Data today announced an interim response from the Phase 2 randomized trial of sapacitabine capsules by mouth, and a novel nucleoside analogue, and the elderly patients suffering from Myelodysplastic syndrome (MDS), which failed hypomethylating agents. They are presented in a poster session of the oral discussion of the American Association for the 2010 Clinical Oncology (ASCO) annual meeting in Chicago, Illinois.
There are no effective treatments for MDS after the failure of treatment hypomethylating agents. Sapacitabine proved promising in this activity is difficult to treat population, which deserves further clinical development of the Movement of Social Democrats, “said Hagop Kantarjian AD, MD, Chairman and Professor, Department of Leukemia, University of Texas MD Anderson Cancer Center in Houston, Texas, and study chair to the stage of sapacitabine 2 study.
We are encouraged by the temporary data in response to suggest that sapacitabine active in MDS patients after treatment with agents such as hypomethylating azacitidine or decitabine, “said Judy H. Chiao, MD, Vice President Cyclacel, clinical development and regulatory affairs.” in the first place the effectiveness of the endpoint of this study is to survive 1 year. We look forward to reporting data the survival of 1 year in late 2010. ”
MDS Phase 2 data
Based on provisional data, the rate of overall response was 24% on the arm, and the schedule for 7 days of low-dose, and 35% for arm B, 7-day schedule of high-dose and 10% for arm C, and a height of 3-day dose schedule . Achieved two of the patients remission of the full and treated both deaths A arm and thirty days from all causes is 4.8% in the arm, 0% for arm B and 15% for arm C about 34% of patients received 4 or more sessions sapacitabine.
Completed a study of treatment of patients between the ages of 61 60 or more with MDS who were treated before with azacitidine or decitabine, or both. Patients were selected through three doses tables sapacitabine (arms A, B and C). All patients had received at least one hypomethylating workers and 15 patients (25%) received two agents hypomethylating, any azacitidine and decitabine. It was about 51% of the 61 patients the baseline bone marrow blast charges above 10%.
It will display a poster (abstract number 6528) will be held today between 2:00 pm – 6:00 pm Central Time between the oral and poster 5:00 PM – 6:00 pm Central Time.
Currently capsules Sapacitabine (CYC682), and nucleoside analogue available orally, and is being evaluated in phase 2 trials in the blood and solid tumors. Sapacitabine acts through a bilateral mechanism to intervene in the structure of DNA by causing the breaking of DNA single-strand and carrying arrest cell cycle progression mainly in G2/M-Phase. Has proved each and every sapacitabine CNDAC, the main metabolite, a powerful anti-tumor activity in preclinical studies.
More than 200 patients receiving sapacitabine in phase 2 studies in acute myeloid leukemia (AML), MDS, Skin T-cell lymphoma (CTCL) and non-small cell lung cancer (NSCLC). Sapacitabine may be administered to approximately 170 patients in five Phase 1 studies with both hematologic malignancies and solid tumors. Studies tumor Steel, has seen 20 patients for a long time, and remained stable disease on study for four months or more, with five NSCLC, one with small cell lung cancer, colon and rectum with four, two with bladder, two with tumor tissue of the digestive system, namely, with the ovary, one with breast, one with the kidney, one with parotitis and one with a primary tumor is unknown. the company expects to report phase 2 data with the transitional sapacitabine in NSCLC in the second half of 2010.
In December 2009 at the annual meeting 51 of the American Society of Hematology (ash), according to company data from a phase of random 2 including staying alive and promising 1-year treatment of the difficulty of the population of elderly patients aged 70 with anti-money laundering and a year or more. During the first quarter of 2010, the company’s protocol assessment (SPA) application to the Food and Drug Administration for the registration phase 3 randomized study of sapacitabine in elderly patients with AML. Sapacitabine is part of a pipeline of small molecule Cyclacel drugs designed to target and stop uncontrolled cell division.
About Cyclacel Pharmaceuticals, inc.
Cyclacel is a biopharmaceutical company developing treatments for oral targeted at different stages of cell cycle control to treat cancer and other serious diseases. three product candidates in clinical development: Sapacitabine (CYC682), and cell cycle modulation nucleoside analog, is in Phase 2 studies for the treatment of acute myeloid leukemia in the elderly, Myelodysplastic syndromes and lung cancer. Seliciclib (or RSS CYC202 roscovitine), a CDK (cyclin dependent kinase) inhibitor, is in phase 2 studies for the treatment of lung cancer and esophageal cancer in phase 1 trial in combination with sapacitabine. CYC116, and Aurora kinase inhibitor, and VEGFR2, in the phase 1 trial in patients with solid tumors. Cyclacel subsidiary markets directly in the drug alignment Xclair United States (R) cream to the skin of the radiation, Numoisyn (R) and Numoisyn liquid (R) appointments of dry mouth. Cyclacel’s strategy is to build a diversified business focused biopharmaceutical blood diseases and tumors based on a range of commercial products and development pipeline of drug candidates, the novel.
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