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Positive Clinical Results From HyBryte Compatibility Study in the Treatment of Cutaneous T-Cell Lymphoma Published in JEADV Clinical Practice

Positive Clinical Results From HyBryte Compatibility Study in the Treatment of Cutaneous T-Cell Lymphoma Published in JEADV Clinical Practice

《JEADV 臨床實踐》上發表的治療皮膚 T 細胞淋巴瘤的 Hybryte 兼容性研究的積極臨床結果
Soligenix ·  05/16 12:00

Published Results Confirm and Extend Response Results from Phase 3 FLASH Study

已發佈的結果證實並擴展了第三階段 FLASH 研究的響應結果

PRINCETON, N.J., May 16, 2024 /PRNewswire/ -- Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that the results of its compatibility study evaluating HyBryte (synthetic hypericin) for the treatment of cutaneous T-cell lymphoma (CTCL) have been published in the Journal of the European Academy of Dermatology & Venereology (JEADV) Clinical Practice. The publication highlights the positive clinical results from study, HPN-CTCL-02, evaluating HyBryte in the treatment of CTCL.

新澤西州普林斯頓,2024 年 5 月 16 日/PRNewswire/--Soligenix, Inc.(納斯達克股票代碼:SNGX)(Soligenix或該公司)是一家後期生物製藥公司,專注於開發和商業化治療醫療需求未得到滿足的罕見疾病的產品。該公司今天宣佈,其評估Hybryte(合成金絲桃素)治療的兼容性研究結果 皮膚 T 細胞淋巴瘤 (CTCL) 一直是 發表在《歐洲皮膚病與性病學會雜誌》(JEADV)臨床實踐雜誌上。該出版物重點介紹了評估Hybryte在CTCL治療中的應用的研究 HPN-CTCL-02 的積極臨床結果。

The open-label study enrolled 9 patients to receive 8 weeks of HyBryte treatment of their cancerous lesions, with an assessment of treatment response conducted at week 10 using the modified Composite Assessment of Index Lesion Severity (mCAILS) score. The treatment response results of 22% following 8 weeks of twice weekly HyBryte therapy reinforces and confirms the results of the Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) trial published in the Journal of the American Medical Association (JAMA) Dermatology, despite the fact that patients in Study HPN-CTCL-02 were specifically selected to have more extensive disease consistent with its potential commercial use. Additionally, in this study all patients had improvements in their cumulative mCAILS score (average improvement of 36.4%, range 8 to 100%). Results in individual lesions showed that 7 of the 27 index lesions (25.9%) had at least a 50% improvement in their mCAILS score and 4 of the 27 index lesions (14.8%) were completely resolved after as little as 8 weeks of treatment. Other key evaluations included measurements of systemic exposure and electrocardiograms, which yielded extremely low and limited levels of systemic hypericin (plateau concentration of approximately 0.00013 μg/mL) detected in the blood and no observable impact to normal sinus rhythm, reinforcing the safety of HyBryte.

這項開放標籤研究招收了9名患者接受爲期8周的Hybryte癌變治療,並在第10周使用修改後的指數病變嚴重程度綜合評估(MCails)評分對治療反應進行了評估。在每週兩次的Hybryte治療8周後,治療反應的結果爲22%,這鞏固並證實了3期FLASH(熒光激活合成金絲桃素)試驗的結果 發表於 美國醫學會雜誌 (JAMA) 皮膚病學,儘管 HPN-CTCL-02 研究中的患者是專門選擇患有與其潛在商業用途相一致的更廣泛疾病的。此外,在這項研究中,所有患者的累積mCails分數都有所改善(平均改善36.4%,範圍在8%至100%之間)。個體病變的結果顯示,27個指數病變中有7個(25.9%)的mCails評分至少提高了50%,27個指數病變中有4個(14.8%)在短短8周的治療後完全消退。其他關鍵評估包括對全身暴露和心電圖的測量,在血液中檢測到的全身金絲桃素(高原濃度約爲0.00013 μg/mL)的水平極低且有限,對正常鼻竇心律沒有明顯影響,從而增強了Hybryte的安全性。

