Positive clinical data of CytRx's aldoxorubicin to be presented at ASCO 2015

May 27 2015

CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company specializing in oncology, today announced an upcoming poster presentation regarding its lead drug candidate, aldoxorubicin, at the 2015 American Society of Clinical Oncology (ASCO) Annual Meeting, which is being held May 29 - June 2, 2015 in Chicago.

"I am impressed by the excellent long-term cardiac safety profile we're seeing in patients who have undergone treatment with aldoxorubicin across several cancer types," said Sant P. Chawla, M.D., F.R.A.C.P., Principal Investigator and Director of the Sarcoma Oncology Center. "Without the major treatment-limiting risk of cardiotoxicity, aldoxorubicin is able to deliver higher and potentially more efficacious doses of doxorubicin to patients over a longer period of time, which could improve clinical outcomes. This safety profile also may allow aldoxorubicin to be combined with other anti-tumor drugs without increasing cardiotoxicity."

"Aldoxorubicin continues to demonstrate no clinically significant cardiac toxicity, a problem that has historically been associated with doxorubicin," said Steven A. Kriegsman, Chairman and CEO of CytRx. "Based on this data, we are allowed by regulatory agencies in each country where clinical trials are being conducted, including the FDA, to treat patients with aldoxorubicin for as long as it is of clinical benefit, which has the potential to significantly improve efficacy."

Details for the ASCO clinical data are as follows:

Poster Presentation

Title: "Longer Term Cardiac Safety of Aldoxorubicin"
Presenter: Sant Chawla, M.D., F.R.A.C.P., Sarcoma Oncology Center
Abstract #: 10546
Date and Time: Sunday, May 30, 2015, 8:00 am – 12:00 pm CT
Session: Sarcoma

Summary: Cardiotoxicity data from 200 patients across 7 clinical trials (1 Phase 3, 3 Phase 2 and 3 Phase 1) evaluating aldoxorubicin was reviewed. The dose range of aldoxorubicin across all trials was 150-5,250 mg/m² administered intravenously every 3 weeks, with the median exposure to aldoxorubicin at 1,750 mg/m² (equivalent to 111-3,900 mg/m² doxorubicin per cycle; median of 1,300 mg/m²). Patients received 1-21 cycles of treatment. Either multigated acquisition (MUGA) scan or echocardiograms were administered at baseline then approximately every 2 months until either study withdrawal or death. All patients had normal cardiac function at baseline with left ventricular ejection fraction (LVEF) > 45% in some studies and 50% in others. Historically, the risk of congestive heart failure (CHF) for doxorubicin increased if cumulative dose exceeded 500 mg/m².

The results demonstrated that no patient exhibited a decrease in LVEF that was below 50% of their institution's normal value. 14% of patients demonstrated a ≥ 10% drop in LVEF and 21% had a ≥ 10% increase in LVEF. Other side effects observed were consistent with effects seen in other anthracycline treatments. Patients in these trials have received up to 5,439 mg/m² of doxorubicin equivalents, or 12 times the peak cumulative dose of standard doxorubicin, without any evidence of cardiotoxicity. These results suggest that aldoxorubicin can be safely administered at cumulative doses of over 2 g/m2 without evidence of cardiotoxicity.