Atossa Genetics Completes Enrollment in Endoxifen Phase 1 Study

Atossa Genetics (NASDAQ:ATOS) completed enrollment for their Phase 1 dose escalation study of Atossa’s proprietary Endoxifen.
As quoted in the press release:

Endoxifen is an active metabolite of the FDA-approved drug tamoxifen, which is currently used to treat breast cancer and for breast cancer prevention in high risk patients.

“We have now completed enrollment in both the oral and topical arms of our proprietary Endoxifen Phase 1 dose escalation study,” commented Dr. Steven Quay, CEO and President of Atossa. “The speed at which this study fully-enrolled is a testament to the enthusiasm for potential new therapies in the breast cancer field, as well as the hard work and dedication of our CRO, CPR Pharma, and the personnel at Atossa.  We hope to report initial top-line data before the end of the quarter and then, subject to favorable Phase 1 results and other regulatory requirements, proceed to one or more Phase 2 studies using both our oral and topical formulations,” added Dr. Quay.
The objectives of this double-blinded, placebo-controlled, repeat dose study of 48 healthy female subjects is to assess the pharmacokinetics of proprietary formulations of both oral and topical Endoxifen dosage forms over 28 days, as well as to assess safety and tolerability. The study is being conducted in two parts based on route of administration.

Click here to read the full press release.

Source: globenewswire.com