"Being able to share the important results of this clinical trial with the world through publication in JEADV is a privilege and highlights the clinical significance of our work with HyBryte," stated Brian Poligone, MD, PhD, Director of the Rochester Skin Lymphoma Medical Group, Fairport, NY, and Principal Investigator for the compatibility study and Leading Enrolling Investigator in the FLASH study. "I have seen firsthand the promise this therapy can offer patients and was happy to build upon our knowledge working with HyBryte in a clinical setting reflective of real-world use. The ease at which photodynamic therapy with HyBryte is conducted and the outstanding safety profile we continue to see as demonstrated by the systemic exposure and cardiac results reviewed in this paper makes me very excited for its potential future clinical use. I look forward to participating in the confirmatory Phase 3 FLASH2 study later this year."

紐約州費爾波特市羅切斯特皮膚淋巴瘤醫學小組主任、相容性研究首席研究員兼FLASH研究首席註冊研究員布萊恩·波利貢說:“能夠通過在JEADV上發表文章與世界分享這項臨床試驗的重要結果是一種榮幸,也凸顯了我們與Hybryte合作的臨床意義。”“我親眼目睹了這種療法可以爲患者帶來的希望,並很樂意在反映現實用途的臨床環境中與Hybryte合作的知識基礎上再接再厲。正如本文回顧的全身暴露和心臟結果所證明的那樣,使用Hybryte進行光動力療法的便捷性以及我們繼續看到的出色安全性使我對它未來的潛在臨床用途感到非常興奮。我很期待參加 確認性 3 期 FLASH2 研究 今年晚些時候。”

About JEADV

關於 JEADV

The Journal of the European Academy of Dermatology and Venereology (JEADV) is a peer reviewed journal that publishes articles of general and practical interest in the field of dermatology and venereology including clinical and basic science topics, as well as research with practical implications. It does so through editorials, review and practice articles, original papers of general interest, short reports, letters to the editor, features and EADV announcements. JEADV has an extensive international readership with over 2 million downloads every year.

《歐洲皮膚病與性病學會雜誌》(JEADV)是一本經過同行評審的期刊,發表皮膚病學和性病學領域具有普遍和實際意義的文章,包括臨床和基礎科學主題,以及具有實際意義的研究。它通過社論、評論和實踐文章、普遍感興趣的原創論文、簡短報告、給編輯的信、專題報道和EADV公告來做到這一點。JEADV 擁有廣泛的國際讀者群,每年下載量超過 200 萬次。

About HyBryte

關於 Hybryte

HyBryte (research name SGX301) is a novel, first-in-class, photodynamic therapy utilizing safe, visible light for activation. 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. The use of visible light in the red-yellow spectrum has the advantage of penetrating more deeply into the skin (much more so than ultraviolet light) and therefore potentially treating deeper skin disease and thicker plaques and lesions. This treatment approach avoids the risk of secondary malignancies (including melanoma) inherent with the frequently employed DNA-damaging drugs and other phototherapy that are dependent on ultraviolet exposure. Combined with photoactivation, hypericin has demonstrated significant anti-proliferative effects on activated normal human lymphoid cells and inhibited growth of malignant T-cells isolated from CTCL patients. In a published Phase 2 clinical study in CTCL, patients experienced a statistically significant (p=0.04) improvement with topical hypericin treatment whereas the placebo was ineffective. HyBryte has received orphan drug and fast track designations from the U.S. Food and Drug Administration (FDA), as well as orphan designation from the European Medicines Agency (EMA).

