COVID-19：AGC，CytoDyn的制造合同：美国FDA，“ Leron Limab” / 3期试验
新型冠状病毒肺炎（COVID-19）：新冠肺炎（COVID-19）：COVID-19：
AGC Biologics：
AGC Biologics Inc.（总部：美国AGC的CDMO子公司）已与CytoDyn签订合同，生产“ leron limab”的原料药。
CytoDyn：
美国的CytoDyn开发了用于新型冠状病毒的候选治疗药物“ Leronlimab”。
美国FDA最近批准了2b / 3期临床试验。
“ Leron limab”：
CytoDyn开发的“ Leronlimab”是为HIV和乳腺癌患者开发的治疗药物。
对患有新的冠状病毒的患者服用该治疗剂具有抑制细胞因子风暴的作用* 2。
在美国，已经将其用于重症新冠状病毒患者，并已证实其效果。
* 1个CDMO：
除了承包生产外还承包和开发制造方法的公司（合同开发与制造组织）
* 2细胞因子风暴：
由于传染病等原因导致血液细胞因子异常增加并发展为多器官衰竭的疾病
新闻｜ AGC
https://www.agc.com/news/detail/1200758_2148.html
CytoDyn to Prepare a Phase 3 Protocol to Submit to the FDA for a Three-Arm Comparative and Combination Trial of Leronlimab and Remdesivir
VANCOUVER, Washington,
May 18, 2020 (GLOBE NEWSWIRE)
CytoDyn Inc. (OTC.QB: CYDY),
a late-stage biotechnology company
developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, today
announced it will be submitting a protocol to the U.S.FDA for a factorial design trial to compare effectiveness of leronlimab versus remdesivir and in combination with remdesivir for the treatment of COVID-19.
Leronlimab
was administered to more than sixty patients with COVID-19 under emergency Investigational New Drug (eINDs) authorizations granted by the FDA.
Preliminary results from this patient population led to CytoDyn’s Phase 2b/3 clinical trial for 390 patients, which is randomized, placebo-controlled with 2:1 ratio (active drug to placebo ratio).
CytoDyn
has also been granted a Phase 2 randomized clinical trial study in the U.S. for a Phase 2 randomized clinical trial for mild-to-moderate COVID-19 population in the U.S.
CytoDyn plans to update the public regarding current eIND results later this week.
CytoDyn Inc. (CYDY)