Double-blind Multicenter Placebo-controlled Study of the Safety and Leukostimulatory Activity of the Preparation "Panagen" in Patients With Breast Cancer

The goal of this trial is to assess the safety, therapeutic dose, and leukostimulatory activity of the preparation Panagen in the therapeutic schemes for treating cancer diseases in the patients receiving a standard chemotherapy for breast cancer of stages II-IV (with distant metastases).

Start Date01 May 2010

Sponsor / Collaborator

Panagen, Limited Liability Company

100 Clinical Results associated with Panagen

100 Translational Medicine associated with Panagen

100 Patents (Medical) associated with Panagen

Literatures (Medical) associated with Panagen

01 Mar 2020·Bulletin of Experimental Biology and MedicineQ4 · MEDICINE

Cytokines of the Lymph and Blood Serum as Markers of Oncogenesis and Efficiency of Therapy in Chemically Induced Breast Cancer in Wistar Rats

Q4 · MEDICINE

Article

Author: Kazakov, O V ; Lykov, A P ; Bogachev, S S ; Orlov, N B ; Strunkin, D N ; Poveshchenko, O V ; Raiter, T V ; Kabakov, A V ; Kim, I I ; Poveshchenko, A F ; Konenkov, V I ; Bondarenko, N A

We studied the levels of serum and lymph cytokines involved in the pathogenesis of BC. BC was induced by injection of N-methyl-N-nitrosourea to Wistar rats. The animals underwent surgery, or received polychemotherapy (cyclophosphamide, methotrexate, and 5-fluorouracil), or surgical treatment was combined with polychemotherapy; in a special group, Panagen (fragmented DNA) was added to polychemotherapy. Cytokine concentration in the lymph was measured using Bio-Plex Pro Rat Cytokoness 24-Plex Assay test system (Bio-Rad). In rats with BC, the content of most studied cytokines (IL-1β, IL-2, IL-4, IL-6, IL-7, IL-12, IL-13, MIP-1α, MIP-3α, RANTES, TNFα, and MCP-1) in the lymph and blood was significantly higher, while the content of IL-10 and GRO/KC was lower than in intact animals. Surgical resection of the tumor led to a significant decrease in the content of both pro- and anti-inflammatory cytokines in the lymph. Polychemotherapy led to a significant decrease in the content of IL-1β, IL-4, IL-6, IL-7, MIP-1α, MIP-3α, and RANTES in the serum and lymph. Comparison of the cytokine content in the serum and lymph of operated animals after polychemotherapy with and without Panagen showed that the content of most cytokines (IL-5, IL-6, IL-7, IL-10, IL-13, IL-17A , IL-18, GRO/KC, IFNγ, and MIP-3α) was higher after Panagen administration.

01 Dec 2016·BMC CancerQ2 · MEDICINE

Five-year disease-free survival among stage II-IV breast cancer patients receiving FAC and AC chemotherapy in phase II clinical trials of Panagen

Q2 · MEDICINE

ArticleOA

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

BACKGROUNDWe report on the results of a phase II clinical trial of Panagen (tablet form of fragmented human DNA preparation) in breast cancer patients (placebo group n = 23, Panagen n = 57). Panagen was administered as an adjuvant leukoprotective agent in FAC and AC chemotherapy regimens. Pre-clinical studies clearly indicate that Panagen acts by activating dendritic cells and induces the development of adaptive anticancer immune response.METHODSWe analyzed 5-year disease-free survival of patients recruited into the trial.RESULTSFive-year disease-free survival in the placebo group was 40 % (n = 15), compared with the Panagen arm - 53 % (n = 51). Among stage III patients, disease-free survival was 25 and 52 % for placebo (n = 8) and Panagen (n = 25) groups, respectively. Disease-free survival of patients with IIIB + C stage was as follows: placebo (n = 6)-17 % vs Panagen (n = 18)-50 %.CONCLUSIONSDisease-free survival rate (17 %) of patients with IIIB + C stage breast cancer receiving standard of care therapy is within the global range. Patients who additionally received Panagen demonstrate a significantly improved disease-free survival rate of 50 %. This confirms anticancer activity of Panagen.TRIAL REGISTRATIONClinicalTrials.gov NCT02115984 from 04/07/2014.

01 Dec 2016·BMC Cancer

Erratum to: 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

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

100 Deals associated with Panagen

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Breast Cancer	Phase 2	Russia	HLB PANAGENE Co., Ltd.	-

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02115984 (Pubmed \| BMC Cancer)	Phase 2	Metastatic breast cancer Adjuvant	80	Placebo	tnmxevejtt(twpykcjamv) = cmxczujtqh khslficbib (gzjkltvgkq )	Positive	18 Aug 2016
				Panagen	tnmxevejtt(twpykcjamv) = vabejjpkvg khslficbib (gzjkltvgkq )
NCT02115984 (CTgov)	Phase 2	Breast Cancer	80	Chemotherapy+Panagen (Chemotherapy & Panagen)	laekyjoded(bnqdfippuh) = zwprgddmpb dzeszlauzo (elpbfjabke, czyltqgfqg - hdswubeppr) View more	-	15 Jul 2014
				Placebo (Chemotherapy & Placebo)	laekyjoded(bnqdfippuh) = ziovukoscs dzeszlauzo (elpbfjabke, wxthyxpjbb - fbxjldgqvh) View more

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