The study enrolled 29 patients, suffered from a variety of solid tumors, including cervical, gastric, melanoma, non-small cell lung (NSCLD), ovarian, pancreatic, prostate, thyroid, urachal and uterine cancers.
The Phase I study was conducted to determine the maximum tolerated dose (MTD), dose limiting toxicities and the pharmacokinetics (PK) of ATI-1123; establish the recommended Phase II dose of ATI-1123; and observe patients for evidence of anti-tumor activity.
Azaya president and CEO Michael Dwyer said the results reported in this Phase I study of ATI-1123 have met all of the company’s scientific goals and exceeded its expectations for the benefits provided to patients.
"Further, because ATI-1123 uses an active ingredient – docetaxel – that is already in use with FDA-approval and kills tumors, it has a much lower development risk profile than a completely new chemical formulation," Dwyer said.
"Based on these study results, ATI-1123 has the potential to be an alternative treatment for patients with advanced solid tumors."
The study found that 76% of the study patients had stable disease and a partial response was observed in one patient with a tumor reduction of 61.3%.
Six pancreatic patients had stable disease, one had a 29% tumor reduction, and five of the six patients previously treated with docetaxel had stable disease and one had a partial response.
Azaya will begin the process of Phase II clinical trials for ATI-1123, based on the positive results from phase I study, which was conducted at the Mary Crowley Cancer Research Center in Dallas and the Institute for Drug Development.
"Additional Phase II clinical trials will be required to assess tumor response in a larger number of patients with specific solid tumor types," Dwyer said.