ILakewood-Amedex, Inc. ibhengeze namhlanje ukuba iqalise isifundo sayo sesibini seSigaba se-2 isebenzisa i-Bisphosphocin Nu-3 antimicrobial ekunyangeni izigulane ezinezilonda ezinyaweni zeswekile (DFU). Bangaphezu kwezigidi ezingama-34 abantu abadala e-United States abanesifo seswekile (Umthombo: CDC), kwaye iingxaki ze-DFU zinoxanduva malunga ne-85% yokunqunyulwa kwamalungu angaphantsi kwe-non-traumatic ngonyaka, kudala ukugula okukhulu, ukufa, kunye nomthwalo wemali inkqubo yezempilo.
Uphononongo lweSigaba se-2 luyi-randomized, i-multi-center, i-double-blind-blind, i-placebo-controlled, i-dose-escalating study ukuvavanya ukhuseleko kunye nokunyamezela kwe-topically application Bisphosphocin Nu-3 gel kwi-Type I okanye i-II ye-diabetes mellitus izigulane ezine-DFU engapheliyo. Ngalo lonke ixesha lotyelelo lwaseklinikhi, izilonda zezigulane ziya kujongwa ukuba kukho naziphi na iinguqu kwindawo kwaye ubunzulu besilonda kunye nolawulo lwebhayoloji luya kuhlolwa.
USteve Parkinson, uMongameli kunye ne-CEO yeLakewood-Amedex, uthe, "Siyavuya kakhulu ukuba siqalise ulingo lwethu lwesibini lwezonyango ekunyangeni ii-DFUs. Kumava ethu angaphambili avavanya i-Nu-3 yonyango lwezigulane ezinezilonda zeenyawo zesifo seswekile, i-Nu-3 yayinyamezeleke kakuhle kwaye akukho ziganeko ezimbi ezichazweyo ezinxulumene nonyango. Ngelixa olu phononongo lwangaphambili lokunyuka kwethamo lungakhange lunikwe amandla okuvelisa idatha esebenzayo ngokwezibalo, lubonise umkhwa okhuthazayo wokuphumelela. Izigulane eziphathwe nge-2% yesisombululo se-Nu-3 iintsuku ezisixhenxe zine-65.5% yokunciphisa indawo yesilonda ngokuphikisana ne-29.9% yokunciphisa ingalo ye-placebo, njengoko kulinganiswe iintsuku ezili-14 emva kokuba unyango luqalile. Ukongeza, i-62.5% yezigulane eziphathwe nge-2% ye-Nu-3 yabona ukunciphisa umthwalo we-microbiological, ngokuchasene ne-20% kwi-placebo. Ngoku iSigaba sethu sesi-2 sophononongo lokunyuka kwedosi luya kwakhela kwisiseko solingo lwangaphambili lweklinikhi ngokusebenzisa ixesha elide lonyango lweentsuku ezingama-28, uxinzelelo oluphezulu lwe-5% lulandelwa yi-10% Nu-3, kunye ne-Nu-3 ephuculweyo. ukwakhiwa kwejeli, konke esikulindeleyo kuya kunika ukuhanjiswa okungcono kwe-Nu-3 kunye nokunyangwa kwamanxeba angapholiyo. Iimpembelelo zosulelo olusentloko kunye nolwenkqubo luhlala lungumthwalo omkhulu kwinkqubo yokhathalelo lwempilo. Sikholelwa ukuba ukuzibophelela kwethu ukuqhubela phambili nokuphuhlisa iqonga letekhnoloji ye-Bisphosphocins yobunini, enonyango olusebenzayo, lwendawo yosulelo oluyingozi, oluhlala lubangelwa zizifo ezinganyangekiyo ngamayeza okubulala iintsholongwane, zombini igram-positive kunye negram-negative, ziya kwenza ukuba ababoneleli bezempilo bakwazi ukujongana ngokukhuselekileyo nangempumelelo. uninzi lwezifo ezibangelwa ziintsholongwane ezibonakala zilucelomngeni ngoku kusetyenziswa iindlela eziqhelekileyo.”
“UGqr. UFelix Sigal, ongomnye weengcaphephe ezibalaseleyo kwicandelo lokuhlangula amalungu eswekile, ukubasebenzi kwiziko lezoNyango laseHollywood Presbyterian kunye neZiko lezoNyango leSibhedlele saseCalifornia. Ugxininise ekunyamekelweni kwenxeba kunye nokuhlenga amalungu esifo seswekile, ngelixa efuna umdla wakhe kuphando lweklinikhi ukwenzela ukuba ukhetho olungcono lonyango kwizigulane zakhe. Siyavuya ukunika ingxelo yokuba uDkt. Sigal ngoku ubhalise isigulane sokuqala kwesi sifundo seSigaba se-2 esivavanya ukusetyenziswa kwejeli ye-Nu-3 kunyango lwezilonda zesifo seswekile, "kusho uSumita Paul, MD, MPH, MBA, iGosa eliyiNtloko lezoNyango. kunye neSekela likaMongameli oPhezulu woPhando kunye noPhuhliso eLakewood-Amedex Inc. "Kuya kuba nezigulane ze-12 eziphathwa nge-Nu-3 gel kwiqela ngalinye lamaqela amabini kunye neqela elincinci le-placebo."
INTO ONOKUYITHATHA KWELI NQAKU:
- Now our Phase 2 dose-escalating study will build on the foundation of the previous clinical trials by using a longer treatment duration of 28 days, a higher concentration of 5% followed by 10% Nu-3, as well as an improved Nu-3 gel formulation, all of which we expect will offer a better delivery of Nu-3 and treatment of nonhealing wounds.
- The Phase 2 study is a randomized, multi-center, double-blind, placebo-controlled, dose-escalating study to evaluate the safety and tolerability of topically applied Bisphosphocin Nu-3 gel on Type I or II diabetes mellitus patients with chronic DFU.
- Felix Sigal, who is one of the most distinguished specialists in the field of diabetic limb salvage, is on staff at both the Hollywood Presbyterian Medical Center and the California Hospital Medical Center.
