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

CytRx Corporation (CYTR), abiopharmaceutical research and development company specializing in oncology,today announced that a paper, titled "A Phase 1b/2 Study of Aldoxorubicin inPatients With Soft Tissue Sarcoma," has been published online in Cancer, theprestigious, peer-reviewed journal of the American Cancer Society.The paper discusses results from CytRx's completed Phase 1b/2 clinical trialwhere 25 patients were enrolled, including 17 patients (68%) with advancedsoft tissue sarcoma (STS).  Data from the trial demonstrated thataldoxorubicin administered at its maximum tolerated dose (MTD) of 350mg/m^2showed a substantial increase in median progression-free survival (PFS) inpatients with advanced STS (n=13).  Partial responses (PR) were achieved in38% of patients and stable disease (SD) was achieved in 46% of patients. Median PFS was 11.25 months and median overall survival (OS) was 21.71months.  Notably, 12 of the 13 patients in the MTD dosing cohort had receivedprior chemotherapy and had experienced either no response or diseaseprogression while on prior therapy.  In addition, patients in this dosingcohort completed a median of 8 dosing cycles, and 9 patients (69%) had a PR orSD lasting ≥4 months.  Aldoxorubicin was generally well tolerated, with noclinically 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, "Thereremains a high unmet need for patients with soft tissue sarcoma, especiallysince many relapse or stop responding to currently available treatments.  Thedata from this study show that aldoxorubicin is clinically active andgenerally well tolerated in this difficult to treat patient population,including in certain patients who had exhibited no objective response to prioranthracycline therapy.""In addition to allowing for higher doses of doxorubicin without the majortreatment-limiting toxicities, this trial also showed that aldoxorubicin canbe administered for up to 8 cycles, a greater number than doxorubicin therapy,the current standard of care," said Steven A. Kriegsman, CytRx President andCEO.  "We are encouraged by the outcome of this trial and by the fact that theFDA has permitted us to treat even beyond 8 cycles in further clinicaltesting, and we are honored to be selected for publication in this prestigiousmedical journal.  Looking forward, we remain on track to complete enrollmentin the ongoing pivotal global Phase 3 clinical trial of aldoxorubicin as asecond-line treatment for STS in the second half of 2015."Aldoxorubicin is currently being studied in a pivotal global Phase 3 clinicaltrial evaluating the efficacy and safety of aldoxorubicin as a second-linetreatment for patients with STS under a Special Protocol Assessment with theFDA.  CytRx is also evaluating aldoxorubicin in two Phase 2 clinical trials,one in patients with late-stage glioblastoma (GBM) and the other inHIV-related Kaposi's sarcoma, a global Phase 2b clinical trial in patientswith relapsed small cell lung cancer, a Phase 1b trial in combination withifosfamide in patients with soft tissue sarcoma, and a Phase 1b trial incombination with gemcitabine in patients with metastatic solid tumors.