Groundbreaking Statistically Significant Interim Results Expand INNO-206’s Potential Therapeutic Indications
INNO-206 Shows Minimal Toxicity Compared to Doxorubicin
LOS ANGELES--(BUSINESS WIRE)-- CytRx Corporation (NASDAQ:CYTR), a biopharmaceutical company specializing in oncology, today announced interim study results that showed its doxorubicin prodrug INNO-206 demonstrated statistically significant anti-tumor activity in human myeloma tumor cells growing in immune-deficient mice compared to a control group, while exhibiting significantly less toxicity than doxorubicin even though INNO-206 was administered at much higher doses. The study is being conducted by the Institute for Myeloma & Bone Cancer Research under the direction of the Institute’s Medical and Scientific Director, noted multiple myeloma authority James R. Berenson, MD. Multiple myeloma is an incurable malignant tumor of the plasma cells in the bone marrow and is the second most common blood-based cancer.
“Early results from our in vivo multiple myeloma model show marked anti-tumor activity of INNO-206. We have been able to administer greater doses of INNO-206 into animals with improved tolerability compared with doxorubicin,” stated Dr. Berenson. “Velcade® in combination with Doxil® (pegylated liposomal doxorubicin) has been FDA-approved for multiple myeloma patients who have received one prior therapy, based on the superior outcomes among patients receiving this combination compared to Velcade alone. Based on our study results, the safety profile and efficacy of this new doxorubicin derivative INNO-206, when tested as a single agent in multiple myeloma growing in animals, show that INNO-206 may offer significant benefits over doxorubicin and related drugs when administered in combination with Velcade.”
“Dr. Berenson is an internationally known oncologist and expert in multiple myeloma, and he has been directly responsible for multiple breakthrough treatments that improve the length and quality of life of multiple myeloma patients. We are delighted with the interim study results indicating that INNO-206 could have a significant role in the treatment of this incurable disease,” said Steven A. Kriegsman, CytRx President and CEO. “The results further expand the potential therapeutic value of INNO-206, which has demonstrated anti-tumor activity in multiple cancers. We plan to explore INNO-206 as a viable treatment in numerous oncology indications, including multiple myeloma.”
In the study, 50 mice with implanted multiple myeloma tumors were randomized into five groups of 10 mice: two INNO-206 groups, two doxorubicin groups and a control group. Starting on day seven following tumor implantation, mice received weekly intravenous injections of INNO-206 (10.8 mg/kg or 21.6 mg/kg), doxorubicin (4 mg/kg or 8 mg/kg) or control. Tumor volume is measured weekly. Interim results show that over the course of three injections, mice treated with INNO-206 showed a statistically significant decrease in tumor size compared to mice in the control group. Perhaps most excitingly, substantially fewer deaths occurred in the INNO-206 dose groups as compared with the doxorubicin groups. Only one fatality occurred in the 10.8 mg/kg INNO-206 group, as compared with nine out of ten fatalities in the low-dose doxorubicin group, and ten out of ten fatalities in the high-dose doxorubicin group. The doxorubicin deaths also occurred much earlier than the fatalities in mice administered INNO-206.
CytRx Chief Medical Officer Daniel Levitt, MD, Ph.D., stated, “The Institute for Myeloma & Bone Cancer Research is employing a specifically designed animal model in which human multiple myeloma tumor implants are able to grow and survive in these mice. This model has been shown to retain the chemo-resistant phenotype of the original patient’s tumor, which assists in evaluating anti-multiple myeloma activity of novel therapies, making the comparative results between INNO-206 and doxorubicin quite encouraging. Based on these results, we intend to expand the scope of our evaluation of INNO-206 in several of Dr. Berenson’s multiple myeloma models.”
CytRx holds the exclusive worldwide rights to INNO-206. The Company has previously announced plans to initiate Phase 2 proof-of-concept clinical trials in patients with pancreatic cancer, gastric cancer and soft tissue sarcomas, upon the completion of optimizing the formulation of INNO-206. Based on the multiple myeloma interim results, the Company is exploring the possibility of rapidly including multiple myeloma in its INNO-206 clinical development plans.
About Multiple Myeloma
The American Cancer Society estimates that more than 80,000 people in the U.S. are currently living with multiple myeloma and more than 20,000 new cases are diagnosed each year. Approximately 10,000 Americans die annually from multiple myeloma. Multiple myeloma is characterized by malignant plasma cells that form tumors in the bone marrow. These plasma cell tumors can spread throughout the bone marrow, thereby disrupting the production of red blood cells and platelets, which normally occur in the bone marrow. Excessive amounts of malignant plasma cells also may decrease the number of white blood cells, which are important in fighting off infections.
INNO-206 is a prodrug of the commonly prescribed chemotherapeutic doxorubicin and was designed to reduce adverse events by controlling release and preferentially targeting the tumor. In a Phase 1 study, doses were administered at up to six times the standard dosing of doxorubicin without an increase in observed side effects over those historically seen with doxorubicin. Objective clinical responses were seen in patients with sarcoma, breast and lung cancers. The Company also has announced that INNO-206 demonstrated statistically significant results in animal models of breast cancer, small cell lung cancer, pancreatic cancer and ovarian cancer. The Company has announced plans in 2010 to initiate Phase 2 proof-of-concept clinical trials with INNO-206 in patients with pancreatic cancer, gastric cancer and soft tissue sarcomas.
CytRx Corporation is a biopharmaceutical research and development company engaged in the development of high-value human therapeutics. The CytRx oncology pipeline includes three programs in clinical development for cancer indications, including INNO-206, bafetinib and tamibarotene. CytRx recently announced plans to initiate Phase 2 clinical trials with its oncology candidate INNO-206 as a treatment for pancreatic cancer, gastric cancer and soft tissue sarcomas. The Company also has announced plans to initiate three Phase 2 clinical trials with bafetinib as a treatment for high-risk B-cell chronic lymphocytic leukemia (B-CLL), glioblastoma multiforme (a common and aggressive type of primary brain tumor) and advanced prostate cancer. In addition, CytRx is developing two drug candidates based on its industry-leading molecular chaperone technology, which aims to repair or degrade misfolded proteins associated with disease. CytRx also maintains a 28% equity interest in publicly traded RXi Pharmaceuticals, Inc. (NASDAQ:RXII). For more information on the Company, 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 timing, outcome or results of any future pre-clinical or clinical testing of INNO-206 as a treatment for multiple myeloma, the risk that any future human testing of INNO-206 for multiple myeloma 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 ability to enter into partnerships or other transactions to advance the clinical development of its portfolio of drug candidates, 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, risks related to the future market value of CytRx's investment in RXi and the liquidity of that investment, 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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