Atossa Genetics Inc., (NasdaqCM; ATOS) is a Seattle-based clinical-stage biopharmaceutical company developing novel therapeutics and delivery methods to treat breast cancer and other breast conditions. ATOS announced on Monday that the FDA has approved an “expanded access” of Atossa’s proprietary oral Endoxifen in the preoperative setting in a U.S. patient awaiting surgery for breast cancer. Under the FDA Expanded Access IND program, the use of Atossa’s proprietary Endoxifen is restricted to this patient only.
The markets reacted positively to this news on Monday as ATOS shot up over 50% and hit a high of $1.85 while trading north of 16.8 million shares or approximately $28-30 million dollars of trading before closing at $1.38.
Note that Atossa is currently conducting a Phase 2 study of its oral Endoxifen in Australia in the “window of opportunity” between diagnosis of breast cancer and surgery. Steven C. Quay, Ph.D., MD, President and CEO stated. “Once a patient is diagnosed with breast cancer, there is a window of time, typically a few weeks, before surgery is performed. Our goal with this study is to show that our proprietary oral Endoxifen can modify the cancer activity in ER+ breast cancer during this ‘window of opportunity.’ Because our Phase 1 study indicated that our oral Endoxifen reaches therapeutic levels within 8 hours and therapeutic steady-state levels in only seven days, we are optimistic we can achieve a valuable treatment effect.”
The Pilot Phase of the study will initially enroll up to eight newly-diagnosed patients with ER+ and HER2 negative (HER2-) stage 1 or 2 invasive breast cancer, requiring mastectomy or lumpectomy. Patients will receive Atossa’s proprietary oral Endoxifen for at least 21 days from the time of diagnosis up to the day of surgery. Provided tumor activity reduction is demonstrated in at least two patients, an additional 17 patients will be enrolled for a total of 25. The primary endpoint is to determine if the administration of oral Endoxifen reduces the tumor activity as measured by Ki-67, which is a marker of cellular proliferation. The secondary endpoints are safety and tolerability and assessment of the study drug on expression levels of both estrogen and progesterone receptors. The impact on additional markers of cellular activity will also be explored. The Phase 2 study is being conducted on behalf of Atossa by CPR Pharma Services Pty Ltd., Thebarton, SA, Australia. CPR Pharma recently completed the successful Phase 1 study of Atossa’s oral and topical Endoxifen in women.
Steven C. Quay, Ph.D., MD, President and CEO commented further, “A physician recently contacted Atossa and requested our proprietary oral Endoxifen for a pre-menopausal, estrogen-receptor positive (ER+) breast cancer patient awaiting surgery. In this setting, the recommended preoperative endocrine systemic therapy is typically an aromatase inhibitor and a drug for ovarian suppression. The patient’s physician was reluctant to use this preoperative therapy as it typically induces menopause and can have other potentially serious side effects. We worked with the physician to apply to the FDA to provide “expanded access” (formerly known as compassionate use) to this patient under an Investigational New Drug (IND) application. We are very pleased to report that the FDA approved this single-patient study, and the patient is currently receiving our proprietary oral Endoxifen preoperatively. This is the same clinical setting as our Phase 2 ‘window of opportunity’ study of preoperative systemic oral Endoxifen in breast cancer patients which is open for enrollment in Australia.”
Note that expanded access, sometimes called “compassionate use, is a potential pathway for a patient with an immediately life-threatening condition or serious disease or condition to gain access to an investigational medical product (drug, biologic, or medical device) for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available. Expanded access may be appropriate when all the following apply: patient has a serious disease or condition, or whose life is immediately threatened by their disease or condition; there is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition; patient enrollment in a clinical trial is not possible; potential patient benefit justifies the potential risks of treatment; providing the investigational medical product will not interfere with investigational trials that could support a medical product’s development or marketing approval for the treatment indication. Investigational drugs, biologics or medical devices have not yet been approved or cleared by FDA and FDA has not found these products to be safe and effective for their specific use. Furthermore, the investigational medical product may, or may not, be effective in the treatment of the condition, and use of the product may cause unexpected serious side effects. For more information, see the FDA website: FDA Expanded Use Website
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Atossa Genetics Announces FDA Approval of Endoxifen for “Expanded Access” as Preoperative Systemic Endocrine Therapy for a U.S. Breast Cancer Patient
Steven C. Quay, Ph.D., MD, President and CEO commented, “A physician recently contacted Atossa and requested our proprietary oral Endoxifen for a pre-menopausal, estrogen-receptor positive (ER+) breast cancer patient awaiting surgery. In this setting, the recommended preoperative endocrine systemic..