Theralase® Provides Update on Phase II Bladder Cancer Clinical Study
Theralase® Provides Update on Phase II Bladder Cancer Clinical Study
TORONTO, April 05, 2022 (GLOBE NEWSWIRE) -- Theralase® Technologies Inc. ("Theralase" or the "Company") (TSXV: TLT) (OTCQB: TLTFF), a clinical stage pharmaceutical company focused on the research and development of light activated Photo Dynamic Compounds ("PDC") 1 and their associated drug formulations, intended for the safe and effective destruction of various cancers, bacteria and viruses, has provided an update on the Phase II Non-Muscle Invasive Bladder Cancer ("NMIBC") Clinical Study ("Study II").
多倫多,2022年4月5日(環球通訊社)-Theralase®Technologies Inc.(“Theralase“或”公司") (TSXV:TLT) (OTCQB:TLTFF),一家臨牀階段的製藥公司,專注於光激活光動力化合物的研究和開發。PDC") 1以及它們的相關藥物配方,旨在安全和有效地摧毀各種癌症、細菌和病毒,提供了第二階段非肌肉浸潤性膀胱癌的最新情況。NMIBC“)臨牀研究(”研究報告II").
As previously announced, Theralase® successfully completed a Phase Ib NMIBC Clinical Study ("Study I"), which enrolled and provided the primary study treatment, at the therapeutic dose, for 3 patients. To date, Study II has enrolled and provided the primary study treatment for 35 patients, which when combined with the Study I data, leads to a total of 38 patients, who have received at a minimum, the primary study treatment.
正如之前宣佈的那樣,Theralase®成功完成NMIBC Ib期臨牀研究(“研究I到目前為止,研究二已經為35名患者登記並提供了主要研究治療,與研究一的數據結合起來,總共有38名患者至少接受了主要研究治療。
Study II Clinical Study Data:
研究II臨牀研究數據:
Assessment (Days) | Complete Response ("CR") 2 | Partial Response ("PR") 3 | Pending 4 | CR (Evaluable Patients) 5 | Total Responders (CR + PR) 6 | Potential Responders (CR + PR + Pending) 7 |
90 | 44.7% | 15.8% | 10.5% | 50.0% | 60.5% | 71.1% |
180 | 31.6% | 15.8% | 28.9% | 44.4% | 47.4% | 76.3% |
270 | 23.7% | 5.3% | 42.1% | 40.9% | 28.9% | 71.1% |
360 | 13.2% | 7.9% | 47.4% | 25.0% | 21.1% | 68.4% |
450 | 13.2% | 5.3% | 47.4% | 25.0% | 18.4% | 65.8% |
評估(天) | 完全回覆(“CR”)2 | 部分響應(PR)3 | 待定4 | CR(可評估患者)5 | 回覆總數(CR+PR)6 | 潛在響應者(CR+PR+待定)7 |
90 | 44.7% | 15.8% | 10.5% | 50.0% | 60.5% | 71.1% |
180 | 31.6% | 15.8% | 28.9% | 44.4% | 47.4% | 76.3% |
270 | 23.7% | 5.3% | 42.1% | 40.9% | 28.9% | 71.1% |
360 | 13.2% | 7.9% | 47.4% | 25.0% | 21.1% | 68.4% |
450 | 13.2% | 5.3% | 47.4% | 25.0% | 18.4% | 65.8% |
On July 30, 2020, the Company optimized the Study II treatment, specifically:
2020年7月30日,公司對研究II治療進行了優化,具體如下:
a) Bladder volume calculation for administration of the study drug and study device volume
b) Study device treatment time
A)用於給藥的膀胱體積計算和研究裝置體積
B)研究器械治療時間
The Study II optimized treatment patients, who received either an optimized primary study treatment or optimized maintenance study treatment consisted of: 23 patients at 90 days, 26 patients at 180 days and 27 patients at each of 270, 360 and 450 days.
