Atossa Genetics (NASDAQ:ATOS) is a mover and shaker out on the Street today, with investors sparking the stock on an almost 17% upturn. Why the excitement? The company announced that the phase 1 study of topical endoxifen in men has completed dosing and clinical visits. Data is expected in 3Q18 which should set the stage to move into a phase 2 program in gynecomastia (male breast enlargement).
“We are now proceeding to the final stages of this study, which are to complete analysis of blood samples and then collect and analyze the data,” commented Steve Quay, Ph.D., M.D., President and CEO of Atossa. “We expect to report preliminary results from the study in the next quarter,” added Dr. Quay.
Maxim analyst Jason McCarthy opined, “Both the topical and oral formulations of endoxifen continue to advance and management is executing on its clinical strategy. Catalysts lay ahead as data emerges from ongoing and upcoming studies, which if positive should drive a higher valuation.”
The objectives of the placebo-controlled, repeat dose study of 24 healthy male volunteers are to assess the pharmacokinetics of a proprietary topical Endoxifen dosage form over 28 days, as well as to assess safety and tolerability.
Atossa is developing topical Endoxifen for a condition in men called gynecomastia, which is male breast enlargement. According to the Mayo Clinic, 25% of men in the U.S. between the ages of 50-69, or approximately 10 million men, suffer from gynecomastia. It is the most common male breast disorder and is caused by a hormone imbalance where testosterone is low compared to estrogen. For example, in prostate cancer treatment, testosterone is suppressed with androgen deprivation therapy resulting is higher estrogen levels that usually triggers gynecomastia. One recent study indicates that up to 90% of men taking androgen deprivation therapy suffer from gynecomastia and breast pain (Handoo Rhee, et al., October 18, 2014, BJU International). There is no FDA-approved pharmaceutical to treat gynecomastia. Current therapeutic approaches in these patients include the daily use of oral estrogen-suppressing medications and prophylactic breast bud irradiation which is often repeated.