Sangamo Stock Spikes As Pfizer Partnership Meets Goal In Late-Stage Study
Sangamo Stock Spikes As Pfizer Partnership Meets Goal In Late-Stage Study
The AFFINE study achieved its primary objective.Sangamo Therapeutics Inc (NASDAQ:SGMO), which developed a treatment in collaboration with Pfizer Inc (NYSE:PFE), received a boost to its stock price after struggling with liquidity issues.
与辉瑞公司合作开发药物的Sangamo Therapeutics Inc. (纳斯达克股票代码: SGMO)，在苦于流动性问题后，股票价格获得提振。
At last check Wednesday, Sangamo was up more than 36.2%, trading at 55 cents per share.
截至周三最后一次核对，Sangamo股价上涨了36.2%，每股交易价格为55美分。
Both companies released results from the Phase 3 AFFINE study of giroctocogene fitelparvovec, an investigational gene therapy for adult patients with moderately severe to severe hemophilia A.
两家公司发布了giroctocogene fitelparvovec阶段三AFFINE研究的结果，该研究是面向中度重度血友病A成人患者的一种基因治疗试验药物。
The AFFINE study achieved its primary objective.
AFFINE研究达成了其主要目标。
Also Read: Second Death – Pfizer Reports Young Boy's Death After One Year Of Gene Therapy Treatment In Muscle Wasting Disorder Trial.
另请参阅：第二例死亡——辉瑞公司报告一名男孩在其进行的肌肉萎缩症临床试验中接受基因治疗一年后去世。
Following a single 3e13 vg/kg dose, the gene therapy demonstrated a statistically significant reduction in mean total ABR compared to the pre-infusion period (1.24 vs 4.73).
在单次3e13 vg/kg的剂量后，与预输注期相比，该基因治疗显示出平均总ABR的显着降低 (1.24比4.73)。
Key secondary endpoints were met and demonstrated superiority compared to prophylaxis.
关键二次终点符合且显示出优越性，与预防治疗相比。
About 84% of participants maintained FVIII activity greater than 5% at 15 months post-infusion, with the majority of participants having FVIII activity greater than or equal to 15%.
大约84%的参与者在输注15个月后仍保持FVIII活性大于5%，大多数参与者的FVIII活性大于或等于15%。
The mean treated ABR showed a statistically significant 98.3% reduction from 4.08 in the pre-infusion period to 0.07 post-infusion (from Week 12 up to at least 15 months [15-44 months]).
治疗后平均ABR显示出统计显着98.3%的降低，从预输注期的4.08下降到输注后的0.07 (从第12周开始至少15个月[15-44个月])。
Among all dosed participants, one participant (1.3%) returned to prophylaxis post-infusion.
在所有接受剂量的参与者中，有一个参与者(1.3%)在输注后返回预防治疗。
In the AFFINE study, giroctocogene fitelparvovec was generally well tolerated.
在AFFINE研究中，giroctocogene fitelparvovec通常耐受良好。
Serious adverse events were reported in 15 patients (20%), including 13 events reported by 10 (13.3%) assessed as related to treatment. Treatment-related adverse events were generally resolved in response to clinical management.
共有15名患者(20%)报告了严重不良事件，其中10名患者(13.3%)与治疗有关。与治疗相关的不良事件通常会在临床管理的响应下得以解决。
Clinical study participants will be evaluated in AFFINE over five years and up to 15 years as part of a long-term follow-up study.
临床研究参与者将在AFFINE研究中接受长达五年，最长可至15年的长期随访研究。
In April, the FDA approved Pfizer's Beqvez (fidanacogene elaparvovec) for moderate to severe hemophilia B.
四月份，美国FDA批准了辉瑞公司的Beqvez (fidanacogene elaparvovec)，用于治疗中度至重度血友病B。
Beqvez is awaiting a decision from the European Medicines Agency following a positive opinion from the EMA's Committee for Medicinal Products for Human Use in May 2024.
Beqvez正在等待欧洲药品管理局的决定，该决定是在5月份获得了欧洲药品管理局人用药品委员会的积极意见。
The FDA put the study of giroctocogene fitelparvovec on hold in November 2021. Pfizer hit pause after some patients experienced blood clotting protein factor VIII activity greater than 150%.
2021年11月，美国FDA暂停了giroctocogene fitelparvovec的研究。辉瑞公司在注意到一些患者的血凝血蛋白因子VIII活性超过150%后，暂停了输注。
Price Action: SGMO stock is up 64.5% at 66 cents, and PFE stock is down 0.10% at $29.46 at last check Wednesday.
截至周三最后一次核对，SGMO股票上涨64.5%，达到66美分，而PFE股票下跌0.10%，至29.46美元。
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