研究II優化治療患者,他們接受優化的主要研究治療或優化的維持研究治療,包括:90天23例,180天26例,270、360和450天各27例。
Study II Clinical Study Data (Optimized: Post August 1, 2020):
研究II臨牀研究數據(優化:2020年8月1日後):
Assessment (Days) | Complete Response ("CR")2 | Partial Response ("PR")3 | Pending4 | CR (Evaluable Patients)5 | Total Responders (CR + PR)6 | Potential Responders (CR + PR + Pending)7 |
90 | 52.2% | 17.4% | 13.0% | 60.0% | 69.6% | 82.6% |
180 | 22.2% | 18.5% | 40.7% | 40.0% | 42.3% | 83.0% |
270 | 14.8% | 3.7% | 59.3% | 36.4% | 18.5% | 77.8% |
360 | 3.7% | 7.4% | 66.7% | 11.1% | 11.1% | 77.8% |
450 | 3.7% | 3.7% | 66.7% | 11.1% | 7.4% | 74.1% |
評估(天) | 完全回覆(“CR”)2 | 部分響應(PR)3 | 待定4 | CR(可評估患者)5 | 回覆總數(CR+PR)6 | 潛在響應者(CR+PR+待定)7 |
90 | 52.2% | 17.4% | 13.0% | 60.0% | 69.6% | 82.6% |
180 | 22.2% | 18.5% | 40.7% | 40.0% | 42.3% | 83.0% |
270 | 14.8% | 3.7% | 59.3% | 36.4% | 18.5% | 77.8% |
360 | 3.7% | 7.4% | 66.7% | 11.1% | 11.1% | 77.8% |
450 | 3.7% | 3.7% | 66.7% | 11.1% | 7.4% | 74.1% |
Note: The interim analyses presented above, should be read and interpreted with caution, as the reported clinical data is early in its presentation. Study II is presently ongoing and new clinical data collected may or may not continue to support the current reported trends.
注:以上提出的中期分析應謹慎閲讀和解釋,因為所報告的臨牀數據是在其呈現的早期。第二項研究目前正在進行中,收集的新臨牀數據可能會支持也可能不會繼續支持目前報道的趨勢。
Study II Objectives:
第二項研究的目標:
- Primary - Efficacy (defined by CR) at any point in time.
- Secondary - Duration of CR (defined by duration of CR lasting a minimum 360 days post-initial CR).
-
Tertiary - Safety measured by incidence and severity of Adverse Events ("AEs") grade 4 or higher that do not resolve within 450 days post primary study treatment. (Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Serious, Grade 4 = Life Threatening and Grade 5 = Death)
- 主要-任何時間點的功效(由CR定義)。
- 次要的-CR的持續時間(由初始CR後至少持續360天的CR的持續時間定義)。
-
三級-以不良事件的發生率和嚴重程度衡量安全(“俄歇電子能譜“)4級或以上,在初步研究治療後450天內仍未痊癒。(1級=輕度,2級=中度,3級=嚴重,4級=生命危險,5級=死亡)。
Performance to Objectives:
實現目標的績效:
Primary:
For 38 patients enrolled and treated in Study II:
44.7% achieved CR at 90 days, with 50% achieving CR with evaluable patients and a potential of 71.1%, if all PR and Pending patients achieved CR
主要:
在研究II中登記和治療的38名患者:
44.7%的患者在90天內達到CR,其中50%的患者在可評估的患者中實現CR,如果所有PR和待定患者都達到CR,則潛在的CR%為71.1%
For 23 patients enrolled and treated in Study II (who received an optimized primary study treatment):
52.2% achieved CR at 90 days, with 60% achieving CR with evaluable patients and a potential of 82.6%, if all PR and Pending patients achieved CR
對於在研究II中登記和治療的23名患者(他們接受了優化的主要研究治療):
52.2%的患者在90天內達到CR,其中60%的患者在可評估的患者中實現CR,如果所有PR和待定患者都達到CR,則潛在的CR%為82.6%
Secondary:
For 38 patients enrolled and treated in Study II:
13.2% achieved CR at 450 days, with 25% achieving CR with evaluable patients and a potential of 65.8%, if all PR and Pending patients achieved CR
次要:
在研究II中登記和治療的38名患者:
13.2%的患者在450天內達到CR,其中25%的患者在可評估的患者中實現CR,如果所有PR和待定患者都達到CR,則潛在的CR%為65.8%
For 27 patients enrolled and treated in Study II (who received an optimized primary or maintenance study treatment):
3.7% achieved CR at 450 days, with 11.1% achieving CR with evaluable patients and a potential of 74.1%, if all PR and Pending patients achieved CR
對於在研究II中登記和治療的27名患者(他們接受了優化的初級或維持研究治療):
3.7%的患者在450天內達到CR,其中11.1%的患者在可評估的患者中實現CR,如果所有PR和待定患者都達到CR,則潛在的CR%為74.1%
Tertiary:
For 38 patients enrolled and treated in Study II, there have been 7 Serious Adverse Events ("SAEs") reported:
第三級:
在研究II中登記和治療的38名患者中,有7個嚴重不良事件(SAE“)報道:
- 1 – Grade 2 (resolved within 1 day)
- 3 – Grade 3 (resolved within 5, 80 and 107 days, respectively)
- 2 – Grade 4 (resolved within 6 and 6 days, respectively)
- 1 – Grade 5 (not resolved))
- 1-2級(在1天內解決)
- 3-3級(分別在5天、80天和107天內解決)
- 2-4級(分別在6天和6天內解決)
- 1-5級(未解決)
Theralase® believes all SAEs reported to date are unrelated to the Study Drug or Study Device, subject to final review and confirmation by the independent Data Safety Monitoring Board ("DSMB").
