(NASDAQ: CYTR), a biopharmaceutical company specializing in oncology, has initiated an open-label, single-center Phase 1b clinical trial to evaluate the pharmacokinetics of its tumor-targeting doxorubicin conjugate aldoxorubicin (formerly known as INNO-206) in patients with metastatic solid tumors who have either relapsed or not responded to treatment with standard therapies. The data obtained from this study will identify the duration of exposure after infusion of aldoxorubicin as well as define the peak drug levels reached after treatment with two different doses of the drug.
The single-center Phase 1b clinical trial will be conducted under the direction of Dr. Monica Mita at Cedars Sinai Medical Center in Los Angeles, California, and will evaluate the pharmacokinetics and safety of a new formulation of aldoxorubicin administered at doses of 230 mg/m2 and 350 mg/m2 every 21 days for up to 8 consecutive cycles. The company expects to use the results from the clinical trial for future regulatory submissions and partnership discussions.
CytRx holds exclusive worldwide rights to aldoxorubicin. In June, the Company announced data from a Phase 1b/2 clinical trial indicating that aldoxorubicin administered at its maximum tolerated dose showed clinical benefit (defined as partial response and stable disease of more than four months following up to eight cycles of treatment) in 10 of 13 (77%) evaluable patients with relapsed or refractory soft tissue sarcoma. All patients in the Phase 1b/2 trial had either not responded to or relapsed after treatment with between one and three prior chemotherapy regimens.
About CytRx Corporation
CytRx Corporation is a biopharmaceutical research and development company specializing in oncology. The CytRx oncology pipeline includes two programs in clinical development for cancer indications:
aldoxorubicin (formerly known as INNO-206)
. With its tumor-targeted doxorubicin conjugate aldoxorubicin, CytRx has initiated an international Phase 2b clinical trial as a treatment for soft tissue sarcomas, has completed its Phase 1b/2 clinical trial primarily in the same indication, recently initiated both a Phase 2 trial for patients with advanced pancreatic ductal adenocarcinomas and a Phase 1b study of aldoxorubicin in combination with doxorubicin in patients with advanced solid tumors, and plans to meet with the FDA in the fourth quarter of 2012 to discuss a potential Phase 3 pivotal trial as a therapy for patients with soft tissue sarcomas whose tumors have progressed following treatment with chemotherapy. Tamibarotene is being tested in a double-blind, placebo-controlled, international Phase 2b clinical trial in patients with non-small-cell lung cancer, and is in a Phase 2 clinical trial as a treatment for acute promyelocytic leukemia (APL). The Company completed its evaluation of a third drug candidate,
, 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 about the Company, visit
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 relating to the outcome, timing and results of CytRx's clinical trials, the risk that any future human testing of aldoxorubicin might not produce results similar to those seen in past human or animal testing, risks related to CytRx's ability to manufacture its drug candidates in a timely fashion, cost-effectively or in commercial quantities in compliance with stringent regulatory requirements, uncertainties regarding whether CytRx will be permitted to conduct a Phase 3 clinical trial with aldoxorubicin as a treatment for STS, 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 aldoxorubicin, tamibarotene or bafetinib, 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.