Innovative Breast Cancer Therapeutics & Delivery Methods Developer Atossa Genetics (ATOS) Reports Trial Progress
Atossa Genetics Inc. (NasdaqCM: ATOS), a clinical-stage pharmaceutical company developing novel therapeutics and delivery methods for breast cancer and other breast conditions, announced recently that it has completed enrollment in its Phase 1 dose escalation study of Atossa’s proprietary Endoxifen. Endoxifen is an active metabolite of the FDA-approved drug tamoxifen, which is currently used to treat breast cancer and for breast cancer prevention in high risk patients.
“We have now completed enrollment in both the oral and topical arms of our proprietary Endoxifen Phase 1 dose escalation study,” commented Dr. Steven Quay, CEO and President of Atossa. “The speed at which this study fully-enrolled is a testament to the enthusiasm for potential new therapies in the breast cancer field, as well as the hard work and dedication of our CRO, CPR Pharma, and the personnel at Atossa. We hope to report initial top-line data before the end of the quarter and then, subject to favorable Phase 1 results and other regulatory requirements, proceed to one or more Phase 2 studies using both our oral and topical formulations,” added Dr. Quay.
The objectives of this double-blinded, placebo-controlled, repeat dose study of 48 healthy female subjects is to assess the pharmacokinetics of proprietary formulations of both oral and topical Endoxifen dosage forms over 28 days, as well as to assess safety and tolerability. The study is being conducted in two parts based on route of administration.
Atossa has also now completed the transfer of its Fulvestrant Microcatheter Phase 2 study from Columbia University Medical Center Breast Cancer Programs, where the study was initiated, to Montefiore Medical Center, New York, NY.
“We are pleased to report that the study has been transferred to Montefiore, which is a nationally-ranked hospital,” commented Dr. Quay. “While we cannot project the timing of completing enrollment in the study at this time, we look forward to providing updates as this clinical trial continues to advance,” stated Dr. Quay.
The Fulvestrant Microcatheter Phase 2 study includes 30 women with ductal carcinoma in-situ (DCIS) or invasive breast cancer slated for mastectomy or lumpectomy. This study will assess the safety, tolerability and distribution of fulvestrant when delivered directly into breast milk ducts of these patients via microcatheters compared to those who receive the same product intramuscularly. The secondary objective of the study is to determine if there are changes in the expression of Ki67 as well as estrogen and progesterone receptors between a pre-fulvestrant biopsy and post-fulvestrant surgical specimen. Digital breast imaging before and after drug administration in both groups will also be performed to determine the effect of fulvestrant on any lesions as well as breast density of the participant. Six study participants will receive the standard intramuscular fulvestrant dose of 500 mg to establish the reference drug distribution, and 24 participants will receive fulvestrant by intraductal instillation utilizing Atossa’s proprietary microcatheter technology.
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