Atossa Genetics starts 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.