Hybryte(研究名稱:SGX301)是一種新穎的、同類首創的光動力療法,利用安全的可見光進行激活。Hybryte中的活性成分是合成金絲桃素,這是一種有效的光敏劑,局部應用於被惡性T細胞吸收的皮膚病變,然後在大約24小時後被安全的可見光激活。在紅黃光譜中使用可見光的優點是可以更深入地穿透皮膚(比紫外線更深),因此有可能治療更深的皮膚病和更厚的斑塊和病變。這種治療方法避免了經常使用的破壞DNA的藥物和其他依賴紫外線照射的光療所固有的繼發性惡性腫瘤(包括黑色素瘤)的風險。結合光活化,金絲桃素對活化的正常人淋巴細胞具有顯著的抗增殖作用,並抑制了從CTCL患者中分離出的惡性T細胞的生長。在CTCL發表的一項2期臨床研究中,患者在局部使用金絲桃素治療後出現了統計學上的顯著改善(p=0.04),而安慰劑無效。Hybryte已獲得美國食品藥品監督管理局(FDA)的孤兒藥和快速通道認定,以及歐洲藥品管理局(EMA)的孤兒藥認定。

The published Phase 3 FLASH trial enrolled a total of 169 patients (166 evaluable) with Stage IA, IB or IIA CTCL. The trial consisted of three treatment cycles. Treatments were administered twice weekly for the first 6 weeks and treatment response was determined at the end of the 8th week of each cycle. In the first double-blind treatment cycle (Cycle 1), 116 patients received HyBryte treatment (0.25% synthetic hypericin) and 50 received placebo treatment of their index lesions. A total of 16% of the patients receiving HyBryte achieved at least a 50% reduction in their lesions (graded using a standard measurement of dermatologic lesions, the CAILS score) compared to only 4% of patients in the placebo group at 8 weeks (p=0.04) during the first treatment cycle (primary endpoint). HyBryte treatment in this cycle was safe and well tolerated.

這個 已發佈第 3 階段 FLASH 試驗 共招收了 169 名 IA 期、IB 期或 IIA CTCL 期患者(166 名可評估)。該試驗包括三個治療週期。在前6周每週進行兩次治療,並在每個週期的第8周結束時確定治療反應。在第一個雙盲治療週期(週期1)中,116名患者接受了Hybryte治療(0.25%合成金絲桃素),50名患者接受了索引病變的安慰劑治療。在接受Hybryte治療的患者中,共有16%的患者病變減少了至少50%(使用皮膚病變的標準衡量標準,即CAILS評分進行分級),而在第一個治療週期(主要終點)的8周(p=0.04)時,安慰劑組的患者中這一比例僅爲4%(p=0.04)。在這個週期中,Hybryte治療是安全的,耐受性良好。

In the second open-label treatment cycle (Cycle 2), all patients received HyBryte treatment of their index lesions. Evaluation of 155 patients in this cycle (110 receiving 12 weeks of HyBryte treatment and 45 receiving 6 weeks of placebo treatment followed by 6 weeks of HyBryte treatment), demonstrated that the response rate among the 12-week treatment group was 40% (p

在第二個開放標籤治療週期(週期2)中,所有患者均接受了Hybryte的索引性病變治療。對該週期中的155名患者(110名接受12周的Hybryte治療,45名接受6周的安慰劑治療,然後接受6周的Hybryte治療)的評估表明,12周治療組的反應率爲40%(與週期1的安慰劑治療率相比,p

The third (optional) treatment cycle (Cycle 3) was focused on safety and all patients could elect to receive HyBryte treatment of all their lesions. Of note, 66% of patients elected to continue with this optional compassionate use / safety cycle of the study. Of the subset of patients that received HyBryte throughout all 3 cycles of treatment, 49% of them demonstrated a positive treatment response (p

第三個(可選)治療週期(週期3)側重於安全性,所有患者都可以選擇接受Hybryte治療所有病變。值得注意的是,66%的患者選擇繼續使用該研究的可選同情心使用/安全週期。在所有三個治療週期中接受HybryTE治療的患者中,有49%的患者表現出積極的治療反應(與在週期1中接受安慰劑的患者相比,p

Overall safety of HyBryte is a critical attribute of this treatment and was monitored throughout the three treatment cycles (Cycles 1, 2 and 3) and the 6-month follow-up period. HyBryte's mechanism of action is not associated with DNA damage, making it a safer alternative than currently available therapies, all of which are associated with significant and sometimes fatal, side effects. Predominantly these include the risk of melanoma and other malignancies, as well as the risk of significant skin damage and premature skin aging. Currently available treatments are only approved in the context of previous treatment failure with other modalities and there is no approved front-line therapy available. Within this landscape, treatment of CTCL is strongly motivated by the safety risk of each product. HyBryte potentially represents the safest available efficacious treatment for CTCL. With very limited systemic absorption, a compound that is not mutagenic and a light source that is not carcinogenic, there is no evidence to date of any potential safety issues.

