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Cyclacel Drug Promising in Myelodysplastic Syndrome

Posted Dec 04 2010 5:30pm

Saturday, December 4, 2010
  Reuters Health Information Logo

By Bill Berkrot

NEW YORK (Reuters) - Nearly a third of patients with the blood cancer myelodysplastic syndrome who were not helped by prior treatment survived for one year after taking an experimental drug being developed by Cyclacel Pharmaceuticals Inc, according to data from a mid-stage study.

The oral drug, sapacitabine, was tested at three dosing regimens in 61 patients aged 60 years and older who failed treatment with at least one hypomethylating agent, such as azacitidine or decitabine.

Patients received a regimen of either 200 milligrams of sapacitabine twice a day for 7 days, 300 mg twice a day for 7 days or 400 mg twice a day for 3 days.

The 1-year survival rate was 29 percent for the low dose group, 30 percent on the 7-day, 300 mg regimen and 35 percent in the 3-day high dose group, according to data presented on Saturday at the American Society of Hematology (ASH) meeting in Orlando, where the latest research into a host of blood disorders was being unveiled.

"The survival data of sapacitabine in this study are promising and warrant further clinical development in this patient population," the study leader, Dr Hagop Kantarjian from MD Anderson Cancer Center in Houston, said in a statement.

"Myelodysplastic syndrome patients have a poor outcome after treatment failures of hypomethylating agents. Effective therapies are urgently needed to improve the survival of these patients," Kantarjian said.

Two patients in the low dose group achieved complete remission, Cyclacel said. The overall response rate -- a secondary goal that combines partial and complete responders -- was 24 percent, 35 percent and 15 percent in the three respective treatment groups.

Death within 30 days from all causes was 6.6 percent, the company said.

Myelodysplastic syndromes, or MDS, is a difficult to treat family of blood cancers caused by the failure of blood cells in bone marrow to develop into mature cells.

A bone marrow transplant is the only known potential cure, but older patients, such as the ones in the Cyclacel study, are often not candidates for a transplant and are typically treated with so-called hypomethylating agents.

Some patients can live with the disease for several years, but many are at high risk of having it transform into acute myelogenous leukemia, or AML, a much faster progressing cancer. Most high risk patients die within one year of being diagnosed, with a mean survival of six to nine months.

Eighty-four percent of patients in the sapacitabine trial were deemed to be at high risk, according to the International Prognostic Scoring System, the company said.

Cyclacel said it is looking to begin enrolling patients in a pivotal Phase III MDS study of sapacitabine that would be used to seek U.S. approval of the drug. The company is also planning Phase III studies of the drug in elderly AML patients.

(Reporting by Bill Berkrot; editing by Andre Grenon)

Reuters Health

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