Cyclacel Pharmaceuticals reaches agreement with FDA on starting late-stage cancer drug study

Cyclacel shares jump on FDA study agreement

BERKELEY HEIGHTS, N.J. — Cyclacel Pharmaceuticals Inc. said Monday it has reached a deal with the Food and Drug Administration on a design for a late-stage study of a potential cancer treatment and plans to begin patient enrollment before the end of 2010.

Shares of Cyclacel surged 31 cents, or nearly 20 percent, to $1.88 in Monday trading. The stock, which traded at a 52-week low of 75 cents last fall, surged to a year-high of $4.08 in January on positive data for its lung cancer drug before steadily sliding downward over the past several months.

The company is developing its sapacitabine oral capsules as a front-line treatment for elderly patients aged 70 years or older with newly diagnosed acute myeloid leukemia. The patients are not candidates for chemotherapy.

AML is a cancer of the blood cells that progresses rapidly and if not treated, could be fatal in a few months. Nearly 9,000 deaths are caused by this cancer each year in the United States

The drug candidate is also currently being studied as a potential treatment for myelodysplastic syndromes — in which blood cells don’t mature in bone marrow — and non-small cell lung cancer.

(This version CORRECTS the company’s name in the 2nd paragraph, and the timing of its share movement.)