Shares of Atossa Genetics (NASDAQ:ATOS) rocketed Thursday after the US Food and Drug Administration gave the green light and offered expanded access to Endoxifen for the post-mastectomy treatment of a pre-menopausal, estrogen-receptor positive breast cancer patient.
The patient already has received a three-week course of Endoxifen prior to her cancer surgery as part of an FDA-approved expanded access program.
READ: Atossa Genetics kicks off Phase 2 study of topical Endoxifen to reduce breast density
“We are extremely pleased that this patient not only benefitted from Endoxifen prior to her surgery, but that the FDA agrees that continued Endoxifen therapy is appropriate for this pre-menopausal patient,” said Dr. Steven Quay, CEO of Atossa. “This positive progress supports our expansion of oral Endoxifen clinical trials.”
In response, investors were enthusiastic about Endoxifen’s prospects, sending Atossa shares up 215.2%, or by $3.25, to $4.76 in afternoon trade Thursday.
Endoxifen is a metabolite of tamoxifen, which is an FDA-approved drug to prevent new as well as recurrent disease in breast cancer patients.
Under the FDA’s agreement, the use of Atossa’s oral Endoxifen is restricted to this one patient. Approval from the Institutional Review Board (IRB) must be won before Endoxifen will be provided to the patient.
Tumor activity from the patient’s initial cancer biopsy was compared to tumor activity at her surgery and found that the cancer cell biological activity was reduced by two measures. Ki-67 activity, a marker of estrogen-receptor breast cancer cell activity, dropped by 50%, and the patient’s estrogen receptor content decreased by over 20%. No safety and tolerability issues like hot flashes and night sweats were reported.
Contact Ellen Kelleher at ellen@proactiveinvestors.com
-- This story has been updated to reflect recent share price movement --