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GeoVax Announces Gedeptin Patient Enrollment Closure for Phase 1/2 Clinical Trial Among Advanced Head and Neck Cancer Patients

GeoVax Announces Gedeptin Patient Enrollment Closure for Phase 1/2 Clinical Trial Among Advanced Head and Neck Cancer Patients

GeoVax宣布结束晚期头颈癌患者1/2期临床试验的Gedeptin患者入组
GlobeNewswire ·  01/04 22:00

Therapy Demonstrated Safety, Stabilization/Shrinkage of Treated Tumors

疗法证明治疗的肿瘤具有安全性、稳定性/收缩性

Expanded Development for Monotherapy and Combination Therapy Anticipated

预计将扩大单一疗法和联合疗法的开发

ATLANTA, GA, Jan. 04, 2024 (GLOBE NEWSWIRE) -- via NewMediaWire – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced the closure of patient enrollment for the Phase 1/2 clinical study evaluating Gedeptin in patients suffering from advanced head and neck cancer.

乔治亚州亚特兰大,2024年1月4日(GLOBE NEWSWIRE)——通过NewMediaWire — 开发针对癌症和传染病的免疫疗法和疫苗的生物技术公司GeoVax Labs, Inc.(纳斯达克股票代码:GOVX)今天宣布结束评估吉德普汀的1/2期临床研究的患者入组 在患有晚期头颈癌的患者中。

Kelly McKee, MD, MPH, GeoVax's Chief Medical Officer, stated, "Completion of this trial will be a significant milestone in our Gedeptin clinical development program. Allowing time for the maximum number of cycles of Gedeptin therapy and patient follow-up, we expect to complete the study by the third quarter of this year. In the interim, we are in active discussions with advisors on protocol development in support of a follow-on Phase 2 or Phase 2/3 trial among patients with advanced head and neck cancer in whom current therapeutic options are suboptimal. Our intent is to discuss this follow-on protocol with the FDA, in conjunction with a complete review of the results of the current trial, to ensure alignment with the regulator's expectations. We expect that such discussions will include addressing the opportunity and basis for an expedited approval pathway."

GeoVax首席医学官医学博士、公共卫生硕士凯利·麦基表示:“这项试验的完成将是我们Gedeptin临床开发计划的重要里程碑。考虑到Gedeptin治疗和患者随访的最大周期有时间,我们预计将在今年第三季度完成这项研究。在此期间,我们正在与顾问就方案制定进行积极讨论,以支持在目前治疗选择不太理想的晚期头颈癌患者中进行后续的2期或2/3期试验。我们的意图是与美国食品药品管理局讨论这一后续协议,同时对当前试验的结果进行全面审查,以确保符合监管机构的预期。我们预计,此类讨论将包括探讨加快批准途径的机会和基础。”

Dr. McKee continued, "Demonstrating the safety, tolerability, and stabilization or shrinkage of injected tumors in patients receiving multiple cycles of Gedeptin opens the door to advancing this promising therapeutic in additional patients with advanced head and neck cancer as well as in patients with other solid tumor types and at multiple points in their therapeutic journey."

麦基博士继续说:“在接受多周期Gedeptin的患者中,证明注射肿瘤的安全性、耐受性、稳定性或收缩性,为在更多晚期头颈癌患者以及其他实体瘤类型患者以及治疗过程中的多个阶段推进这种有前途的治疗方法打开了大门。”

David Dodd, GeoVax's Chairman and CEO, commented, "We believe that the successful completion of the current trial, in conjunction with earlier findings from the completed Phase 1 first-in-human trial and preclinical investigations, provide a sound rationale for proceeding with further Gedeptin investigations. These will include adjustments to the Gedeptin treatment regimen and combination with immune checkpoint inhibitors in advanced head and neck cancer as well as for additional cancerous and non-cancerous tumor indications. These advances represent a significant potential opportunity for GeoVax to improve the performance of immune checkpoint inhibitors and/or introduce Gedeptin as a treatment option in patients with earlier-stage disease."

GeoVax董事长兼首席执行官大卫·多德评论说:“我们认为,当前试验的成功完成,加上已完成的1期首次人体试验和临床前研究的先前发现,为进一步开展Gedeptin研究提供了合理的理由。这将包括调整Gedeptin治疗方案,与免疫检查点抑制剂联合用于晚期头颈癌以及其他癌性和非癌性肿瘤适应症。这些进展为GeoVax提供了一个重要的潜在机会,可以改善免疫检查点抑制剂的性能和/或将Gedeptin作为早期疾病患者的治疗选择。”

About Gedeptin

关于 Gedeptin

Gedeptin is a novel patented product/technology for the treatment of solid tumors through a gene therapy strategy known as Gene-Directed Enzyme Prodrug Therapy (GDEPT). In GDEPT, a vector is used to selectively transduce tumor cells with a nonhuman gene, which expresses an enzyme that can convert a nontoxic prodrug into a very toxic antitumor compound in situ.

