An investigator-initiated, comparative, two-arm, randomized, open-labelled, single centre study to evaluate the safety, tolerability and efficacy of oral insulin twice daily and oral insulin once daily along with metformin 500 mg in subjects with type 2 diabetes mellitus (dm) who are currently on insulin. - Nil

开始日期2024-09-17

申办/合作机构-

NCT00948493 / No longer availableN/A

An Open-Label Treatment Investigational New Drug (IND) for the Use of Generex Oral-lyn™ in Patients With Type 1 or Type 2 Diabetes Mellitus

The objective of this Treatment IND protocol is to provide Generex Oral-lyn™ to patients with serious or life-threatening Type 1 or Type 2 diabetes mellitus, with no satisfactory alternative therapy available for treatment of diabetes, and who are not eligible to participate in the ongoing pivotal clinical trial (Protocol GEN-084-OL). This protocol is intended as a substitute for the Single Patient IND mechanism to obtain Generex Oral-lyn™.

开始日期-

申办/合作机构

Generex Biotechnology Corp.

100 项与 Oral insulin(Generex Biotechnology Corp.) 相关的临床结果

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100 项与 Oral insulin(Generex Biotechnology Corp.) 相关的转化医学

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100 项与 Oral insulin(Generex Biotechnology Corp.) 相关的专利（医药）

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项与 Oral insulin(Generex Biotechnology Corp.) 相关的文献（医药）

2024-08-01·Inflammation

RP105 Attenuates Ischemia/Reperfusion-Induced Oxidative Stress in the Myocardium via Activation of the Lyn/Syk/STAT3 Signaling Pathway

Article

作者: Liu, Haiyin ; Yang, Jun ; Liu, Li ; Zhai, Yuhong ; Wu, Jingyi ; Huang, Cuiyuan ; Wang, Wei ; Yang, Jian ; Li, Wenqiang ; Xiang, Zujin ; Huang, Yifan ; Zhang, Jing

Although our previous studies have established the crucial role of RP105 in myocardial ischemia/reperfusion injury (MI/RI), its involvement in regulating oxidative stress induced by MI/RI remains unclear. To investigate this, we conducted experiments using a rat model of ischemia/reperfusion (I/R) injury. Adenovirus carrying RP105 was injected apically at multiple points, and after 72 h, the left anterior descending coronary artery was ligated for 30 min followed by 2 h of reperfusion. In vitro experiments were performed on H9C2 cells, which were transfected with recombinant adenoviral vectors for 48 h, subjected to 4 h of hypoxia, and then reoxygenated for 2 h. We measured oxidative stress markers, including superoxide dismutase (SOD) and glutathione peroxidase (GSH-Px) activities, as well as malondialdehyde (MDA) concentration, using a microplate reader. The fluorescence intensity of reactive oxygen species (ROS) in myocardial tissue was measured using a DHE probe. We also investigated the upstream and downstream components of the signal transducer and activator of transcription 3 (STAT3). Upregulation of RP105 increased SOD and GSH-Px activities, reduced MDA concentration, and inhibited ROS production in response to I/R injury in vivo and hypoxia reoxygenation (H/R) stimulation in vitro. The overexpression of RP105 led to a decrease in the myocardial enzyme LDH in serum and cell culture supernatant, as well as a reduction in infarct size. Additionally, left ventricular fraction (LVEF) and fractional shortening (LVFS) were improved in the RP105 overexpression group compared to the control. Upregulation of RP105 promoted the expression of Lyn and Syk and further activated STAT phosphorylation, which was blocked by PP2 (a Lyn inhibitor). Our findings suggest that RP105 can inhibit MI/RI-induced oxidative stress by activating STAT3 via the Lyn/Syk signaling pathway.