Theralase®相信到目前為止報告的所有SAE與研究藥物或研究設備無關,有待獨立數據安全監測委員會的最終審查和確認(“數字用户線路板").
Conclusion:
結論:
Study II has delivered significant clinical results to date for the primary, secondary and tertiary objectives.
到目前為止,研究II已經為主要、第二和第三目標提供了重要的臨牀結果。
Dr. Vera Madzarevic, Ph.D., Director of Clinical Development and Quality Assurance at Theralase® stated, "From the 38 patients treated to date in Study II, those evaluable patients, have achieved 50.0% CR at 90 days and 25.0% have maintained this CR for at least 450 days, since primary study treatment. Additionally, total responders (CR +PR) at 90 days is 60.5% and 18.4% at 450 days; however, there is significant data still pending. This provides clinical support for achieving the primary and secondary objectives of Study II. The tertiary objective clinical data is promising, as only 7 SAEs were reported to date. Theralase® believes these 7 SAEs are unrelated to the Study Drug or Study Device. In conclusion, it is encouraging to see, from the preliminary clinical data that the Company has accumulated to date, that if the trends continue, then Theralase® is on track to achieving the primary, secondary and tertiary Study II objectives."
Vera Madzarevic博士,董事,Theralase臨牀開發和質量保證®述明,“從研究II中到目前為止接受治療的38名患者中,那些可評估的患者在90天內獲得了50.0%的CR,25.0%的患者自主要研究治療以來保持了至少450天的CR。此外,90天的總應答率(CR+PR)為60.5%,450天的總應答率為18.4%;然而,仍有大量數據懸而未決。這為實現研究II的主要和次要目標提供了臨牀支持。第三個目標的臨牀數據是有希望的,因為到目前為止只有7例SAE被報道。Theralase®認為這7種SAE與研究藥物或研究設備無關。總而言之,從該公司迄今積累的初步臨牀數據來看,令人鼓舞的是,如果這種趨勢繼續下去,那麼Theralase®正在按部就班地實現第二次研究的主要、第二和第三項目標。"
Dr. Arkady Mandel M.D. Ph.D. D.Sc., Interim Chief Executive Officer and Chief Scientific Officer, Theralase® stated, "I am encouraged by the clinical results to date, which demonstrate the potential to fill an unmet need for patients diagnosed with BCG-Unresponsive NMIBC. These patients are facing bladder removal and by delivering them a complete response with a durability lasting up to 15 months post primary study treatment, Theralase® is providing them an opportunity to retain their bladder and the quality of life associated with it."
Arkady Mandel博士,Theralase臨時首席執行官兼首席科學官®述明,“我對迄今為止的臨牀結果感到鼓舞,這些結果表明,卡介苗反應遲鈍的NMIBC患者有潛力滿足未得到滿足的需求。Theralase説,這些患者面臨着膀胱切除,在初次研究治療後,通過給予他們持續長達15個月的耐受性來實現完全緩解®為他們提供了保留膀胱和與之相關的生活質量的機會。"
Definitions:
定義:
1 PDCs are light sensitive molecules that are able to produce highly volatile singlet oxygen and Reactive Oxygen Species ("ROS"), that can induce inactivation of cancer cells, bacteria or viruses through oxidative stress, when activated by light at a particular wavelength.
