BETHESDA, Md., Nov. 22, 2023 /PRNewswire/ -- Northwest Biotherapeutics (OTCQB: NWBO) ("NW Bio"), a biotechnology company developing DCVax personalized immune therapies for solid tumor cancers, provided an update today about the final preparations for the Marketing Authorization Application (MAA) that will be submitted to the Medicines and Healthcare Products Regulatory Agency (MHRA)(the equivalent of the U.S. FDA) in the U.K. for commercial approval of the Company's DCVax-L treatment for glioblastoma.
The Company previously reported that one key section of the MAA package remained to be completed and to then be delivered to an independent publisher for quality control checking of citations, numbers, cross-references, formatting and the like, in preparation for the submission.
The Company provided an update that most of the work has been completed on the key section of the MAA that remained to be done at the time of the prior update, as well as on required supporting documents, the majority of which have been delivered to the publisher/QC team. That team is now under way on this final stage of their work.
As described in the Company's prior update, it is anticipated that the publisher/QC team will need several weeks to complete their work on both the last portion of the MAA package and the integrated whole. Their work is independent of the Company.
About Northwest Biotherapeutics
Northwest Biotherapeutics is a biotechnology company focused on developing personalized immunotherapy products designed to treat cancers more effectively than current treatments, without toxicities of the kind associated with chemotherapies, and on a cost-effective basis, in both North America and Europe. The Company has a broad platform technology for DCVax dendritic cell-based vaccines. The Company's lead program involves DCVax-L treatment for glioblastoma (GBM). GBM is the most aggressive and lethal form of brain cancer, and is an "orphan disease." The Company has completed a 331-patient Phase III trial of of DCVax-L for GBM, and the results have been presented in scientific meetings and published in JAMA Oncology. The Company has also developed DCVax-Direct for inoperable solid tumor cancers. It has completed a 40-patient Phase I trial and, as resources permit, plans to pursue Phase II trials. The Company previously conducted a Phase I/II trial with DCVax-L for advanced ovarian cancer together with the University of Pennsylvania.
馬里蘭州貝塞斯達,2023年11月22日 /PRNewswire/ — 開發針對實體瘤癌症的dcVax個性化免疫療法的生物技術公司西北生物療法(OTCQB:NWBO)(“NW Bio”)今天提供了將提交給藥品和保健產品監管局(MHRA)(相當於美國食品藥品管理局)的上市許可申請(MAA)的最終準備工作的最新情況。在英國申請該公司治療膠質母細胞瘤的dcvax-L療法的商業批准。
該公司此前曾報告稱,MAA包中的一個關鍵部分仍有待完成,然後將交付給獨立出版商,對引文、數字、交叉引用、格式等進行質量控制檢查,爲提交做準備。
該公司提供了最新信息,即MAA的關鍵部分的大部分工作已經完成,而在先前更新時仍有待完成,以及所需的支持文件,其中大部分已交付給出版商/質量控制團隊。該小組目前正處於工作的最後階段。
正如公司先前更新中所述,預計出版商/質量控制團隊將需要幾周時間才能完成MAA軟件包的最後部分和綜合整體的工作。他們的工作獨立於公司。
關於Northwest Biotherapeutics公司
Northwest Biotherapeutics是一家生物技術公司,專注於開發個性化免疫療法產品,這些產品旨在在北美和歐洲以具有成本效益的方式比目前的治療方法更有效地治療癌症,不產生與化療相關的毒性。該公司擁有基於 dcVax 樹突狀細胞的疫苗的廣泛平台技術。該公司的主要項目涉及膠質母細胞瘤(GBM)的dcvax-L治療。GBM 是最具侵略性和致命性的腦癌,也是一種 “孤兒病”。該公司已經完成了一項針對GBM的dcvax-L的331名患者的III期試驗,結果已在科學會議上公佈,並發表在《JAMA Oncology》上。該公司還爲無法手術的實體瘤癌開發了DCVax-Direct。它已經完成了一項40名患者的I期試驗,並計劃在資源允許的情況下進行二期試驗。該公司此前曾與賓夕法尼亞大學一起使用DCVax-L進行了一項針對晚期卵巢癌的I/II期試驗。