Xinji announced positive data on luspatercept
Release date: 2018-06-29 Recently, Celgene announced that its anemia drug luspatercept reached the primary and secondary endpoints in Phase III trials. The drug was developed in collaboration with Celgene and Acceleron. The results showed that luspatercept significantly reduced the need for transfusion in patients with myelodysplastic syndrome (MDS). Luspatercept (ACE-536) is a novel fusion protein that blocks the TGF beta superfamily erythropoietin inhibitor and is a new therapeutic option worth exploring. The phase II, multicenter, open dose-exploration trial (PACE-MDS) and long-term extension trials included MDS patients with low-risk and intermediate-risk-1 IPSS scores, and patients with non-proliferative chronic mononuclear leukemia (leukocytes) The number <13?000/μL), these patients have anemia (with or without red blood cell infusion therapy). Myelodysplastic syndrome is a heterogeneous myeloid clonal disease originating from hematopoietic stem cells. It is characterized by abnormal differentiation and development of myeloid cells, which is characterized by ineffective hematopoiesis, refractory cytopenia, hematopoietic failure, and high risk. Acute myeloid leukemia (AML) transformation. MDS treatment mainly solves two major problems: bone marrow failure and complications, AML transformation. As far as the patient population is concerned, the natural course and prognosis of patients with MDS are very different, and the treatment should be individualized. Although the company announced little details, it did record that the drug Medalist trial reached its primary endpoint and two secondary endpoints. Most importantly, luspatercept does not require red blood cell transfusion for at least 8 weeks compared to placebo, and patients can achieve highly statistically significant improvements. In October last year, Shinki announced that it will terminate its two Phase III clinical trials (RESOLVE and its extension test SUSTAIN) for its Crohn's disease drug, oral SMAD7 antisense RNA drug mongersen, and another phase III clinical DEFINE that has not yet recruited patients. Will be cancelled. This drug is still underway in another major IBD, stage II ulcerative colitis. Affected by this news, Xinji shares plunged 11%, and the market value of 10 billion was extinguished. In March of this year, its drug ozanimod was officially rejected by the US Food and Drug Administration (FDA), the company's most anticipated late-stage drug. After this, some analysts pointed out that the luspatercept in Celgene's later product line must achieve positive results in order to help the company tide over the difficulties. The unstable financial situation previously released by New Base has shocked and worried the market, but investors seem to be sensible by the prospect of acquiring Juno and becoming a leader in CAR-T therapy. Jayne Backstrom, chief medical officer of Celgene, said: "The results of the three-stage Medallist trial of the anemia drug luspatercept indicate that luspatercept is a potential clinical benefit for the treatment of chronic anemia in patients with low to moderate-risk myelodysplastic syndrome as a red blood cell maturation agent." Acceleron and Celgene plan to submit luspatercept listing applications in the US and Europe in the first half of 2019. Affected by this good news, Celgene's stock rose 1.2% in after-hours trading on Thursday, and Acceleron XLRN rose 11%. Celgene's long-standing therapeutic areas are hematological diseases. Luspatercept will continue to contribute to the superiority of Celgene's hematology field if it has the potential to prolong life. Celgene believes the drug is another heavy drug after Revlimid and Pomalyst. (Sina Pharmaceutical Compilation / Fan Dongdong) Article reference source: Finaly, Celgene wins. Anemia drug luspatercept – partnered with Acceleron – scores in PhIII trial Source: Sina Pharmaceutical News Industry Microscope,Industrial Stereo Microscope,Industrial Digital Microscope,Measuring Microscope Ningbo ProWay Optics & Electronics Co., Ltd. , https://www.proway-microtech.com