share_log

MEI Pharma Reports Initial Data From Clinical Study Evaluating ME-344 In Combination With Bevacizumab In Relapsed Metastatic Colorectal Cancer Patients

MEI Pharma Reports Initial Data From Clinical Study Evaluating ME-344 In Combination With Bevacizumab In Relapsed Metastatic Colorectal Cancer Patients

MEI Pharma 報告了臨床研究的初步數據,該研究評估 ME-344 與貝伐珠單抗聯合治療復發轉移性結直腸癌患者
Benzinga ·  04/11 20:05

– Cohort 1 Exceeds Predetermined Non-Progression Threshold in the Ongoing Phase 1b Study –

— 在正在進行的1b期研究中,隊列1超過了預先確定的非進展閾值—

– ME-344 in Combination with Bevacizumab was Generally Well-tolerated with no Evidence of Overlapping Toxicity –

— ME-344 與貝伐珠單抗聯合使用總體耐受性良好,沒有重疊毒性的證據 —

– MEI to Continue Advancing ME-344 via Development of a New Formulation with the Potential to Increase Biological Activity, Patient Convenience and Commercial Opportunity –

— MEI 將通過開發一種有可能增加生物活性、患者便利性和商業機會的新配方繼續推進 ME-344 的發展 —

MEI Pharma, Inc. (NASDAQ:MEIP), a clinical-stage pharmaceutical company evaluating novel drug candidates to address known resistance mechanisms to standard-of-care cancer therapies, today reported that 25% of evaluable patients with relapsed metastatic colorectal cancer ("mCRC") in Cohort 1 of the ongoing Phase 1b study evaluating ME-344, an investigational inhibitor of mitochondrial oxidative phosphorylation ("OXPHOS"), in combination with bevacizumab (Avastin) had no disease progression at Week 16. This landmark analysis exceeded the 20% threshold set in the Clinical Study Protocol to add an additional 20 patients to the study via the initiation of Cohort 2. The combination was also observed to be generally well-tolerated to date. While the threshold was met to proceed to Cohort 2, it was separately reported today that following a strategic review, the Company decided to continue to advance ME-344 development via its ongoing development of a new formulation rather than through the addition of a new cohort. The Company believes this represents the optimal approach to leveraging the potential of the program. The Company has already initiated research and development activity of the new formulation with encouraging results, with the goal of increasing biological activity, improving convenience of administration and increasing commercial opportunity.

MEI Pharma, Inc.(納斯達克股票代碼:MEIP)是一家臨床階段的製藥公司,正在評估新的候選藥物,以解決標準護理癌症療法的已知耐藥機制。該公司今天報告稱,正在進行的線粒體氧化磷酸化抑制劑 ME-344(“OXC”)的1b期研究隊列中,有25%的復發轉移性結直腸癌(“mCRC”)患者中有25%可評估的復發轉移性結直腸癌(“mCRC”)患者 PHOS”)與貝伐珠單抗(阿瓦斯汀)聯合使用在第16周沒有疾病進展。這項具有里程碑意義的分析超過了臨床研究方案中設定的20%的閾值,即通過啓動隊列2將另外20名患者加入研究。迄今爲止,還觀察到該組合的耐受性普遍良好。儘管已達到進入第二隊列的門檻,但今天另有報道稱,經過戰略審查,該公司決定通過持續開發新配方,而不是通過增加新隊列來繼續推進 ME-344 的開發。該公司認爲,這是利用該計劃潛力的最佳方法。該公司已經啓動了新配方的研發活動,取得了令人鼓舞的成果,目標是提高生物活性,改善管理便利性並增加商業機會。

"The data reported today, including progression-free survival, overall survival, and safety results of the combination, represent an important development supporting the potential of ME-344 in combination with Avastin to induce synthetic lethality in tumors using a completely novel therapeutic strategy," said Richard Ghalie, chief medical officer of MEI Pharma. "The development of a new formulation with enhanced biologic activity is aimed at further improving patient outcomes and treatment convenience in a well-tolerated manner."

MEI Pharma首席醫學官理查德·加利說:“今天公佈的數據,包括該組合的無進展存活率、總存活率和安全性結果,代表了支持 ME-344 與阿瓦斯汀聯合使用一種全新的治療策略在腫瘤中誘發合成殺傷力的潛力。”“開發一種具有增強生物活性的新配方旨在以良好的耐受性進一步改善患者預後和治療便利性。”

"At MEI we are committed to our mission of developing novel drug candidates to address known resistance mechanisms to standard-of-care cancer therapies, and ME-344 holds significant potential as a novel therapeutic strategy to advance this mission," said David Urso, president and chief executive officer of MEI Pharma. "We believe that the best approach to optimize the potential of ME-344 for patients, prioritize resource utilization, and build value for shareholders, is to continue advancing the program via development of a new formulation of ME-344. In the short term, this plan will reduce expenditures on the ME-344 program and ultimately, if successful, create an improved formulation for continued clinical development."

MEI Pharma總裁兼首席執行官戴維·烏爾索表示:“在MEI,我們致力於履行我們的使命,即開發新的候選藥物,以解決標準護理癌症療法的已知耐藥機制,而 ME-344 作爲推進這一使命的新型治療策略具有巨大潛力。”“我們認爲,優化 ME-344 對患者的潛力、優先考慮資源利用併爲股東創造價值的最佳方法是通過開發 ME-344 的新配方繼續推進該計劃。在短期內,該計劃將減少 ME-344 計劃的支出,如果成功,最終將爲持續的臨床開發創造更好的配方。”

譯文內容由第三人軟體翻譯。


以上內容僅用作資訊或教育之目的,不構成與富途相關的任何投資建議。富途竭力但無法保證上述全部內容的真實性、準確性和原創性。
    搶先評論