Theriva™ Biologics 宣布 VIRAGE 臨床試驗的第二次獨立數據監測委員會會議結果積極
Theriva™ Biologics（NYSE American: TOVX）今天宣布，VIRAGE 的第二次獨立數據監測委員會（IDMC）會議顯示，VCN-01 與標準化療法（吉西他濱/納米白蛋白紫杉醇）聯合使用時，對於轉移性胰腺導管腺癌（PDAC）患者的耐受性良好，且不良事件（AE）的發生率與預期一致。
臨床數據顯示良好耐受性
IDMC 由胰腺癌及腫瘤病毒領域的專家組成，對來自美國五個中心和西班牙九個中心的 101 名患者的完整安全性數據進行了審查。VCN-01 的不良事件概況與之前的臨床試驗一致，最常見的與 VCN-01 相關的不良事件（如發燒、流感樣疾病、嘔吐、噁心及肝酶升高）都是暫時性和可逆的。在第二劑 VCN-01（於第 92 天施用）之後，這些不良事件的發生率明顯下降，且嚴重程度也有所減輕。IDMC 指出，VCN-01 治療組的不良事件類型和數量與胰腺癌患者的預期相符，並且符合治療的持續時間及腫瘤病毒的使用。VIRAGE 研究的患者招募已於 2024 年 9 月結束，預計初步臨床結果數據將於 2025 年第二季度公布。
未來展望
Theriva Biologics 首席執行官 Steven A. Shallcross 表示：「這次 IDMC 對 VCN-01 安全性數據的正面評估，進一步確認了對轉移性胰腺導管腺癌患者反覆施用 VCN-01 的可行性。我們現在正致力於在 2025 年第二季度公布初步臨床結果。如果結果積極，這些數據將與 FDA 和 EMA 之前的反饋結合，指導我們設計可能的三期登記試驗，並與監管機構進行討論。」
關於 VIRAGE 研究
VIRAGE 是一項針對新診斷的轉移性 PDAC 患者的 IIb 階段臨床試驗，該試驗為開放性、隨機對照、多中心設計。患者在美國五個中心和西班牙九個中心參加。無論是在對照組還是 VCNO-1 治療組，患者均接受標準化療法（吉西他濱/納米白蛋白紫杉醇），並在 28 天的循環中持續治療，直至病情惡化。在 VCNO-1 治療組中，患者在開始第一和第四個化療循環的七天前接受靜脈注射 VCN-01（分別在研究的第 1 天和第 92 天）。試驗的主要評估指標包括總生存期以及 VCN-01 的安全性和耐受性，其他評估指標則包括無進展生存期、客觀反應率及 VCN-01 的生物分佈、複製和免疫反應等數據。
關於 VCN-01
VCN-01 是一種腫瘤病毒，旨在選擇性且積極地在腫瘤細胞內複製，並破壞腫瘤基質的屏障，這種屏障對癌症治療構成重要的物理和免疫抑制障礙。這一獨特的作用機制使 VCN-01 能夠實現多重抗腫瘤效果，包括選擇性感染和裂解腫瘤細胞、改善化療藥物的滲透和灌注，以及提高腫瘤的免疫原性，從而使其暴露於患者的免疫系統和聯合免疫療法的藥物之下。VCN-01 已在多種癌症的臨床試驗中施用，涉及超過 142 名患者，包括 PDAC（與化療聯合使用）、頭頸部鱗狀細胞癌（與免疫檢查點抑制劑聯合使用）、卵巢癌（與 CAR-T 細胞療法聯合使用）、結直腸癌及視網膜母細胞瘤（通過玻璃體內注射）。
對 Theriva™ Biologics 的看法
Theriva™ Biologics 是一家專注於開發針對癌症及相關疾病的臨床階段公司，致力於解決重大醫療需求。該公司正在開發一種新的腫瘤病毒平台，旨在通過靜脈、玻璃體及腫瘤內給藥，觸發腫瘤細胞死亡，並促進患者免疫系統的持久抗腫瘤反應。除了 VCN-01，該公司的其他候選藥物包括 SYN-004 和 SYN-020，這些藥物均針對特定的臨床需求而設計。
這次的研究結果不僅展示了 VCN-01 的潛力，也反映了腫瘤病毒療法在癌症治療中的重要性。隨著臨床數據的積累，這些創新療法有望為患者帶來新的希望，特別是在治療難治性癌症方面。未來的研究將如何進一步推進這一領域，值得我們持續關注。
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"intro": "Create an ultra realistic 8K UHD DSLR photo based on the attached image as a reference of facial features, maintaining 100% likeness.",
"subject": {
"identity": "A stylish beautiful woman portrayed as Cleopatra performing a sacred night-time royal dance, embodying divine seduction, power, and celestial authority.",
"angle": "Full-body high-fashion editorial portrait captured at a cinematic 3/4 angle, ultra-crisp clarity with no blur.",
"pose": {
"body_position": "She is captured mid-dance inside a temple courtyard at night, her body angled gracefully, hips grounded, torso lifted, creating a powerful and sensual silhouette.",
"movement": "Her arms are raised in slow ceremonial motion while one leg steps forward, fully revealing her feet and lower legs as part of the ritual stance.",
"expression": "A calm, hypnotic, commanding gaze directed toward the camera—quiet dominance wrapped in sensual mystery."
