Atossa Therapeutics Inc (NASDAQ:ATOS) has given the last patient’s final dose in its Karisma-Endoxifen clinical trial, aimed at reducing the chances of breast cancer.
Some 240 people took part in the phase two trial, which began in November, Atossa said on Wednesday.
This saw patients with measurable mammographic breast density (MBD) randomly dosed with placebo, or between one and two milligrams of (Z)-endoxifen for six months.
Reductions in MBD were then studied to investigate the drug’s effects in lowering density, with this said to be linked to reduced chances of breast cancer.
“We look forward to seeing the breast density reduction data in the coming months and sharing it with regulatory authorities as it will allow us to further progress plans for a potential Phase 3, registrational study,” chief executive Steven Quay said.
According to Atossa, women with the highest density are six times more likely to develop breast cancer than those with the lowest.
Atossa’s oral formulation of (Z)-endoxifen does not require liver metabolism to give off therapeutic effects and bypasses the stomach.
(Z)-endoxifen itself is the most potent modulator for estrogen receptor inhibition and also causes estrogen receptor degradation.
“Completing dosing of the final patient [...] is an important milestone for Atossa and our robust (Z)-endoxifen development program,” Quay added.