Ua hoʻolaha ʻo Helixmith i kēia lā ʻo kā lākou hoʻolaha ʻana, "Gene therapy for diabetic neuropathy: A randomized, placebo-controlled phase III study of VM202, a plasmid DNA encoding human hepatocyte growth factor," ʻo ia kekahi o nā ʻatikala kiʻekiʻe-10 i hoʻoiho ʻia ma Clinical and ʻEpekema Translational (CTS) ma 2021. ʻO CTS ka paʻi kūhelu o ka American Society for Clinical Pharmacology & Therapeutics (ASCPT) a e hōʻike ana i ka noiʻi kumu e kōkua ana i ka ʻike ʻana i ka hale hana me ka hōʻoia a me ka mālama ʻana i nā maʻi kanaka. ʻO Kauka John Kessler, ke Kumu o Neurology ma Northwestern ka mea kākau mua ma kēia noiʻi. ʻO kēia ka mua o ka gene therapy phase 3 i hana ʻia no ka ʻeha. Wahi a Alethea Gerding, Luna Hoʻoponopono, ASCPT, "Ua hoʻoiho ʻia ka ʻatikala ma mua o 3,000 mau manawa, ʻo ia hoʻi ua hōʻea i kahi ākea ākea honua. ʻO ka pahuhopu nui o CTS ʻo ia ka lilo ʻana i kukui o ka ʻepekema unuhi, a ʻo nā ʻatikala e like me kāu e hōʻike maopopo ana i ka waiwai o ka ʻepekema unuhi."
Ma ka pepa, VM202 (donaperminogene seltoplasmid), he plasmid DNA e hoʻopili ana i ke kanaka HGF (hepatocyte growth factor) gene, i hoʻomohala ʻia e Helixmith Co. Ltd, ua hōʻike nā mea kākau i ka VMDN-003b, intramuscular injections o VM202 hāʻawi i ka hōʻemi ʻeha no ka ʻoi aku o 8 mau mahina ma hope o ka pōʻai hope o ka mālama ʻana a ʻoi aku ka maikaʻi o ka palekana a me ka hoʻomanawanui, e like me nā haʻawina mua. ʻO kekahi o nā mea koʻikoʻi koʻikoʻi ma ka VMDN-003b a me ke aʻo ʻana o ka pae II, ʻoi aku ka maikaʻi o ka VM202 i nā kumuhana ʻaʻole ma pregabalin a i ʻole gabapentin, ʻelua o nā lāʻau lapaʻau i kuhikuhi ʻia ma ke kahua DPN.
He mau hopena koʻikoʻi ko kēia mau hopena ma mua o 4.2 miliona mau kānaka i ka US i ʻike ʻia e loaʻa i ka DPN ʻeha a kokoke i ka 1.3 miliona mau maʻi i manaʻo ʻia he refractory, ʻo ia hoʻi, ʻaʻole hana nā lāʻau i kēia manawa no lākou (Painful Diabetic Neuropathy, GlobalData 2018) .
Ua hoʻokuʻu ʻo Helixmith i kahi hoʻāʻo ʻelua ʻāpana 3 no DPN, REGAiN-1A (VMDN-003-2), ma US a ke manaʻo nei e hoʻokuʻu i nā hopena laina kiʻekiʻe ma ka hopena o 2022. Ke hoʻolālā nei ka hui e hoʻomaka i ke kolu o ka māhele 3 no DPN i ka hapa lua o 2022.
Nā mea nui o ka pepa CTS
• VM202 (donaperminogene seltoplasmid) mea mua-i-papa, proprietary, non-viral, hiki ho'ōla hou plasmid DNA gene therapy, mai ka non-clinical kuanaʻike holoholona.
• Ua mālama ʻia ka haʻawina Phase 3 no ka DPN ʻeha i ʻelua mau ʻāpana, hoʻokahi no 9 mahina (VMDN-003; ʻelima haneli mau kumuhana) a hoʻokahi me ka hoʻonui ʻana o 3 mau mahina i 12 mahina (VMDN-003b; 101 mau kumuhana).
• Hoʻomau ka palekana a me ka hoʻomanawanui o VM202 i ka maikaʻi loa, e like me nā haʻawina mua.
• He mau hopena koʻikoʻi ko kēia mau hopena ma mua o ka 4.2 miliona poʻe ma US i ʻike ʻia e loaʻa i ka DPN ʻeha a kokoke i ka 1.3 miliona mau maʻi e pale ʻole i ka hana ʻole o nā lāʻau lapaʻau i kēia manawa no lākou.
E pili ana i ka Diabetic Peripheral Neuropathy
ʻO DPN ʻeha kahi pilikia maʻamau a hoʻonāwaliwali o ka maʻi diabetes mellitus i loaʻa ka hopena maikaʻi ʻole i ka maikaʻi o ke ola, hiamoe, a me ke ʻano. ʻO nā lāʻau lapaʻau o kēia manawa he palliative a ʻaʻole i hoʻopaʻa ʻia i nā mīkini i lalo o ka DPN ʻeha. Eia kekahi, ua kaupalena pinepine ʻia ka hōʻailona hōʻailona, a nui nā mea maʻi me ka DPN ʻeha e hoʻohana mau i ka opioids.
He aha e lawe ʻia mai kēia ʻatikala:
- One of the most clinically important findings in both VMDN-003b and the phase II study is that VM202 was more effective in subjects not on pregabalin or gabapentin, two of the most prescribed medicine in the DPN field.
- Ltd, authors reported that in VMDN-003b, intramuscular injections of VM202 provided pain reduction for more than 8 months after the last cycle of treatment and that the safety and tolerability was highly favorable, consistent with previous studies.
- Helixmith launched a second phase 3 trial for DPN, REGAiN-1A (VMDN-003-2), in the US and are targeting release of top line results by the end of 2022.
