Investors are apparently looking forward to getting some insight on how Atossa Genetics (NASDAQ:ATOS) fared in its early-stage study of its experimental oral drug endoxifen.
Endoxifen is the active ingredient in the commonly-used tamoxifen, a drug first approved by the U.S. Food and Drug Administration (FDA) 40 years ago used to treat breast cancer and in breast cancer survivors to prevent relapse.
The first step down the regulatory pathway for a proprietary metabolite of an approved drug is a Phase 1 study in healthy volunteers, which is what Atossa completed with a 48-patient, dose escalation trial this summer. The trial's purpose is to verify safety, tolerability and to get a better read on the pharmacokinetics of the drug. Being that the patients are healthy, efficacy is of no consideration in this type of study.
Atossa is developing the drug in two formulations, an oral and a topical, with patients in different arms of the study receiving either topical or oral plus topical endoxifen.
Preliminary results from the topical delivery cohort released last month showed the study met its endpoints of safety (no drug-related serious adverse events), tolerability (all dose levels well tolerated) and pharmacokinetics (endoxifen crossed the skin barrier, as confirmed by detection in blood levels). Regardless of delivery method, volunteers received 28 days of therapy.
Now the company is ready to report preliminary results from the oral portion of the double-blind, placebo-controlled trial. Atossa will be hosting a conference call at 10 a.m. EDT this Wednesday (Oct. 25) to disclose the data to date.
Obviously, investors will be looking for all the endpoints to be met again, allowing Atossa to move forward with additional clinical studies in breast cancer patients to further build the safety profile and look for evidence of efficacy.
Traders are bidding up the stock in Monday morning trading, making it one of the best performing NASDAQ-listed companies. Shares closed on Friday at 48 cents and gapped ahead to 54 cents before rising as high as 64 cents and then settling to 59 cents at the noon hour EDT.
