Paradigm Biopharmaceuticals Ltd. ya ruwaito cewa batutuwan farko sun kasance bazuwar kuma an saka su a cikin Amurka (US) a cikin PARA_OA_002 gwaji na asibiti mai mahimmanci, kimanta injectable pentosan polysulfate sodium (PPS/Zilosul®) don maganin ciwon da ke hade da gwiwa osteoarthritis (kOA). ). An tabbatar da bazuwar batun farko a Jami'ar Arewa maso yamma, Chicago, ta Jagoran Bincike, Dokta Thomas Schnitzer MD, Ph.D.
Muhimmin Mataki na III na duniya, PARA_OA_002, a halin yanzu binciken yana nunawa tare da yin rajistar batutuwa a cikin shafuka takwas a duk faɗin Ostiraliya da 21 daga cikin rukunin yanar gizo 56 da aka zaɓa a cikin Kunna rukunin yanar gizo na Clinical na Amurka ya kasance muhimmiyar mahimmanci ga Paradigm daga farkon shekarar kalanda don ba da damar. babban tafki na m 'yan takara da za a gano a fadin da kunna shafukan da kuma fara aikin tantancewa. Za a ci gaba da kunna yanar gizo a cikin Amurka, kuma ana farawa da wuraren Burtaniya da EU a cikin CY22.
"Don sanya batutuwanmu na farko bazuwar a cikin Amurka muhimmin ci gaba ne a cikin shirin asibiti na OA. Ƙungiyar likitocin Paradigm ta yi aiki tuƙuru don farawa da kunna shafuka a ko'ina cikin Amurka, kuma muna ganin yawancin batutuwa suna shiga cikin lokacin nunawa a duk faɗin Amurka Muna sa ran ci gaba da ci gaba mai ƙarfi a cikin shirin na Mataki na III da ba da rahoto game da daukar ma'aikata masu mahimmanci. Mahimmanci ga masu hannun jarinmu,” in ji Dokta Donna Skerrett, Babban Jami’in Kula da Lafiya na Paradigm kuma Shugaba na wucin gadi.
ABUBUWAN DA ZA KU GUDU DAGA WANNAN LABARI:
- The global pivotal Phase III, PARA_OA_002, study is currently screening and enrolling subjects in eight sites across Australia and 21 of the 56 selected sites in the U.
- Clinical trial site activation has been a critical focus for Paradigm from the start of the calendar year to enable a large pool of potential candidates to be identified across the activated sites and begin the screening process.
- The Paradigm clinical team has been working tirelessly to initiate and activate sites throughout the U.
