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CytRx Announces Publication of Phase 1b/2 Aldoxorubicin Clinical Data in Soft Tissue Sarcoma in Cancer, the Peer-Reviewed Journal of the American Cancer Society

LOS ANGELES, Oct. 20, 2014 /PRNewswire/ -- CytRx Corporation (CYTR), a biopharmaceutical research and development company specializing in oncology, today announced that a paper, titled "A Phase 1b/2 Study of Aldoxorubicin in Patients With Soft Tissue Sarcoma," has been published online in Cancer, the prestigious, peer-reviewed journal of the American Cancer Society.

The paper discusses results from CytRx's completed Phase 1b/2 clinical trial where 25 patients were enrolled, including 17 patients (68%) with advanced soft tissue sarcoma (STS).  Data from the trial demonstrated that aldoxorubicin administered at its maximum tolerated dose (MTD) of 350mg/m2 showed a substantial increase in median progression-free survival (PFS) in patients with advanced STS (n=13).  Partial responses (PR) were achieved in 38% of patients and stable disease (SD) was achieved in 46% of patients.  Median PFS was 11.25 months and median overall survival (OS) was 21.71 months.  Notably, 12 of the 13 patients in the MTD dosing cohort had received prior chemotherapy and had experienced either no response or disease progression while on prior therapy.  In addition, patients in this dosing cohort completed a median of 8 dosing cycles, and 9 patients (69%) had a PR or SD lasting ≥4 months.  Aldoxorubicin was generally well tolerated, with no clinically significant cardiotoxicities and no drug-related deaths.

The full publication can be accessed online here.

Sant P. Chawla, M.D., F.R.A.C.P., Director of the Sarcoma Oncology Center, renowned sarcoma expert and principal investigator of the trial stated, "There remains a high unmet need for patients with soft tissue sarcoma, especially since many relapse or stop responding to currently available treatments.  The data from this study show that aldoxorubicin is clinically active and generally well tolerated in this difficult to treat patient population, including in certain patients who had exhibited no objective response to prior anthracycline therapy."

"In addition to allowing for higher doses of doxorubicin without the major treatment-limiting toxicities, this trial also showed that aldoxorubicin can be administered for up to 8 cycles, a greater number than doxorubicin therapy, the current standard of care," said Steven A. Kriegsman, CytRx President and CEO.  "We are encouraged by the outcome of this trial and by the fact that the FDA has permitted us to treat even beyond 8 cycles in further clinical testing, and we are honored to be selected for publication in this prestigious medical journal.  Looking forward, we remain on track to complete enrollment in the ongoing pivotal global Phase 3 clinical trial of aldoxorubicin as a second-line treatment for STS in the second half of 2015."

Aldoxorubicin is currently being studied in a pivotal global Phase 3 clinical trial evaluating the efficacy and safety of aldoxorubicin as a second-line treatment for patients with STS under a Special Protocol Assessment with the FDA.  CytRx is also evaluating aldoxorubicin in two Phase 2 clinical trials, one in patients with late-stage glioblastoma (GBM) and the other in HIV-related Kaposi's sarcoma, a global Phase 2b clinical trial in patients with relapsed small cell lung 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 patients with metastatic solid tumors.

About Soft Tissue Sarcoma (STS)

STS is an umbrella term for more than 50 subtypes of cancer that occur in the muscles, fat, blood vessels, tendons and other connective tissues in the body.  Last year an estimated 38,000 new cases of soft tissue sarcoma were reported and more than 13,000 deaths were attributed to this cancer in the U.S. and Europe.  Patients with metastatic, locally advanced or unresectable soft tissue sarcomas have a poor prognosis with progression-free survival of approximately 2 months to 4.6 months and median overall survival of approximately 9 months to 12 months.  CytRx has been granted orphan drug designation by the FDA and EMEA for the treatment of patients with soft tissue sarcomas.

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 (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 recently 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.  

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 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.

Investor Relations:
Argot Partners
Michelle Carroll
212.600.1902
[email protected]

Media:
Argot Partners
Eliza Schleifstein
973.361.1546
[email protected]

Company Contact:
CytRx Corporation
David J. Haen
Vice President, Business Development and Investor Relations
310-826-5648, x304
[email protected]

SOURCE CytRx Corporation

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