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:
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Determine the maximum tolerated dose (MTD), dose limiting toxicities
and the pharmacokinetics (PK) of ATI-1123
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Establish the recommended Phase II dose of ATI-1123
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Observe patients for evidence of anti-tumor activity
Study Population:
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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
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Nine of the enrolled study patients had been previously treated with
standard docetaxel
Results for MTD and Dosing Objectives:
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The MTD was observed at a dose of 90mg/m2 with an enhanced
PK profile compared to docetaxel
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No new toxicities were observed compared to the published toxicity
profile of docetaxel
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Given the observed activity, the recommended Phase II dose is 90 mg/m2
Results for Clinical Benefit Objective:
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76% of the study patients (22 patients) had stable disease and one
patient had a partial response with a tumor reduction of 61.3%
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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.