Atossa Advancing Into Phase 2 Study to Reduce Gynecomastia In Men Starting Prostate Cancer Therapy
Gynecomastia is male breast enlargement and accompanying pain, which according to the Mayo Clinic, affects 25% of men in the U.S. between the ages of 50-69, or approximately 10 million men. It is the most common male breast disorder and is caused by a hormone imbalance where testosterone levels are lower than estrogen. Gynecomastia is caused by, among other things, any number of commonly prescribed medications, such as androgen deprivation therapy to treat prostate enlargement and prostate cancer, anti-anxiety medications, cancer treatments (chemotherapy), and some heart medications.
Gynecomastia is not only painful and embarrassing, it can also cause men to stop taking their prescribed medication. In prostate cancer treatment, testosterone is suppressed resulting in higher estrogen levels that often 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 use of daily oral estrogen-suppressing medications and prophylactic breast bud irradiation which is often repeated. Gynecomastia can create quality of life issues, with some patients attempting to hide the condition with compression garments and, in some cases, undergoing plastic surgery.
Seattle-based Atossa Genetics Inc. (NASDAQ: ATOS), a clinical-stage biopharmaceutical company developing novel therapeutics and delivery methods for breast cancer and other breast conditions, reported earlier today their preliminary results from its Phase 1 dose- escalation study of its proprietary topical Endoxifen in male subjects. All objectives were announced to have been successfully met as follows:
- Safety: There were no clinically significant safety signals and no clinically significant adverse events in participants receiving topical Endoxifen.
- Tolerability: Topical Endoxifen was well tolerated at each dose level and for the dosing duration utilized in the study.
- Pharmacokinetics: Blood samples showed no measurable topical Endoxifen.
Dr. Steven C. Quay, CEO, and President of Atossa stated, “Based on these positive preliminary results, we are advancing our topical Endoxifen into a Phase 2 study to reduce gynecomastia in men starting prostate cancer therapy. We anticipate retaining a clinical research organization to manage that study in the fourth quarter of 2018. In addition to advancing our mens’ program into a Phase 2 study, we also have multiple Phase 2 studies in women addressing large markets with significant unmet needs: breast cancer and a condition called mammographic breast density. We look forward to reporting progress on these programs in the fourth quarter of 2018 and into 2019.”
Atossa Genetics hosted a conference call to discuss preliminary results today at 10 am Eastern time. A replay of the call will be available approximately one hour after the end of the call through October 13, 2018. The replay can be accessed via Atossa’s website or by dialing 877-344-7529 (domestic) or 412-317-0088 (international) or Canada Toll-Free at 855-669-9658. The replay access code is 10124008.