CytRx and Cephalon Oncology Therapies to be Evaluated as Treatment for Relapsed Acute Promyelocytic Leukemia.
LOS ANGELES -- CytRx Corporation (NASDAQ:CYTR), a biopharmaceutical company engaged in the development and commercialization of human therapeutics, today announced the initiation of a dose escalation study with its oncology drug candidate tamibarotene combined with TRISENOX([R]) (arsenic trioxide) injection (marketed by Cephalon, Inc.) in patients with relapsed acute promyelocytic leukemia (APL). There are two primary trial objectives. The first is to determine the safety and preliminary efficacy of combining tamibarotene with arsenic trioxide as a treatment for relapsed or refractory APL. The second objective is to determine the appropriate dose for future clinical trials in which CytRx would test the utility of the tamibarotene/arsenic trioxide combination as a first-line treatment for subjects who prefer not to be exposed to anthracyclines. The dose escalation study is being financed jointly by CytRx and Cephalon.
"This trial represents an important step in our ultimate goal of evaluating tamibarotene as a first-line treatment for APL," said Steven Kriegsman, CytRx President and CEO. The majority of patients with newly diagnosed APL are currently treated with all-trans retinoic acid (ATRA) plus anthracycline-based chemotherapy, typically followed by maintenance with ATRA with or without low-dose chemotherapy. "This clinical trial will expand upon our current ongoing STAR-1 registration clinical trial that is evaluating tamibarotene's efficacy and safety as a third-line treatment," according to Mr. Kriegsman.
In the multi-center Phase I dose escalation trial, between 16 and 22 relapsed APL subjects in three dose groups will be treated with 2-3 six-week cycles of intravenous arsenic trioxide and self-administered oral tamibarotene tablets with 2-6 weeks between cycles. Initially, three to six subjects will be entered in the group receiving the lowest dose. If no more than one dose-limiting toxic event is reported, the dose will be escalated to the next cohort and this process will continue until the maximum dose is achieved or the maximum tolerated dose (MTD) is identified. A total of 10 subjects will be enrolled at the maximum dose or the MTD for one or two additional cycles of therapy and evaluated for disease remission. The dose for the subsequent Phase 2 trial will be the dose at which at least five of six subjects tolerate the treatment or the maximum dose used in this trial.
"We hypothesize that the combination of tamibarotene and arsenic trioxide will result in a similar complete response rate as the ATRA and arsenic trioxide combination, but with decreased toxicities, such as hyperleukocytosis, APL differentiation syndrome and rash and potentially a lower relapse rate," said Jessica K. Altman M.D., Assistant Professor of Medicine at Northwestern University Feinberg School of Medicine. Dr. Martin S. Tallman, Professor of Medicine stated, "Because tamibarotene appears to be more potent and more selective than ATRA, we anticipate that the tamibarotene/arsenic trioxide combination may be more effective and less prone to drug resistance than ATRA combined with arsenic trioxide." Drs. Altman and Tallman will serve as principal co-investigators for the trial.
There are currently no approved third-line treatment options for refractory APL subjects, an annual market that CytRx estimates at approximately $20 million in the United States and $25 million in Europe. The estimated annual market potential in the U.S. and Europe for an expanded label for tamibarotene that includes refractory, maintenance and front-line therapy is up to $150 million, As announced recently, CytRx has been granted European Orphan Drug status for tamibarotene as a third-line APL. While currently focused on U.S. approval for tamibarotene, CytRx considers Orphan Drug status as an important step in its future plans to pursue European Union approval for tamibarotene as a treatment for APL.
About Acute Promyelocytic Leukemia (APL)
Acute promyelocytic leukemia (APL) is a subtype of acute myeloid leukemia (AML) characterized by the balanced chromosomal translocation, (15;17) that results in the creation of the fusion gene product PML/RAR-alpha which is critical in the pathogenesis of the disease. APL occurs in 10% to 15% of adults with AML; and in the United States, and there are approximately 1,500 cases of APL diagnosed each year. The disease is clinically notable for life-threatening coagulopathy that has historically been the major cause of death.
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 programs in clinical development for cancer indications, including tamibarotene in a registration study for the treatment of refractory acute promyelocytic leukemia (APL). 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 39% equity interest in publicly traded RXi Pharmaceuticals, Inc. (NASDAQ:RXII). For more information on the Company, visit www.cytrx.com.
TRISENOX is indicated for the induction of remission and consolidation in patients with APL who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is characterized by the presence of the t(15;17) translocation of PML/RAR-alpha gene expression.
Important Safety Information
In clinical trials, serious adverse events, grade 3 or 4, were common. Those events attributable to TRISENOX in the phase 2 study of 40 patients with refractory or relapsed APL included QTc interval prolongation (n=16), APL differentiation syndrome (n=3), hyperleukocytosis (n=3), atrial dysrhythmias (n=2), hyperglycemia (n=2), and torsade de pointes (n=1).
Full Prescribing Information, including BOXED WARNING, is available at www.TRISENOX.com.
For more information about Cephalon, please visit www.cephalon.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 the Company's planned dose escalation study with tamibarotene combined with arsenic trioxide in subjects with relapsed acute promyelocytic leukemia APL, whether, based on the results of that study or other factors, the Company will proceed with subsequent clinical trials to test the utility of tamibarotene as first-line and refractory treatments for APL, and the timing, outcome or results of any such trials, uncertainties as to whether tamibarotene and arsenic trioxide will clinically demonstrate a similar complete response rate as the ATRA and arsenic trioxide combination, but with a lower relapse rate and decreased toxicities, risks related to CytRx's need for additional capital or strategic partnerships to fund its ongoing working capital needs and development efforts, 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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|Date:||Sep 14, 2009|
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