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BMC Cancer
Published in: BMC Cancer 1/2015

Open Access 01-12-2015 | Research article

Results of multicenter double-blind placebo-controlled phase II clinical trial of Panagen preparation to evaluate its leukostimulatory activity and formation of the adaptive immune response in patients with stage II-IV breast cancer

Authors: Anastasia S Proskurina, Tatiana S Gvozdeva, Ekaterina A Alyamkina, Evgenia V Dolgova, Konstantin E Orishchenko, Valeriy P Nikolin, Nelly A Popova, Sergey V Sidorov, Elena R Chernykh, Alexandr A Ostanin, Olga Y Leplina, Victoria V Dvornichenko, Dmitriy M Ponomarenko, Galina S Soldatova, Nikolay A Varaksin, Tatiana G Ryabicheva, Stanislav N Zagrebelniy, Vladimir A Rogachev, Sergey S Bogachev, Mikhail A Shurdov

Published in: BMC Cancer | Issue 1/2015

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Abstract

Background

We performed a multicenter, double-blind, placebo-controlled, phase II clinical trial of human dsDNA-based preparation Panagen in a tablet form. In total, 80 female patients with stage II-IV breast cancer were recruited.

Methods

Patients received three consecutive FAC (5-fluorouracil, doxorubicin and cyclophosphamide) or AC (doxorubicin and cyclophosphamide) adjuvant chemotherapies (3 weeks per course) and 6 tablets of 5 mg Panagen or placebo daily (one tablet every 2–3 hours, 30 mg/day) for 18 days during each chemotherapy course. Statistical analysis was performed using Statistica 6.0 software, and non-parametric analyses, namely Wilcoxon-Mann–Whitney and paired Wilcoxon tests. To describe the results, the following parameters were used: number of observations (n), median, interquartile range, and minimum-maximum range.

Results

Panagen displayed pronounced leukostimulatory and leukoprotective effects when combined with chemotherapy. In an ancillary protocol, anticancer effects of a tablet form of Panagen were analyzed. We show that Panagen helps maintain the pre-therapeutic activity level of innate antitumor immunity and induces formation of a peripheral pool of cytotoxic CD8+ perforin + T-cells. Our 3-year follow-up analysis demonstrates that 24% of patients who received Panagen relapsed or died after the therapy, as compared to 45% in the placebo cohort.

Conclusions

The data collected in this trial set Panagen as a multi-faceted “all-in-one” medicine that is capable of simultaneously sustaining hematopoiesis, sparing the innate immune cells from adverse effects of three consecutive rounds of chemotherapy and boosting individual adaptive immunity. Its unique feature is that it is delivered via gastrointestinal tract and acts through the lymphoid system of intestinal mucosa. Taken together, maintenance of the initial levels of innate immunity, development of adaptive cytotoxic immune response and significantly reduced incidence of relapses 3 years after the therapy argue for the anticancer activity of Panagen.

Trial registration

ClinicalTrials.gov NCT02115984 from 04/07/2014.
Appendix
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Metadata
Title
Results of multicenter double-blind placebo-controlled phase II clinical trial of Panagen preparation to evaluate its leukostimulatory activity and formation of the adaptive immune response in patients with stage II-IV breast cancer
Authors
Anastasia S Proskurina
Tatiana S Gvozdeva
Ekaterina A Alyamkina
Evgenia V Dolgova
Konstantin E Orishchenko
Valeriy P Nikolin
Nelly A Popova
Sergey V Sidorov
Elena R Chernykh
Alexandr A Ostanin
Olga Y Leplina
Victoria V Dvornichenko
Dmitriy M Ponomarenko
Galina S Soldatova
Nikolay A Varaksin
Tatiana G Ryabicheva
Stanislav N Zagrebelniy
Vladimir A Rogachev
Sergey S Bogachev
Mikhail A Shurdov
Publication date
01-12-2015
Publisher
BioMed Central
Published in
BMC Cancer / Issue 1/2015
Electronic ISSN: 1471-2407
DOI
https://doi.org/10.1186/s12885-015-1142-z

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