Jun 14 2012
Azaya Therapeutics, Inc. announced final results from the Phase I study
of its anti-cancer drug, ATI-1123 (liposomal docetaxel), today. The
results showed that 79 percent of heavily pretreated patients received
benefit from ATI-1123. The 29 patients enrolled in the study suffered
from a variety of solid tumors, including cervical, gastric, melanoma,
non-small cell lung (NSCLD), ovarian, pancreatic, prostate, thyroid,
urachal and uterine cancers.
Based on these very positive results, Azaya will begin the process to
move ATI-1123 to Phase II clinical trials.
The Phase I study was conducted at the Mary Crowley Cancer Research
Center in Dallas and the Institute for Drug Development at the Cancer
Therapy & Research Center at The University of Texas Health Science
Center at San Antonio. The objectives of the study were 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
-
Observe patients for evidence of anti-tumor activity
Study Population:
-
As noted, patients enrolled in the study had a variety of solid tumors
including cervical, gastric, melanoma, non-small cell lung (NSCLC),
ovarian, pancreatic, prostate, thyroid, urachal and uterine cancers
-
Nine of the enrolled study patients had been previously treated with
standard docetaxel
Results for MTD and Dosing Objectives:
-
The MTD was observed at a dose of 90mg/m2 with an enhanced
PK profile compared to docetaxel
-
No new toxicities were observed compared to the published toxicity
profile of docetaxel
-
Given the observed activity, the recommended Phase II dose is 90 mg/m2
Results for Clinical Benefit Objective:
-
76% of the study patients (22 patients) had stable disease and one
patient had a partial response with a tumor reduction of 61.3%
-
Six pancreatic patients had stable disease and one had a 29% tumor
reduction
Of the six patients previously treated with docetaxel, five of them had
stable disease and one had a partial response when treated with ATI-1123.
John Nemunaitis, M.D., the Executive Director of the Mary Crowley
Cancer Research Centers in Dallas, said: "Our cancer center
treated 18 patients in this study. All of the patients tolerated the
drug well. We had 2 patients with prostate cancer, one of them remained
on treatment with ATI-1123 for 14 months, and we had 6 patients with
pancreatic cancer, most maintained stable disease for at least 3 months.
I am very encouraged about this product as a result of our patient
outcomes."
Steve Weitman, M.D., Ph.D., Director of the Institute for Drug
Development at CTRC in San Antonio, said: "This novel therapy
clearly has shown anti-tumor activity in a very resistant and refractory
patient population. These initial results are very encouraging
and warrant further study."
Michael Dwyer, President and CEO of Azaya, said: "The results
reported in this Phase I study of ATI-1123 have met all of our
scientific goals and exceeded our 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."
"Based on these study results," Dwyer said, "ATI-1123 has the
potential to be an alternative treatment for patients with advanced
solid tumors. Additional Phase II clinical trials will be
required to assess tumor response in a larger number of patients with
specific solid tumor types. Azaya will be aggressively pursuing
these opportunities to explore benefit for more patients."