Gedeptin是一种新的专利产品/技术,用于通过一种称为基因导向酶前药疗法(GDEPT)的基因治疗策略治疗实体瘤。在GDEPT中,载体用于选择性地转导具有非人类基因的肿瘤细胞,该基因表达一种可以将无毒前药转化为毒性极强的抗肿瘤化合物的酶 就地

The ongoing Phase 1/2 trial (ClinicalTrials.gov Identifier: NCT03754933) is evaluating the safety and efficacy of repeat cycles of Gedeptin therapy in patients with recurrent head and neck squamous cell carcinoma (HNSCC), with tumor(s) accessible for injection and no curable treatment options. The protocol entails up to five treatment cycles, each consisting of three intratumoral injections of Gedeptin over two days followed by infusion of a prodrug, fludarabine phosphate, once a day for three days. A completed Phase 1 dose-ranging study demonstrated that treating a tumor with a single cycle of Gedeptin, followed by fludarabine infusions, was well tolerated, with evidence of a reduction in tumor size in patients with solid tumors.

正在进行的1/2期试验(ClinicalTrials.gov标识符:NCT03754933)正在评估复发性头颈部鳞状细胞癌(HNSCC)患者的重复周期Gedeptin疗法的安全性和有效性,肿瘤可以注射,没有可治愈的治疗选择。该方案包括多达五个治疗周期,每个周期包括在肿瘤内注射三次格德普汀,然后输注前药磷酸氟达拉滨,每天一次,持续三天。一项已完成的1期剂量范围研究表明,使用单周期的Gedeptin治疗肿瘤,然后进行氟达拉滨输液,具有良好的耐受性,有证据表明实体瘤患者的肿瘤大小会减小。

A previously reported interim data review demonstrated:

先前报告的中期数据审查显示:

  • No dose limiting toxicities or serious adverse events (SAEs) are definitively attributable to treatment. Additionally, no adverse events above grade 3 severity have been reported.
  • Up to 5 cycles of Gedeptin treatment have been administered without limiting sequelae. Intratumoral expression of the PNP transgene by RT-PCR has been established in treated tumors studied to date.
  • Impairment of tumor growth (i.e., "stable disease" using RECIST 1.1 evaluation criteria) in targeted lesions was seen in 5 of 7 patients; tumor response assessment in one patient remains under study.
  • 任何剂量限制毒性或严重不良事件 (SAE) 都不能明确归因于治疗。此外,未报告严重程度超过 3 级的不良事件。
  • 在不限制后遗症的情况下,已经进行了多达5个周期的Gedeptin治疗。迄今为止研究的经过治疗的肿瘤中,已经通过RT-PCR确定了PNP转基因的瘤内表达。
  • 7名患者中有5名出现靶向病变中肿瘤生长受损(即使用RECIST 1.1评估标准的 “稳定疾病”);一名患者的肿瘤反应评估仍在研究中。

The current study is being funded in part by the FDA pursuant to its Orphan Products Clinical Trials Grants Program. The FDA has also granted Gedeptin orphan drug status for the intratumoral treatment of anatomically accessible oral and pharyngeal cancers, including cancers of the lip, tongue, gum, floor of mouth, salivary gland, and other oral cavities.

根据美国食品药品管理局的孤儿产品临床试验补助计划,当前的研究部分资金由美国食品药品管理局资助。美国食品药品管理局还授予了Gedeptin孤儿药地位,用于肿瘤内治疗解剖学上可获得的口腔癌和咽癌,包括唇癌、舌癌、牙龈癌、口底癌、唾液腺癌和其他口腔癌。

About GeoVax

关于 GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel therapies and vaccines for solid tumor cancers and many of the world's most threatening infectious diseases. The company's lead program in oncology is a novel oncolytic solid tumor gene-directed therapy, Gedeptin, presently in a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax's lead infectious disease candidate is GEO-CM04S1, a next-generation COVID-19 vaccine targeting high-risk immunocompromised patient populations. Currently in three Phase 2 clinical trials, GEO-CM04S1 is being evaluated as a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, and as a booster vaccine in patients with chronic lymphocytic leukemia (CLL). In addition, GEO-CM04S1 is in a Phase 2 clinical trial evaluating the vaccine as a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. GeoVax has a leadership team who have driven significant value creation across multiple life science companies over the past several decades. For more information, visit our website: .

