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
拜欧德萨药品有限公司
Positive Phase 1 Clinical Data of MTX110 in DMG Brain Cancer Demonstrating Increased Survival Presented at ISPNO 2024
MTX110治疗DMG脑癌的一期临床数据呈现出生存率提高，已在ISPNO 2024上进行了介绍。
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(vs 10.0 Months in Historical Reference Cohort)
仅经过两次输注的优化剂量治疗，针对所有患者的中位整体生存期均为16.5个月。
(与历史参考队列的10.0个月相比)
（DATELINE）7月2日 - 生物德萨制药股份有限公司（"Biodexa"）（纳斯达克股票代码：BDRX）是一家收购为主的临床阶段生物制药公司，开发用于治疗存在未满足医疗需求的疾病的创新产品线。本公司宣布，MTX110用于弥漫性中线小胶质母细胞瘤（"DMG"）f / k / a弥漫性内在骨髓桥状胶质母细胞瘤或DIPG一个孤儿儿童脑癌的一项一期研究的数据于周末在费城的第21届儿科神经肿瘤国际研讨会（ISPNO 2024）上发布。
(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，该治疗对患者耐受良好。调查员评估出一个4级别的不良事件与药品无关，但与输注和肿瘤解剖有关。大多数其他不良事件与输注有关，被认为是2到3级别。
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.
虽然该研究获得的功效并不可靠，但中位无进展生存期（PFS）为10个月（范围为8到20个月），该研究中患者的总体生存率（OS）为16.5个月（范围从12到35个月）。这与316例中位OS的13个月（韦尔纳·贾森等人，2015年《神经肿瘤》17（1）：160-166）相比较优。
总体而言，患者对治疗的耐受性良好。调查人员评估有一起与药物无关但与输注和肿瘤解剖相关的4级不良事件。大多数其他不良事件与输注有关，被认为是2至3级。
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).
虽然该研究的功效没有得到可靠的证明，但中位无进展生存期(PFS)为10个月，范围为8至20个月，该研究患者的总体生存期(OS)为16.5个月，范围为12至35个月。这与316例中OS的中位数比较有利。(Jansen et al, 2015. Neuro-Oncology 17(1):160-166)。