Nano-Cap Theriva Biologics' Investigational Drug For Transplant-Related Complication Shows Safety In Bone Marrow Transplant Patients
Nano-Cap Theriva Biologics' Investigational Drug For Transplant-Related Complication Shows Safety In Bone Marrow Transplant Patients
As per data from Benzinga Pro, the stock is trading higher on a strong session volume of 18.61 million compared to an average volume of 671.35K.On Thursday, Theriva Biologics, Inc. (NYSE:TOVX) revealed the outcome of the Data and Safety Monitoring Committee (DSMC) review of results from the second cohort of its Phase 1b/2a trial of SYN-004 (ribaxamase) in allogeneic hematopoietic cell transplant (HCT) recipients to prevent acute graft-versus-host disease (aGVHD).
週四，Theriva Biologics, Inc.（紐交所:TOVX）公佈了第二隊列SYN-004（ribaxamase）在異基因造血幹細胞移植（HCT）受體中防止急性移植物抗宿主病（aGVHD）的1b/2a期試驗結果的數據和安全監測委員會（DSMC）審查結果。
Allogeneic hematopoietic cell transplant is a type of bone marrow transplant.
異基因造血幹細胞移植是一種骨髓移植的類型。
GVHD is a common complication when transplanted donor cells recognize the recipient's tissues as foreign and attack them.
GVHD是移植的供體細胞認爲受體組織爲異物並攻擊它們的常見併發症。
As per data from Benzinga Pro, the stock is trading higher on a strong session volume of 18.61 million compared to an average volume of 671.35K.
根據Benzinga Pro的數據，該股票的交易量爲1861萬，高於平均交易量的67.135萬。
The study is ongoing and remains blinded; however, key findings from blinded data for Cohort 2 are included below:
該研究正在進行中，並保持掩蓋狀態；然而，以下爲第2隊列的盲數據中的關鍵發現：
- Adverse events (AEs) and serious adverse events (SAEs) observed in cohort 2 were typical of those observed in allo-HCT patients, and no AEs or SAEs were related to the study drug treatment.A total of 15 SAEs were reported among ten patients, with the most common SAE being infections and infestations, including sepsis.
- No patients died within the 30-day follow-up period after the last dose of the study drug; one patient died 95 days and another 211 days after the last dose of the study drug due to cancer relapse and pneumonia, respectively (not related to the study drug).
- Consistent with the findings from Cohort 1 and previous studies of SYN-004 in healthy volunteers, no patient blood samples were positive for SYN-004 at any time point.
- The pharmacokinetics of piperacillin, which SYN-004 can metabolize, were as expected for this patient population.
- 隊列2觀察到的不良事件（AEs）和嚴重不良事件（SAEs）與異基因HCt患者中觀察到的典型情況相似，並且沒有任何與研究藥物治療有關的不良事件或嚴重不良事件。十名患者中報告了15起SAEs，其中最常見的SAE是感染和寄生蟲感染，包括敗血症。
- 在最後一次用藥後的30天跟蹤期內，沒有患者死亡；一名患者在最後一次用藥後95天死亡，另一名在用藥後211天死亡，分別由於癌症復發和肺炎（與研究藥物無關）。
- 與隊列1的發現和SYN-004在健康志願者中的先前研究一致，任何時間點的患者血樣均未檢測到SYN-004。
- SYN-004可以代謝哌拉西林的藥代動力學對這個病人群體來說符合預期。
Based on a review of the safety and pharmacokinetic data, the DSMC has recommended that the study proceed to enroll Cohort 3, in which SYN-004 or placebo will be administered in combination with the IV beta-lactam antibiotic cefepime.
根據安全性和藥代動力學數據的審查，DSMC建議研究繼續招募第3隊列，該隊列中將合併給予SYN-004或安慰劑與靜脈β-內酰胺類抗生素頭孢哌酮。
"These encouraging data support the clinical advancement of SYN-004 and build on the growing data that underscore its therapeutic potential. The first 2 cohorts have shown that active SYN-004 is not found in the blood of allo-HCT patients after repeated oral doses, in part alleviating the concern that SYN-004 might be absorbed in patients with poor intestinal barrier function and potentially interfere with IV antibiotics," said Steven Shallcross, CEO.
「這些鼓舞人心的數據支持SYN-004的臨床推進，並且基於逐漸增多的數據突顯其治療潛力。前兩隊列顯示，在反覆口服劑量後，活性的SYN-004並未在同種異基因造血幹細胞移植患者的血液中發現，部分緩解了SYN-004可能被吸收進入腸道屏障功能不良的患者並可能干擾靜脈抗生素的擔憂，」 CEO史蒂文·沙爾克羅斯表示。
Price Action: TOVX stock is up 33.30% at $1.65 at the last check on Thursday.
股價走勢：TOVX股票在週四最後交易時點上漲33.30%，報1.65美元。
- Medicare Drug Price Negotiation Program Gets Final Guidance For Second Cycle, $1.5B Savings Expected
- 醫保藥品價格談判項目獲得第二輪最終指導，預計可節省15億美元。
