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Aileron Begins Treating p53-Mutated Breast Cancer Patients in Study of Chemo-Protective Drug

NEW YORK – Aileron Therapeutics said Thursday that patients with p53-mutated breast cancer have begun receiving ALRN-6924, its drug designed to prevent chemotherapy-related toxicities, in a Phase Ib trial.

The randomized-controlled trial will involve 30 patients with p53-mutated breast cancer who are receiving neoadjuvant treatment with doxorubicin plus cyclophosphamide and docetaxel and assess whether ALRN-6924 can protect against bone marrow toxicities and other adverse effects.

All patients in the trial will receive doxorubicin plus cyclophosphamide followed by docetaxel as neoadjuvant treatment. Eight patients with p53-wild type breast cancer will receive this regimen without ALRN-6924 and serve as the control group. A dozen patients with p53-mutated tumors will be randomized to two different ALRN-6924 doses in the first part of the study. Once a dose of ALRN-6924 is established, in the second part of the study, 10 patients will receive the chemo regimen and the selected ALRN-6924 dose.

Doxorubicin plus cyclophosphamide and docetaxel is known to cause severe neutropenia in up to three-quarters of patients and alopecia in 90 percent of those receiving the regimen. In earlier, nonclinical studies, the Boston-based firm found that ALRN-6924 was able to stop cell cycling and protect bone marrow stem cells, epithelial gut mucosa cells, and hair follicles from chemo-induced toxicities.

Aileron further demonstrated in a proof-of-concept study that the drug reduced bone marrow toxicities in patients with small cell lung cancer who had been treated with topotecan. Last year, Aileron started a Phase Ib trial of ALRN-6924 to explore the chemo-protective effects of the drug in patients with p53-mutated non-small cell lung cancer. In that trial, 60 patients received carboplatin or pemetrexed with ALRN-6924 or a placebo.

"Dosing of the first patients in our Phase 1b trial in patients with p53-mutated neoadjuvant breast cancer is an important step in advancing our vision to bring chemoprotection to all patients with p53-mutated cancer regardless of the type of cancer or chemotherapy," Aileron President and CEO Manuel Aivado said in a statement. "This breast cancer trial may potentially open an additional regulatory opportunity with established precedents for supportive care drug approvals."