INNO-406 Demonstrates Positive Clinical Responses In Phase 1 Trial In Patients With Chronic Myeloid Leukemia

Main Category: Lymphoma / Leukemia / Myeloma
Also Included In: Blood / Hematology;  Cancer / Oncology;  Clinical Trials / Drug Trials
Article Date: 13 Nov 2008 - 4:00 PDT

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CytRx Corporation (Nasdaq:CYTR), a biopharmaceutical company engaged in the development and commercialization of human therapeutics, today announced that INNO-406, CytRx's potent, orally available, rationally designed, dual Bcr-Abl and Lyn-kinase inhibitor, demonstrated clinical responses in patients with Chronic Myeloid Leukemia (CML). INNO-406 is being evaluated for the treatment of patients with CML and other leukemias that have a certain mutation called the Philadelphia Chromosome (Ph+) and are intolerant of or resistant to imatinib (Gleevec®) and second line tyrosine kinase inhibitors (i.e. dasatinib (Sprycel®) and nilotinib (Tasigna®)).

CML is a type of cancer that starts in blood-forming cells of the bone marrow and invades the blood. In 2007, the American Cancer Society estimated that approximately 4,600 new cases of CML were diagnosed in the US and that the number will increase as the population ages. Current estimates are that worldwide CML prevalence will increase by 10,000 patients a year, reaching a population of 110,000 in 2010. The global market is estimated to be $5.5 billion by 2012.

"INNO-406 is part of a recent strategic acquisition designed to accelerate and complement CytRx's own internal efforts to build an oncology drug franchise," stated Steven A. Kriegsman, CytRx's President and CEO. "We are enthusiastic about our oncology drug products, and we believe that these encouraging results from the first clinical trial of INNO-406 demonstrate that our corporate oncology strategy may result in significant value added to CytRx. We are waiting for additional results from non-clinical studies, as well as the completion of a comprehensive corporate strategic review, to determine the most efficient and effective path to move INNO-406 forward in development."

The clinical trial was designed to identify the optimal dose for possible future studies by escalating doses from 30 mg once a day up to 480 mg twice a day in a total of 56 patients with Ph+ leukemias. 31 patients had CML in chronic phase (CML-CP), nine were in accelerated phase (CML-AP), seven were in blast phase (CML-BP), and nine had Ph+ Acute Lymphocytic Leukemia. The clinical trial was conducted at seven clinical sites in the US, Germany, and Israel, with Hagop Kantarjian, MD (Professor & Chairman, Department of Leukemia, The University of Texas, M.D. Anderson Cancer Center) serving as the Principal Investigator.

All patients had demonstrated intolerance or resistance to imatinib, and the majority of patients had also demonstrated intolerance or resistance to a second, and in some cases a third, BCR-ABL inhibiting tyrosine kinase inhibitor. A positive, dramatic decrease in the number of leukemia cells in the bone marrow was seen in 35% of the patients that were randomly chosen to begin their treatment with the optimal INNO-406 dose of 240 mg twice per day.

The maximum tolerated dose was determined to be 240 mg given twice per day based on evidence of increasing potential liver toxicity at higher doses. Common adverse events (observed in greater than 20% of patients in the 240 mg twice per day dose group) were gastrointestinal related, swelling, and fatigue. There was no evidence of fluid accumulating around the lungs or significant changes in a certain heart rhythm called QTc prolongation that are serious side effects known to occur in patients treated with approved drugs for this indication. Only 13% of patients, across all dose groups, discontinued dosing due to unacceptable toxicity.

About CytRx Corporation

CytRx Corporation is a biopharmaceutical research and development company engaged in the development of high-value human therapeutics. The CytRx drug development pipeline includes six programs in clinical development, including tamibarotene in registration studies for the treatment of acute promyelocytic leukemia (APL). In addition to a portfolio of oncology programs, CytRx is developing two drug candidates identified based on its industry-leading molecular chaperone technology which aims to repair or degrade misfolded proteins associated with disease. The Company owns and operates a research and development facility in San Diego. CytRx also maintains a 45% equity interest in RXi Pharmaceuticals Corporation (Nasdaq: RXII). For more information on the Company, visit http://www.cytrx.com.

Forward-Looking Statements

This press release may contain 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 and uncertainties related to the outcome or results of any future pre-clinical or clinical testing of INNO-406, the significant time and expense that will be incurred in developing the potential commercial application for INNO-406, the need for additional capital, or a strategic partnership, to fund the development of INNO-406, and other risks and uncertainties described in CytRx's Form 10-Q for the quarter ended September 30, 2008 and other recently filed SEC documents, such as its most recent annual report on Form 10-K. 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.

CytRx Corporation

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