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news.ResearchPoint and Azaya Therapeutics (Azaya) have initiated phase I trial of ATI-1123, a new formulation of docetaxel, and enrolled the first patient for the same. The open-label, dose escalation study is being managed by ResearchPoint.
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The company said that ATI-1123 has the same active ingredient as the FDA approved drug, Taxotere (docetaxel). The study is being conducted at two premier Texas cancer centers, in patients with advanced solid tumors.
The goal of the phase I study is to determine the maximum tolerated dosage that can be given to patients, in addition to determining the safety and pharmacokinetics of the drug. The clinical study plans to enroll approximately 24 patients at South Texas Accelerated Research Therapeutics (START) in San Antonio and the Mary Crowley Cancer Research Center in Dallas, over the next 12-15 months.
Nicole Gallegos, manager of clinical operations at Azaya, said: “The ResearchPoint team has proved their experience and value in successfully assisting Azaya achieve this important company milestone. ResearchPoint brought to the table a full suite of clinical research services for our first ATI-1123 Phase I study, and it is great that they are Texas based as well.”