Precigen Announces Study Data For PRGN-2012 For Recurrent Respiratory Papillomatosis Patients; Phase 1/2 Pivotal Study Met Primary And Efficacy Endpoints
Precigen Announces Study Data For PRGN-2012 For Recurrent Respiratory Papillomatosis Patients; Phase 1/2 Pivotal Study Met Primary And Efficacy Endpoints
– Phase 1/2 pivotal study met the primary safety and efficacy endpoints –
– 1/2期關鍵研究達到主要安全性和有效性終點——
– 51% (18 out of 35) of patients achieved Complete Response, requiring no surgeries after treatment with PRGN-2012; complete responses have been durable beyond 12 months with median duration of follow up of 20 months as of data cutoff –
– 35名患者中有51% (18人)在PRGN-2012治療後達到完全緩解狀態，無需手術治療；完全緩解狀態經持續超過12個月，在數據截止時間的20個月中位隨訪期內得以維持——
– 86% of patients (30 out of 35) had a decrease in surgical interventions in the year after PRGN-2012 treatment compared to the year prior to treatment; RRP surgeries reduced from a median of 4 pre-treatment to 0 post-treatment –
– 35名患者中有86% (30人)在接受PRGN-2012治療後的一年內手術干預減少，降低了RRP手術的中位數，由術前的4次降至術後的0次——
– PRGN-2012 was well-tolerated with no dose-limiting toxicities and no treatment-related adverse events greater than Grade 2 –
– PRGN-2012治療耐受性良好，無劑量限制毒性，無治療相關的2級以上不良事件——
– PRGN-2012 treatment induced HPV 6/11-specific T cell responses in RRP patients with a significantly greater expansion of peripheral HPV-specific T cells in responders compared with non-responders –
– PRGN-2012治療誘導RRP患者產生HPV6/11特異性T細胞反應，響應者周圍HPV特異T細胞明顯增加，而非響應者則無明顯增加——
– PRGN-2012 significantly (p < 0.0001) improved Derkay and quality of life scores in complete responders –
– PRGN-2012治療明顯（p
– RRP is a rare, devastating HPV-mediated chronic disease characterized by growth of benign tumors for which the current standard-of-care is repeated surgeries; if approved, PRGN-2012 has the potential to be the first FDA-approved therapeutic for the treatment of RRP –
– RRP是一種罕見、具有破壞性的HPV介導的慢性疾病，其特點是良性腫瘤的生長，目前的標準護理是反覆手術；如果獲批，PRGN-2012有望成爲治療RRP的首個FDA批准的治療藥物—— –
– Clinical data associated with favorable safety, strong efficacy, ease of administration, and immunological responses, position PRGN-2012 to potentially be the preferred treatment-of-choice for RRP –
– 有利的臨床數據——安全性良好，療效強，易於給藥，免疫反應強——使PRGN-2012有潛力成爲RRP的首選治療藥物——
– PRGN-2012 rolling BLA submission, under an accelerated approval pathway, is anticipated in the second half of 2024 –
– PRGN-2012滾動式BLA提交預計於2024年下半年在加速批准通路下進行——