CytRx Corporation (Nasdaq:CYTR), a biopharmaceutical company specializing in oncology, announced positive study results indicating that INNO-206, a tumor-targeting pro-drug formulation of the commonly prescribed chemotherapy agent doxorubicin, safely and effectively delivered doxorubicin at higher doses than conventional doxorubicin to human myeloma cancers grown in immune-deficient mice. The study was directed by leading multiple myeloma expert James R. Berenson, MD, Medical & Scientific Director of the Institute for Myeloma & Bone Cancer Research, and presented in a poster session at the 52 nd Annual Meeting and Exposition of the American Society of Hematology (ASH) in Orlando, Florida. “Anthracyclines including doxorubicin have been shown to be effective in the treatment of a variety of different cancers; however, the efficacy of these drugs either as single agents or in combination therapies is limited by their myelosuppressive, cardiac and dermatological side effects,” said Dr. Berenson. “INNO-206’s albumin-binding pro-drug formulation allows for the release of doxorubicin only under acidic conditions that are commonly present within tumor tissue. Using INNO-206, we were able to increase doxorubicin delivery to human myeloma tumors in this mouse model using doses that were unattainable with conventional doxorubicin. The results showed statistically significant shrinkage of tumors with INNO-206 at doses substantially greater yet still safer compared to doxorubicin alone in human tumor-bearing mice. Doxorubicin combination chemotherapy is an approved treatment for multiple myeloma.” CytRx President and CEO Steven A. Kriegsman said, “This study provides further evidence of INNO-206’s tumor-targeting capability that could lead to superior efficacy compared to currently available anthracyclines, such as doxorubicin, in treating cancer patients. This is important as we believe INNO-206 could have similar applicability in multiple cancer indications. We are currently working towards completion of drug manufacturing optimization and scale-up, in anticipation of moving into Phase 2 clinical trials initially in soft tissue sarcomas and pancreatic cancer, following a brief safety study of the new formulation.”
In the study, conducted at the Institute for Myeloma & Bone Cancer Research, 10 mice treated with INNO-206 at 10.8 mg/kg (7 mg/kg doxorubicin equivalents) showed markedly smaller tumor volumes and immunoglobulin G (IgG) levels on days 28 (tumor volumes: P = 0.0152; hIgG: P = 0.0019), 35 (tumor volumes: P = 0.0051; hIgG: P = 0.0006) and 42 (tumor volumes: P = 0.0036; hIgG: P = 0.0113) compared to vehicle-treated mice. Of the INNO-206 treated mice, 90% were alive for the duration of the 42-day study. In contrast, those treated with doxorubicin at 4 and 8 mg/kg showed similar tumor shrinkage but resulted in significant toxicity and death (4 mg/kg resulted in 3/10 and 9/10 deaths on days 28 and 35, respectively; 8 mg/kg, 5/10, 8/10 and 10/10 deaths occurred on days 21, 28 and 35, respectively).About the ASH Annual Meeting The American Society of Hematology (ASH) annual meeting is the largest gathering of hematology and hematology-oncology professionals in the world. This four-day conference provides a forum for discussing the latest scientific advances in the field and offers breakthrough research in the form of abstract-based sessions, as well as invited lectures and special events. About INNO-206 INNO-206 is a tumor-targeting pro-drug 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.
About CytRx CorporationLos Angeles-based CytRx Corporation is a biopharmaceutical research and development oncology company engaged in the development of high-value human therapeutics. The CytRx oncology pipeline includes three programs in clinical development for cancer indications: bafetinib, tamibarotene and INNO-206. The Company is evaluating bafetinib in the ENABLE Phase 2 clinical trial in high-risk B-cell chronic lymphocytic leukemia (B-CLL) and the PROACT Phase 2 clinical trial in advanced prostate cancer, and is conducting a pharmacokinetic clinical trial in brain cancer. With its tumor-targeting pro-drug candidate INNO-206, CytRx plans to initiate Phase 2 proof-of-concept clinical trials as a treatment for pancreatic cancer and soft tissue sarcomas, following an abbreviated safety trial. CytRx's pipeline also includes tamibarotene, which it is testing in patients with non-small-cell lung cancer and which is in a registration clinical trial as a treatment for acute promyelocytic leukemia (APL). 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 17% equity interest in publicly traded RXi Pharmaceuticals, Inc. (NASDAQ: RXII). For more information on the Company, visit http://www.cytrx.com. Forward-Looking Statements 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 or uncertainties regarding regulatory approvals for current and future clinical testing of INNO-206 and the scope of the clinical testing that may eventually be required by regulatory authorities for INNO-206, the significant time and expense that will be incurred in developing any of the potential commercial applications for INNO-206, including for soft tissue sarcomas and pancreatic cancer, the risk that any future human testing of INNO-206 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 need for additional capital or strategic partnerships to fund its ongoing working capital needs and development efforts, including any future clinical development of bafetinib, 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.