Seattle Based Atossa Genetics Opens Their First Phase 2 Study Using Proprietary Topical Endoxifen For MDB
Seattle based Atossa Genetics Inc. (Nasdaq: ATOS), a clinical-stage pharmaceutical company developing novel therapeutics and delivery methods to treat breast cancer and other breast conditions has opened its Phase 2 study of proprietary topical Endoxifen on mammographic breast density, or MBD, reduction. The Phase 2 study is being conducted at Stockholm South General Hospital in Sweden and is being led by principal investigator Dr. Per Hall, MD, Ph.D., Head of the Department of Medical Epidemiology and Biostatistics at Karolinska Institutet. The primary endpoint is to determine if topical Endoxifen administration results in an individual change in MBD, which will be measured after three and six months of entering the study. The secondary endpoints are safety and tolerability. Ninety participants will be randomized to one of three groups (one placebo group and two groups of different strengths of topical Endoxifen) with 30 participants per group. The objective of the study is to determine if MBD is reduced, and if so, the results will drive sample size calculations for a future Phase III study. Enrollment is anticipated to be completed by the end of 2018.
Steve Quay, Ph.D., MD, President and CEO of Atossa stated, “Opening our first Phase 2 study using our proprietary topical Endoxifen marks a major milestone in our clinical development. We look forward to working with Dr. Hall and his clinic to enroll women in this ground-breaking study and to move our topical Endoxifen a step closer to treating women with MBD. We are also making progress with our proprietary oral Endoxifen and have been evaluating a potential new indication in the pre-surgery, or “window of opportunity,” setting which involves treating newly diagnosed breast cancer patients prior to surgery. We believe this indication could have a quicker clinical and regulatory pathway. We plan to start a Phase 2 study in the next quarter in this window of opportunity setting and/or a Phase 2 study in breast cancer survivors who are “refractory” to tamoxifen.”
Endoxifen is an active metabolite of tamoxifen. Tamoxifen is an FDA-approved drug to prevent new breast cancer as well as recurrent breast cancer in breast cancer patients. Tamoxifen itself must be broken down by the liver into active compounds (metabolites), of which Endoxifen is the most active. Atossa has completed a comprehensive Phase 1 clinical study using both a topical and an oral formulation of Endoxifen. Results from the topical arm of the Phase 1 study indicated that the topical formulation was safe, well tolerated and that topical Endoxifen crossed the skin barrier in a dose-dependent fashion.
Shares Of Atossa Moved Higher
Shares of Atossa (ATOS) moved higher today closing at $2.41/share up +2.99%.
Maxim Group’s Biotechnology Analyst Jason McCarthy issued an update report recently and maintained his “Buy rating” and his $10/price target.