9 December 2019 - - US-based specialty pharmaceutical company Eagle Pharmaceuticals, Inc. (NASDAQ: EGRX) has commenced dosing in a pilot clinical study to assess the unique characteristics of its fulvestrant product candidate, which has the potential to enhance estrogen receptor inhibition and improve patient outcomes, the company said.

The results of the pilot study will inform the design of the company's pivotal trial, which Eagle expects to commence in 2020.

Fulvestrant, an estrogen receptor antagonist with no agonist properties, is approved by the US Food and Drug Administration for the treatment of advanced hormone-related breast cancers.

The therapeutic effect of fulvestrant relies on its ability to inhibit ERs in cancer cells by binding to and downregulating, or blocking, the ER in breast cancer cells. Recent studies have shown that higher residual ER availability is associated with early disease progression.

Fulvestrant is indicated as a monotherapy treatment of hormone receptor -positive, human epidermal growth factor receptor 2 -negative advanced breast cancer in postmenopausal women not previously treated with endocrine therapy, or HR-positive advanced breast cancer in postmenopausal women with disease progression following endocrine therapy, or as a combination therapy for the treatment of: (1) HR-positive, HER2-negative advanced or metastatic breast cancer in postmenopausal women, in combination with ribociclib, as initial endocrine based therapy or following disease progression on endocrine therapy, or (2) HR-positive, HER2-negative advanced or metastatic breast cancer, in combination with palbociclib or abemaciclib, in women with disease progression after endocrine therapy.

Eagle is a specialty pharmaceutical company focused on developing and commercializing injectable products that address the shortcomings, as identified by physicians, pharmacists and other stakeholders, of existing commercially successful injectable products.