In January 11, 2011, the company opened enrollment of the SEAMLESS pivotal Phase III trial for the company's sapacitabine oral capsules as a front-line treatment of elderly patients aged 70 years or older with newly diagnosed AML who are not candidates for intensive induction chemotherapy.
Cyclacel is using decitabine as the active control arm for its trial. Decitabine (Dacogen) is manufactured by Astex Pharma's and was recently approved in Europe but not yet in the U.S.
The most extensive clinical trial data of dacogen in AML is the DACO-016 Phase III study initiated in 2006 and presented at ASCO in 2011. DACO-016 was a randomized open-label Phase III trial of Dacogen versus physician's choice (supportive care or low-dose cytarabine) in elderly patients with newly diagnosed AML with poor- or intermediate-risk cytogenetics.
Cyclacel chose decitabine as an active control arm as it is one of the treatment options recommended by the National Comprehensive Cancer Network's Clinical Practice Guidelines, said Judy Chiao, M.D., Cyclacel VP of clinical development and regulatory affairs.
Cyclacel is looking at giving greater hope to older patients diagnosed with acute myeloid leukemia. Considering the current environment demonstrating a six month survival profile, people are not going to see much of a benefit to going through potentially two months of chemotherapy to a short time past that point. Generally, they will just be going home to try and preserve some quality of life in the time they have left.
In a recent presentation at the BIO CEO & Investor Conference, Cyclacel described why it feels sapacitabine can succeed. The drug uses a lower level of intensity which helps the immune system while treating. The company also notes that most elderly are unable to sustain chemotherapy. In fact, in early data from the company's Phase III SEAMLESS trial, safety indicators show a sapacitabine/decitabine combination to have a mortality rate in the first two months of 13% versus 36% for chemotherapy and 20% for decitabine alone.
In the investor conference, the company goes on to say that the oral dose of sapacitabine is well tolerated with multiyear maintenance dosing achieved.
•A SEAMLESS Phase III enrollment update •NDSMB (Data and Safety Monitoring Board) review of SEAMLESS •Update on Phase II data in myelodysplastic syndromes after HMAs (Hypomethylating Agent) •Update on Phase I data for sapacitabine and selleciclib in patients with solid tumors
Last week, Cyclacel announced two important additions to its patent portfolio. Within this announcement, CEO Spiro Rombotis, commented;
"The grants of the '792 and '790 patents are important enhancements of sapacitabine's intellectual property estate. They supplement sapacitabine's existing composition of matter, dosing regimen and combination treatment patent protection and support US and EU market exclusivity toward the end of the next decade. We are pursuing a broad intellectual property strategy providing us with a strong foundation to achieve our clinical and commercial objectives for sapacitabine and our other assets. As we continue to enroll SEAMLESS, our pivotal Phase III trial of sapacitabine as front-line treatment in elderly patients with acute myeloid leukemia, we look forward to providing additional updates for sapacitabine this year, including Phase II data in myelodysplastic syndromes, AML preceded by MDS, and solid tumors."
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