- Pivotal Phase 3 Study of Olvi-Vec in Platinum Resistant/Refractory Ovarian Cancer Initiated in September 2022 - - Phase 2 Trial of Olvi-Vec- Demonstrated Clinical Reversal of Platinum Resistance and Refractoriness and Met Primary Endpoint of Objective Response Rate with Durable Responses - WESTLAKE VILLAGE, Calif., Nov.

-Olvi Vec在铂类耐药/难治性卵巢癌中的关键阶段3研究于2022年9月启动--Olvi Vec的第2阶段试验-证明了铂类耐药性和难治性的临床逆转，并符合客观反应率的主要终点，具有持久的反应-WESTLAKE村，加利福尼亚州，11月。

27, 2023 (GLOBE NEWSWIRE) -- Genelux Corporation (NASDAQ: GNLX), a late clinical-stage immuno-oncology company, today announced that the United States Food and Drug Administration (FDA) has granted Fast Track designation for the development program of Olvi-Vec (olvimulogene nanivacirepvec) for the treatment of patients with platinum resistant/refractory ovarian cancer.

272023（GLOBE NEWSWIRE）-Genelux Corporation（纳斯达克股票代码：GNLX）是一家晚期临床阶段免疫肿瘤公司，今天宣布美国食品和药物管理局（FDA）已批准开发计划的快速通道名称Olvi-Vec（olvimulogene nanivacirepvec）用于治疗铂类耐药/难治性卵巢癌患者。

“The Fast Track designation granted for Olvi-Vec underscores its potential to address unmet medical needs in ovarian cancer, a significant recognition as we continue to enroll our Phase 3 OnPrime study,” said Thomas Zindrick, President, Chairman and CEO of Genelux. “We eagerly anticipate ongoing engagement with the FDA as we progress in the development of this promising treatment.” Genelux is currently conducting OnPrime/GOG-3076, a Phase 3 multi-center, randomized, open-label registrational trial evaluating the efficacy and safety of Olvi-Vec in combination with platinum-based chemotherapy in patients with platinum-resistant/refractory ovarian cancer.

Genelux主席兼首席执行官Thomas Zindrick说：“Olvi Vec授予的快速通道名称强调了其解决卵巢癌未满足医疗需求的潜力，这是我们继续参加第3阶段OnPrime研究的重要认可。”。“随着我们在开发这种有前景的治疗方法方面取得进展，我们热切期待与FDA持续合作。”Genelux目前正在进行OnPrime/GOG-3076，这是一项评估疗效的3期多中心，随机，开放标签注册试验Olvi-Vec联合铂类化疗治疗铂类耐药/难治性卵巢癌的安全性和安全性。

More information about the trial is accessible at www.ClinicalTrials.gov, identifier NCT05281471. The purpose of Fast Track designation is to facilitate the development and hasten the review process of drugs aimed at treating serious and life-threatening conditions, ensuring that an approved product can swiftly enter the market.

有关该试验的更多信息，请访问www.ClinicalTrials.gov，标识符为NCT05281471。快速通道指定的目的是促进开发并加快旨在治疗严重和危及生命的疾病的药物审查过程，确保获得批准的产品能够迅速进入市场。

Notable aspects of Fast Track designation encompass regular engagements with the FDA review team, and, if spec.

快速通道指定的显着方面包括与FDA审查小组的定期约定，以及如果指定的话。