CytRx Announces the Presentation of Favorable Results from Novel Combination of Aldoxorubicin and Do
CytRx Announces the Presentation of Favorable Results from Novel Combination of Aldoxorubicin and Doxorubicin in a Phase 1b Clinical Trial at ASCO Conference
Combination Safely Delivered to Patients with Advanced Solid Tumors; Objective Responses Observed
LOS ANGELES--(BUSINESS WIRE)-- CytRx Corporation (NAS: CYTR) , a biopharmaceutical research and development company specializing in oncology, announced that preliminary results from a Phase 1b clinical trial determined that aldoxorubicin, the Company's improved version of the widely used chemotherapeutic agent doxorubicin, administered at 90% of its single agent dose can be safely delivered in combination with doxorubicin administered at 50% of its single agent dose to patients with advanced solid tumors. The data from this clinical trial will be discussed today in a poster presentation at the American Society of Clinical Oncology (ASCO) conference in Chicago.
The Phase 1b data was included in an abstract, "Phase 1b Trial of Combining Aldoxorubicin Plus Doxorubicin," authored by Kamalesh Kumar Sankhala, M.D.; Sant P. Chawla, M.D.; Victoria S. Chua; Doris Quon, M.D.; Allison Bonk; Vivek Narashimhan; Monish Sodhi; and Nina Krishna, from the Sarcoma Oncology Center in Santa Monica, Calif., and Hillary Dinh, Ph.D., Scott Wieland, Ph.D., CytRx's Senior Vice President of Drug Development, and Daniel Levitt, M.D., Ph.D., CytRx's Executive Vice President and Chief Medical Officer. Dr. Sankhala, of the Institute for Drug Development, Cancer Therapy and Research Center, University of Texas Health Science Center at San Antonio, presented the data at the ASCO conference.
"The preliminary trial data show that none of the patients terminated treatment due to an adverse event and no cardiac toxicities were observed," said Dr. Levitt. "This is important as doxorubicin, either alone or in combination with ifosfamide, is still considered the mainstay chemotherapeutic agent for the treatment of advanced, unresectable tumors. However, doxorubicin has significant side effects, including chronic cardiotoxicity, which limits the dosage to a level below its maximum anti-tumor capabilities. Several patients in the trial had good objective tumor responses with others demonstrating prolonged stable disease. It is possible that this unique combination allows better penetration of each drug into the tumor as well as an enhanced ability to treat both small and large tumor metastases."
"We are delighted to share the results of this trial and are pleased that we were accepted for presentation at the premier oncology conference," said Steven A. Kriegsman, CytRx President and CEO. "We plan to continue testing the combination of aldoxorubicin and doxorubicin at the optimal dose indicated in the Phase 1b clinical trial to an expanded group of patients with chondrosarcomas or chordomas to determine safety and preliminary efficacy in these normally chemotherapy-insensitive malignancies. The purpose of further evaluation is to extend our intellectual property portfolio and potentially increase market penetration with aldoxorubicin for the treatment of patients with solid tumors."
Studies in animal models of human pancreatic and ovarian cancers conducted at the Tumor Biology Institute in Freiburg, Germany demonstrated that aldoxorubicin plus doxorubicin administered at 50% of their respective maximum tolerated doses provided complete and prolonged tumor remission with minimal weight loss compared with each drug administered at its individual maximum tolerated dose. Results of this research were published in the peer-reviewed International Journal of Pharmaceutics.
Clinical and preclinical trials indicate that aldoxorubicin, which combines doxorubicin with a proprietary protein-binding linker platform technology, concentrates doxorubicin at the site of the tumor, thereby reducing the toxic side effects associated with systemic delivery. CytRx holds the exclusive worldwide rights to aldoxorubicin, as well as option rights to the platform technology that serves as the linker with doxorubicin.
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 testing of aldoxorubicin in combination with doxorubicin as a therapy for advanced solid tumors, might not produce results similar to those seen in past human or animal testing, including the initial Phase 1b 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.
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