Clinical Trials

  • In this prospective, single-arm study stage IV, palliative, NSCLC patients were administered Pandimex (HemoMex I) and Careseng-SG2 (HemoMex S)only.
  • The study were target subjects between 18 and 75 years of age, who had been diagnosed with stage IV NSCLC, have at least one remote metastatic lesion, had not responded to their last chemotherapy treatment, were currently only receiving palliative treatment, and had an expected survival of at least three months.
  • Preliminary results indicated the use of PandiMex (HemoMex I) and Careseng SG2 (HemoMex S) as palliative treatment in non-small cellular lung cancer cases caused common improvement of condition in patients. It was expressed in positive mood, appetite changes, energy increase, etc. The above mentioned provided them more activity and improvement of their life style, intoxication, induced by the tumor process- decreased and electrolytic balance –corrected. In 26.7% cases the process of tumor growth was seen to be stabilized.

  • This study is a prospective, single-arm study comparing patients treated with Careseng SG2 (HemoMex S) and radiotherapy. The study will target 30 subjects between 18 and 75 years of age, who suffer from breast cancer that is either recurrent with bone metastasis or inoperable.
  • The primary objective of this study is to assess the tumor response following treatment with Careseng SG2 (HemoMex S) in conjunction with radiotherapy in patients with advanced, recurrent breast cancer.
  • A secondary objective is to assess the Quality of Life (QoL) in these breast cancer patients.
  • Subjects will be treated at Day 0 to 25 days of teletherapy and 40 days of oral Careseng SG2 (HemoMex S) (RT+C). Teletherapy will be administered as a single 40 Gy dose, daily from Day 5 to Day 30, using a Cobalt-60 machine.

    The performed study revealed that: effectiveness of treatment was evident-all hematological indicators were stable; the general condition of patients was improved, it was expressed in positive mood, appetite changes, energy increase, etc. All these provided them more activity and improvement of their life style. Also the sharp decrease of intoxication was observed as well as the correction of electrolytic balance.

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.

This trial showed that PandiMex (HemoMex I) could (Please see graph at top of Study 3):

  • 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.

The primary objectives of this study is to determine the efficacy and safety of Careseng SG2 (HemoMex S) in reducing toxicity of chemotherapy agents for the treatment of Breast Cancer and Ovarian Cancer in combination with standard chemotherapy regimens.

Secondary objectives are:

  • To assess the tumor response after 16 weeks of chemotherapy and Careseng SG2 (HemoMex S) treatment.
  • To assess the subjects’ Quality of Life. ​

In this prospective, single-arm study, solid tumor patients administered Careseng SG2 (HemoMex S) along with standard chemotherapy regimens treatment will be compared to retrospective controls that have received only standard chemotherapy regimens treatment. Patients eligible for recruitment into the study will have been diagnosed with Breast Cancer and Ovarian Cancer. Subjects are eligible for primary treatment with chemotherapy (induction chemotherapy) and have an expected survival of at least six month. During the treatment was dynamic research of blood rates (WBC, Platelets, Neutrophils, Haemoglobin), chemistry (AST, ALT, bilrubin, BUN, prothrombin time, creatinine, K+, Na+, Cl-, Ca++ ), tumor markers CA125 for Ovarian cancer patients, CA15-3 for breast cancer patients, CT scan till and after the treatment, ECG, Karnofsky performance status.

(Please see graphs at top of Study 4)

Conclusion: Careseng SG2 (HemoMex S) was used in combination with standard chemotherapy regimens in the treatment of solid tumor. Under observation were 40 patients in control and study groups, (25 patients with Breast Cancer and 15 patients with the Ovarian Cancer).

  • Out of 40 patients – 1 patient died during the treatment and 39 patients received the full course of the study.
  • There was no any patient with allergic response and abdominal disorders.
  • Analyzing the results of the treatment of patients with the Breast Cancer was established, that combination of standard chemotherapy regimens with Careseng SG2 (HemoMex S) increases the effect of the treatment 2.5 times.
  • The patients with the Ovarian Cancer had the same effect of the treatment in the control and study groups.
  • Progressing of the tumor process in control group was more 1-1.5 times then in study group.
  • The Careseng SG2 (HemoMex S) improves the tolerance of standard chemotherapy regimens and increases the treatment effect of patients with the Breast Cancer, in particular.