CytRx Corporation announced initial data from a Phase 1b clinical trial evaluating the pharmacokinetics and safety of aldoxorubicin, its novel conjugate of the widely used chemotherapeutic agent doxorubicin, in patients with metastatic solid tumors who have either relapsed or not responded to treatment with standard therapies. The data indicate that aldoxorubicin has a distribution half-life of 20-24 hours following infusion, which is significantly longer than doxorubicin’s initial half-life of five minutes. The data also demonstrate that aldoxorubicin demonstrated a distribution to healthy tissues that was 250-fold lower than that of doxorubicin.
“The initial trial results provide positive insights about how aldoxorubicin acts within the body, which is an important component of regulatory submissions and could point to its safety and effectiveness,” said Steven A. Kriegsman, CytRx President and CEO. “A longer half-life and narrow drug distribution to healthy tissues are potentially beneficial characteristics, because the drug remains active for increased time periods with decreased potential for toxicity.
“In the clinical trial, aldoxorubicin has shown prolonged clinical activity in two trial patients with small cell lung cancer who had failed other therapies, including a partial tumor response,” he added. “This was observed even at the lower, well-tolerated dose. We may consider further investigating aldoxorubicin in this indication among several others in the future. In fact, aldoxorubicin could be active against a variety of cancers, having shown to be superior to widely used doxorubicin in multiple animal models of cancer.”
The open-label, single-center Phase 1b clinical trial is being conducted under the direction of Dr. Monica Mita at Cedars-Sinai Medical Center in Los Angeles. Aldoxorubicin is being administered at doses of 230 mg/m2 and 350 mg/m2 every 21 days for up to 8 consecutive cycles.