ASSESMENT OF SAFETY, TOLERABILITY, AND HEMOPOIETIC ACTIVITY OF PREPARATION :PANAGEN; IN HEALTHY VOLUNTEERS

Summary. Study investigates the tolerability and e& ects on hemopoiesis drug «Panagen». ' e drug is a mixture of fragments a full genomic DNA, isolated from the placenta healthy women. Phase 1 clinical study, conducted on the basis Irkutsk Regional Oncology Dispensary, in accordance with the requirements of normative documents. ' e drug was tested in 30 healthy volunteers, in various dose regimes. ' e study established the optimal dose of the drug and showed good tolerability and safety. On the basis of the received data, recommended further study in phase 2 clinical trials as a stimulator of hemopoiesis in cancer patients receiving chemotherapy. Key words: «Panagen», stimulators of hematopoiesis, nucleic acids. I…Œ˜ˆ„‚“€Œ„„…’ — ˆ„“ˆ‹“ˆ† ‹…‰ ƒˆ†„…‘“ˆ„ƒ… „ˆ-‹€Œ’Œ““ˆ† —…’…ˆƒŒ€S“……. s˜’ “€ˆ”…˜S†ƒ…†… … ˜Œ‘Œ“…’ %ƒˆ‡ˆ “ˆ›ˆ‘“ˆ‡ˆ ‰Œ†„ƒ‹…’ —…’…ˆ“€Œ“S€Sƒˆ‹, …„“ˆ˜#™‚-"ƒ„’ „ƒ…’‚˜’ƒˆ€Ž ‡Œ’ˆ“ˆ%™S — “€Œ“S€SƒŽ, ˆ›˜S‰S"-!…Œ „“ˆ„ˆ›“ˆ„ƒ#" ‚„…˜…‹Sƒ# “€ˆ˜…”Œ€Sœ…" … ‰…””Œ-€Œ“œ…€ˆ‹†‚ †˜Œƒˆ† †€ˆ‹…. ° “…’ ˆƒ“ˆ„’ƒ„’ ‹Œ!Œ„ƒ‹S, …’Œ"!…Œ €S™“‚" „ƒ€‚†ƒ‚€‚, …„ƒˆ‘“…† “€ˆ…„—ˆ$‰Œ“…’ … ’Œ—S“…™’ ‰Œ†„ƒ‹…’, “€…‘Œ’, †S$‰ˆ† ‡€‚““Œ “€…„‚!