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Sapu BioScience and Cromos Pharma Initiating P201 – A Registrational Trial for OT-101 in Pancreatic Cancer

Sapu BioScience and Cromos Pharma Initiating P201 – A Registrational Trial for OT-101 in Pancreatic Cancer

Sapu BioScience 和 Cromos Pharma 正在啓動 P201 — 一項針對胰腺癌的 OT-101 註冊試驗
GlobeNewswire ·  2023/08/23 19:10

AGOURA HILLS, Calif., Aug.  23, 2023  (GLOBE NEWSWIRE) -- Oncotelic Therapeutics, Inc (OTCQB:OTLC) ("Oncotelic", the "Company" or "We" or "Our"), announced today its joint venture partner, GMP Biotechnology Limited's wholly owned subsidiary – Sapu Bioscience, LLC ("Sapu"), together with with Cromos Pharma, LLC ("Cromos"), a US-based international contract research organization ("CRO"), to conduct Sapu's registrational trial for OT-101 in Pancreatic Cancer.

環球通訊社加利福尼亞州阿古拉山2023年8月23日電Oncotelic Treateutics,Inc(OTCQB:OTLC)(以下簡稱“Oncotelic”,“公司”或“我們”)今天宣佈,其合資夥伴GMP Biotech Limited的全資子公司Sapu Bioscience,LLC(以下稱“Sapu”)與總部位於美國的國際合同研究組織(CRO)Cromos Pharma,LLC(“Cromos”)將共同進行Sapu針對OT-101治療胰腺癌的註冊試驗。

P201: A Randomized Phase 2b/Phase 3 Study of the TGF-β2 Targeting Antisense Oligonucleotide OT-101 in Combination with FOLFIRINOX Compared with FOLFIRINOX Alone in Patients with Advanced and Unresectable or Metastatic Pancreatic Cancer.

P201:一項針對反義寡核甘酸OT-101的轉化生長因數-β2聯合FOLFIRINOX與單用FOLFIRINOX治療晚期、不可切除或轉移性胰腺癌患者的2b/3期隨機研究。

The rates of pancreatic cancer are rising—and are rising faster among younger women, particularly Black women, than among men of the same age. Pancreatic cancer has the highest mortality rate of all major cancers, accounting for 3% of all cancer deaths in the U.S., and is more common among men than women. Addressing this urgent medical need, Oncotelic, through Sapu, is launching a registrational Phase 2b/Phase 3 trial with their TGF-β2 targeting therapy, OT-101 in combination with Standard of Care- (FOLFIRINOX) against pancreatic cancer. This is a multinational trial with sites across the USA, EU, and China involving up to 500 patients. Sapu has engaged Cromos Pharma, an international midsized CRO, to assist in the conduct of the trial. Leveraging Cromos Pharma's distinguished oncological expertise, this collaboration underscores the joint commitment to bring innovative treatments to cancer patients.

胰腺癌的發病率正在上升--在年輕女性中,尤其是黑人女性中,胰腺癌的發病率上升得比同齡男性更快。胰腺癌是所有主要癌症中死亡率最高的,佔美國所有癌症死亡人數的3%,男性比女性更常見。為了滿足這一緊迫的醫療需求,Oncotelic通過SAPU推出了一項註冊的2b期/3期試驗,他們的轉化生長因數-β2靶向療法OT-101與標準護理-(FOLFIRINOX)相結合,用於治療胰腺癌。這是一項跨國試驗,地點遍及美國、歐盟和中國,涉及多達500名患者。薩普已聘請國際中型CRO Cromos Pharma協助進行試驗。利用Cromos Pharma卓越的腫瘤學專業知識,這項合作強調了為癌症患者帶來創新治療的共同承諾。

Cromos Pharma's renowned proficiency in site selection, and its vast global network for patient enrollment, stands as an invaluable asset for this clinical trial venture. Handling complex trials with precision, Cromos Pharma's unparalleled expertise should ensure efficient, high-quality site choices and good global patient onboarding. For a trial of such magnitude and intricacy, Cromos Pharma's involvement is pivotal and will ensure streamlined operations and meticulous execution that can potentially hasten the time towards finding a solution for this devastating cancer.