1PDCs是一種光敏分子,能夠產生高度揮發性的單線態氧和活性氧物種(“ROS“),當被特定波長的光激活時,可通過氧化應激誘導癌細胞、細菌或病毒滅活。
2 Complete Response ("CR") is defined according to the FDA Guideline "BCG-Unresponsive Nonmuscle Invasive Bladder Cancer: Developing Drugs and Biologics for Treatment Guidance for Industry" (U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research ("CDER") Center for Biologics Evaluation and Research ("CBER") - February 2018):
2完整的答覆(“鉻“)是根據FDA的指南定義的”卡介苗無反應的非肌肉浸潤性膀胱癌:開發治療指導工業的藥物和生物製品“(美國衞生與公眾服務部食品和藥物管理局藥物評估和研究中心(”CDER“)生物製品評價與研究中心(”CBER“)-2018年2月):
"For single-arm trials of patients with BCG-Unresponsive disease using intravesical therapies without systemic toxicity, the FDA defines a Complete Response ("CR") as at least one of the following:
對於使用無全身毒性的BCG無反應性疾病患者進行的單臂試驗,FDA定義為完全應答(鉻“)至少作為下列之一:
- Negative cystoscopy and negative (including atypical) urine cytology
- Positive cystoscopy with biopsy-proven benign or low-grade NMIBC and negative cytology
- Negative cystoscopy with malignant urine cytology, if cancer is found in the upper tract or prostatic urethra and random bladder biopsies are negative"
- 膀胱鏡檢查陰性和尿細胞學檢查陰性(包括不典型)
- 膀胱鏡檢查陽性,活檢證實為良性或低度惡性NMIBC,細胞學檢查陰性
- 膀胱鏡檢查陰性與惡性尿液細胞學檢查,如果發現上尿路或前列腺尿道癌,隨機進行的膀胱活檢均為陰性。
3 Partial Response ("PR") is defined as patients who display either positive cystoscopy and negative urine cytology or negative cystoscopy and positive urine cytology during an assessment visit. According to the FDA guidance, patients participating in Study II, who are currently diagnosed as PR, may be re-classified as CR, if the cystoscopy is positive, low grade NMIBC is detected and the urine cytology is negative or if urine cytology is positive, cystoscopy is negative and upper tract or prostatic urethra urothelial cell carcinoma is detected.
3部分響應(“印刷機“)是指在評估訪問期間,膀胱鏡檢查陽性而尿細胞學檢查陰性或膀胱鏡檢查陰性而尿細胞學檢查陽性的患者。根據FDA的指導,參與研究II的患者如果目前被診斷為PR,可能會被重新分類為CR,如果膀胱鏡檢查呈陽性,則低級別NMIBC被檢測到,而尿細胞學檢查為陰性,如果尿細胞學檢查呈陽性,則膀胱鏡檢查呈陰性,而上尿路或前列腺尿路上皮細胞癌被發現。
4 Pending is defined as patients, who have not been assessed at a specific time point; hence, their clinical data is currently awaiting assessment.
4待定定義為尚未在特定時間點進行評估的患者;因此,他們的臨牀數據目前正在等待評估。
5 CR (Evaluable Patients) is defined as patients who have demonstrated CR with evaluable data; hence, excluding patients who have clinical data Pending.
5CR(可評估患者)被定義為具有可評估數據證明CR的患者;因此,不包括臨牀數據待定的患者。
6 Total Responders (CR + PR) is defined as patients who have demonstrated either a CR or PR.
6總應答者(CR+PR)被定義為已經表現為CR或PR的患者。
7 Potential Responders (CR + PR + Pending) is defined as patients who have demonstrated a CR, PR or have clinical data Pending.
7潛在應答者(CR+PR+Pending)被定義為已經表現為CR、PR或臨牀數據待定的患者。
About Study II
Study II utilizes the therapeutic dose of TLD-1433 (0.70 mg/cm2) activated by the proprietary TLC-3200 medical laser system. Study II is focused on enrolling and treating approximately 100 to 125 BCG-Unresponsive NMIBC Carcinoma In-Situ ("CIS") patients in up to 15 Clinical Study Sites ("CSS") located in Canada and the United States.
關於研究II
研究II使用治療劑量TLD-1433(0.70 mg/cm2)由專有的TLC-3200醫用激光系統激活。研究II的重點是招募和治療大約100至125例卡介苗無反應的NMIBC原位癌(順式“)多達15個臨牀研究站點的患者(”CSS“)位於加拿大和美國。
About TLD-1433
TLD-1433 is a patented PDC with over 10 years of published peer reviewed preclinical research and is currently under investigation in Study II.
關於TLD-1433
TLD-1433是一種獲得專利的PDC,已發表了10多年的同行評議的臨牀前研究,目前正在進行研究II。
About Theralase® Technologies Inc.
Theralase® is a clinical stage pharmaceutical company dedicated to the research and development of light activated compounds and their associated drug formulations with a primary objective of efficacy and a secondary objective of safety in the destruction of various cancers, bacteria and viruses.
