Alpha Tau Submits To Japanese PMDA For Pre-Market Approval Of Alpha DaRT In Patients With Recurrent Head And Neck Cancer
Alpha Tau Submits To Japanese PMDA For Pre-Market Approval Of Alpha DaRT In Patients With Recurrent Head And Neck Cancer
Alpha Tau Medical Ltd. ("Alpha Tau") (NASDAQ:DRTS, DRTSW))))), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT, and HekaBio K.K. ("HekaBio") a Japan-based healthcare investment, development and commercialization platform which is partnered with Alpha Tau, announced today that Japan's Pharmaceuticals and Medical Devices Agency ("PMDA") has accepted Alpha Tau's submission requesting shonin pre-market approval of Alpha DaRT in patients with recurrent head & neck cancer, following multiple pre-submission consultation meetings with the PMDA per common practice in Japan. This submission is based upon Alpha DaRT's clinical trial results in Japan which exceeded the target endpoints for safety and efficacy in patients with recurrent head and neck cancer.
Alpha Tau Medical Ltd.（“Alpha Tau”）（納斯達克股票代碼：DRTS，DRTSW））），創新型α-放射癌症療法Alpha Dart的開發商，以及總部位於日本的醫療保健投資、開發和商業化平台HekaBio K.K.（“HekaBio”）今天宣佈，日本製藥和醫療器械管理局（“PMDA”）已接受Alpha Tau的合作提交請求 shonin 在日本與PMDA舉行了多次提交前諮詢會議之後，Alpha dArt在複發性頭頸癌患者中獲得了上市前批准。本次提交的依據是Alpha Dart在日本的臨床試驗結果，該結果超過了複發性頭頸癌患者的安全性和有效性的目標終點。
The head and neck cancer indication includes all solid tumor cancer types after prior radiation treatment, including squamous cell carcinoma, basal cell carcinoma, and melanoma. According to the most recent registry of the Japan Society of Head & Neck Cancer, there are more than 10,000 new cases of head and neck cancers in Japan each year. Alpha Tau and HekaBio are in advanced discussions with a number of large biopharmaceutical companies regarding a potential long-term commercial partnership in Japan for this and future indications.
頭頸部癌適應症包括先前接受放射治療後的所有實體瘤癌類型，包括鱗狀細胞癌、基底細胞癌和黑色素瘤。根據日本頭頸癌學會的最新登記資料，日本每年有超過10,000例新的頭頸癌病例。Alpha Tau和HekaBio正在與多家大型生物製藥公司就日本針對這一和未來適應症的潛在長期商業合作伙伴關係進行深入討論。
Uzi Sofer, CEO of Alpha Tau, noted, "We identified Japan as an important strategic market and initiated a local clinical trial early on in our clinical development, and we are excited that this trial has not only met but exceeded its endpoints. We are working on all necessary preparations ahead of potential approval and commercialization, while continually considering other indications for initiating clinical trial investigation in Japan based on the specific patient needs there."
Alpha Tau首席執行官Uzi Sofer指出：“我們將日本確定爲重要的戰略市場，並在臨床開發的早期就啓動了一項本地臨床試驗，我們很高興這項試驗不僅達到而且超過了終點。在潛在的批准和商業化之前，我們正在努力做好所有必要的準備工作，同時根據患者的特定需求，不斷考慮在日本啓動臨床試驗研究的其他適應症。”
Rob Claar, CEO of HekaBio, added, "I am pleased that following the successful completion of the clinical trial and collaborative consultations to date, the PMDA has accepted our submission. In light of the relatively high mortality rate and significant morbidities associated with existing treatments in head & neck cancer, we are excited about the potential to bring a new alternative to the Japanese market. We continue to work with Alpha Tau to find the best commercial partner for the Japanese market, in order to be prepared for launch as quickly as possible."
HekaBio首席執行官羅布·克拉爾補充說：“我很高興在迄今爲止成功完成臨床試驗和合作磋商之後，PMDA接受了我們的提交。鑑於與頭頸癌現有治療方法相關的死亡率相對較高，發病率高，我們對爲日本市場帶來新替代品的潛力感到興奮。我們將繼續與Alpha Tau合作，爲日本市場尋找最佳的商業合作伙伴，以便儘快爲上市做好準備。”