echemi logo
Product
  • Product
  • Supplier
  • Inquiry
    Home > Medical News > Latest Medical News > Wanchun Medicine Punablin International Multi-Center Phase 3 study reached the main endpoint and all secondary endpoints

    Wanchun Medicine Punablin International Multi-Center Phase 3 study reached the main endpoint and all secondary endpoints

    • Last Update: 2021-01-09
    • Source: Internet
    • Author: User
    Search more information of high quality chemicals, good prices and reliable suppliers, visit www.echemi.com
    Punablin is expected to be a major breakthrough treatment in CIN for 30 years, according to the press release.
    Punabrin is a "first-in-class" bird's ostrich nucleotide exchange factor (GEF-H1) activator developed by Wanchun Pharmaceuticals, which can reduce the early occurrence of CIN by reversing the blocking formation of neutrophils in the bone marrow induced by chemotherapy drugs, maintaining neutral granulocyte levels within the normal range, and achieving early protection of white blood cells in the bone marrow, with a mechanism different from G-CSF (granulocyte collection stimulation factor).
    September, Punablin was recognized by the FDA as a breakthrough therapy and included in the breakthrough treatment by China's National Drug Administration (NMPA).
    According to the press release, PROTECTIVE-2 is a double-blind, positive-controlled International Multi-Center Phase 3 study designed to compare the efficacy of 40mg Punabrin combined with 6mg ppedicin and 6 mg ppedicin in breast cancer patients receiving TAC (dosytamin, atomycin and cyclophosphamide) chemotherapy.
    final data analysis included data on 221 patients (111 in the combined treatment group and 110 in the single-drug treatment group in Pfeisting).
    Compared with the single-drug treatment group in Pyphedrine, the combined treatment group showed significant statistically significant improvements in the following areas, and the important data were summarized as follows: Major endpoints (percentage of patients without level 4 neutral granulocytosis): Joint treatment group 31. 5% vs. 13.6% of the single-drug treatment group, CI: 17.90 (7.13, 28.66) and p=0.0015.
    key secondary endpoint: DSN (ANC<0.5×109/L) :p day 1 of cycle 1 - DSN: p - 0.03 DSN: p - 0.03 Average ANC minimum (×109/L) :p - 0.0002 Duration of severe neutral granulocytosis in cycle 1 (ANC-lt;0.1×109/L) :p-0.0004 Safety: The 4-level AE occurrence (58.6%) was lower in the combined treatment group than in the Pfa gesting monodrug treatment group (80.0%).
    severe neutral granulocytosis is the most serious hematologically toxic disease caused by chemotherapy drugs.
    cell collection stimulation factor is the only drug approved since 1991 to prevent severe neutral granulocyte reduction.
    literature shows that even with the application of granulocyte collection stimulation factors, more than 80% of patients in some chemotherapy programs will still have stage 4 neutral granulocyte reduction, and the lowest point of absolute neutral granulocyte count usually occurs in the 6th to 8th day, serious infection, fever, mycosis and death and other adverse clinical consequences still occur from time to time.
    Therefore, for patients with possible chemotherapy for severe neutral granulocyte reduction, it is necessary to prevent the occurrence of severe neutral granulocyte reduction at the source and minimize the adverse clinical consequences associated with cytocytosis.
    PROCYCTIVE-2 results show that Punablin, with its unique mechanism of action, can quickly act to protect neutral granulocytes in the first 8 days, complementing G-CSF when used, significantly reducing the full-cycle severe CIN rate caused by chemotherapy in patients with non-myelin cancer.
    , the study used the percentage of non-severe CIN as the main endpoint indicator of effectiveness, and established a new standard for severe CIN treatment, which has important clinical significance.
    : Breaking the 30-year silence in the CIN field, Punablin International Multi-Center Phase III clinical trial PROTECTIVE-2 reached primary and all key secondary endpoints and achieved positive results. Retrieved Nov 16, 2020, from Wanchun Pharmaceuticals Source: Supplied
    This article is an English version of an article which is originally in the Chinese language on echemi.com and is provided for information purposes only. This website makes no representation or warranty of any kind, either expressed or implied, as to the accuracy, completeness ownership or reliability of the article or any translations thereof. If you have any concerns or complaints relating to the article, please send an email, providing a detailed description of the concern or complaint, to service@echemi.com. A staff member will contact you within 5 working days. Once verified, infringing content will be removed immediately.

    Contact Us

    The source of this page with content of products and services is from Internet, which doesn't represent ECHEMI's opinion. If you have any queries, please write to service@echemi.com. It will be replied within 5 days.

    Moreover, if you find any instances of plagiarism from the page, please send email to service@echemi.com with relevant evidence.