LOS ANGELES, May 27, 2015 /PRNewswire/ -- 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:
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.
A full abstract of the presentation can be accessed on the ASCO website at http://abstracts.asco.org/156/AbstView_156_145435.html.
The widely used chemotherapeutic agent doxorubicin is delivered systemically and is highly toxic, which limits its dose to a level below its maximum therapeutic benefit. Doxorubicin also is associated with many side effects, especially the potential for damage to heart muscle at cumulative doses greater than 450 mg/m2. Aldoxorubicin combines doxorubicin with a novel single-molecule linker that binds directly and specifically to circulating albumin, the most plentiful protein in the bloodstream. Protein-hungry tumors concentrate albumin, thus increasing the delivery of the linker molecule with the attached doxorubicin to tumor sites. In the acidic environment of the tumor, but not the neutral environment of healthy tissues, doxorubicin is released. This allows for greater doses (3 ½ to 4 times) of doxorubicin to be administered while reducing its toxic side effects. In studies thus far there has been no evidence of clinically significant effects of aldoxorubicin on heart muscle, even at cumulative doses of drug well in excess of 2,000 mg/m2.
About CytRx Corporation
CytRx Corporation is a biopharmaceutical research and development company specializing in oncology. CytRx currently is focused on the clinical development of aldoxorubicin (formerly known as INNO-206), its improved version of the widely used chemotherapeutic agent doxorubicin. CytRx has initiated under a special protocol assessment a pivotal Phase 3 global trial with aldoxorubicin as a therapy for patients with soft tissue sarcomas whose tumors have progressed following treatment with chemotherapy, and has announced that it has received approval from the FDA to continue dosing patients with aldoxorubicin until disease progression in that clinical trial. CytRx is currently evaluating aldoxorubicin in a global Phase 2b clinical trial in small cell lung cancer, a Phase 2 clinical trial in HIV-related Kaposi's sarcoma, a Phase 2 clinical trial in patients with late-stage glioblastoma (brain cancer), a Phase 1b trial in combination with ifosfamide in patients with soft tissue sarcoma, and a Phase 1b trial in combination with gemcitabine in subjects with metastatic solid tumors. CytRx has completed a global Phase 2b clinical trial with aldoxorubicin as a first-line therapy for soft tissue sarcomas, a Phase 1b/2 clinical trial primarily in the same indication, a Phase 1b clinical trial of aldoxorubicin in combination with doxorubicin in patients with advanced solid tumors and a Phase 1b pharmacokinetics clinical trial in patients with metastatic solid tumors. CytRx plans to expand its pipeline of oncology candidates at its laboratory facilities in Freiburg, Germany, based on novel linker technologies that can be utilized with multiple chemotherapeutic agents and may allow for greater concentration of drug at tumor sites. For more information about CytRx Corporation, visit www.cytrx.com.
This press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Such statements involve risks and uncertainties that could cause actual events or results to differ materially from the events or results described in the forward-looking statements, including risks relating to the outcome, timing and results of CytRx's clinical trials, the timing or FDA approval of projected commercial sales of aldoxorubicin, the risk that any future human testing of aldoxorubicin might not produce results similar to those seen in past human or animal testing, risks related to CytRx's ability to manufacture its drug candidates in a timely fashion, cost-effectively or in commercial quantities in compliance with stringent regulatory requirements, risks related to CytRx's need for additional capital or strategic partnerships to fund its ongoing working capital needs and development efforts, including the Phase 3 clinical development of aldoxorubicin, risks related to lawsuits that have been brought against the Company and its officers and/or directors for alleged violations of the securities laws, and the risks and uncertainties described in the most recent annual and quarterly reports filed by CytRx with the Securities and Exchange Commission and current reports filed since the date of CytRx's most recent annual report. All forward-looking statements are based upon information available to CytRx on the date the statements are first published. CytRx undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
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