Wanchun "Punablin" International Multi-Center Phase III clinical trials obtained positive results

On November 16th, Wanchun Pharmaceuticals announced that the international multi-center Phase III study PROTECTIVE-2 for the treatment of chemotherapy-neutral granulocytosis (CIN) in breast cancer had reached the main endpoint, with 31.5% and 13.6% of patients without level 4 neutral granulocyte reduction in the combined treatment group and the Pfeisting single drug group.
addition, all the key secondary endpoints of the study were statistically significant, including the duration of severe neutral granulocyte reduction (DSN) and the minimum absolute count of neutral granulocytes (ANC).
Compared to Pfeisting single-drug therapy, The combined treatment of Punablin and Pyphedrine is expected to bring long-term clinical benefits to patients, such as reducing fever-neutral granulocytosis (FN) to bring total lifetime benefits to patients, in addition to playing a CIN protective role at an early stage.
PROCYCTIVE-2 International Multi-Center Phase III Clinical Study is a Phase III Global Multi-Center, Double-Blind, Positive Controlled Clinical Study that compares Pnabrin (40mg) in breast cancer patients receiving TAC (Dossyta, amycin, and cyclophosphamide) with the treatment of Pyphedrine Single Drug Efficacy.
Final data analysis included data on 221 patients (111 cases in the combined treatment group and 110 cases in the single-drug treatment group in the Pfeisting single-drug treatment group), and compared with the single-drug treatment group in the Pyega-Gestin single-drug treatment group, the combined treatment group showed significant statistically significant improvements in the following areas, and the important data were summarized as follows: - Major endpoints (not occurred) Percentage of patients with level 4 neutral granulocyte reduction: 31.5% of the combined treatment group vs. 13.6% of the single-drug treatment group, CI: 17.90 (7.13, 28.66), p=0.0015.
key secondary endpoints: o DSN (ANC<0.5×109/L) on day 1-8 of cycle 1 :p s DSN:p=0.03o Cycle 1 average ANC minimum value (×109/L) :p 0.0002o Duration of Severe Neutral Granulocyte Reduction in Cycle 1 (ANC× 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 Pampigstin single-drug treatment group (80.0%).
Plinabulin is an activator of the ostrich nucleotide exchange factor (GEF-H1), which has a unique mechanism of action in DC maturation, antigen delivery and T-cell activation.
Punabrin is a non-G-CSF drug that reduces the occurrence of early CINs by reversing the blocking of neutrophils in the bone marrow induced by chemotherapy drugs, maintaining neutrophil levels within the normal range, and achieving early protection of white blood cells in the bone marrow.
studies have shown that Punabrin prevents multiple severe CINs caused by chemotherapy drugs with different anti-tumor mechanisms.
CIN is the most serious hematologically toxic disease caused by chemotherapy drugs.
G-CSF is the only drug approved for the prevention of severe CIN since 1991.
literature shows that even with G-CSF, more than 80% of patients in some chemotherapy programs will still have level 4 CINs, and the lowest point of absolute neutral granulocyte count (ANC) usually occurs on the 6th to 8th day, with clinical adverse consequences such as severe infection, fever, mycobacteremia and death still occurring from time to time.
, for patients with the possibility of severe CIN chemotherapy, severe CIN must be prevented at the source to minimize the adverse clinical consequences associated with CIN.
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 time, 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.
Huang, said: "The results of the PROTECTIVE-2 study give us a lot of confidence.
Punabrin is a new generation of immuno-anti-tumor drugs, because Punablin in DC maturity, antigen delivery and T-cell resuspension has a unique mechanism of action, we are actively promoting Punablin and classic release (chemical) therapy and PD-1 and other clinical research, hoping to create a 'golden key' for future cancer immunotherapy.
" Du Lihua said: "Just 2 months ago, Punablin obtained the Chinese and American drug regulatory system "breakthrough treatment varieties" double-identified, published today Phase III clinical results, once again proved that Punabrin is expected to become a 30 years of CIN field of breakthrough treatment varieties, Punablin with immuno-anti-tumor drugs to achieve a breakthrough in the field of CIN is a miracle."
CDE has the world's leading review capabilities and the world's cutting-edge vision, courage, as well as China's independent innovation drug recognition and support.
We will more efficiently strengthen communication with NMPA and FDA reviewers, quickly and effectively promote the registration of Punablin, U.S. double NDA, and strive to take the lead in China to market, as soon as possible for the benefit of the vast number of patients.
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