… „‹ˆ… “€Œ…’‚!Œ„ƒ‹S … “Œ‰ˆ„ƒSƒ†… [3,6]. Aˆ…„† ‹Œ!Œ„ƒ‹, ˆƒ˜…‘S"!…—„’ ‹Ž„ˆ†ˆ† ‡Œ’ˆ„ƒ…’‚˜…€‚"!Œ† S†ƒ…‹“ˆ-„ƒ#" “€… ˆƒ„‚ƒ„ƒ‹…… ƒˆ†„…‘Œ„†…— „‹ˆ†„ƒ‹, ’‹˜’Œƒ„’ “ˆ-“€Œ$“Œ’‚ S†ƒ‚S˜#“Ž’. • ƒŒ‘Œ“…Œ ’“ˆ‡…— ˜Œƒ, …“ƒŒ€Œ„ ‹Ž™Ž‹S"ƒ “€Œ“S€S-ƒŽ %†™ˆ‡Œ““Ž— s€°, „“ˆ„ˆ›“ŽŒ “€ˆ“…†Sƒ# ‹ †˜Œƒ†‚ … S†ƒ…‹…€ˆ‹Sƒ# “€ˆœŒ„„Ž €Œ“S€Sœ…… †˜Œƒˆ‘“Ž— “ˆ‹€Œ$-‰Œ“…†, …“‰‚œ…€ˆ‹S““Ž— ˆ›˜‚‘Œ“…Œ’ [7,8]. s“ˆ„ˆ›“ˆ„ƒ# %†™ˆ‡Œ““Ž— ‡ˆ’ˆ˜ˆ‡…‘“Ž— “‚†˜Œ…“ˆ‹Ž— †…„˜ˆƒ ‚„…˜…-‹Sƒ# ‡Œ’ˆ“ˆ%™ ›Ž˜S ‚„ƒS“ˆ‹˜Œ“S ƒS†$Œ “S ‰€‚‡…— ’ˆ‰Œ-˜’— ’…Œ˜ˆ„‚“€Œ„„……, ‹ ‘S„ƒ“ˆ„ƒ… œ…ƒˆ„ƒSƒ…‘Œ„†ˆ† [12]. *„…˜Œ“…Œ †ˆ„ƒ“ˆ’ˆ™‡ˆ‹ˆ‡ˆ … „Œ˜Œ™Œ“ˆ‘“ˆ‡ˆ †€ˆ‹Œƒ‹ˆ-€Œ“…’ ›Ž˜ˆ ˆ›“S€‚$Œ“ˆ … “€… ‹‹Œ‰Œ“…… s€° ™‰ˆ€ˆ‹Ž’ $…‹ˆƒ“Ž’ [11].žŒ™‚˜#ƒSƒˆ’ %†„“Œ€…’Œ“ƒS˜#“Ž— €S›ˆƒ “ˆ …„„˜Œ‰ˆ‹S-“…" ‡Œ’ˆ„ƒ…’‚˜…€‚"!…—, …’’‚“ˆ’ˆ‰‚˜…€‚"!…— … “€ˆ-ƒŒ†ƒˆ€“Ž— „‹ˆ†„ƒ‹ “‚†˜Œ…“ˆ‹Ž— †…„˜ˆƒ ‹ “S‘Œ† „ƒ€S“Œ ’‹˜’Œƒ„’ „ˆ™‰S“…Œ … …„“ŽƒS“…Œ ‹ †˜…“…†Œ ƒS†…— “€Œ“S€S-ƒˆ‹ †S† sŒ€…“Sƒ, sŒ™ˆ†„…“Sƒ, Aˆ˜…‰S“. +ƒ… ˜Œ†S€„ƒ‹Œ“-“ŽŒ „€Œ‰„ƒ‹S, ˆ„“ˆ‹S““ŽŒ “S s€°, ˆ†S™Ž‹S"ƒ ‚“…‹Œ€-„S˜#“Ž† ‡Œ’ˆ„ƒ…’‚˜…€‚"!…† %””Œ†ƒ, “Œ™S‹…„…’ˆ ˆƒ ‹…‰S œ…ƒˆ„ƒSƒ…†S …/…˜… ˜‚‘Œ‹ˆ† ƒŒ€S“…… [1,2,4,13].¾‰“S†ˆ, €S™€Œ‘Œ““ŽŒ † †˜…“…‘Œ„†ˆ’‚ “€…’Œ“Œ“…" “€Œ“S€SƒŽ “ˆ˜‚‘Œ“Ž …™ ‡ŒƒŒ€ˆ˜ˆ‡…‘“ˆ‡ˆ ‰˜’ ‘Œ˜ˆ‹Œ†S ›…ˆ˜ˆ‡…‘Œ„†ˆ‡ˆ ’SƒŒ€…S˜S. •“ƒŒ“„…‹“ˆ„ƒ# $Œ ˜Œ††ˆ-„ƒ…’‚˜…€‚"!