Hybryte的整體安全性是這種治療的關鍵屬性,在三個治療週期(週期1、2和3)和6個月的隨訪期中都進行了監測。Hybryte的作用機制與DNA損傷無關,因此它是一種比目前可用的療法更安全的替代方案,所有這些療法都伴有嚴重的,有時甚至是致命的副作用。這些風險主要包括黑色素瘤和其他惡性腫瘤的風險,以及嚴重皮膚損傷和皮膚過早老化的風險。目前可用的治療只有在先前使用其他方式的治療失敗的情況下才能獲得批准,並且沒有經批准的一線療法可用。在這種格局中,每種產品的安全風險在很大程度上推動了對CTCL的治療。Hybryte可能是CTCL現有最安全、最有效的治療方法。由於全身吸收非常有限,該化合物不具有誘變性,光源不致癌,因此迄今沒有證據表明存在任何潛在的安全問題。

Following the first Phase 3 study of HyBryte for the treatment of CTCL, the FDA and the EMA indicated that they would require a second successful Phase 3 trial to support marketing approval. With agreement from the EMA on the key design components, the second, confirmatory study, called FLASH2, is expected to be initiated before the end of 2024. This study is a randomized, double-blind, placebo-controlled, multicenter study that will enroll approximately 80 subjects with early-stage CTCL. The FLASH2 study replicates the double-blind, placebo-controlled design used in the first successful Phase 3 FLASH study that consisted of three 6-week treatment cycles (18 weeks total), with the primary efficacy assessment occurring at the end of the initial 6-week double-blind, placebo-controlled treatment cycle (Cycle 1). However, this second study extends the double-blind, placebo-controlled assessment to 18 weeks of continuous treatment (no "between-Cycle" treatment breaks) with the primary endpoint assessment occurring at the end of the 18-week timepoint. In the first Phase 3 study, a treatment response of 49% (p

繼Hybryte治療CTCL的首項3期研究之後,美國食品藥品管理局和歐洲藥品管理局表示,他們需要第二次成功的3期試驗才能支持上市批准。隨着EMA就關鍵設計組成部分達成協議,第二項名爲 FLASH2 的確認性研究預計將在2024年底之前啓動。這項研究是一項隨機、雙盲、安慰劑對照的多中心研究,將招收大約80名早期CTCL的受試者。這個 FLASH2 研究 複製了首次成功的3期FLASH研究中使用的雙盲、安慰劑對照的設計,該研究包括三個6周的治療週期(總共18周),主要療效評估發生在最初的6周雙盲、安慰劑對照治療週期(週期1)結束時。但是,第二項研究將雙盲、安慰劑對照的評估延長至連續治療18周(沒有 “週期間” 治療中斷),主要終點評估發生在18周的時間點結束時。在第一項3期研究中,觀察到完成18周(3個週期)治療的患者的治療反應爲49%(與週期1中接受安慰劑的患者相比,p

In addition, the FDA awarded an Orphan Products Development grant to support the evaluation of HyBryte for expanded treatment in patients with early-stage CTCL, including in the home use setting. The grant, totaling $2.6 million over 4 years, was awarded to the University of Pennsylvania that was a leading enroller in the Phase 3 FLASH study.

