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Genelux Corporation a late-stage clinical immuno-oncology company, today announced that the first patient has been dosed in the U.S.-based Phase 2 (VIRO-25) trial evaluating systemically delivered Olvi-Vec in patients with recurrent non-small cell lung cancer (NSCLC) who have failed frontline platinum and immune checkpoint inhibitor (ICI) therapies.'Today's milestone holds profound significance for patients with recurrent non-small cell lung cancer who face limited therapeutic options,' said Thomas Zindrick, President, CEO and Chairman of Genelux.
Genelux Corporation是一家晚期临床免疫肿瘤学公司,今天宣布,第一名患者已经在美国的第二阶段(VIRO-25)试验中服用了药物,该试验评估了复发性非小细胞肺癌(NSCLC)患者的全身递送Olvi-Vec,这些患者的一线铂类和免疫检查点抑制剂(ICI)治疗失败。”Genelux总裁、首席执行官兼董事长托马斯·津德里克(ThomasZindrick)说,今天的里程碑对于面临有限治疗选择的复发性非小细胞肺癌患者具有深远意义。
'This Phase 2 trial, in addition to our ongoing Phase 1b/2 trial evaluating intravenous delivered Olvi-Vec in patients with recurrent small cell lung cancer, co-sponsored with Newsoara Biopharma Co. Ltd., signifies the key advancement of Olvi-Vec to potentially be an important systemically administered oncolytic virus treatment option, setting the stage for the future of this promising field.'The VIRO-25 clinical trial (NCT06463665), is an open-label, randomized study in NSCLC designed to evaluate the efficacy and safety of an intravenously delivered oncolytic vaccinia virus, Olvi-Vec, followed by platinum-doublet chemotherapy + Physician's Choice of ICI compared with docetaxel in patients with advanced or metastatic NSCLC who have shown first disease progression while on front-line treatment or maintenance ICI therapy after front-line treatment with platinum-doublet chemotherapy + ICI as standard of care.
“除了我们正在进行的1b/2期试验评估复发性小细胞肺癌患者静脉注射Olvi-Vec外,这项2期试验还与Newsoara Biopharma co.Ltd.共同赞助,标志着Olvi-Vec的关键进展可能成为一种重要的全身给药溶瘤病毒治疗选择,为这一有前景的领域的未来奠定了基础。”VIRO-25临床试验(NCT06463665)是一项针对非小细胞肺癌的开放标签随机研究,旨在评估静脉注射溶瘤痘苗病毒Olvi-Vec的疗效和安全性,然后是铂双联化疗+医生选择的ICI与多西紫杉醇相比,晚期或转移性非小细胞肺癌患者在一线治疗或维持ICI治疗后表现出首次疾病进展,以铂双联化疗+ICI作为一线治疗标准。
Olvi-Vec’s previous data suggests a manageable safety profile, and this trial looks to further confirm the hypothesis that Olvi-Vec may resensitize to platinum in multiple tumor types. Genelux expects interim data readout in mid-2025.About Olvi-VecOlvi-Vec is a proprietary, modified oncolytic vaccinia virus, a stable DNA vir.
Olvi Vec之前的数据表明其安全性可控,该试验旨在进一步证实Olvi Vec可能对多种肿瘤类型的铂重新敏感的假设。Genelux预计将在2025年年中公布中期数据。关于Olvi-VecOlvi-Vec是一种专有的,改良的溶瘤痘苗病毒,一种稳定的DNA病毒。