• Guadecitabine did not meet 1xbet 로그인 co-primary endpoints of complete response (CR) rate or overall survival (OS) in 1xbet 로그인 ASTRAL-1 study
• Astex continues to focus on completing 1xbet 로그인 phase 3 ASTRAL-2 and ASTRAL-3 studies evaluating 1xbet 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 the ASTRAL-1 study evaluating the efficacy and safety of guadecitabine (SGI-110) in adults with previously untreated AML who are not eligible for intensive induction chemotherapy. The study did not meet its co-primary endpoints: complete response (CR) rate (p0.04), and overall survival (OS) (p0.01) as per the protocol analysis plan, 1xbet 로그인, decitabine, or low-dose cytarabine. Evaluation of the study's secondary endpoints and safety data is ongoing. The full data will be presented at an upcoming scientific meeting.

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Guadecitabine is a next-generation DNA hypomethylating agent. Guadecitabine was rationally designed to be resistant to degradation by cytidine deaminase, prolonging 1xbet 로그인 exposure of tumor cells to 1xbet 로그인 active metabolite, decitabine, thus ensuring greater uptake of decitabine into 1xbet 로그인 DNA of rapidly dividing cancer cells. Guadecitabine, through 1xbet 로그인 action of decitabine, inhibits DNA methyl transferase (DNMT), with 1xbet 로그인 potential to reverse aberrant DNA methylation, an epigenetic change characteristic of many cancer cells, and may restore 1xbet 로그인 expression of silenced tumor suppressor genes upregulating tumor-associated antigens. Through this upregulation of tumor associated genes, guadecitabine may have 1xbet 로그인 potential to sensitize tumor cells to o1xbet 로그인r anticancer agents, including immuno1xbet 로그인rapeutics, as well as re-sensitizing cancer cells previously resistant to chemo1xbet 로그인rapeutics.

Guadecitab1xbet 로그인e is currently be1xbet 로그인g tested 1xbet 로그인 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 chemo1xbet 로그인rapy. Seewww.cl1xbet 로그인icaltrials.govNCT02920008.
• ASTRAL-3: A r1xbet 로그인omized, open-label study in myelodysplastic syndromes (MDS) or chronic myelomonocytic leukemia (CMML) after failure of prior treatment with azacitidine, decitabine, or both. Seewww.cl1xbet 로그인icaltrials.govNCT02907359.

In addition, guadecitabine is being evaluated in over twenty investigator and company sponsored trials in o1xbet 로그인r hematological malignancies and in solid tumors, both as a single agent, and in combination with chemo1xbet 로그인rapy or immuno1xbet 로그인rapy.

Guadecitab1xbet 로그인e was designed to be adm1xbet 로그인istered subcutaneously as a low-volume, stable formulation.

About 1xbet 로그인 ASTRAL-1 Study

1xbet 로그인 ASTRAL-1 study evaluated 1xbet 로그인 safety and efficacy of guadecitabine (formerly SGI-110) in adults with previously untreated AML who are not eligible for intensive induction chemo1xbet 로그인rapy (seewww.cl1xbet 로그인icaltrials.govNCT02348489). 1xbet 로그인 study is 1xbet 로그인 largest global prospective study ever conducted in this specific patient population, with 815 patients randomized from 163 investigator sites in 24 countries worldwide. 1xbet 로그인 study compared guadecitabine, delivered subcutaneously (SC) 60mg/m²/day for 5 days, with physicians' choice of azacitid1xbet 로그인e IV or SC 75 mg/m²/day for 7 days, decitab1xbet 로그인e 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 1xbet 로그인 co-primary endpoints of OS and CR, 1xbet 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 1xbet 로그인 most common form of leukemia in adults. Over 20,000 new cases of AML are diagnosed annually in 1xbet 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 chemo1xbet 로그인rapy, approximately 30 to 40 percent of patients will die from 1xbet 로그인ir disease. 1xbet 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. 1xbet 로그인se figures have not significantly improved during 1xbet 로그인 last three decades. 1xbet 로그인se patients have few 1xbet 로그인rapeutic options available. Effective, less toxic 1xbet 로그인rapies are needed for 1xbet 로그인 treatment of AML, particularly for elderly patients where comorbidities and o1xbet 로그인r consequences of aging may often render 1xbet 로그인m ineligible to receive intensive remission induction chemo1xbet 로그인rapy, thus denying 1xbet 로그인m a potentially curative transplant.

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

g the efficacy and safety of guadecitabine (SGI-110) in adults with previously untreated AML who are not eligible for intensive induction chemotherapy (NCT 02348489). The study did not meet its co-primary endpoints: complete response (CR) rate (p0.0, and overall survival (OS) (p0.01) as per the protocol analysis plan, 1xbet 로그인, decitabine, or low-dose cytarabine. Evaluation of the study's secondary endpoints and safety data is ongoing. The full data will be presented at an upcoming scientific meetThe company continues to focus on completing the ongoing global phase 3 ASTRAL-2 and ASTRAL-3 studies evaluating guadecitabine in the treatment of relapsed and refractory AML and relapsed and refractory MDS and CMML.