此外,美國食品和藥物管理局還發放了孤兒產品開發補助金,以支持對Hybryte的評估,以擴大對早期CTCL患者的治療,包括在家庭使用環境中。這筆補助金在4年內總額爲260萬美元,發放給了賓夕法尼亞大學,該大學是第三階段FLASH研究的主要註冊者。

About Cutaneous T-Cell Lymphoma (CTCL)

關於皮膚 T 細胞淋巴瘤 (CTCL)

CTCL is a class of non-Hodgkin's lymphoma (NHL), a type of cancer of the white blood cells that are an integral part of the immune system. Unlike most NHLs which generally involve B-cell lymphocytes (involved in producing antibodies), CTCL is caused by an expansion of malignant T-cell lymphocytes (involved in cell-mediated immunity) normally programmed to migrate to the skin. These malignant cells migrate to the skin where they form various lesions, typically beginning as patches and may progress to raised plaques and tumors. Mortality is related to the stage of CTCL, with median survival generally ranging from about 12 years in the early stages to only 2.5 years when the disease has advanced. There is currently no cure for CTCL. Typically, CTCL lesions are treated and regress but usually return either in the same part of the body or in new areas.

CTCL 是一類非霍奇金淋巴瘤(NHL),一種白細胞癌,是免疫系統不可分割的一部分。與大多數通常涉及B細胞淋巴細胞(參與產生抗體)的NHL不同,CTCL是由惡性T細胞淋巴細胞(參與細胞介導免疫)的擴張引起的,通常編程爲遷移到皮膚。這些惡性細胞遷移到皮膚,形成各種病變,通常以斑塊的形式開始,並可能發展成凸起的斑塊和腫瘤。死亡率與CTCL的階段有關,中位存活率通常從早期的約12年到疾病進展後的2.5年不等。目前尚無治癒CTCL的方法。通常,CTCL 病變會得到治療並消退,但通常會在身體的同一部位或新的部位復發。

CTCL constitutes a rare group of NHLs, occurring in about 4% of the more than 1.7 million individuals living with the disease in the United States and Europe (European Union and United Kingdom). It is estimated, based upon review of historic published studies and reports and an interpolation of data on the incidence of CTCL that it affects approximately 31,000 individuals in the U.S. (based on SEER data, with approximately 3,200 new cases seen annually) and approximately 38,000 individuals in Europe (based on ECIS prevalence estimates, with approximately 3,800 new cases annually).

CTCL是罕見的NHL群體,在美國和歐洲(歐盟和英國)170多萬該病患者中,約有4%發生在CTCL中。根據對歷史上已發表的研究和報告的回顧以及對CTCL發病率數據的插值,據估計,CTCL影響美國約31,000人(基於SEER數據,每年出現約3,200例新發病例)和歐洲約38,000人(根據ECIS流行率估計,每年約有3,800例新發病例)。

About Soligenix

關於 Soligenix

Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. Our Specialized BioTherapeutics business segment is developing and moving toward potential commercialization of HyBryte (SGX301 or synthetic hypericin sodium) as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma (CTCL). With successful completion of the second Phase 3 study, regulatory approvals will be sought to support potential commercialization worldwide. Development programs in this business segment also include expansion of synthetic hypericin (SGX302) into psoriasis, our first-in-class innate defense regulator (IDR) technology, dusquetide (SGX942) for the treatment of inflammatory diseases, including oral mucositis in head and neck cancer, and (SGX945) in Behçet's Disease.

Soligenix是一家處於後期階段的生物製藥公司,專注於開發和商業化治療醫療需求未得到滿足的罕見疾病的產品。我們的專業生物療法業務部門正在開發Hybryte(SGX301 或合成金絲桃素鈉),這是一種利用安全可見光治療皮膚T細胞淋巴瘤(CTCL)的新型光動力療法,並朝着潛在的商業化方向發展。隨着第二階段3研究的成功完成,將尋求監管部門的批准,以支持全球潛在的商業化。該業務領域的開發項目還包括將合成金絲桃素(SGX302)擴展到牛皮癬、我們首創的先天防禦調節劑(IDR)技術、用於治療炎症性疾病(包括頭頸癌的口腔粘膜炎)的dusquetide(SGX942)以及白塞氏病的(SGX945)。

