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Callisto Pharmaceuticals study of anti-leukemia drug L-Annamycin is expanded

04-18-2006

Callisto Pharmaceuticals, Inc., (KAL, CA4) announced the expansion of its ongoing research trial of L-Annamycin, the company's drug candidate to treat adult patients with relapsed or refractory acute lymphocytic leukemia (ALL), to a third clinical trial site.

The new site to join the phase I/IIa clinical trial of L-Annamycin is the Roswell Park Cancer Institute in Buffalo, New York, one of the nation's leading cancer research centers. The first patient at this site was enrolled on March 6, 2006 under the direction of Meir Wetzler, the principal investigator at Roswell Park.

"We are very pleased to announce this latest benchmark in our development of a promising new compound to treat acute lymphocytic leukemia, a serious cancer of the blood for which new treatments are desperately needed," said Donald Picker, Callisto's executive VP of Research and Development. "The Roswell Park Cancer Institute is one of the nation's preeminent institutions for the study of cancer, and we are very gratified that clinicians there will be helping to advance the clinical trial of L-Annamycin. This new clinical trial site provides an additional pool of potential patients for the present study."

In previous published animal studies, L-Annamycin has demonstrated that it can kill tumor cells that are resistant to other anthracycline anticancer drugs. In addition, earlier studies have shown that L-Annamycin may have other key advantages over other anthracycline drugs, including a decreased risk of treatment-related cardiomyopathy (inflammation of the heart muscle), a complication associated with this family of anticancer drugs.

Callisto additionally plans to evaluate L-Annamycin for the treatment of children with refractory or relapsed ALL, and refractory or relapsed acute myelogenous leukemia (AML), respectively, as well as in the treatment of adults with relapsed or refractory AML in combination with Ara-C. Callisto intends to begin separate clinical trials in these populations in 2006. If these trials are successful, an even broader population of leukemia patients could benefit from L-Annamycin.

The first clinical trials of L-Annamycin were initiated in December, 2005 at the University of Texas M.D. Anderson Cancer Center, in Houston, Texas, where it remains ongoing.

L-Annamycin is one of two anticancer drugs in development by Callisto that has received Orphan Drug designation by the FDA. This designation guarantees that after FDA approval of the drug, the sponsoring company has marketing exclusivity within the United States for 7 years following commercial launch. The FDA's Orphan drug designation also provides significant additional benefits to the sponsoring company, including eligibility for research grants and protocol assistance, opportunities for regulatory agency assistance on review of clinical protocols, and waiver of the Prescription Drug User Fee Act (PDUFA) filing fee.

This article was prepared by Clinical Oncology Week editors from staff and other reports. Copyright 2006, Clinical Oncology Week via NewsRx.com.