Kuyesa kwa Gene Therapy kwa Diabetic Neuropathy Chimodzi mwazolemba zotsitsidwa kwambiri

Helixmith adalengeza lero kuti kufalitsa kwawo, "Gene therapy for diabetesic neuropathy: a randomized, placebo-controlled phase III phunziro la VM202, plasmid DNA encoding human hepatocyte growth factor," inali imodzi mwa nkhani 10 zomwe zatsitsidwa kwambiri mu Clinical and Translational Science (CTS) mu 2021. CTS ndi buku lovomerezeka la American Society for Clinical Pharmacology & Therapeutics (ASCPT) ndipo likuwunikira kafukufuku woyambirira womwe umathandizira kutulukira kwa labotale pozindikira komanso kuchiza matenda a anthu. Dr. John Kessler, Pulofesa wa Neurology ku Northwestern ndiye wolemba wamkulu pa phunziroli. Iyi inali gawo loyamba la chithandizo cha jini 3 yomwe idachitikapo chifukwa cha ululu. Malinga ndi a Alethea Gerding, Managing Editor, ASCPT, “Nkhaniyi yakopera maulendo oposa 3,000, kutanthauza kuti yafikira anthu ambiri padziko lonse lapansi. Cholinga chachikulu cha CTS ndicho kukhala chizindikiro cha sayansi yomasulira, ndipo nkhani ngati zanu zimasonyeza bwino lomwe kufunika kwa sayansi yomasulira.”

Mu pepala, VM202 (donaperminogene seltoplasmid), plasmid DNA encoding HGF yaumunthu (hepatocyte growth factor) jini, yopangidwa ndi Helixmith Co. Ltd, olemba adanena kuti mu VMDN-003b, jekeseni ya intramuscular ya VM202 inapereka kuchepetsa ululu kwa oposa 8. miyezi pambuyo mkombero wotsiriza wa mankhwala ndi kuti chitetezo ndi tolerability anali kwambiri yabwino, mogwirizana ndi maphunziro m'mbuyomu. Chimodzi mwazofunikira kwambiri pazachipatala mu VMDN-003b ndi phunziro la gawo lachiwiri ndikuti VM202 inali yothandiza kwambiri pamaphunziro osati pa pregabalin kapena gabapentin, awiri mwa mankhwala omwe amalembedwa m'munda wa DPN.

Zotsatirazi zimakhala ndi zofunikira zachipatala chifukwa anthu oposa 4.2 miliyoni ku US amadziwika kuti akuvutika ndi DPN yowawa ndipo pafupifupi odwala 1.3 miliyoni amaonedwa kuti ndi otsutsa, kutanthauza kuti mankhwala omwe alipo panopa sakugwira ntchito kwa iwo (Painful Diabetic Neuropathy, GlobalData 2018) .

Helixmith inayambitsa kuyesa kwa gawo lachiwiri la DPN, REGAiN-3A (VMDN-1-003), ku US ndipo ikufuna kutulutsa zotsatira zapamwamba kumapeto kwa 2. Kampani ikukonzekera kuyambitsa gawo lachitatu la DPN. mu theka lachiwiri la 2022.

Mfundo zazikuluzikulu za pepala la CTS

• VM202 (donaperminogene seltoplasmid) ndi njira yoyamba, yodalirika, yopanda mavairasi, yomwe ingathe kukonzanso DNA ya plasmid gene gene therapy, kuchokera ku zinyama zopanda chithandizo.

• Phunziro la Phase 3 la DPN yopweteka linachitidwa m'magawo awiri, imodzi kwa miyezi 9 (VMDN-003; maphunziro mazana asanu) ndi imodzi yowonjezereka kwa miyezi 3 mpaka miyezi 12 (VMDN-003b; maphunziro a 101).

• Chitetezo ndi kulolerana kwa VM202 kukupitiliza kuwoneka ngati kovomerezeka, kogwirizana ndi maphunziro am'mbuyomu.

• Zotsatirazi zimakhala ndi zofunikira zachipatala chifukwa anthu oposa 4.2 miliyoni ku US amadziwika kuti akuvutika ndi DPN yowawa ndipo pafupifupi odwala 1.3 miliyoni amakhala osagwirizana chifukwa mankhwala omwe alipo panopa sakugwira ntchito kwa iwo.

Za Diabetic Peripheral Neuropathy

Painful DPN ndizovuta komanso zofooketsa za matenda a shuga omwe amakhudza kwambiri moyo, kugona, komanso momwe akumvera. Mankhwala amakono ndi ochepetsetsa ndipo samayang'ana njira zomwe zimayambitsa DPN yowawa. Komanso, chithandizo cha zizindikiro nthawi zambiri chimakhala chochepa, ndipo odwala ambiri omwe ali ndi ululu wa DPN amagwiritsabe ntchito opioids.