CytRx has initiated dose escalation study with its oncology drug candidate tamibarotene combined with TRISENOX injection in patients with relapsed acute promyelocytic leukemia (APL).
According to CytRx, there are two primary trial objectives. The first is to determine the safety and preliminary efficacy of combining tamibarotene with arsenic trioxide as a treatment for relapsed or refractory APL. The second objective is to determine the appropriate dose for future clinical trials in which CytRx would test the utility of the tamibarotene/arsenic trioxide combination as a first-line treatment for subjects who prefer not to be exposed to anthracyclines.
Steven Kriegsman, president and CEO of CytRx, said: “This trial represents an important step in our ultimate goal of evaluating tamibarotene as a first-line treatment for APL. This clinical trial will expand upon our current ongoing STAR-1 registration clinical trial that is evaluating tamibarotene’s efficacy and safety as a third-line treatment.”
Jessica Altman assistant professor of Medicine at Northwestern University Feinberg School of Medicine, “We hypothesise that the combination of tamibarotene and arsenic trioxide will result in a similar complete response rate as the ATRA and arsenic trioxide combination, but with decreased toxicities, such as hyperleukocytosis, APL differentiation syndrome and rash and potentially a lower relapse rate.”
Dr Martin Tallman, professor of Medicine, said: “Because tamibarotene appears to be more potent and more selective than ATRA, we anticipate that the tamibarotene/arsenic trioxide combination may be more effective and less prone to drug resistance than ATRA combined with arsenic trioxide.”
The dose escalation study is being financed jointly by CytRx and Cephalon.