EXCLUSIVE: Oragenics' Concussion Drug Clears FDA-Required Cardiotoxicity Testing, Planning For Phase Trials Underway
EXCLUSIVE: Oragenics' Concussion Drug Clears FDA-Required Cardiotoxicity Testing, Planning For Phase Trials Underway
Oragenics conducted hERG ion channel studies on ONP-002 under Good Laboratory Practices (GLP) with On Thursday, Oragenics Inc. (NYSE:OGEN) announced that its lead candidate for treating concussion completed a study that indicates ONP-002 does not cause cardiotoxicity.
週四，Oragenics公司（NYSE：OGEN）宣佈，其治療腦震盪的主要候選藥物已完成一項研究，表明ONP-002不會導致心臟毒性。
ONP-002 is a new chemical entity (NCE) designed to target the brain by being delivered into the nasal cavity and then onward to the brain.
ONP-002是一種新的化學實體（NCE），旨在通過被輸送到鼻腔然後向大腦進發來瞄準大腦。
Before conducting a clinical trial, the FDA requires pharmaceuticals to be tested on cardiac receptors to ensure that they do not show any causes of electrical malformations.
在進行臨床試驗之前，FDA要求必須對心臟受體進行藥物測試，以確保不會出現任何電生理畸形。
Oragenics conducted hERG ion channel studies on ONP-002 under Good Laboratory Practices (GLP) with Charles River Laboratories (NYSE:CRL).
Oragenics公司在好實驗室規範（GLP）下與查爾斯·裏維實驗室（NYSE：CRL）進行了對ONP-002的hERG離子通道研究。
Like previous non-GLP hERG studies, inhibitory concentrations were greater than 10 micromolar.
與以前的非GLP hERG研究一樣，抑制濃度大於10微摩爾。
Based on Phase 1 ONP-002 clinical trial dosing and subsequent blood plasma concentrations, ONP-002 is expected to have a large cardiac safety margin, suggesting that ONP-002 treatment for concussion will not cause cardiac arrhythmia (irregular heartbeat).
基於1期ONP-002臨床試驗劑量和隨後的血漿濃度，預計ONP-002將具有較大的心臟安全餘量，表明ONP-002治療腦震盪不會引起心律失常（不規則心跳）。
Concussion, a mild traumatic brain injury that affects brain function, is a significant unmet medical need, with an estimated 69 million cases reported annually worldwide.
腦震盪是一種影響腦功能的輕度創傷性腦損傷，是一個重大的未滿足醫療需求，全球每年有大約6900萬例報告。
Common causes of concussions include falls, motor vehicle accidents, and contact sports.
引起腦震盪的常見原因包括跌倒、機動車事故和接觸性運動。
According to the CDC, the total annual healthcare cost for nonfatal traumatic brain injuries (TBIs) exceeds $40.6 billion.
根據疾控中心（CDC），非致命性創傷性腦損傷（TBI）的總年度醫療保健成本超過406億元。
Additionally, post-concussion symptoms, which can occur in up to 20% of affected individuals, are linked to long-term disability.
此外，長達20%的腦震盪後症狀與長期殘疾有關。
In July, the company said that a Phase 2 study in concussed patients is being planned to assess safety and feasibility while analyzing ONP-002's effectiveness based on patient blood biomarker profiles and functional outcomes.
今年7月，該公司表示正在計劃一項第2階段的腦震盪患者研究，以評估安全性和可行性，同時通過分析患者的血液生物標誌物和功能結果來分析ONP-002的有效性。
In June, Oragenics completed a prototype of its automated intranasal device for use in concussed patients who are initially confused, dazed, or unconscious in the acute phase of injury.
今年6月，Oragenics公司完成了其自動化鼻內裝置的原型開發，用於在傷勢急性期間最初處於困惑、發呆或昏迷狀態的腦震盪患者治療。
Price Action: OGEN stock was trading higher by 4.50% at $1.01 premarket at the last check on Thursday.
股票價格：週四上午最後一次查詢時，OGEN股票以1.01美元的漲幅上漲了4.50%。
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