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), 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/m^2 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.