CytRx Announces Initial Results from Pharmacokinetics Clinical Trial with Aldoxorubicin in Solid Tum
CytRx Announces Initial Results from Pharmacokinetics Clinical Trial with Aldoxorubicin in Solid Tumors
Aldoxorubicin shows prolonged clinical activity in two clinical trial patients with small cell lung cancer who have failed other therapies
Data show that aldoxorubicin demonstrates a significant 250-fold lower distribution to healthy tissue compared with doxorubicin
LOS ANGELES--(BUSINESS WIRE)-- CytRx Corporation (NAS: CYTR) , a biopharmaceutical research and development company specializing in oncology, announced initial data from a Phase 1b clinical trial evaluating the pharmacokinetics and safety of aldoxorubicin, its novel conjugate of the widely used chemotherapeutic agent doxorubicin, in patients with metastatic solid tumors who have either relapsed or not responded to treatment with standard therapies. The data indicate that aldoxorubicin has a distribution half-life of 20-24 hours following infusion, which is significantly longer than doxorubicin's initial half-life of five minutes. The data also demonstrate that aldoxorubicin demonstrated a distribution to healthy tissues that was 250-fold lower than that of doxorubicin.
"The initial trial results provide positive insights about how aldoxorubicin acts within the body, which is an important component of regulatory submissions and could point to its safety and effectiveness," said Steven A. Kriegsman, CytRx President and CEO. "A longer half-life and narrow drug distribution to healthy tissues are potentially beneficial characteristics, because the drug remains active for increased time periods with decreased potential for toxicity.
"In the clinical trial, aldoxorubicin has shown prolonged clinical activity in two trial patients with small cell lung cancer who had failed other therapies, including a partial tumor response," he added. "This was observed even at the lower, well-tolerated dose. We may consider further investigating aldoxorubicin in this indication among several others in the future. In fact, aldoxorubicin could be active against a variety of cancers, having shown to be superior to widely used doxorubicin in multiple animal models of cancer."
The open-label, single-center Phase 1b clinical trial is being conducted under the direction of Dr. Monica Mita at Cedars-Sinai Medical Center in Los Angeles. Aldoxorubicin is being administered at doses of 230 mg/m2 and 350 mg/m2 every 21 days for up to 8 consecutive cycles.
About CytRx Corporation
CytRx Corporation is a biopharmaceutical research and development company specializing in oncology. The CytRx oncology pipeline is focused on the clinical development of aldoxorubicin (formerly known as INNO-206), its improved version of the widely used chemotherapeutic agent doxorubicin. 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, and has initiated a Phase 1b pharmacokinetics clinical trial in patients with metastatic solid tumors and a Phase 1b study of aldoxorubicin in combination with doxorubicin in patients with advanced solid tumors. The Company is initiating an international Phase 3 pivotal trial under a special protocol assessment (SPA) with aldoxorubicin as a therapy for patients with soft tissue sarcomas whose tumors have progressed following treatment with chemotherapy. CytRx is expanding its pipeline of oncology candidates based on a novel linker platform technology that can be utilized with multiple chemotherapeutic agents and could allow for greater concentration of drug at tumor sites. The Company also has rights to two additional drug candidates, tamibarotene and bafetinib. The Company completed its evaluation of 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, and is evaluating further development of tamibarotene. For more information about CytRx Corporation, visit 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 relating to the outcome, timing and results of CytRx's clinical trials, the risk that any future human testing of aldoxorubicin, including the conclusion of the Phase 1b clinical trial evaluating the pharmacokinetics and safety of aldoxorubicin, might not produce results similar to those seen in past human or animal testing, including the initial Phase 1b pharmacokinetics results, 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, risks related to CytRx's need for additional capital or strategic partnerships to fund its ongoing working capital needs and development efforts, including the Phase 3 clinical development of aldoxorubicin, 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.
Legend Securities, Inc.
Vice President, Business Development
KEYWORDS: United States North America California
The article CytRx Announces Initial Results from Pharmacokinetics Clinical Trial with Aldoxorubicin in Solid Tumors originally appeared on Fool.com.Try any of our Foolish newsletter services free for 30 days. We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy.
Copyright © 1995 - 2013 The Motley Fool, LLC. All rights reserved. The Motley Fool has a disclosure policy.