Œ‡ˆ %””Œ†ƒS s€° ’ˆ$Œƒ ™S‹…„Œƒ# ˆƒ Œ5 ‹…‰ˆ‹ˆ† “€…“S‰˜Œ$“ˆ„ƒ… [10].• ¾¾¾ “AS“S‡Œ“” €S™€S›ˆƒS“ “€Œ“S€Sƒ «AS“S‡Œ“» ‹ ‹…‰Œ ƒS›˜Œƒˆ†, “€Œ‰„ƒS‹˜’"!…† „ˆ›ˆ† ”€S‡’Œ“ƒ…€ˆ-‹S““Ž† “‚†˜Œˆ“€ˆƒŒ…‰“Ž† †ˆ’“˜Œ†„, ‹Ž‰Œ˜Œ““Ž† …™ “˜SœŒ“ƒŽ ‘Œ˜ˆ‹Œ†S. s“ˆ„ˆ› “ˆ˜‚‘Œ“…’ “ˆ™‹ˆ˜’Œƒ ‹Ž‰Œ-˜…ƒ# “ˆ˜“ˆœŒ““‚" ‡Œ“ˆ’“‚" s€° „ „ˆ—€S“Œ“…Œ’ ƒŒ— ŒŒ ”€S‡’Œ“ƒˆ‹, †ˆƒˆ€ŽŒ “€ˆ‘“ˆ S„„ˆœ……€ˆ‹S“Ž „ ›Œ˜†S’… ’‰Œ€“ˆ‡ˆ ’Sƒ€…†„S. žS™’Œ€ ”€S‡’Œ“ƒ…€ˆ‹S““ˆ† s€° †ˆ˜Œ›˜Œƒ„’ ˆƒ 200 ‰ˆ 6000 “S€ ˆ„“ˆ‹S“…†. • ‰ˆ†˜…“…‘Œ-„†…— …„„˜Œ‰ˆ‹S“…’— “€Œ“S€Sƒ “€ˆ’‹˜’˜ €S‰…ˆ™S!…ƒ“ŽŒ „‹ˆ†„ƒ‹S, „ƒSƒ…„ƒ…‘Œ„†… ™“S‘…’ˆ ‚’Œ“#‘S˜ €ˆ„ƒ %†„-“Œ€…’Œ“ƒS˜#“ˆ† ˆ“‚—ˆ˜… ‚ ’Ž‘Œ†, S ƒS† $Œ ˆ†S™Ž‹S˜ ‡Œ’ˆ„ƒ…’‚˜…€‚"!ŒŒ ‰Œ†„ƒ‹…Œ “€… œ…†˜ˆ”ˆ„”S“ˆ‹ˆ† ’…Œ˜ˆ„‚“€Œ„„…… [9,5,15]. • “S„ƒˆ’!ŒŒ ‹€Œ’’ ˆ”ˆ€’˜Œ“Ž ˜S›ˆ€Sƒˆ€“Ž† €Œ‡˜S-’Œ“ƒ “S “€ˆ…™‹ˆ‰„ƒ‹ˆ „‚›„ƒS“œ…… “€Œ“S€SƒS «AS“S‡Œ“», ˆ“Žƒ“ˆ-“€ˆ’Ž‘˜Œ““Ž† €Œ‡˜S’Œ“ƒ “S “€ˆ…™‹ˆ‰„ƒ‹ˆ ƒS›˜Œƒ…€ˆ‹S““ˆ† ”ˆ€’Ž “€Œ“S€SƒS, “€ˆŒ†ƒŽ S „‚›„ƒS“œ…" … ˜Œ†S€„ƒ‹Œ““‚" ”ˆ€’‚, ƒŒ—“…‘Œ„†…Œ ‚„˜ˆ-‹…’ “S „Ž€#Œ [14]. =Œ˜# €S›ˆƒŽ: …™‚‘…ƒ# ›Œ™ˆ“S„“ˆ„ƒ#, “Œ€Œ“ˆ„…’ˆ„ƒ# … ‹ˆ™’ˆ$“‚" ‡Œ’ˆ„ƒ…’‚˜…€‚"!‚" S†ƒ…‹“ˆ„ƒ# “€Œ“S-€SƒS «AS“S‡Œ“», ‹ €S’†S— †˜…“…‘Œ„†ˆ‡ˆ …„„˜Œ‰ˆ‹S“…’ ”S™Ž 1 ‚ ™‰ˆ€ˆ‹Ž— ‰ˆ›€ˆ‹ˆ˜#œŒ‹.