Atossa Genetics Inc (NASDAQ:ATOS) investors are upbeat today upon news that this biotech player’s breast health program is getting an expansion. Specifically, the company is ready to launch a breast health initiative to investigate topical Endoxifen in men- biotech buzz sending shares on a nearly 9% upturn.
The ATOS team hopes this Phase 1 trial will act as the groundwork to explore men’s breast health down the line, with enrollment now opening.
For context, Tamoxifen is an active metabolite of tamoxifen, an FDA approved drug for breast cancer in women. The objectives of the placebo-controlled, repeat dose study of 24 healthy male volunteers are to assess the pharmacokinetics of proprietary topical Endoxifen dosage forms over 28 days, as well as to assess safety and tolerability.
Dr. Steven Quay, Ph.D., MD, President and CEO of Atossa, commented that “Initiating a program for mens’ breast health is a natural extension for our proprietary Endoxifen, which has focused on women to date. This Phase 1 study of topical Endoxifen in men should serve as a foundation for future development into mens’ breast health, including male breast cancer and gynecomastia. Men being treated for prostate cancer currently have limited options to address the gynecomastia that is associated with their cancer treatment, such as breast-bud irradiation, estrogen suppression therapy and surgery.”
“After reviewing the data obtained from our recently-completed Phase 1 study in women, expanding our program to include the men, whose breast health is often underserved, was a logical next step. We have progressed rapidly in this endeavor having engaged the necessary contract research organizations and having submitted and received approval to open the study for enrollment. This will be the first of other studies targeting mens’ breast health. We look forward to reporting progress on this study as well as the other anticipated studies we are commencing in 2018,” concluded Dr. Quay.
The study is being conducted on behalf of Atossa by CPR Pharma Services Pty Ltd., Thebarton, SA, Australia. CPR Pharma recently completed the successful Phase 1 study of Atossa’s oral and topical Endoxifen in women.
According to TipRanks, Jason Kolbert of Maxim is bullish on this biotech player, rating a Buy on ATOS shares with a $2 price target. Notably, Kolbert’s target expectations suggest a 257% upside from where the stock is currently trading.