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Cyclacel shares up 20% on DSMB recommendation for phase 3 leukemia trial

Published: 11:35 13 Oct 2011 EDT

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Cyclacel Pharmaceuticals (NASDAQ:CYCC) said Thursday the independent Data Safety Monitoring Board (DSMB) recommended that it continue its planned phase three trial of sapacitabine in elderly patients suffering from leukemia.

Shares jumped 20.89% to 56 cents Thursday morning.

The DSMB reviewed data from a total 46 patients receiving oral doses of sapacitabine from the lead-in stage of the clinical trials and from the pilot phase 1/2. Each patient is over the age of 70 and suffers from acute myeloid leukemia (AML), a blood cancer that is uncommon in people under the age of 40.

AML progresses rapidly and can be fatal in months if left untreated. Each of the patients in the study were either ineligible for chemotherapy, or refused the highly intrusive traditional cancer therapy.

Cyclacel VP of Clinical Development and Regulatory Affairs, Dr. Judy H. Chiao said: "The objective of the randomized stage of the [phase 3] study is to establish the role of sapacitabine in the front-line treatment of AML in this population with a high unmet medical need."

Sapacitabine, Cyclacel's lead product candidate, works by breaking apart a strand of DNA and stopping the reproduction cycle of cancer cells.

The trials administered oral doses of sapacitabine in alternating cycles with decibatine, a drug that treats a variety of blood-related conditions, known as myelodysplastic syndromes. Patients received an intravenous 20 milligram per square metre (mg/m2) dose of decibatine each day for five consecutive days of a four week cycle, and an orally administered 300 mg dose of sapacitabine twice per day for three days for two weeks of a four week even cycle.

The trials tested the drug's safety, based on dose-limiting toxicity, and efficacy, based on an eight-week mortality rate. The lead-in study found a 9.5% dose limiting toxicity rate, and a 14.3% mortality rate at eight weeks, while the pilot phase 1/2 study found no dose-limiting toxicities and a 12% mortality rate at eight weeks.

The study's principal investigator, Dr. Hagop Kantarjian had previously published reports that showed patients with AML receiving chemotherapy treatment had a median survival of only 4.6 months. This was associated with an eight-week mortality rate of 36%.

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