GT Biopharma, Inc. (OTCMKTS: GTBP) is setting the stage for a strong day in the market today after announcing positive data from and the advancement of a Phase I/II clinical trial. Here’s what’s going on:
GTBP Announces The Advancement Of Its TriKE Clinical Trial
In the press release, GT Biopharma said that it has completed the treatment of patients enrolled at Dose Levels one and two in the dose-escalation Phase one portion of its GTB-3550 TriKe Phase I/II clinical trial.
Moreover, the company said that it has begun enrolling patients for Dose Level 3 in its clinical trial. Not to mention, the data from Dose Levels one and two proved to be overwhelmingly positive.
GTBP said that the first patient treated with GTB-3550 in the trial achieved stable disease. The achievement was measured by the number of AML blasts observed in the patient’s bone marrow before and after treatment.
Moreover, the company saw an increase in the patient’s total NK cell population that it believes is attributable to the IL-15 component of GTB-3550. There was also no observed appreciable increase of any hyper-active T-cell population.
Importantly, none of the four patients treated with GTB-3550 to date have experienced constitutional adverse reactions or other reactions that are generally seen in patients who receive immuno-oncology therapeutics.
In a statement, Mr. Anthony Cataldo, Chairman and CEO at GTBP, had the following to offer:
“We are pleased to be able to advance to the next higher dose level in our first-in-human trial of GTB-3550, and hope to continue to see additional signals of efficacy and safety at the higher dose level.”
This News Is Huge
The news released by GT Biopharma proved to be overwhelmingly positive. So far, the Phase I portion of the clinical trial is doing what it was intended to do. The data is showing that GTB-3550 is safe and tolerable in 100% of patients it has been provided to thus far. Moreover, the trial has shown signs of efficacy in severely ill AML patients.
Should GTBP bring the treatment to market, it would be tapping into a massive opportunity. By the year 2025, the AML treatment market is expected to grow to be worth approximately $2.2 billion. With incredible early-stage success in a seriously ill patient population that has few therapeutic options GTBP is a stock that should be watched very closely.
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