CytRx Corporation, a biopharmaceutical company that specializes in cancer treatment, announced that they have initiated a Phase 2 clinical trial to determine preliminary efficacy and safety of aldoxorubicin for the treatment of HIV-derived Kaposi’s sarcoma.
The open-labeled Phase 2 study is being conducted at the Louisiana State University Health Sciences Center in New Orleans. Up to 30 patients divided into 3 groups will receive aldoxorubicin at 50, 100 or 150 mg/m2 by 30 minute-injection intravenously every 3 weeks until evidence of tumor progression, unacceptable toxicity, or withdrawal of consent. Researchers will then proceed to evaluate the size, number, and modularity of skin lesions in order to determine aldoxorubicin’s preliminary efficacy and monitor adverse events to assess the drug’s safety. The uptake of aldoxorubicin in the lesions will be evaluated as well.
“Aldoxorubicin has demonstrated effectiveness against a range of tumors in both human and animal studies, thus we are optimistic in regard to a potential treatment for Kaposi’s sarcoma. The current standard-of-care for severe dermatological and systemic KS is liposomal doxorubicin (Doxil®). However, many patients exhibit minimal to no clinical response to this agent, and that drug has significant toxicity and manufacturing issues,” said CytRx President and CEO Steven A. Kriegsman. “In addition to obtaining valuable information related to Kaposi’s sarcoma, this trial represents another opportunity to validate the value and viability of our linker technology platform.” The company expects to announce Phase-2 study results in the second quarter of 2015.
Kaposi’s sarcoma is an orphan indication, meaning that only a small portion of the population has been diagnosed with the disease (fewer than 200,000 individuals in the country), and in turn, little research and drug development is being conducted to treat and cure it. The FDA’s Orphan Drug Act may grant orphan drug designation to a drug such as aldoxorubicin that treats a rare disease like Kaposi’s sarcoma, offering market exclusivity for seven years, fast-track status in some cases, tax credits, and grant monies to accelerate research.