2024-07-01·iScience

Decoding sunitinib resistance in ccRCC: Metabolic-reprogramming-induced ABAT and GABAergic system shifts

Article

作者: Ding, Lei ; Li, Jie ; Tang, Zhentao ; Zhang, Qian ; Zhang, Shaobo ; Zang, Pan ; Qian, Jian ; Liang, Chao ; Guo, Zhisheng ; Shao, Pengfei ; Zhai, Qidi ; Han, Peng ; Li, Yibo ; Yan, Ye ; Li, Pu ; Ni, Chenbo

Sunitinib, a primary treatment for clear cell renal cell carcinoma (ccRCC), frequently encounters the challenge of resistance development. Metabolic reprogramming, a characteristic change in ccRCC, is likely linked to this resistance. Our research revealed a notable decrease in the expression of the key metabolic gene ABAT in ccRCC, which contributed to diminished sensitivity to sunitinib. Downregulation of ABAT led to an increase in the intracellular level of gamma-aminobutyric acid (GABA), triggering abnormal activation of the G-protein-coupled receptor GABA-B. This activation resulted in increased transactivation of the tyrosine kinase receptors SYK and LYN, thereby reducing the antitumor and antiangiogenic properties of sunitinib. However, the application of SYK and LYN inhibitors successfully inhibited this effect. The transactivation of SYK and LYN caused resistance to the antiangiogenic effects of sunitinib through the upregulation of PGF protein levels. Furthermore, the combined application of an LYN inhibitor with sunitinib has been shown to enhance therapeutic efficacy.

2024-01-03·European journal of endocrinology

Breast cancer risk association with postmenopausal hormone therapy: Health Insurance Database in South Korea–based cohort study

Article

作者: Kim, Taeran ; Cho, Hyunjin ; Yuk, Jin-Sung ; Gwak, Geumhee

Abstract:

Context:

Although many physicians have been concerned that the menopausal hormones used currently in clinical practice may affect the risk of breast cancer, there are currently few informative updated studies about the associations between menopausal hormone therapy (MHT) and the risk of breast cancer.

Objective:

This study aims to evaluate the association between the risk of breast cancer and MHT using the National Health Insurance Database in South Korea (HISK) cohort between 2002 and 2019 retrospectively.

Methods:

Postmenopausal women over 40 years of age from 2003 to 2011 were selected as the subject population, and their follow-up data were collected until 2019. We analyzed the risk and mortality of breast cancer according to the type of MHT received, namely, tibolone, combined estrogen plus progestin by manufacturer (CEPM), oral estrogen, combined estrogen plus progestin by physician (CEPP), or topical estrogen.

Results:

The risk of breast cancer increased in the CEPM group [hazard ratio (HR) 1.439, 95% CI 1.374-1.507, P-value < .001] in comparison with the non-MHT group. However, no significant associations were found between the use of tibolone, oral estrogen, CEPP, or topical estrogen and breast cancer risk in comparison with the non-MHT group (HR 0.968, 95% CI 0.925-1.012; HR 1.002, 95% CI 0.929-1.081; HR 0.929, 95% CI 0.75-1.15; HR 1.139, 95% CI 0.809-1.603). The mortality rate from breast cancer is lower in the MHT group in comparison with the non-MHT group, indicating that significant associations were found for tibolone, CEPM, and oral estrogen (HR 0.504, 95% CI 0.432-0.588; HR 0.429, 95% CI 0.352-0.522; HR 0.453 95% CI 0.349-0.588, P-value < .001).

Conclusions:

This study suggests that the risk of breast cancer is increased by drugs in the CEPM group but not by tibolone, oral estrogen, CEPP, or topical estrogen. The mortality rate from breast cancer is lower with MHT (tibolone, CEPM, oral estrogen) than without MHT.

