CytRx (CYTR) Will Present Aldoxorubicin Phase 1b/2 Data at CTOS Annual Meeting

October 28, 2015 9:01 AM EDT
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CytRx (Nasdaq: CYTR) announced that a poster titled "A Phase 1b/2 Study of Aldoxorubicin plus Ifosfamide/Mesna in Untreated Sarcoma Patients" will be presented at the 20th Annual Connective Tissue Oncology Society (CTOS) Annual Meeting in Salt Lake City, Utah, November 4 - 7, 2015. The poster will discuss the trial design and current results of CytRx's on-going clinical trial in patients with metastatic soft and non-soft tissue sarcomas. In this study, 7 subjects received 170 mg/m2 aldoxorubicin, and 3 subjects received 250 mg/m2 aldoxorubicin (125 or 185 mg/m2 doxorubicin equivalents), administered intravenously every 4 weeks. All patients also received 1 gram/m2/day ifosfamide/mesna administered as a continuous 24 hour infusion for up to 14 days, every 4 weeks. As of September 30, 2015, 8 subjects demonstrated tumor shrinkage, with 3 subjects having documented partial responses. Six subjects are still receiving treatment. Grade 3 or 4 adverse events included neutropenia (90%), anemia (70%), nausea or vomiting (10%) and febrile neutropenia (10%). No subject exhibited cardiotoxicity by echocardiogram.

Dr. Sant Chawla M.D., F.R.A.C.P., Director of the Sarcoma Oncology Center and principal investigator for this trial stated, "The use of doxorubicin with ifosfamide and mesna remains a treatment option for many sarcoma patients. Replacing doxorubicin with aldoxorubicin may lead to improved clinical outcomes for these first-line sarcoma patients, since we already know that aldoxorubicin demonstrated superiority to doxorubicin in the previously completed Phase 2b trial in first-line tissue sarcomas."

"The presentation of the Phase 1b/2 clinical trial data at CTOS demonstrates to the sarcoma community the potential use of aldoxorubicin as part of a multi-drug regimen to treat sarcomas," said Steven A. Kriegsman, CytRx's Chairman and Chief Executive Officer. "The on-going trial will generate important dosing, safety and efficacy data in treatment-naive patients. We remain excited about the prospects of aldoxorubicin in our pivotal global Phase 3 trial in sarcoma patients that have previously received chemotherapy, with top-line data expected in the second half of 2016."

Phase 1b/2 Trial Design

Aldoxorubicin is administered at escalating doses by intravenous infusion (IVI) on Day 1 every 28 days, and 1 gm/m2/day of ifosfamide and an equivalent dose of mesna is administered via continuous infusion with a portable at-home pump for up to 14 days every 28 days starting on Day 1 of each cycle, until disease progression, unacceptable toxicity or the patient withdraws consent. The primary objective of the trial is to determine the preliminary safety of administration of aldoxorubicin in combination with ifosfamide in patients with metastatic, locally advanced, or unresectable STS as measured by the frequency and severity of adverse events (AEs), abnormal findings on physical examination, laboratory tests, vital signs, echocardiograms (ECHO) or multiple-gated acquisition (MUGA) scans, electrocardiogram (ECG) results, and weight. The secondary objective of the trial is to evaluate the activity of aldoxorubicin in combination with ifosfamide/mesna in this population, assessed by overall response rate (ORR), progression-free survival (PFS) and PFS at 4 and 6 months. This Phase 1b/2 trial is being conducted at the Sarcoma Oncology Center in Santa Monica, California.



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