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|Ref Type||Journal Article|
|Authors||Ponomarenko DM, Klimova ID, Chapygina YA, Dvornichenko VV, Zhukova NV, Orlova RV, Manikhas GM, Zyryanov AV, Burkhanova LA, Badrtdinova II, Oshchepkov BN, Filippova EV, Orlov SV, Kolesnikov SI, Sufianov AA, Baum SR, Zaitzeva OY, Komissarov AB, Grudinin MP, Kiselev OI, Tsyb AF, Venanzi F, Shcherbinina V, Chursov A, Gabai VL, Shneider AM|
|Title||Safety and efficacy of p62 DNA vaccine ELENAGEN in a first-in-human trial in patients with advanced solid tumors.|
|Date||2017 Aug 08|
|Abstract Text||Elenagen is a plasmid encoding p62/SQSTM1, the first DNA vaccine possessing two mutually complementing mechanisms of action: it elicits immune response against p62 and mitigates systemic chronic inflammation. Previously, Elenagen demonstrated anti-tumor efficacy and safety in rodent tumor models and spontaneous tumors in dogs. This multicenter I/IIa trial evaluated safety and clinical activity of Elenagen in patients with advanced solid tumors. Fifteen patients were treated with escalating doses of Elenagen (1- 5 mg per doses, 5 times weekly) and additional 12 patients received 1 mg dose. Ten patients with breast and ovary cancers that progressed after Elenagen were then treated with conventional chemotherapy. Adverse events (AE) were of Grade 1; no severe AE were observed. Cumulatively twelve patients (44%) with breast, ovary, lung, renal cancer and melanoma achieved stable disease for at least 8 wks, with 4 of them (15%) had tumor control for more than 24 wks, with a maximum of 32 wks. The patients with breast and ovary cancers achieved additional tumor stabilization for 12-28 wks when treated with chemotherapy following Elenagen treatment. Therefore, Elenagen demonstrated good safety profile and antitumor activity in advanced solid tumors. Especially encouraging is its ability to restore tumor sensitivity to chemotherapy.|
|Molecular Profile||Treatment Approach|
|Gene Name||Source||Synonyms||Protein Domains||Gene Description||Gene Role|
|Drug Name||Trade Name||Synonyms||Drug Classes||Drug Description|
|Elenagen||Elenagen is a DNA vaccine comprising a plasmid that contains SQSTM1, which encodes for p62, resulting in the prevention of tumor growth and enhancement of chemotherapeutic sensitivity (PMID: 28881846).|
|Gene||Variant||Impact||Protein Effect||Variant Description||Associated with drug Resistance|
|Molecular Profile||Indication/Tumor Type||Response Type||Therapy Name||Approval Status||Evidence Type||Efficacy Evidence||References|
|Unknown unknown||breast cancer||not applicable||Elenagen + Tamoxifen||Phase Ib/II||Actionable||In a Phase Ib/II trial, a chemorefractory patient with breast cancer demonstrated restored chemotherapeutic sensitivity upon sequential treatment of Elenagen and Nolvadex (tamoxifen), which resulted in stable disease (PMID: 28881846).||28881846|
|Unknown unknown||Advanced Solid Tumor||not applicable||Elenagen||Phase Ib/II||Actionable||In a Phase I/IIa trial, Elenagen treatment resulted in a best response of stable disease in 44% (12/27) of patients with advanced solid tumors (PMID: 28881846).||28881846|
|Unknown unknown||triple-receptor negative breast cancer||not applicable||Cyclophosphamide + Doxorubicin + Elenagen||Phase Ib/II||Actionable||In a Phase Ib/II trial, chemorefractory patients with triple-receptor negative breast cancer demonstrated restored chemotherapeutic sensitivity upon sequential treatment of Elenagen and the combined therapy, Cytoxan (cyclophosphamide) and Adriamycin (doxorubicin), which resulted in stable disease (PMID: 28881846).||28881846|