Clinical Study 3 – PandiMex (HemoMex I) for neutropenia patients caused by chemo/radio therapy
A Preliminary report of PandiMex (HemoMex I) for the treatment of Bone Marrow Suppression Caused by Chemo Therapy.
In this prospective, randomized two-arm study, patient whose hemogenesis was compromised post-chemo administered different dosage of Pandimex (one day and two days treatment with 4000mg dosage end two day with 6000mg) . Patients eligible for recruitment into the study have been diagnosed with cancer, had currently developed netropenia after received standard chemotherapy and had an expected survival of at least six months.
Ninety patients with White Blood Cell count below 3ˣ109/L after chemotherapy were enrolled into three groups administrated with 3 dosage of HemoMex I (A: 6000mg/day×2 days; B: 4000mg/day×2 days; C: 4000mg/day ×1 day ). The average WBC count before HemoMex I treatment were 2.28 ˣ 109/L, 2.19 ˣ 109/L, 2.31 ˣ 109/L for these three groups respectively, among which 30 subjects in total have WBC count below 2 ˣ 109/L. Toxicity and adverse events were assessed according NCI Common Toxicity Criteria Manual. After HemoMex I administration, the average WBC count increased to 5.3 ˣ 109/L, 4.7 ˣ 109/L, 4.3 ˣ 109/L (Group A, B, C) respectively, and maintained this level during the follow-up period. No severe adverse events have been observed, all patients were well tolerated. The adverse events observed were related to allergic reactions (Grade I to Grade II). Subjective benefits had been observed, for example improvement in appetite, sleep, general health conditions and extent of pain. In conclusions, HemoMex I used alone appears to be clinically active in treating bone marrow suppression caused by chemo/radio therapy. It is well-tolerated at the doses studied. According to clinical data now available, regimen 4000mg per day, two consecutive day treatment is good enough to relieve myelosuppression due to cytotoxic agents for cancer patients.
||Comparison of effectiveness of these three groups.
4000mg two day’s shot is the best.
Regimen of 2000mg two days’ administration is now ongoing.
This trial showed that PandiMex (HemoMex I) could:
- Stimulate the release of leucocytes from bone marrow pool
- Recover the function of bone marrow: proliferation & differentiation of progenitor cells
- Effective >96%, even very low WBC count.