}
},
"appearance": {
"outfit": "An ultra-bongga Cleopatra couture gown with an all-crystal bodice that fits like jeweled armor. Thousands of hand-set crystals, diamonds, and glass stones in gold, champagne, clear, and iridescent tones form sacred Egyptian motifs—cobras, sun disks, lotus symbols—entirely through crystal placement. The neckline is daring yet elegant, supported by invisible illusion mesh. From the waist, the skirt opens into flowing sheer silk and organza panels in ivory and soft gold, designed with a high front opening that intentionally exposes her legs and feet during movement. Crystal chains and beaded fringe sway rhythmically with every step, enhancing sensual motion.",
"accessories": "A dramatic Egyptian ceremonial headpiece with gold and crystal detailing, an oversized layered gold collar necklace, sculpted crystal arm cuffs, finger armor rings, a crystal-and-gold waist belt, and delicate gold anklets accentuating her bare feet.",
"hair": "Her hair is sleek, glossy, and perfectly controlled, styled to balance the weight of the crystal headpiece while allowing elegant movement.",
"makeup": "Ultra-glam, colorful Egyptian night makeup—bold elongated black kohl eyeliner, intense eyeshadow layered in turquoise, emerald, sapphire blue, violet, and metallic gold. Beneath the eyes, intricate ceremonial ink drawings in fine black and gold lines inspired by ancient Egyptian markings. Skin is luminous with molten-gold highlights, brows strong and defined, lips finished in a sensual nude-bronze satin."
},
"props": {
"ritual_elements": [
"Burning incense bowls releasing thick aromatic smoke",
"Golden sistrum placed near the dance space",
"Tall ceremonial torches lining the temple floor"
]
},
"background": {
"macro_environment": "A grand ancient Egyptian temple courtyard at night, reserved for sacred royal rituals.",
"midground_details": "Towering sandstone columns, massive statues of Isis and Hathor, carved temple walls, flowing linen drapes, and ceremonial platforms illuminated by firelight.",
"micro_elements": "Torch flames reflecting off crystal surfaces, fine dust particles glowing in the night air, incense smoke wrapping around her legs and feet, detailed stone floor textures beneath her bare feet, crystal fringe in motion, and sharply defined shadows—everything rendered in extreme detail with zero blur."
},
"lighting": {
"type": "Cinematic night lighting using torches, oil lamps, and subtle moonlight.",
"effect": "Firelight ignites the crystal bodice with prismatic sparkle while moonlight softly outlines her legs and feet, creating a dramatic, sensual, and divine atmosphere."
},
"camera": {
"camera_type": "DSLR",
"resolution": "8K UHD",
"lens": "50mm prime lens",
"aperture": "f/8 for full-body and environment sharpness",
"iso": 100,
"shutter_speed": "1/200s to freeze elegant motion clearly",
"focus": "Extreme sharp focus on crystal bodice, facial features, legs, feet, and temple details, no bokeh, no blur"
},
"style": "Ultra high-fashion editorial, night temple ritual, all-crystal couture, sexy yet sacred, ancient Egyptian royalty reimagined, cinematic realism, extremely detailed, sharp, iconic"
}](https://ssfuture.shop/wp-content/uploads/ai_gen_1766006158-167x300.png)