项与 Oral insulin(Generex Biotechnology Corp.) 相关的新闻（医药）

2024-06-26

·BioSpace

Oramed Letter to Shareholders - June 26, 2024

Stock Repurchase Program Scilex Senior Secured Note Phase 3 Oral Insulin Trial in US JV with Chinese Partner, HTIT NEW YORK, June 26, 2024 /PRNewswire/ -- Oramed Pharmaceuticals Inc. (Nasdaq: ORMP) (TASE: ORMP) ("Oramed") ( ), a clinical-stage pharmaceutical company focused on the development of oral drug delivery platforms, today issued a Letter to Shareholders from its Chief Executive Officer, Nadav Kidron. Dear Shareholders, In light of our recent announcement regarding Oramed's $20 million stock repurchase program, we believe this is an opportune moment to provide our shareholders with a comprehensive update on our activities and progress. As this development demonstrates our confidence in Oramed's value and potential, we felt it was important to contextualize this decision within the broader landscape of our ongoing initiatives and future plans. This letter serves to offer you insights into our current position, strategic direction, and the exciting opportunities that lie ahead for Oramed. We remain committed to transparent communication and are pleased to share this overview with you. Scilex Senior Secured Note The repayment schedule from Scilex Holding Company for its Senior Secured Note commenced on December 21, 2023, with fixed installments due quarterly. As of today, Oramed has received $40 million out of the total $102 million principal (excluding interest and exit fees). This represents a significant portion of the expected returns from this strategic investment. The next milestone in this repayment plan is a $20 million installment, scheduled for September of this year. Phase 3 Oral Insulin Program Oramed has proactively engaged in constructive dialogue with the U.S. Food and Drug Administration regarding a new Phase 3 protocol. This refined approach is strategically focused on specific patient subgroups identified as significant responders through comprehensive analysis of both Phase 2 and Phase 3 data. By leveraging these insights, we aim to optimize the potential for success in our potential upcoming trial. This adaptive strategy underscores our commitment to advancing oral insulin therapy and potentially addressing a critical unmet need in diabetes management. Oramed-HTIT Joint Venture Update Oramed and its long-term partner, Hefei Tianhui Biotech Co., Ltd. (HTIT), are finalizing the formation of a joint venture (JV) centered around Oramed's cutting-edge oral drug delivery technology. The U.S.-based JV will focus on developing, marketing, and commercializing innovative products from Oramed's oral insulin and POD™ (Protein Oral Delivery) pipeline, leveraging HTIT's advanced manufacturing capabilities. The JV will receive a significant capital infusion, with HTIT committing $70 million in cash and Oramed investing $25 million in cash and stock. These funds are strategically allocated to support the successful completion of the Phase 3 trial in the U.S., along with other crucial clinical and business activities. Furthermore, we are exploring strategies with HTIT to capitalize on their production capabilities and the expected launch of oral insulin sales. While synergies exist, the proposed transactions are complex, and there is no certainty that we will be able to close on any or all of them. We will keep you informed as progress is made. In summary, Oramed maintains a strong cash position, bolstered by solid progress on the Scilex note transaction. We are making strides towards initiating a new Phase 3 trial for our oral insulin program while actively pursuing the joint venture opportunity with HTIT. These strategic initiatives position us to drive significant shareholder value. Thank you for your continued support as we work diligently to achieve major milestones. We look forward to providing updates on our progress. Sincerely, Nadav Kidron Chief Executive Officer About Oramed Pharmaceuticals Oramed Pharmaceuticals (Nasdaq/TASE: ORMP) is a platform technology pioneer in the field of oral delivery solutions for drugs currently delivered via injection. The Company's novel Protein Oral Delivery (POD™) technology is designed to protect drug integrity and increase absorption. Oramed has offices in the United States and Israel. For more information, please visit . Forward-looking statements: This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 and other Federal securities laws. Words such as "expects," "anticipates," "intends," "plans," "believes," "seeks," "estimates" and similar expressions or variations of such words are intended to identify forward-looking statements. For example, we are using forward-looking statements when we discuss Oramed's opportunities and ability to increase shareholder value, our potential repurchase of our shares, the benefits of the Scilex note and related transactions, the value of Scilex, its growth trajectory, commercial portfolio and infrastructure and clinical stage pipeline, the anticipated regulatory approval of HTIT's clinical trial data and the timing of such approval, the expected timing and achievement of milestones, the potential development, benefits, safety, efficacy and timing of our oral insulin program, our intention to begin a Phase 3 oral insulin trial in the U.S. and the timing of such trial, the potential benefits, capabilities and overall success of our JV with HTIT, the closing of the transactions contemplated by the JV including receipt of expected capital contributions, the completion of clinical trials related to the JV and the expected launch of oral insulin sales in China, and the ability of our balance sheet to allow us to continue to the development of our oral insulin program and take advantage of strategic opportunities. In addition, historic results of scientific research and clinical trials do not guarantee that the conclusions of future research or trials will suggest identical or even similar conclusions. These forward-looking statements are based on the current expectations of the management of Oramed only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements, including the risks and uncertainties related to the progress, timing, cost, and results of clinical trials and product development programs; difficulties or delays in obtaining regulatory approval or patent protection for our product candidates; competition from other pharmaceutical or biotechnology companies; and our ability to obtain additional funding required to conduct our research, development and commercialization activities. In addition, the following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; delays or obstacles in launching our clinical trials; changes in legislation; inability to close the transactions contemplated by our JV with HTIT in a timely manner or at all; inability of Scilex to repay the Note or our inability to realize the value of the Scilex warrants issued or transferred to us; inability to timely develop and introduce new technologies, products and applications; lack of validation of our technology as we progress further and lack of acceptance of our methods by the scientific community; inability to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties that may develop with our process; greater cost of final product than anticipated; loss of market share and pressure on pricing resulting from competition; laboratory results that do not translate to equally good results in real settings; our patents may not be sufficient; and finally that products may harm recipients, all of which could cause the actual results or performance of Oramed to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Oramed undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Oramed, reference is made to Oramed's reports filed from time to time with the Securities and Exchange Commission. Company Contact: +1-844-9-ORAMED ir@oramed.com Logo - View original content: SOURCE Oramed Pharmaceuticals Inc. Company Codes: NASDAQ-SMALL:ORMP, Berlin:OJU1, TelAviv:ORMP, Dusseldorf:OJU1, Frankfurt:OJU1, Munich:OJU1, Stuttgart:OJU1

