CytRx Initiates International Phase 2b Clinical Trial with INNO-206 in Advanced Soft Tissue Sarcoma

Published on Thursday, 22 December 2011 08:35 Written by TradersHuddle Staff

LOS ANGELES-( Business Wire )-

CytRx Corporation (Nasdaq: CYTR), a biopharmaceutical company specializing in oncology, today announced the initiation of an international Phase 2b clinical trial to evaluate the preliminary efficacy and safety of its tumor-targeting doxorubicin conjugate INNO-206 in patients with late-stage soft tissue sarcoma. The Phase 2b clinical trial will provide the first direct clinical trial comparison of INNO-206 with native doxorubicin, which is dose-limited due to toxicity, as a first-line therapy.

“This trial is the next important step in advancing the development of INNO-206 and follows encouraging response and safety indications from the group of patients with advanced solid tumors, principally soft tissue sarcomas, in the Phase 1b/2 clinical trial,” said CytRx President and CEO Steven A. Kriegsman. “We are addressing an unmet medical need as patients with late-stage sarcomas have a poor prognosis, with progression-free survival of around four to five months and median overall survival averaging approximately 15 months.”

Daniel Levitt, M.D., Ph.D., Chief Medical Officer at CytRx said, “Several chemotherapy regimens have been explored as palliative therapy for patients with advanced soft tissue sarcomas, with combinations of ifosfamide and doxorubicin appearing to offer the highest response rates and longest time to progression. However, these regimens are quite toxic, especially for older patients, and have not significantly increased survival in these individuals. INNO-206 may represent a significant improvement over doxorubicin, as INNO-206, with its tumor-targeting linker, allows us to deliver a doxorubicin dose equivalent of 3½ times the standard doxorubicin dose administered to sarcoma patients without any apparent increased toxicity. Because doxorubicin should be released from INNO-206 at the site of the tumor due to its acid-sensitive linker, higher concentrations of this lethal drug can accumulate within the malignant cells.”

The Phase 2b clinical trial with INNO-206 in patients with soft tissue sarcomas is an international trial under the direction of world-renowned expert in soft tissue sarcoma treatment Sant P. Chawla, M.D., F.R.A.C.P., Director of the Sarcoma Oncology Center in Santa Monica, Calif. Dr. Chawla also is acting as principal investigator for the Company’s ongoing Phase 1b/2 clinical trial with INNO-206.

The Phase 2b clinical trial’s primary objectives are to measure the progression-free survival, tumor response and overall survival of patients with advanced soft tissue sarcomas treated with INNO-206. This clinical trial also will assess the safety of INNO-206 compared to doxorubicin in this patient population through a number of indicators, including the frequency and severity of adverse events. The open-label trial will enroll 105 patients with metastatic, locally advanced or unresectable soft tissue sarcoma at approximately 30 study centers in the U.S., Hungary, Romania, Ukraine, Russia, India and Australia. Patients will be randomized into two groups with twice as many receiving INNO-206 as doxorubicin. Patients will be treated intravenously once every 21 days for up to eight consecutive cycles with INNO-206 administered drug at 350 mg/m² (260 mg/m² doxorubicin equivalents) and doxorubicin administered at 75 mg/m² .

About INNO-206

INNO-206 is a novel conjugate of doxorubicin that binds covalently to albumin, the most abundant protein in blood plasma, and is circulated throughout the body. Doxorubicin is a standard chemotherapeutic treatment for a variety of cancers and is used either alone or in combination with other chemotherapy agents. INNO-206 is designed with a linker that releases doxorubicin in the low pH environment of tumors, concentrating the chemotherapeutic agent where it preferentially damages the tumor while minimizing the effect on healthy tissues. This conjugate formulation has the potential to safely deliver greater amounts of doxorubicin directly to the tumor compared with standard doxorubicin treatment, which could lead to improved efficacy.

CytRx holds the exclusive worldwide rights to INNO-206 – a platform technology designed to reduce adverse events by controlling drug release and preferentially targeting tumors. In addition to doxorubicin, several other chemotherapy agents have been attached to the linker used for INNO-206, including paclitaxel, cisplatin and methotrexate, and may be incorporated into future clinical development by CytRx.

About CytRx Corporation

CytRx Corporation is a biopharmaceutical research and development oncology company engaged in the development of high-value human therapeutics. The CytRx oncology pipeline includes three programs in clinical development for cancer indications: INNO-206, tamibarotene and bafetinib. With its tumor-targeted doxorubicin conjugate INNO-206, CytRx has initiated an international Phase 2b clinical trial as a treatment for soft tissue sarcomas, is completing its ongoing Phase 1b/2 clinical trial and plans to initiate a Phase 2 trial for an undisclosed solid tumor indication in the first half of 2012. CytRx's pipeline also includes tamibarotene, which it is testing in a double-blind, placebo-controlled, international Phase 2b clinical trial in patients with non-small-cell lung cancer, and which is in a clinical trial as a treatment for acute promyelocytic leukemia (APL). The Company is evaluating bafetinib in the ENABLE Phase 2 clinical trial in high-risk B-cell chronic lymphocytic leukemia (B-CLL), and plans to seek a partner for further development of bafetinib. For more information on the Company, visit http://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 or uncertainties related to the outcome, timing and results of CytRx's Phase 1b/2 and Phase 2b clinical trials for INNO-206 in patients with advanced solid tumors, the risk that INNO-206 might not show greater efficacy than doxorubicin notwithstanding the administration of higher doses than the standard of care, the risk that additional longer-term dosing of INNO-206 might cause adverse events not seen to date in CytRx's Phase 1b/2 trial, the risk that patients in the Phase 2b clinical trial might not respond as well as the initial patients in the Phase 1b/2 clinical trial, uncertainties regarding whether INNO-206 effectively targets doxorubicin to tumors, uncertainties regarding regulatory approvals for current and future clinical testing of INNO-206 and the scope of the clinical testing that may eventually be required by regulatory authorities for INNO-206, the significant time and expense that will be incurred in developing any of the potential commercial applications for INNO-206, including for soft tissue sarcomas, risks related to CytRx's ability to manufacture its drug candidates, including INNO-206, 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 any future clinical development of INNO-206, 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 RelationsLegend Securities, Inc.Thomas Wagner800-385-5790 x152718-233-2600 This e-mail address is being protected from spambots. You need JavaScript enabled to view it.