BETHESDA, Md., Aug. 29, 2023 /PRNewswire/ -- Northwest Biotherapeutics (OTCQB: NWBO) ("NW Bio"), a biotechnology company developing DCVax personalized immune therapies for solid tumor cancers, announces that it plans to submit a Marketing Authorization Application (MAA) in the U.K., to the Medicines and Healthcare Products Regulatory Agency (MHRA)(the equivalent of the U.S. FDA), for commercial approval of the Company's DCVax-L treatment for glioblastoma.
The Company believes that it has now completed all of the remaining prerequisites for such an application, including certain steps related to implementation of the approved Pediatric Investigation Plan and submission of the required formal notification to the MHRA of the upcoming MAA. As the Company reported in its recent 10-Q filing, the Company is in the final stages of completing the application package itself.
The Company anticipates submitting the MAA in approximately the next 30-45 days. The Company plans to request that the MHRA review the MAA under the 150-business day process that the MHRA has established to accelerate the availability of new medicines for patients in the U.K.
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 is a 331-patient Phase III trial of DCVax-L for newly diagnosed Glioblastoma multiforme (GBM). GBM is the most aggressive and lethal form of brain cancer, and is an "orphan disease." This Phase III trial has been completed, 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.
Disclaimer
Statements made in this news release that are not historical facts, including statements concerning plans for DCVax are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "expect," "believe," "intend," "design," "plan," "continue," "may," "will," "anticipate," and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those projected in any forward-looking statement. Readers should not rely upon forward-looking statements. There are a number of important factors that could cause actual results to differ materially from those anticipated, including, without limitation, risks related to delays or uncertainties in regulatory processes, risks related to the Company's ability to achieve timely performance of third parties, risks related to whether the Company's products will be viewed as demonstrating safety and efficacy, risks related to the Company's ongoing ability to raise additional capital, and other risks included in the Company's Securities and Exchange Commission ("SEC") filings. Additional information on the foregoing risk factors and other factors, including Risk Factors, which could affect the Company's results, is included in its SEC filings. Finally, there may be other factors not mentioned above or included in the Company's SEC filings that may cause actual plans, results or timelines to differ materially from those projected in any forward-looking statement. The Company assumes no obligation to update any forward-looking statements as a result of new information, future events or developments, except as required by securities laws.
CONTACTS
Northwest Biotherapeutics
Dave Innes
804-513-4758
[email protected]
Les Goldman
240-234-0059
[email protected]
馬里蘭州貝塞斯達,2023年8月29日 /PRNewswire/ — 開發DCVax實體瘤個性化免疫療法的生物技術公司西北生物治療公司(OTCQB:NWBO)(“NW Bio”)宣佈,計劃在英國向藥品和保健產品監管局(MHRA)(相當於美國食品藥品管理局)提交上市許可申請(MAA),該公司的膠質母細胞瘤dcVax-L治療方法獲得商業批准。
該公司認爲,它現在已經完成了此類申請的所有剩餘先決條件,包括與實施已批准的兒科調查計劃以及向MHRA提交即將到來的MAA所需的正式通知有關的某些步驟。正如該公司在最近的10季度文件中所報告的那樣,該公司本身已進入完成申請包的最後階段。
該公司預計大約在接下來的30-45天內提交MAA。該公司計劃要求MHRA根據MHRA爲加快英國患者獲得新藥而制定的150個工作日的程序對MAA進行審查。
關於西北生物治療公司
Northwest Biotherapeutics是一家生物技術公司,致力於在北美和歐洲開發個性化免疫療法產品,這些產品旨在比目前的治療方法更有效地治療癌症,不存在與化療相關的毒性,並且具有成本效益。該公司擁有基於dcVax樹突狀細胞的疫苗的廣泛平台技術。該公司的主導項目是一項針對新診斷的多形性膠質母細胞瘤(GBM)的dcVax-L的331名患者的III期試驗。GBM是最具侵略性和致命性的腦癌形式,是一種 “孤兒病”。該三期試驗已經完成,結果已在科學會議上公佈,並發表在《JAMA Oncology》上。該公司還開發了用於無法手術的實體瘤癌的DCVax-Direct。它已經完成了一項40名患者的一期試驗,並在資源允許的情況下計劃進行II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。
免責聲明
根據1995年《私人證券訴訟改革法》的含義,本新聞稿中非歷史事實的陳述,包括有關DCVax計劃的聲明,均爲前瞻性陳述。諸如 “期望”、“相信”、“打算”、“設計”、“計劃”、“繼續”、“可能”、“將”、“預期” 之類的詞語以及類似的表達方式旨在識別前瞻性陳述,儘管並非所有前瞻性陳述都包含這些識別詞。實際結果可能與任何前瞻性陳述中的預測存在重大差異。讀者不應依賴前瞻性陳述。有許多重要因素可能導致實際業績與預期存在重大差異,包括但不限於與監管程序延誤或不確定性相關的風險、與公司實現第三方及時業績的能力相關的風險、與公司產品是否被視爲具有安全性和有效性相關的風險、與公司持續籌集額外資金的能力相關的風險以及公司證券交易委員會(“SEC”)中包含的其他風險”) 申報。有關上述風險因素和其他因素(包括可能影響公司業績的風險因素)的更多信息,已包含在美國證券交易委員會的文件中。最後,可能還有其他未提及或未包含在公司向美國證券交易委員會提交的文件中的因素,這些因素可能導致實際計劃、業績或時間表與任何前瞻性陳述中的預測存在重大差異。除非證券法要求,否則公司沒有義務因新信息、未來事件或事態發展而更新任何前瞻性陳述。
聯繫人
西北生物治療公司
戴夫英尼斯
804-513-4758
[電子郵件保護]
萊斯·戈德曼
240-234-0059
[電子郵件保護]