Cromos Pharma在選址方面的著名熟練程度以及其龐大的全球患者登記網路,是這家臨床試驗企業的寶貴資產。通過精確地處理複雜的試驗,Cromos Pharma公司無與倫比的專業知識應該可以確保高效、高質量的地點選擇和良好的全球患者入選。對於如此大規模和錯綜複雜的試驗,Cromos Pharma的參與至關重要,並將確保簡化的操作和細緻的執行,這可能會加快找到這種毀滅性癌症的解決方案的時間。

"Over the past years we have been meticulously planning this trial to ensure its success. Spearheaded by our discovery that suppression of TGFβ2 could more than double survival in pancreatic cancer, we have engineered the trial to deliver a decisive win against pancreatic cancer. We look forward to engage physicians and patients in this critically important clinical trial," expressed Dr. Vuong Trieu, CEO of Sapu and Oncotelic.

Sapu和Oncotelic首席執行官Vuong Trieu博士表示:“在過去的幾年裡,我們一直在精心計劃這項試驗,以確保它的成功。在我們發現抑制轉化生長因數β2可以將胰腺癌的存活率提高一倍以上的情況下,我們設計了這項試驗,使其在對抗胰腺癌方面取得了決定性的勝利。我們期待著讓醫生和患者參與這項至關重要的臨床試驗。”

"It's truly an honor for Cromos to collaborate with Sapu and Oncotelic, visionaries within the oncology space. With over 20 years in the drug development cycle I have witnessed firsthand the monumental impact such partnerships can have on advancing medicine. Our expertise will ensure that this clinical trial's complexities are navigated with precision and efficiency. Together, we aim to break new ground to bring a new therapy to those affected by pancreatic cancer," said Dr. Vlad Bogin, MD, FACP, CEO & Founder of Cromos Pharma.

Cromos Pharma公司首席執行官兼創始人弗拉德·博金博士說:“與Sapu和Oncotelic這兩位腫瘤學領域的有遠見卓識的人合作,對Cromos公司來說真的是一種榮譽。在藥物開發週期中有20多年的經驗,我親眼目睹了這種夥伴關係對醫學進步的巨大影響。我們的專業知識將確保這項臨床試驗的複雜性得到精確和高效的處理。我們共同致力於開闢新的領域,為那些受胰腺癌影響的人帶來新的治療方法。”

About Cromos

關於克羅莫斯

Founded in 2004 and headquartered in the United States, Cromos Pharma is an international CRO. Cromos offers comprehensive clinical research solutions, covering all trial phases and a wide range of therapeutic areas. These areas include oncology, cardiovascular diseases, and gastroenterology. Over its almost 20-year journey, Cromos Pharma has successfully completed more than 300 clinical trials, demonstrating its commitment to excellence and precision. Its mission is to expedite the development of drugs and devices that save lives and enhance its quality. Cromos Pharma achieves this by combining innovation with validated best practices, reducing drug development time and costs while maintaining unparalleled quality standards. Cromos Pharma serves a diverse clientele, including Global Pharma, Biotechs, and other notable CROs. It has a strong operational presence across the US, Central and Eastern Europe, and Central and Southwestern Asia. Their country-specific operations cover Bulgaria, Croatia, Czech Republic, Estonia, Georgia, Hungary, Kazakhstan, Latvia, Lithuania, Moldova, Poland, Romania, Serbia, Slovak Republic, Slovenia, Türkiye, and Ukraine. For collaborations or inquiries, please contact them at inquiry@cromospharma.com.

