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, CA, USA I May 21, 2013 I CytRx Corporation (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.
SOURCE: CytRx
Post Views: 250
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, CA, USA I May 21, 2013 I CytRx Corporation (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.
SOURCE: CytRx
Post Views: 250
