CytRx Presents Updated Aldoxorubicin Clinical Trial Results at the 2016 American Society of Clinical Oncology Annual Meeting

LOS ANGELES, June 6, 2016 /PRNewswire/ -- CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company specializing in oncology, today announced the presentation of three posters featuring updated clinical data from its aldoxorubicin clinical trials at the 2016 American Society of Clinical Oncology (ASCO) Annual Meeting being held June 3-7, 2016, at McCormick Place in Chicago.

"The clinical data presented this year at ASCO continues to support the safety and activity of aldoxorubicin in multiple high unmet need tumor types, including in late-stage and heavily pre-treated patients," commented Daniel Levitt, M.D., Ph.D., CytRx's Executive Vice President and Chief Medical Officer.  "With over 550 cancer patients treated with aldoxorubicin to date, oncologists are becoming comfortable with the safety and utility profile of the drug."

The details for the ASCO 2016 poster presentations are as follows:

Title: Phase 2 study of aldoxorubicin in relapsed glioblastoma
Date/Time: June 4, 2016 1:00pm-5:00pm
Poster Session: Central Nervous System Tumors; Abstract 2027
Summary: This ongoing Phase 2 clinical trial is evaluating aldoxorubicin in patients with relapsed glioblastoma (GBM).  Twenty-eight patients who had prior treatment with surgery, radiation and temozolomide therapy were enrolled and received either 250mg/m² or 350mg/m² of aldoxorubicin once every three weeks.  To date, aldoxorubicin has demonstrated anti-tumor activity and appears to be relatively well-tolerated with patients receiving a median of 3 or 4 cycles (range 1-20) depending on the dose group.  No evidence of central nervous system toxicity or clinically significant cardiac toxicity has been observed.  Best responses in 21 subjects according to MRI were 3 patients with partial response (PR) and 7 patients with stable disease (SD).  Additionally, two patients underwent surgery following aldoxorubicin treatment, and the pathology analysis of the removed tissue showed no viable tumor.  The median overall survival was 8.6 months (95% CI: 7.8-10.1) with seven patients still on study and being followed.

This study provides the first evidence that aldoxorubicin's albumin-binding mechanism allows it to cross the blood-brain barrier, unlike doxorubicin, and kill glioblastoma cells.  Following the completion of this trial, CytRx will evaluate the clinical path forward for aldoxorubicin as a treatment for advanced GBM. 

Title: Phase 1b study of aldoxorubicin + gemcitabine in metastatic solid tumors
Date/Time: June 5, 2016 8:00am-11:30am
Poster Session: Developmental Therapeutics – Clinical Pharmacology and Experimental Therapeutics; Abstract: 2523
Summary: This ongoing Phase 1b study is evaluating aldoxorubicin in combination with gemcitabine in patients with metastatic solid tumors.  To date, 29 heavily pre-treated patients (median prior regimens 3-4; range 0-15) have been enrolled in four different dose combination cohorts.  Of 18 evaluable patients, 13 of 18 (72%) had clinical benefit including two partial responses and 11 patients with stable disease.  The confirmed partial responses were in a patient with ovarian cancer and a patient with uterine leiomyosarcoma.  Across all dose groups the number of completed cycles range from 1-17, and cumulative doxorubicin exposure ranges from 208mg to 4,103mg.  Doses of 200 mg/m² aldoxorubicin with 500 mg/m² gemcitabine appears to be best tolerated.  Patients continue to be treated in the final dose cohort.

Although patients in this trial had a variety of different types of cancer, the future focus of this combination will be the treatment of ovarian and endometrial adenocarcinoma.

Title: Treatment of HIV-associated Kaposi's sarcoma with aldoxorubicin
Date/Time: June 6, 2016 8:00am-11:30am
Poster Session: Sarcoma; Abstract: 11038
Summary: This ongoing open-label Phase 2 clinical trial is evaluating the efficacy and safety of low dose aldoxorubicin for the treatment of Kaposi's sarcoma (KS) in HIV-infected patients.  Fifteen patients have been enrolled and received either 50, 100, or 150 mg/m² of aldoxorubicin once every three weeks.  To date, significant anti-tumor activity has been observed.  At these low doses, 11 of 13 (85%) patients have achieved partial responses at cycle 4, and at the end of the study, 8 of 12 (67%) patients have demonstrated partial responses.  Two patients continue to be treated.  Aldoxorubicin was very well-tolerated in these patients with advanced Kaposi's sarcoma due to the low doses administered. Importantly, determining the drug concentration within the tumor, a key goal of the trial, was successfully achieved.  In 12 of 14 (86%) patients for whom there was adequate tissue for analysis, higher doxorubicin concentrations were detected within the KS lesion relative to non-tumor tissue.

The high level of activity and important tolerability of low dose aldoxorubicin will allow long term usage in this very difficult to treat group of patients. 

About Aldoxorubicin
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, its improved version of the widely used chemotherapeutic agent doxorubicin, and DK049, a novel drug conjugate which is expected to enter clinical trials in 2016.  CytRx is also expanding its pipeline of oncology candidates at its laboratory facilities in Freiburg, Germany, through its LADR™ (Linker Activated Drug Release) technology platform, a discovery engine designed to leverage CytRx's expertise in albumin biology and linker technology for the development of a new class of anti-cancer therapies.

Forward-Looking Statements
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 testing of aldoxorubicin and preclinical testing of its LADR™ linker technology platform, the outcome, timing or results of CytRx's clinical testing of aldoxorubicin, the risk that any future pre-clinical or human testing of compounds based on the LADR™ technology platform might not show efficacy or reduced side effects of those compounds, 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 2 and Phase 3 clinical development of aldoxorubicin for SCLC and STS, respectively, and the preclinical and clinical development of compounds based on the LADR™ technology platform, 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.

Company Contact:

CytRx Corporation
David J. Haen
Vice President, Business Development and Investor Relations
(310) 826-5648, ext 304
[email protected]

Investor Relations:
Alexander Capital, LP
(855) 288-ALEX (2539)
[email protected] 

SOURCE CytRx Corporation

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