Biodexa Pharmaceuticals Reports Phase 1 Clinical Data Of MTX110 In DMG Brain Cancer Demonstrating Increased Survival Presented At ISPNO 2024
Biodexa Pharmaceuticals Reports Phase 1 Clinical Data Of MTX110 In DMG Brain Cancer Demonstrating Increased Survival Presented At ISPNO 2024
Biodexa Pharmaceuticals PLC
拜歐德薩藥品有限公司
Positive Phase 1 Clinical Data of MTX110 in DMG Brain Cancer Demonstrating Increased Survival Presented at ISPNO 2024
MTX110治療DMG腦癌的一期臨床數據呈現出生存率提高，已在ISPNO 2024上進行了介紹。
After Only Two Infusions and Two Patients at Optimal Dose,
Median Overall Survival Across all Patients was 16.5 Months
(vs 10.0 Months in Historical Reference Cohort)
僅經過兩次輸注的優化劑量治療，針對所有患者的中位整體生存期均爲16.5個月。
(與歷史參考隊列的10.0個月相比)
（DATELINE）7月2日 - 生物德薩製藥股份有限公司（"Biodexa"）（納斯達克股票代碼：BDRX）是一家收購爲主的臨床階段生物製藥公司，開發用於治療存在未滿足醫療需求的疾病的創新產品線。本公司宣佈，MTX110用於瀰漫性中線小膠質母細胞瘤（"DMG"）f / k / a瀰漫性內在骨髓橋狀膠質母細胞瘤或DIPG一個孤兒兒童腦癌的一項一期研究的數據於週末在費城的第21屆兒科神經腫瘤國際研討會（ISPNO 2024）上發佈。
(DATELINE) JULY 2 -- Biodexa Pharmaceuticals PLC ("Biodexa" or the "Company") (NASDAQ:BDRX), an acquisition-focused clinical stage biopharmaceutical company developing a pipeline of innovative products for the treatment of diseases with unmet medical needs, announces data from a Phase 1 study of MTX110 in Diffuse Midline Glioma ("DMG") f/k/a Diffuse Intrinsic Pontine Glioma, or DIPG, an orphan pediatric brain cancer were presented over the weekend at the 21st International Symposium on Pediatric Neuro-Oncology (ISPNO 2024) in Philadelphia, PA.
一期研究表明，該治療對患者耐受良好。調查員評估出一個4級別的不良事件與藥品無關，但與輸注和腫瘤解剖有關。大多數其他不良事件與輸注有關，被認爲是2到3級別。
Results of the Phase 1 study
Overall, the treatment was well tolerated by patients. There was one Grade 4 adverse event assessed by the investigators as unrelated to the drug but related to the infusion and tumor anatomy. Most other adverse events were related to infusion and were deemed Grade 2 to 3.
雖然該研究獲得的功效並不可靠，但中位無進展生存期（PFS）爲10個月（範圍爲8到20個月），該研究中患者的總體生存率（OS）爲16.5個月（範圍從12到35個月）。這與316例中位OS的13個月（韋爾納·賈森等人，2015年《神經腫瘤》17（1）：160-166）相比較優。
總體而言，患者對治療的耐受性良好。調查人員評估有一起與藥物無關但與輸注和腫瘤解剖相關的4級不良事件。大多數其他不良事件與輸注有關，被認爲是2至3級。
Although the study was not powered to reliably demonstrate efficacy, median progression free survival (PFS) was 10 months (range 8 to 20 months) and overall survival (OS) of patients in the study was 16.5 months (range 12 to 35 months). This compares favourably with median OS in a cohort of 316 cases of 10.0 months (Jansen et al, 2015. Neuro-Oncology 17(1):160-166).
雖然該研究的功效沒有得到可靠的證明，但中位無進展生存期(PFS)爲10個月，範圍爲8至20個月，該研究患者的總體生存期(OS)爲16.5個月，範圍爲12至35個月。這與316例中OS的中位數比較有利。(Jansen et al, 2015. Neuro-Oncology 17(1):160-166)。(Jansen等人，2015年。神經腫瘤學17（1）：160-166）。