临床3期

2023-08-03

·Pharmaceutical Technology

Oramed and HTIT to form joint venture for oral drug products

The JV will commence a Phase III clinical trial of oral insulin in the US. Credit: Okrasiuk / Shutterstock.com Oramed Pharmaceuticals and Hefei Tianhui Biotech (HTIT) have entered an agreement to form a joint venture (JV) to advance oral drug products. The JV will focus on advancing Oramed’s oral drug delivery technology worldwide and will commercialise the products based on the oral insulin and protein oral delivery pipeline. Recommended Reports Reports Innovation in Pharmaceuticals: Pancreatic extract-based compositions GlobalData Reports Innovation in Pharmaceuticals: Adenovirus-based medicinal compositions GlobalData View all Companies Intelligence Oramed Pharmaceuticals Inc Oramed Ltd Oravax Medical Inc JV View all The JV will also leverage the manufacturing expertise and technologies of HTIT. HTIT will invest $60m in the JV in its initial stage while Oramed will make an investment of $10m. Both parties will hold equal stakes. The JV will hold worldwide marketing rights to oral drug delivery technology and focus on the development and commercialisation of drug products across the globe. The companies will also commence a Phase III clinical trial of oral insulin in the US. Oramed CEO Nadav Kidron stated: “HTIT has successfully completed a Phase III oral insulin trial and submitted a new drug application to the National Medical Products Administration with marketing approval currently pending in China. “HTIT has state-of-the-art facilities, manufacturing capabilities and the know-how needed to produce oral insulin on an international scale. “This JV is a true opportunity to leverage our strengths, as well as those of our partners to fast-track our pipeline towards commercialisation.” The company entered agreements with Oravax Medical in March 2021 to form a JV for oral Covid-19 vaccine development.

临床3期疫苗

2023-08-02

·PRNewswire

Oramed Signs Term Sheet with HTIT to Create a Joint Venture to Advance Oral Drug Delivery Technology Globally