Cromos Pharma成立於2004年,總部設在美國,是一家國際CRO。Cromos提供全面的臨床研究解決方案,涵蓋所有試驗階段和廣泛的治療領域。這些領域包括腫瘤學、心血管疾病和胃腸病。在近20年的歷程中,Cromos Pharma成功完成了300多項臨床試驗,證明瞭其對卓越和精確度的承諾。它的使命是加快藥物和設備的開發,以拯救生命並提高其質量。Cromos Pharma通過將創新與經過驗證的最佳實踐相結合來實現這一目標,在保持無與倫比的質量標準的同時減少藥物開發時間和成本。Cromos Pharma為不同的客戶提供服務,其中包括Global Pharma、生物技術公司和其他著名的CRO。它在美國、中歐和東歐以及中亞和西南亞都有強大的業務存在。他們的國別業務覆蓋保加利亞、克羅埃西亞共和國、捷克共和國、愛沙尼亞、喬治亞、匈牙利、哈薩克、拉脫維亞、立陶宛、莫耳爾多瓦、波蘭、羅馬尼亞、塞爾維亞、斯洛伐克、斯洛****亞、Türkiye和烏克蘭。如需合作或查詢,請發送電子郵件至Query@croere arma.com與他們聯繫。

About Oncotelic

關於Oncotelic

Oncotelic (f/k/a Mateon Therapeutics, Inc.), was formed in the State of New York in 1988 as OXiGENE, Inc., was reincorporated in the State of Delaware in 1992, and changed its name to Mateon Therapeutics, Inc. in 2016, and Oncotelic Therapeutics, Inc. in November 2020. Oncotelic is seeking to leverage its deep expertise in oncology drug development to improve treatment outcomes and survival of cancer patients with a special emphasis on rare pediatric cancers. Oncotelic has rare pediatric designation for Diffuse Intrinsic Pontine Glioma ("DIPG" through OT-101) through its 45% joint venture, GMP Biotechnology Limited, melanoma (through CA4P), and Acute Myeloid Leukemia ("AML" through OXi 4503). Oncotelic also acquired PointR Data Inc. in November 2019 to build an AI driven biotechnology company. Further, Oncotelic acquired AL-101, during the 4th quarter of 2021, for the intranasal delivery of apomorphine. We intend to develop AL-101 for the treatment of Parkinson Disease, erectile dysfunction, female sexual disorder and hypoactive sexual desire disorder. All these ailments have a very large population suffering from them and there is a need for treatments for each. For more information on AL-101, refer to our Annual Report on Form 10-K/A filed with the SEC on April 19, 2023.

Oncotelic(f/k/a Mateon Treateutics,Inc.)於1988年在紐約州成立,OxiGENE,Inc.於1992年在特拉華州重新註冊,2016年更名為Mateon Treateutics,Inc.,2020年11月更名為Oncotelic Treateutics,Inc.。Oncotelic正在尋求利用其在腫瘤學藥物開發方面的深厚專業知識來改善癌症患者的治療結果和存活率,特別強調罕見的兒科癌症。Oncotelic通過其持有45%股份的合資企業GMP Biotech Limited,罕見地被指定為彌漫性固有橋腦膠質瘤(DIPG至OT-101)、黑色素瘤(通過CA4P)和急性髓系白血病(AML至Oxi 4503)。Oncotelic還在2019年11月收購了PointR Data Inc.,以建立一家人工智慧驅動的生物技術公司。此外,Oncotelic在2021年第四季度收購了AL-101,用於阿樸嗎啡的鼻內給藥。我們打算開發AL-101用於治療帕金森病、勃起功能障礙、女性****和性慾減退障礙。所有這些疾病都有非常多的人患有這些疾病,需要對每一種疾病進行治療。有關AL-101的更多資訊,請參閱我們於2023年4月19日提交給美國證券交易委員會的Form 10-K/A年度報告。

Contact Information:

聯繫方式:

For Oncotelic Therapeutics, Inc.:
Investor Relations
ir@oncotelic.com

對於Oncotelic Treateutics公司:
投資者關係
郵箱:ir@oncotelic.com

譯文內容由第三人軟體翻譯。


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