug Response Predictor (DRP®) platform, which the company has used to develop a companion diagnostic to help identify which patients are most likely to benefit from IXEMPRA®, Allarity owns exclusive development rights for the drug in Europe. This is key because as promising as any new cancer treatment may be, the reality is that many patients may not respond or at least not respond as strongly as they would to a different treatment. Most cancer drugs approved by the FDA have a response rate of 40% or less, meaning fewer than half of patients will see a significant reduction in tumor size.