Atossa Therapeutics Inc (OTCMKTS: ATOS) is a clinical-stage biopharma organization, is looking to develop and discover innovative medications, and is currently concentrating on coronavirus and breast cancer, has been conducting Phase 2 of their Endoxifen Breast Cancer study and recently released their final data concerning their Phase 2 trials.
The data they released on June 9 stated as follows:
· Primary Endpoints– Ki-67 reduction was achieved. What’s commonly used to measure tumor cell activity, the Ki-67 component was reduced to 6% from a 25.6% average. This was a 65.1% reduction. This component was reduced to less than 25% in all patients, which is fantastic because studies have shown that you can improve long-term survival when you go below this percentage.
· Secondary Endpoints– (Tolerability and Safety): Adverse events were all mild. There were no unusual lab findings (urinalysis, coagulation, hematology, serum chemistry). There were also no differences in ECGs, physical examinations, and vital signs. These three results showed that Endoxifen is both well tolerated and considered safe. The study wasn’t discontinued due to any adverse events.
Atossa’s Chief Executive Officer and President, Steven Quay, Ph.D., M.D, stated that they are now planning on quickly advancing the development of Endoxifen because they got such favorable results. He further claimed that they have now started the non-clinical toxicology process required to get the drug’s approval.
Even though numerous FDA-approved neoadjuvant breast cancer therapies aren’t estrogen receptor-positive, there are currently only about a handful of approved breast cancer therapies for the roughly 77% of breast cancers out there that are estrogen receptor-positive.
The study used seven newly diagnosed people with estrogen receptor-positive breast cancer, requiring lumpectomy and mastectomy. Patients received the Endoxifen drug orally for at least two full weeks. This was done from when the patients were diagnosed with breast cancer up to their intended day of surgery. The primary goal was to find out whether Endoxifen can help reduce Ki-67. The secondary goal was to determine whether the drug itself was both safe and tolerable. Both gave very positive results.