JV will have global marketing rights to oral drug delivery technology HTIT to invest $60 million, Oramed to invest $10 million into JV HTIT to provide a supply agreement for oral insulin capsule JV to advance registration of oral insulin in the United States and other countries NEW YORK, Aug. 2, 2023 /PRNewswire/ -- Oramed Pharmaceuticals Inc. (NASDAQ: ORMP) (TASE: ORMP) () announced today that it has signed a non-binding term sheet with Hefei Tianhui Biotech Co., Ltd. ("HTIT") to establish a joint venture ("JV") based on Oramed's oral drug delivery technology. The proposed JV would focus on the development and worldwide commercialization of innovative products based on Oramed's oral insulin and POD™ (Protein Oral Delivery) pipeline and HTIT's manufacturing capabilities and technologies. The JV is subject to the execution of a binding definitive agreement. "We are thrilled to further our relationship with HTIT, expanding the reach of our oral drug delivery technology to a global market," said Oramed Chief Executive Officer, Nadav Kidron. "HTIT has successfully completed a Phase 3 oral insulin trial and submitted a New Drug Application ("NDA") to the National Medical Products Administration ("NMPA"), with marketing approval currently pending in China. HTIT has state-of-the-art facilities, manufacturing capabilities and the know-how needed to produce oral insulin on an international scale. This JV is a true opportunity to leverage our strengths as well as those of our partners to fast-track our pipeline towards commercialization." Scope of the Joint Venture The JV would be responsible for developing, marketing and commercializing drug products globally, focusing on Oramed's oral insulin and POD™ technology, as well as other assets in the Oramed pipeline. The parties intend for the JV to initiate a Phase 3 oral insulin trial in the United States. Structure of Joint Venture Oramed and HTIT would initially hold equal shares in the JV, with each owning 50% of the equity. The Board of Directors would initially consist of equal representation from HTIT and Oramed, ensuring that both parties have an equal say in decision-making. As part of the Joint Venture, HTIT will make an initial investment of $60 million, while Oramed will invest $10 million. About Oramed Pharmaceuticals Oramed Pharmaceuticals (Nasdaq/TASE: ORMP) is a platform technology pioneer in the field of oral delivery solutions for drugs currently delivered via injection. The company's novel Protein Oral Delivery (POD™) technology is designed to protect drug integrity and increase absorption. Oramed has offices in the United States and Israel. For more information, please visit . About HTIT Hefei Tianhui Biotechnology Co., Ltd. (HTIT) has a state-of-the-art oral insulin manufacturing facility in Hefei, China. HTIT is a high-tech company focused on biopharmaceutical product manufacturing and R&D with an emphasis on the oral delivery of therapeutic macromolecules. Forward-looking statements: This press release contains forward-looking statements. For example, we are using forward-looking statements when we discuss potential marketing approval by HTIT and commercialization in China, the potential to enter into definitive documentation with respect to the JV, which is currently still under negotiation according to the understanding set forth in the non-binding term sheet, the potential safety and efficacy of oral insulin and the potential of Oramed and/or the JV to move forward with its oral insulin product and fast-track its pipeline towards commercialization. These forward-looking statements are based on the current expectations of the management of Oramed only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements, including the ability of the parties to reach agreement on a definitive JV agreement and the transactions contemplated by the term sheet, which may not occur; Oramed's process to evaluate strategic options; the terms, timing, structure, benefits and costs of any strategic transaction and whether any transaction will be consummated at all; the impact of any strategic transaction on Oramed; the outcomes of any litigation, regulatory proceedings, inquiries or investigations to which Oramed may be subject; the ability to obtain financing or third-party approvals as needed; our ability to achieve the intended benefits of our strategic initiatives; the risks and uncertainties related to the progress, timing, cost, and results of clinical trials and product development programs; difficulties or delays in obtaining regulatory approval or patent protection for our product candidates; competition from other pharmaceutical or biotechnology companies; and our ability to obtain additional funding required to conduct our research, development and commercialization activities. In addition, the following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; delays or obstacles in launching our clinical trials; changes in legislation; inability to timely develop and introduce new technologies, products and applications; lack of validation of our technology as we progress further and lack of acceptance of our methods by the scientific community; inability to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties that may develop with our process; greater cost of final product than anticipated; loss of market share and pressure on pricing resulting from competition; laboratory results that do not translate to equally good results in real settings; our patents may not be sufficient; that products may harm recipients; and other factors discussed in the "Risk Factors" section of Oramed's most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, which are on file with the Securities and Exchange Commission and in other filings that Oramed makes with the Securities and Exchange Commission in the future. All of these factors could cause the actual results or performance of Oramed to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Oramed undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. Company Contact: Zach Herschfus +1-844-9-ORAMED [email protected] Logo: SOURCE Oramed Pharmaceuticals Inc.

临床3期引进/卖出

100 项与 Oral insulin(Generex Biotechnology Corp.) 相关的药物交易

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