Our Public Health Solutions business segment includes development programs for RiVax, our ricin toxin vaccine candidate, as well as our vaccine programs targeting filoviruses (such as Marburg and Ebola) and CiVax, our vaccine candidate for the prevention of COVID-19 (caused by SARS-CoV-2). The development of our vaccine programs incorporates the use of our proprietary heat stabilization platform technology, known as ThermoVax. To date, this business segment has been supported with government grant and contract funding from the National Institute of Allergy and Infectious Diseases (NIAID), the Defense Threat Reduction Agency (DTRA) and the Biomedical Advanced Research and Development Authority (BARDA).

我們的公共衛生解決方案業務部門包括我們的蓖麻毒素候選疫苗RivaX的開發計劃,以及針對絲狀病毒(例如馬爾堡和埃博拉)和我們預防 COVID-19(由SARS-CoV-2引起)的候選疫苗CivaX的疫苗計劃。我們的疫苗計劃的開發採用了我們專有的熱穩定平台技術,即ThermoVax。迄今爲止,該業務部門得到了美國國家過敏和傳染病研究所(NIAID)、國防威脅減少局(DTRA)和生物醫學高級研究與發展局(BARDA)的政府撥款和合同資助。

For further information regarding Soligenix, Inc., please visit the Company's website at https://www.soligenix.com and follow us on LinkedIn and Twitter at @Soligenix_Inc.

有關 Soligenix, Inc. 的更多信息,請訪問該公司的網站 https://www.soligenix.com 然後關注我們 領英 還有推特在 @Soligenix_Inc

This press release may contain forward-looking statements that reflect Soligenix's current expectations about its future results, performance, prospects and opportunities, including but not limited to, potential market sizes, patient populations, clinical trial enrollment, the expected timing for closing the offering described herein and the intended use of proceeds therefrom. Statements that are not historical facts, such as "anticipates," "estimates," "believes," "hopes," "intends," "plans," "expects," "goal," "may," "suggest," "will," "potential," or similar expressions, are forward-looking statements. These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements, and include the expected amount and use of proceeds from the offering and the expected closing date of the offering. Soligenix cannot assure you that it will be able to successfully develop, achieve regulatory approval for or commercialize products based on its technologies, particularly in light of the significant uncertainty inherent in developing therapeutics and vaccines against bioterror threats, conducting preclinical and clinical trials of therapeutics and vaccines, obtaining regulatory approvals and manufacturing therapeutics and vaccines, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further funding to support product development and commercialization efforts, including grants and awards, maintain its existing grants which are subject to performance requirements, enter into any biodefense procurement contracts with the U.S. Government or other countries, that it will be able to compete with larger and better financed competitors in the biotechnology industry, that changes in health care practice, third party reimbursement limitations and Federal and/or state health care reform initiatives will not negatively affect its business, or that the U.S. Congress may not pass any legislation that would provide additional funding for the Project BioShield program. In addition, there can be no assurance as to the timing or success of any of its clinical/preclinical trials. Despite the statistically significant result achieved in the first HyBryte (SGX301) Phase 3 clinical trial for the treatment of cutaneous T-cell lymphoma, there can be no assurance that the second HyBryte (SGX301) Phase 3 clinical trial will be successful or that a marketing authorization from the FDA or EMA will be granted. Additionally, although the EMA has agreed to the key design components of the second HyBryte (SGX301) Phase 3 clinical trial, no assurance can be given that the Company will be able to modify the development path to adequately address the FDA's concerns or that the FDA will not require a longer duration comparative study. Notwithstanding the result in the first HyBryte (SGX301) Phase 3 clinical trial for the treatment of cutaneous T-cell lymphoma and the Phase 2a clinical trial of SGX302 for the treatment of psoriasis, there can be no assurance as to the timing or success of the clinical trials of SGX302 for the treatment of psoriasis. Further, there can be no assurance that RiVax will qualify for a biodefense Priority Review Voucher (PRV) or that the prior sales of PRVs will be indicative of any potential sales price for a PRV for RiVax. Also, no assurance can be provided that the Company will receive or continue to receive non-dilutive government funding from grants and contracts that have been or may be awarded or for which the Company will apply in the future. These and other risk factors are described from time to time in filings with the Securities and Exchange Commission (the "SEC"), including, but not limited to, Soligenix's reports on Forms 10-Q and 10-K. Unless required by law, Soligenix assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.