關於Theralase®科技公司
Theralase®是一家臨牀階段的製藥公司,致力於光活性化合物及其相關藥物配方的研究和開發,主要目標是療效,次要目標是銷燬各種癌症、細菌和病毒的安全性。
Additional information is available at and
欲瞭解更多信息,請訪問和
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
多倫多證券交易所風險交易所及其監管服務提供商(該術語在多倫多證券交易所的政策中定義)均不對本新聞稿的充分性或準確性承擔責任。
Forward Looking Statements
前瞻性陳述
This news release contains "forward-looking statements" within the meaning of applicable Canadian securities laws. Such statements include, but are not limited to, statements regarding the Company's proposed development plans with respect to Photo Dynamic Compounds and their drug formulations. Forward looking statements may be identified by the use of the words "may, "should", "will", "anticipates", "believes", "plans", "expects", "estimate", "potential for" and similar expressions including statements related to the current expectations of Company's management for future research, development and commercialization of the Company's Photo Dynamic Compounds and their drug formulations, including preclinical research, clinical studies and regulatory approvals.
本新聞稿包含適用於加拿大證券法的“前瞻性陳述”。這些陳述包括但不限於關於該公司提出的有關動態光化合物及其藥物配方的開發計劃的陳述。前瞻性陳述可通過使用下列詞語來識別:“可能, "應該", "將要", "預期", "vbl.相信,相信", "平面圖", "期望", "估算", "潛在的以及類似的表述,包括與公司管理層目前對公司光動力化合物及其藥物配方的未來研究、開發和商業化的期望有關的陳述,包括臨牀前研究、臨牀研究和監管批准。
These statements involve significant risks, uncertainties and assumptions; including, the ability of the Company to: adequately fund, and secure the requisite regulatory approvals to successfully complete a Phase II NMIBC clinical study in a timely fashion and implement its development plans. Other risks include: the ability of the Company to successfully commercialize its drug formulations, the risk that access to sufficient capital to fund the Company's operations may not be available or may not be available on terms that are commercially favorable to the Company, the risk that the Company's drug formulations may not be effective against the diseases tested in its clinical studies, the risk that the Company's fails to comply with the term of license agreements with third parties and as a result loses the right to use key intellectual property in its business, the Company's ability to protect its intellectual property, the timing and success of submission, acceptance and approval of regulatory filings, and the impacts of public health crises, such as COVID-19. Many of these factors that will determine actual results are beyond the Company's ability to control or predict.
這些陳述涉及重大風險、不確定因素和假設,包括公司是否有能力:為及時成功完成NMIBC第二階段臨牀研究並實施其發展計劃提供充足資金,並獲得必要的監管批准。其他風險包括:公司成功地將其藥物配方商業化的能力,可能無法獲得或可能無法以對公司有利的商業條款獲得足夠資本為公司的運營提供資金的風險,公司的藥物配方可能對其臨牀研究中測試的疾病無效的風險,公司未能遵守與第三方的許可協議條款並因此失去在其業務中使用關鍵知識產權的權利的風險,公司保護其知識產權的能力,提交、接受和批准監管文件的時間和成功,以及公共衞生危機的影響,如新冠肺炎。其中許多將決定實際結果的因素超出了公司的控制或預測能力。
Readers should not unduly rely on these forward- looking statements which are not a guarantee of future performance. There can be no assurance that forward looking statements will prove to be accurate as such forward looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results or future events to differ materially from the forward-looking statements.
讀者不應過度依賴這些前瞻性陳述,因為它們不能保證未來的業績。不能保證前瞻性表述將被證明是準確的,因為此類前瞻性表述涉及已知和未知的風險、不確定性和其他因素,這些因素可能導致實際結果或未來事件與前瞻性表述大不相同。
Although the forward-looking statements contained in the press release are based upon what management currently believes to be reasonable assumptions, the Company cannot assure prospective investors that actual results, performance or achievements will be consistent with these forward-looking statements.
儘管新聞稿中包含的前瞻性陳述是基於管理層目前認為合理的假設,但公司不能向潛在投資者保證實際結果、業績或成就將與這些前瞻性陳述一致。
All forward-looking statements are made as of the date hereof and are subject to change. Except as required by law, the Company assumes no obligation to update such statements.
所有前瞻性陳述都是自本新聞稿發佈之日起作出的,可能會發生變化。除法律另有規定外,本公司不承擔更新此類聲明的義務。
For More Information:
有關詳細信息,請訪問:
1.866.THE.LASE (843.5273)
416.699.LASE (5273)
1.866.THE.LASE(843.5273)
416.699.LASE(5273)
Kristina Hachey, CPA
Chief Financial Officer
khachey@theralase.com
416.699.LASE (5273) x 224
克里斯蒂娜·哈奇,註冊會計師
首席財務官
郵箱:khaceh@theralase.com
416.699.LASE(5273)x 224
譯文內容由第三人軟體翻譯。