Breast Cancer Innovator Atossa Genetics Receives Second Positive Interim Safety Review from Independent Safety Committee in Study of Men With Male Breast Enlargement
Seattle based Atossa Genetics Inc. (ATOS), a clinical-stage pharmaceutical company developing novel therapeutics and delivery methods to treat breast cancer and other breast conditions, has received a second positive interim safety review on its Phase 1 study of topical Endoxifen in men, which is being developed to address gynecomastia (or male breast enlargement). The objectives of this double-blinded, placebo-controlled, repeat dose study of 24 healthy male subjects is to assess the pharmacokinetics of proprietary formulations of topical endoxifen dosage forms over 28 days, as well as to assess safety and tolerability. The study is being conducted on behalf of Atossa by CPR Pharma Services Pty Ltd., Thebarton, SA, Australia. The Independent Safety Committee reviewed the blinded data generated from the second group in the study (eight subjects) and concluded that the study may advance to the final dosing level.
Gynecomastia is male breast enlargement and accompanying pain. It is the most common male breast disorder and is caused by a hormone imbalance where testosterone is low compared to estrogen. In prostate cancer treatment, testosterone is suppressed resulting is higher estrogen levels that usually triggers gynecomastia. Prophylactic breast bud irradiation is commonly used in prostate cancer patients, but must often be repeated. 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). According to the Mayo Clinic, although it can affect men at almost any age, it is most prevalent in men ages 50-69, affecting at least 1 in 4 men in this age group. 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 these important medications.
Atossa will host a corporate conference call to discuss the Company’s business on Wednesday, May 16, 2018, at 4:30 EDT. The call is being provided so that stockholders and potential investors can hear directly from senior management about the Company’s business with a focus on recent developments. Due to expected high call attendance, participants are asked to pre-register for the call through the following link: http://dpregister.com/10120189. Please note that registered participants will receive their dial-in number upon registration and will dial directly into the call without delay. Those without internet access or who are unable to pre-register may dial in by calling: 1-844-824-3830 (domestic), 1-412-317-5140 (international) and Canada Toll-Free: 1-855-669-9657. Callers should ask to be joined into the Atossa Genetics call.
The conference call will also be available through a live webcast through the Company’s IR events page at http://ir.atossagenetics.com/ir-calendar or through the following link: https://services.choruscall.com/links/atos180507.html.
Dr. Steven Quay, Ph.D., MD, President and CEO of Atossa stated, “We can now advance to the next level of the study which is to escalate the dosage in the third and final cohort of subjects as we continue to monitor safety and tolerability in the first and second cohorts of the study. We plan to complete enrollment this quarter and announce results from the study next quarter.”
There are no FDA-approved therapeutics for gynecomastia. Breast-bud irradiation, use of compression garments and plastic surgery are the most common approaches used to treat gynecomastia.