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EXCLUSIVE: Soligenix's Cancer Candidate Shows Encouraging Action With Extended Treatment At One Year

EXCLUSIVE: Soligenix's Cancer Candidate Shows Encouraging Action With Extended Treatment At One Year

獨家消息:Soligenix的癌症候選藥物在一年期延長治療中顯示出令人鼓舞的效果
Benzinga ·  01/14 12:15

On Tuesday, Soligenix Inc. (NASDAQ:SNGX) announced an interim update on the open-label, investigator-initiated study (IIS) evaluating extended HyBryte (synthetic hypericin) treatment for up to 12 months in patients with early-stage cutaneous T-cell lymphoma (CTCL), a type of cancer that starts in the T-lymphocytes, a type of white blood cell that fights infection.

在週二,Soligenix, Inc. (納斯達克: SNGX) 公佈了關於開放標籤、研究者發起的研究 (IIS) 的臨時更新,該研究評估了對早期皮膚 T 細胞淋巴瘤 (CTCL) 患者進行長達 12 個月的 HyBryte(合成高超靜)治療的效果,這是一種始於 T 淋巴細胞的癌症,一種抗擊感染的白血球。

Cutaneous T-cell lymphoma is a group of rare blood cancers that affects the skin.

皮膚 T 細胞淋巴瘤是一組影響皮膚的罕見血癌。

Nine patients have been enrolled and treated with HyBryte over up to 54 weeks.

已有九名患者被招募並接受了長達 54 周的 HyBryte 治療。

Also Read: Soligenix Kickstarts Dusquetide Mid-Stage Study For Patients With Inflamed Blood Vessels

另請閱讀:Soligenix啓動Dusquetide中期研究,針對有炎症的血管患者

Patients have responded positively to HyBryte therapy, with over 70% (5 of the 6 subjects who have completed at least 18 weeks of therapy) already achieving "Treatment Success."

患者對 HyBryte 治療反應積極,在完成至少 18 周治療的 6 名受試者中,有超過 70%(5 名)已經實現了 "治療成功"。

Treatment Success is predefined in the study's protocol as a greater than or equal to 50% improvement in the cumulative mCAILS (modified Composite Assessment of Index Lesion Severity) score compared to the baseline.

在研究協議中,治療成功被預定義爲與基線相比,累積的 mCAILS(修訂版綜合評估指徵病變嚴重性)得分提高了大於或等於 50%。

Three of the five Treatment Successes were achieved within the first 12 weeks of treatment, with two patients achieving a "complete response" by 18 weeks.

在治療的頭 12 周內,五個治療成功中的三個達成,其中兩名患者在 18 周內實現了 "完全緩解"。

Of the remaining patients, two have recently started the study, and two had to drop out for logistical reasons. One showed a substantial improvement (>30%) by their Week 18 visit. In addition, HyBryte appears to be safe and well-tolerated in all patients.

在剩餘患者中,兩人最近開始了研究,另外兩人因後勤原因退出。一名患者在第 18 周的檢查中顯示出顯著改善(>30%)。此外,HyBryte 在所有患者中似乎是安全且耐受良好的。

In December, Soligenix announced that patient enrollment had opened for its confirmatory Phase 3 study evaluating HyBryte (synthetic hypericin) for CTCL.

在12月,Soligenix宣佈已開始患者招募,進行其確認性第三階段研究,評估HyBryte(合成的高倍色素)用於CTCL。

The confirmatory Phase 3 study, FLASH2, builds on the previous statistically significant Phase 3 (FLASH) study, as well as a recent comparative study (HPN-CTCL-04) and an ongoing investigator-initiated study, each further supporting the design of the FLASH2 clinical trial.

確認性III期研究FLASH2建立在之前統計顯著的III期(FLASH)研究以及最近的比較研究(HPN-CTCL-04)和正在進行的研究者發起的研究之上,進一步支持FLASH2臨牀試驗的設計。

The active ingredient in HyBryte is synthetic hypericin, a potent photosensitizer that is topically applied to skin lesions that is taken up by the malignant T-cells, and then activated by safe, visible light approximately 24 hours later.

HyBryte的活性成分是合成的高倍色素,這是一種強效的光敏劑,局部應用於皮膚病變,被惡性T細胞吸收,然後在大約24小時後由安全的可見光激活。

Price Action: SNGX stock closed at $3.13 on Monday.

價格動態:SNGX股票週一收盤價爲3.13美元。

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譯文內容由第三人軟體翻譯。


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