Ua hōʻike ʻo Paradigm Biopharmaceuticals Ltd. ua hoʻokaʻawale ʻia nā kumuhana mua a kau ʻia ma ʻAmelika Hui Pū ʻIa (US) i ka PARA_OA_002 pivotal clinical trial, e loiloi ana i ka injectable pentosan polysulfate sodium (PPS/Zilosul®) no ka mālama ʻana i ka ʻeha e pili ana me ka osteoarthritis (kOA). ). Ua hōʻoia ʻia ka randomization kumuhana mua ma Northwestern University, Chicago, e Lead Investigator, Dr. Thomas Schnitzer MD, Ph.D.
ʻO ka pae honua pivotal Phase III, PARA_OA_002, ke nānā ʻana a me ke kākau inoa ʻana i nā kumuhana ma ʻewalu mau kahua ma waena o Australia a me 21 o nā kahua 56 i koho ʻia ma ka US Clinical hoʻāʻo kahua hoʻāla ʻia he mea koʻikoʻi no Paradigm mai ka hoʻomaka ʻana o ka makahiki alemanaka e hiki ai. he loko nui o nā moho e ʻike ʻia ma nā wahi i hoʻāla ʻia a hoʻomaka i ke kaʻina hana nānā. E hoʻomau ʻia ka hana ʻana o ka pūnaewele ma US, a ke hoʻomaka pū ʻia nei nā pūnaewele UK a me EU ma CY22.
"ʻO ka loaʻa ʻana o kā mākou mau kumuhana mua i ka US he mea koʻikoʻi koʻikoʻi i ka papahana lapaʻau OA. Ke hana luhi nei ka hui lapaʻau Paradigm i ka hoʻomaka ʻana a me ka hoʻāla ʻana i nā pūnaewele ma ʻAmelika Hui Pū ʻIa, a ke ʻike nei mākou i ka nui o nā kumuhana e komo ana i ka pae screening a puni ka US. nā milestones i ko mākou poʻe kuleana, "wahi a Kauka Donna Skerrett, ka Luna Hoʻokele o Paradigm a me Interim CEO.
He aha e lawe ʻia mai kēia ʻatikala:
- 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.
