November , 2014
By Mark Terry, BioSpace.com Breaking News Staff
Los Angeles-based CytRx Corporation (CYTR) announced today Tuesday that the U.S. Food and Drug Administration (FDA) has placed the company’s clinical trials for aldoxorubicin on partial clinical hold. Patients currently enrolled can continue with treatment or comparison drugs, but new patients will not be enrolled until the hold is lifted.
Aldoxorubicin is a combination cancer medication, combining doxorubicin with a novel single-molecule linker. The linker molecule directly binds to circulating albumin. Specific types of tumors concentrate albumin, so the new medication increases delivery of the drug to those tumors. Studies have indicated this allows for 3.5 to 4 times the doses of doxorubicin to be administered with lower toxic side effects.
However, the study is on a partial hold because of a reported death of a patient with advanced-stage cancer. Although not a part of the study, the patient had been administered aldoxorubicin under CytRx’s expanded access (“compassionate use”) program. The FDA has requested CytRx change the study’s inclusion/exclusion criteria that would include more patient screening assessments and an evaluation of serum electrolytes before receiving aldoxorubicin.
CytRx said in a statement it believes this partial hold will be resolved soon and the enrollment rates and timelines will not change. CytRx expects preliminary results from the Phase 2 clinical trial of aldoxorubicin in Kaposi’s Sarcoma will be announced in the second quarter of 2015 and preliminary results from an ongoing Phase 2 trial of the compound in glioblastoma multiforme will be announced in the first half of 2015.
The company plans to complete enrollment of an ongoing pivotal Phase 3 trial of the drug in second-line soft tissue sarcoma by the end of 2015.
CytRx announced on Oct. 29 the publication of a paper titled “Therapeutic Efficacy of Aldoxorubicin in an Intracranial Xenograft Mouse Model of Human Glioblastoma” in the journal Neoplasia (Volume 16, Issue 10). This article expands on previous preclinical data showing that aldoxorubicin increased survival by about 2.5 times in in vivo xenograft tumor models of human glioblastoma multiforme (GBM) tumors in mouse brains when compared to doxorubicin.
“In this study, aldoxorubicin inhibited the growth of GBM tumors and significantly increased survival compared to both doxorubicin alone and vehicle,” said Om Prakas, research professor of medicine at the Stanley S. Scott Cancer Center, Louisiana State University Health Sciences Center in New Orleans, in a statement. “Aldoxorubicin also showed promising signs of accumulation and retention in tumor tissue, but not in the normal brain areas adjacent to the tumor tissue, supporting the theory that aldoxorubicin does not have an adverse effect on the normal brain cells surrounding the tumor margins.”
