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12:00 AM
Jul 21, 2014
 |  BioCentury  |  Product Development

Seamless solution in AML

Why Cyclacel, FDA devised novel protocol for AML Phase III

In an effort to overcome recruiting challenges for elderly patients with acute myelogenous leukemia, Cyclacel Pharmaceuticals Inc. and FDA agreed on a SPA for a registrational Phase III study that incentivizes enrollment with an active comparator not approved for the indication in the U.S., coupled with an open-label design that encourages patients in the experimental arm to stay in the trial.

Sapacitabine is an analog of the nucleoside cytosine that induces apoptosis of cancer cells in two ways: interfering with DNA synthesis and repair by homologous recombination, and slowing transit through the cell cycle.

Cyclacel is studying the cell cycle modulator in the Phase III SEAMLESS trial in patients aged 70 years or older with newly diagnosed AML who are not candidates for intensive chemotherapy.

According to President and CEO Spiro Rombotis, up to 80% of AML patients are either unfit for chemotherapy or refuse it. These patients are difficult to enroll in studies because they may be elderly and have co-morbidities. Plus, their short life expectancy means patients are reluctant to enter a trial that could make them feel worse, or imposes burdens like travel to an infusion center that interfere with the quality of their remaining time.

"The predicament is that not only will these patients not do well on chemotherapy, but patients have caught on and refuse to participate in trials with chemotherapies. That doesn't mean patients won't enroll, but they are hard to find," Rombotis said.

To solve that problem, Cyclacel and FDA...

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