本新聞稿可能包含前瞻性陳述,這些陳述反映了Soligenix當前對其未來業績、業績、前景和機遇的預期,包括但不限於潛在的市場規模、患者群體、臨床試驗入組、本文所述的預計完成發行的時間以及由此產生的收益的預期用途。非歷史事實的陳述,例如 “預期”、“估計”、“相信”、“希望”、“打算”、“計劃”、“期望”、“目標”、“可能”、“建議”、“意願”、“潛力” 或類似表述,均爲前瞻性陳述。這些陳述受許多風險、不確定性和其他因素的影響,這些因素可能導致未來時期的實際事件或結果與這些聲明所表達或暗示的內容存在重大差異,包括髮行收益的預期金額和用途以及預期的發行截止日期。Soligenix無法向您保證,它將能夠成功開發基於其技術的產品,獲得監管部門的批准或商業化,特別是考慮到開發針對生物恐怖威脅的療法和疫苗、進行療法和疫苗的臨床前和臨床試驗、獲得監管部門批准以及生產療法和疫苗所固有的巨大不確定性,不會因爲臨床困難或延誤而減少或停止產品開發和商業化工作試驗或由於研發工作缺乏進展或未取得積極成果,它將能夠成功獲得任何進一步的資金來支持產品開發和商業化工作,包括補助金和獎勵,維持其受績效要求約束的現有補助金,與美國政府或其他國家簽訂任何生物防禦採購合同,能夠與生物技術行業中規模更大、資金更充足的競爭對手競爭,改變醫療保健實踐,第三黨派報銷限制和聯邦和/或州醫療改革舉措不會對其業務產生負面影響,也不會使美國國會通過任何爲BioShield項目提供額外資金的立法。此外,無法保證其任何臨床/臨床前試驗的時機或成功。儘管首項治療皮膚T細胞淋巴瘤的Hybryte(SGX301)3期臨床試驗取得了具有統計學意義的結果,但無法保證第二項Hybryte(SGX301)3期臨床試驗會成功,也無法保證美國食品藥品管理局或歐洲藥品管理局的上市許可將獲得批准。此外,儘管EMA已同意第二項Hybryte(SGX301)3期臨床試驗的關鍵設計組成部分,但無法保證該公司能夠修改開發路徑以充分解決FDA的擔憂,也無法保證FDA不需要更長時間的比較研究。儘管首項治療皮膚 T 細胞淋巴瘤的 HybryTE (SGX301) 3 期臨床試驗和 SGX302 治療牛皮癬的 2a 期臨床試驗取得了結果,但尚無法保證治療牛皮癬的 SGX302 臨床試驗的時機或成功與否。此外,無法保證RivaX是否有資格獲得生物防禦優先審查券(PRV),也無法保證PRV的先前銷售將表明RivaXPRV的任何潛在銷售價格。此外,無法保證公司將從已經或可能授予或將來將要申請的補助金和合同中獲得或繼續獲得非稀釋性的政府資助。向美國證券交易委員會(“SEC”)提交的文件中會不時描述這些和其他風險因素,包括但不限於Soligenix關於10-Q和10-K表的報告。除非法律要求,否則Soligenix不承擔因新信息或未來事件而更新或修改任何前瞻性陳述的義務。

SOURCE  SOLIGENIX, INC.

來源 SOLIGENIX, INC.

譯文內容由第三人軟體翻譯。


以上內容僅用作資訊或教育之目的,不構成與富途相關的任何投資建議。富途竭力但無法保證上述全部內容的真實性、準確性和原創性。
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