FDA Stops Enrollment In CytRx's Aldoxorubicin Cancer Trials

CytRx was order by the FDA to stop enrolling patients in its clinical trials for aldoxorubicin in cancer indications. The company announced the partial clinical hold in a press release, stating the FDA placed the enrollment hold while allowing current patients to keep taking aldoxorubicin or comparator drugs. The clinical hold was implemented following the death of a patient. CytRx stated that it remains committed to enrolling patients in the Phase 3 trial investigating aldoxorubicin in soft tissue sarcoma.

Aldoxorubicin

Aldoxorubicin combines doxorubicin, a widely used chemotherapeutic agent, with a single-molecule linker. The formulation allows for the administration of much higher doses of doxorubicin. Currently, doxorubicin is administered at doses lower than its therapeutic potential because of its highly toxic side effects including heart muscle damage. Aldoxorubicin binds to circulating albumin, a protein in the bloodstream, thereby delivering the therapeutic payload in the tumor environment. CytRx states that the novel linker and delivery system allows for doxorubicin doses 3½ to 4 times higher. The agent also reduces toxic side effects, including heart muscle damage.

FDA Action

The FDA notified CytRx that all aldoxorubicin clinical trials were placed on partial clinical hold. The FDA’s action was due to the death of a patient who had not qualified for aldoxorubicin clinical trials, but was receiving aldoxorubicin under the company's expanded access or compassionate use program. CytRx is amending aldoxorubicin study protocols at the FDA’s request. These adjustments include inclusion/exclusion criteria, patient screening assessments, and evaluation of serum electrolytes prior to aldoxorubicin administration.

CytRx states that it is working with the FDA to release the clinical hold and resume enrolling patients. The company believes that its timeline for the trial is still valid, with the goal to complete enrollment of the Phase 3 trial by the end of 2015.The company expects to announce data from a Phase 2 trial of aldoxorubicin in Kaposi's Sarcoma in the second quarter of 2015. In the first half of 2015, it will share Phase 2 data on aldoxorubicin in glioblastoma multiforme.

About CytRx

CytRx Corporation is headquartered in Los Angeles, CA. The company focuses on oncology and its lead candidate aldoxorubicin (formerly known as INNO-206). The company is testing the agent in HIV-related Kaposi's sarcoma, late-stage glioblastoma (brain cancer), soft tissue sarcoma, and metastatic solid tumors. At its laboratory facilities in Freiburg, Germany, CytRx is working on novel linker technologies to concentrate chemotherapeutic agents at tumor sites.