Atossa Genetics Initiates Additional Drug Development Program
Oral Endoxifen for Patients Refractory to Tamoxifen
(firmenpresse) - SEATTLE, WA -- (Marketwired) -- 06/07/16 -- Atossa Genetics Inc. (NASDAQ: ATOS) today announced that it has initiated a new drug development program with oral endoxifen. Endoxifen is an active metabolite of tamoxifen, an FDA approved drug for breast cancer patients to prevent recurrence as well as new breast cancer.
Dr. Steve Quay, President and CEO, commented, "We have made substantial progress with this drug candidate: we have filed patent applications; contracted for the initial drug supply; and we have identified its initial indication -- breast cancer patients who are refractory to tamoxifen thereby getting little or no benefit from the drug. It is estimated that over one million people take tamoxifen annually in the United States and that up to 50% of those patients are refractory for any number of reasons, including low levels of a liver enzyme."
Atossa has received valuable input from the Medicines and Healthcare Products Regulatory Agency, or the MHRA, which is the United Kingdom health regulatory authority. Written guidance from the FDA is expected this week.
Atossa will pursue strategic initiatives that include completion of the product development to support an IND filing to the FDA, which is anticipated to occur later this year.
Atossa Genetics Inc. is a clinical-stage pharmaceutical company developing novel therapeutics and delivery methods to treat breast cancer and other breast conditions. For more information, please visit .
Forward-looking statements in this press release, which Atossa undertakes no obligation to update, are subject to risks and uncertainties that may cause actual results to differ materially from the anticipated or estimated future results, including the risks and uncertainties associated with actions and inactions by the FDA, the outcome or timing of regulatory approvals needed by Atossa, lower than anticipated rate of patient enrollment, results of clinical studies, the safety and efficacy of Atossa''s products and services, performance of clinical research organizations and investigators, obstacles resulting from proprietary rights held by others, such as patent rights, and other risks detailed from time to time in Atossa''s filings with the Securities and Exchange Commission, including without limitation its periodic reports on Form 10-K, 10-Q and 8-K, each as amended and supplemented from time to time.
Atossa Genetics Inc.
Kyle Guse
CFO and General Counsel
(O) 800-351-3902
CorProminence LLC
Scott Gordon
President
(O) 516-222-2560
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Datum: 07.06.2016 - 06:00 Uhr
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News-ID 1439864
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