– Designed to determine maximum tolerated dose of INNO-206 as an important step toward CytRx’s planned Phase 2 clinical trial in soft tissue sarcoma –
LOS ANGELES--(BUSINESS WIRE)-- CytRx Corporation (Nasdaq: CYTR), a biopharmaceutical company specializing in oncology, today announced that it has initiated an open-label Phase 1b safety and dose escalation clinical trial with INNO-206 at the Sarcoma Oncology Center in Santa Monica, California. The clinical trial will include up to 24 patients with advanced solid tumors who have failed standard therapies.
INNO-206 is a tumor-targeting pro-drug of the commonly prescribed chemotherapeutic doxorubicin, and was designed to improve efficacy and reduce adverse events through controlled release and preferential targeting of tumors. Doxorubicin is currently the only FDA-approved drug on the market for soft tissue sarcoma, and is a standard chemotherapeutic treatment for a variety of other cancers. Objective clinical responses have been seen with INNO-206 in patients with sarcoma, breast and lung cancers in an earlier Phase 1 trial.
“Determining the maximum dose of INNO-206 in patients with solid tumors is a major step forward in advancing this oncology drug candidate’s development,” said CytRx President and CEO Steven A. Kriegsman. “We have already completed drug formulation and manufacturing optimization in anticipation of moving rapidly into Phase 2 clinical programs following completion of this clinical trial.
“We are delighted to be working with the well-respected Sarcoma Oncology Center. We expect that a number of patients enrolled in the clinical trial will have advanced soft tissue sarcoma, which could yield significant information, especially as this is the first of several indications for planned Phase 2 clinical testing with INNO-206,” he added.
Chief Medical Officer Daniel Levitt, MD, Ph.D., said, “This clinical trial will allow us to evaluate the safety of administering doses of INNO-206 that are over 2 to 4 times the standard dose of doxorubicin, which we believe we can accomplish without an increase in observed side effects over those historically seen with doxorubicin. We are encouraged by the fact that INNO-206 has demonstrated significantly greater efficacy than doxorubicin in animal models of breast cancer, small cell lung cancer, renal cancer, pancreatic cancer and ovarian cancer.”
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: bafetinib, tamibarotene and INNO-206. The Company is evaluating bafetinib in the ENABLE Phase 2 clinical trial in high-risk B-cell chronic lymphocytic leukemia (B-CLL) and the PROACT Phase 2 clinical trial in advanced prostate cancer, and is conducting a pharmacokinetic clinical trial in brain cancer. With its tumor-targeting pro-drug candidate INNO-206, CytRx is conducting a safety trial with plans to initiate Phase 2 proof-of-concept clinical trials as a treatment for soft tissue sarcomas and pancreatic cancer. CytRx's pipeline also includes tamibarotene, which it is testing in patients with non-small-cell lung cancer and which is in a registration clinical trial as a treatment for acute promyelocytic leukemia (APL). For more information on the Company, visit http://www.cytrx.com.
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 clinical trial for INNO-206 in patients with advanced solid tumors or planned Phase 2 clinical trials for INNO-206 as a treatment for soft tissue sarcomas or pancreatic cancer, uncertainties regarding regulatory approvals for current and future clinical testing of tamibarotene 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 or pancreatic cancer, the risk that any future human testing of INNO-206 for might not produce results similar to those seen in animals, 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.
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INDUSTRY KEYWORDS: Health Biotechnology Clinical Trials Oncology Pharmaceutical