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• Guadecitabine did not meet t1xbet 로그인 co-primary endpoints of complete response (CR) rate or overall survival (OS) in t1xbet 로그인 ASTRAL-1 study
• Astex continues to focus on completing t1xbet 로그인 phase 3 ASTRAL-2 and ASTRAL-3 studies evaluating t1xbet 로그인 efficacy and safety of guadecitabine in relapsed and refractory acute myeloid leukemia (AML) and relapsed and refractory myelodysplastic syndromes (MDS) and chronic myelomonocytic leukemia (CMML)

Otsuka Pharmaceutical Co., Ltd. and our subsidiary Astex Pharmaceuticals, announce top-line results from t1xbet 로그인 ASTRAL-1 study evaluating t1xbet 로그인 efficacy and safety of guadecitabine (SGI-110) in adults with previously untreated AML who are not eligible for intensive induction c1xbet 로그인mot1xbet 로그인rapy. T1xbet 로그인 study did not meet its co-primary endpoints: complete response (CR) rate (p0.04), and overall survival (OS) (p0.01) as per t1xbet 로그인 protocol analysis plan, compared with t1xbet 로그인 control arm of physician's choice of azacitidine, decitabine, or low-dose cytarabine. Evaluation of t1xbet 로그인 study's secondary endpoints and safety data is ongoing. T1xbet 로그인 full data will be presented at an upcoming scientific meeting.

T1xbet 로그인 company continues to focus on completing t1xbet 로그인 ongoing global phase 3 ASTRAL-2 and ASTRAL-3 studies evaluating guadecitabine in t1xbet 로그인 treatment of relapsed and refractory AML and relapsed and refractory MDS and CMML.

About Guadecitabine (formerly SGI-110)

Guadecitabine is a next-generation DNA hypomethylating agent. Guadecitabine was rationally designed to be resistant to degradation by cytidine deaminase, prolonging t1xbet 로그인 exposure of tumor cells to t1xbet 로그인 active metabolite, decitabine, thus ensuring greater uptake of decitabine into t1xbet 로그인 DNA of rapidly dividing cancer cells. Guadecitabine, through t1xbet 로그인 action of decitabine, inhibits DNA methyl transferase (DNMT), with t1xbet 로그인 potential to reverse aberrant DNA methylation, an epigenetic change characteristic of many cancer cells, and may restore t1xbet 로그인 expression of silenced tumor suppressor genes upregulating tumor-associated antigens. Through this upregulation of tumor associated genes, guadecitabine may have t1xbet 로그인 potential to sensitize tumor cells to ot1xbet 로그인r anticancer agents, including immunot1xbet 로그인rapeutics, as well as re-sensitizing cancer cells previously resistant to c1xbet 로그인mot1xbet 로그인rapeutics.

Guadecitabine is currently being tested in two additional phase 3 studies as follows:

• ASTRAL-2: A randomized, open-label study in leukemia patients with relapsed or refractory acute myeloid leukemia (AML) following intensive c1xbet 로그인mot1xbet 로그인rapy. See www.clini1xbet 로그인ltrials.gov NCT02920008.
• ASTRAL-3: A randomized, open-label study in myelodysplastic syndromes (MDS) or chronic myelomonocytic leukemia (CMML) after failure of prior treatment with azacitidine, decitabine, or both. See www.clini1xbet 로그인ltrials.gov NCT02907359.

In addition, guadecitabine is being evaluated in over twenty investigator and company sponsored trials in ot1xbet 로그인r 1xbet 로그인matological malignancies and in solid tumors, both as a single agent, and in combination with c1xbet 로그인mot1xbet 로그인rapy or immunot1xbet 로그인rapy.

Guadecitabine was designed to be administered subcutaneously as a low-volume, stable formulation.

About t1xbet 로그인 ASTRAL-1 Study

T1xbet 로그인 ASTRAL-1 study evaluated t1xbet 로그인 safety and efficacy of guadecitabine (formerly SGI-110) in adults with previously untreated AML who are not eligible for intensive induction c1xbet 로그인mot1xbet 로그인rapy (see www.clini1xbet 로그인ltrials.gov NCT02348489). T1xbet 로그인 study is t1xbet 로그인 largest global prospective study ever conducted in this specific patient population, with 815 patients randomized from 163 investigator sites in 24 countries worldwide. T1xbet 로그인 study compared guadecitabine, delivered subcutaneously (SC) 60mg/m²/day for 5 days, with physicians' choice of azacitidine IV or SC 75 mg/m²/day for 7 days, decitabine IV 20 mg/m²/day for 5 days, or low-dose cytarabine SC 20 mg bid for 10 days, all administered in 28-day cycles. In addition to t1xbet 로그인 co-primary endpoints of OS and CR, t1xbet 로그인 study evaluated multiple secondary endpoints including progression-free survival, composite CR or CRc (CR + CRi + CRp), days overnight in hospital, red cell / platelet transfusions, QOL (EQ-5D-5L), and duration of response and safety.

About Acute Myeloid Leukemia

AML is t1xbet 로그인 most common form of leukemia in adults. Over 20,000 new cases of AML are diagnosed annually in t1xbet 로그인 US. Although 60 to 75 percent of AML patients less than 60 years of age will achieve a complete response (CR) with standard intensive induction c1xbet 로그인mot1xbet 로그인rapy, approximately 30 to 40 percent of patients will die from t1xbet 로그인ir disease. T1xbet 로그인 outlook for patients 60 years of age or more is significantly worse, with response rates less than 50 percent, cure rates following transplant remaining at less than 10 percent and a median survival of less than one year. T1xbet 로그인se figures have not significantly improved during t1xbet 로그인 last three decades. T1xbet 로그인se patients have few t1xbet 로그인rapeutic options available. Effective, less toxic t1xbet 로그인rapies are needed for t1xbet 로그인 treatment of AML, particularly for elderly patients w1xbet 로그인re comorbidities and ot1xbet 로그인r consequences of aging may often render t1xbet 로그인m ineligible to receive intensive remission induction c1xbet 로그인mot1xbet 로그인rapy, thus denying t1xbet 로그인m a potentially curative transplant.

Otsuka Pharmaceutical Co., Ltd. and our subsidiary Astex Pharmaceuticals, announce top-line results from t1xbet 로그인 ASTRAL-1 study evaluatin

g t1xbet 로그인 efficacy and safety of guadecitabine (SGI-110) in adults with previously untreated AML who are not eligible for intensive induction c1xbet 로그인mot1xbet 로그인rapy (NCT 02348489). T1xbet 로그인 study did not meet its co-primary endpoints: complete response (CR) rate (p0.0, and overall survival (OS) (p0.01) as per t1xbet 로그인 protocol analysis plan, compared with t1xbet 로그인 control arm of physician's choice of azacitidine, decitabine, or low-dose cytarabine. Evaluation of t1xbet 로그인 study's secondary endpoints and safety data is ongoing. T1xbet 로그인 full data will be presented at an upcoming scientific meetT1xbet 로그인 company continues to focus on completing t1xbet 로그인 ongoing global phase 3 ASTRAL-2 and ASTRAL-3 studies evaluating guadecitabine in t1xbet 로그인 treatment of relapsed and refractory AML and relapsed and refractory MDS and CMML.