Early results show promise for Kaposi’s Sarcoma drug

CytRx Corp., a Los Angeles-based biopharmaceutical research and development firm, has released interim results of its phase 2 clinical trial evaluating the safety and efficacy of aldoxorubicin for the treatment of Kaposi’s Sarcoma (KS) in HIV-infected patients.

The results are based on trials involving nine patients, six of whom had the most dire KS prognosis. Four of the nine patients had received one to eight prior liposomal doxorubicin (Doxil®) cycles. Efficacy results demonstrated that all nine patients experienced a decrease in skin lesions and in the number of cancer cells expressing the KS virus DNA. Of the six patients with lung tumors, four showed either a partial or complete response, with no patient experiencing disease progression.

Thus far in the trial, data show that aldoxorubicin can be detected in all tumor biopsies 24 hours following drug administration. Preliminary safety results showed that just two patients experienced a grade 4 adverse event. Other adverse events were mild; most were unrelated to aldoxorubicin.

A company news release quotes CytRx President and C.E.O. Steven Kriegsman as saying, “The current standard of care for severe dermatological and systemic KS is Doxil. However, many patients experience significant toxicity or exhibit minimal to no clinical response to this agent. Aldoxorubicin has demonstrated effectiveness against a range of tumors in the phase 2 clinical trial. Thus we are optimistic in regard to its potential as a treatment for KS.”

Given a positive outcome of the ongoing phase 2 trial, CytRx plans to discuss with the Food and Drug Administration a potential pathway for the registration of aldoxorubicin for use in KS. The trial is being conducted at the Louisiana State University Health Sciences Center in New Orleans, with additional sites being considered to expedite enrollment.