GeoVax Labs, Inc. 是一家处于临床阶段的生物技术公司,为实体瘤癌和许多世界上最具威胁性的传染病开发新疗法和疫苗。该公司在肿瘤学领域的领先项目是一种新型的溶瘤实体瘤基因定向疗法 Gedeptin,目前正在进行一项针对晚期头颈癌的多中心 1/2 期临床试验。GeoVax 的主要候选传染病是 GEO-CM04S1,这是一种针对高风险免疫功能低下患者群体的下一代 COVID-19 疫苗。目前正在三项二期临床试验中,GEO-CM04S1 被评估为免疫功能低下的患者(例如血液系统癌症患者和其他目前授权的 COVID-19 疫苗不足的患者群体)的初级疫苗,以及慢性淋巴细胞白血病(CLL)患者的加强疫苗。此外,GEO-CM04S1 正在进行二期临床试验,评估该疫苗在先前接种过 mRNA 疫苗的健康患者中是一种更强大、更耐用的 COVID-19 增强剂。GeoVax拥有一支领导团队,在过去的几十年中,他们推动了多家生命科学公司的重大价值创造。想要查询更多的信息, 访问我们的网站:.

Forward-Looking Statements

前瞻性陈述

This release contains forward-looking statements regarding GeoVax's business plans. The words "believe," "look forward to," "may," "estimate," "continue," "anticipate," "intend," "should," "plan," "could," "target," "potential," "is likely," "will," "expect" and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax is able to obtain acceptable results from ongoing or future clinical trials of its investigational products, GeoVax's immuno-oncology products and preventative vaccines can provoke the desired responses, and those products or vaccines can be used effectively, GeoVax's viral vector technology adequately amplifies immune responses to cancer antigens, GeoVax can develop and manufacture its immuno-oncology products and preventative vaccines with the desired characteristics in a timely manner, GeoVax's immuno-oncology products and preventative vaccines will be safe for human use, GeoVax's vaccines will effectively prevent targeted infections in humans, GeoVax's immuno-oncology products and preventative vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete development, there is development of competitive products that may be more effective or easier to use than GeoVax's products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control.

本新闻稿包含有关GeoVax业务计划的前瞻性陈述。“相信”、“展望”、“可能”、“估计”、“继续”、“预测”、“打算”、“应该”、“计划”、“可能”、“目标”、“潜在”、“很可能”、“将”、“期望” 等词语以及与我们相关的类似表述旨在识别前瞻性陈述。我们的这些前瞻性陈述主要基于我们当前对未来事件和财务趋势的预期和预测,我们认为这些事件和财务趋势可能会影响我们的财务状况、经营业绩、业务战略和财务需求。由于多种因素,实际结果可能与这些陈述中包含的结果存在重大差异,包括:GeoVax是否能够从其研究产品的正在进行或未来的临床试验中获得可接受的结果,GeoVax的免疫肿瘤学产品和预防性疫苗可以引起预期的反应,这些产品或疫苗可以有效使用,GeoVax的病毒载体技术可以充分放大对癌症抗原的免疫反应,GeoVax可以开发和生产其免疫肿瘤学产品和预防剂及时具有所需特性的疫苗,GeoVax的免疫肿瘤学产品和预防性疫苗可以安全地供人使用,GeoVax的疫苗将有效预防人类靶向感染,GeoVax的免疫肿瘤学产品和预防性疫苗将获得许可和上市所需的监管批准,GeoVax筹集完成开发所需的资金,正在开发可能比GeoVax更有效或更易于使用的竞争产品 GeoVax的产品将能够进入有利地位制造和分销协议以及GeoVax无法控制的其他因素。

Further information on our risk factors is contained in our periodic reports on Form 10-Q and Form 10-K that we have filed and will file with the SEC. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.

有关我们风险因素的更多信息包含在我们已经提交并将向美国证券交易委员会提交的10-Q表和10-K表的定期报告中。我们在此作出的任何前瞻性陈述仅代表其发表之日。可能导致我们实际结果不同的因素或事件可能会不时出现,我们不可能全部预测。除非法律要求,否则我们没有义务公开更新任何前瞻性陈述,无论是由于新信息、未来发展还是其他原因。

Company Contact: Investor Relations Contact: Media Contact:
info@geovax.com paige.kelly@sternir.com sr@roberts-communications.com
678-384-7220 212-698-8699 202-779-0929
公司联系人: 投资者关系联系人: 媒体联系人:
info@geovax.com paige.kelly@sternir.com sr@roberts-communications.com
678-384-7220 212-698-8699 202-779-0929

译文内容由第三方软件翻译。


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