相关临床试验
5
1 进行中
药物批准
0
批准总数
监管机构
0
监管机构数
成立时间
2009
进行中（未招募）
1
20.0%
已完成
2
40.0%
招募中
2
40.0%
暂无批准数据
- RenovoRx presented new pharmacokinetic and pharmacodynamic data from its Phase III TIGeR-PaC trial at ASCO GI 2026, demonstrating reduced systemic gemcitabine levels with intra-arterial delivery. - The sub-study of 16 patients showed that TAMP therapy with intra-arterial gemcitabine resulted in increased levels of inactive metabolites and decreased CA 19-9 biomarker levels compared to standard intravenous treatment. - The targeted drug-delivery approach may improve local drug potency while reducing chemotherapy-related side effects for patients with locally advanced pancreatic cancer.
- RenovoRx achieved over $400,000 in second quarter 2025 revenue from commercial sales of its FDA-cleared RenovoCath drug-delivery device, marking strong growth in its first two full quarters of commercialization. - The independent Data Monitoring Committee recommended continuation of the pivotal Phase III TIGeR-PaC trial for locally advanced pancreatic cancer after reviewing interim data, with 95 patients randomized and 61 events recorded as of August 2025. - The company expanded its commercial footprint to thirteen cancer center customers approved to purchase RenovoCath, including several National Cancer Institute-designated centers, with four centers actively using the device and making repeat orders.
- RenovoRx has launched the PanTheR Post-Marketing Registry Study, a multi-center observational study designed to evaluate the long-term safety and real-world effectiveness of the FDA-cleared RenovoCath drug-delivery device in patients with solid tumors. - The University of Vermont Cancer Center will be the first site to initiate patient enrollment, with additional cancer centers expected to commence enrollment before the end of September 2025. - The registry study will capture real-world data across diverse cancer types and clinical environments, potentially informing future clinical trial designs and evidence-based treatment strategies. - Participating cancer centers will purchase RenovoCath devices from RenovoRx for use in the study, representing a revenue-generating opportunity for the company.
- DelveInsight's 2025 report reveals over 80 companies are actively developing more than 80 pipeline therapies for pancreatic ductal adenocarcinoma treatment. - Key pharmaceutical companies including Genentech, Revolution Medicines, and Merck Sharp & Dohme are conducting Phase 3 trials with promising novel therapeutic approaches. - Emerging therapies such as Onvansertib, Nadunolimab, and Zimberelimab represent diverse mechanisms of action targeting treatment resistance and immune suppression in pancreatic cancer. - Recent regulatory approvals include Anocca's VIDAR-1 Phase I/II trial targeting KRAS-positive advanced pancreatic cancer, demonstrating growing focus on precision medicine approaches.
- RenovoRx received U.S. patent NO. 12,290,564 for "Methods for Treating Tumors," expanding protection of its Trans-Arterial Micro-Perfusion (TAMP) therapy platform through November 2037. - The patent covers novel methods for local drug delivery near tumors using the company's FDA-cleared RenovoCath device, marking the ninth U.S. patent in RenovoRx's growing intellectual property portfolio. - This patent strengthens commercial protection for RenovoCath as the company scales commercialization efforts and advances its Phase III TIGeR-PaC trial evaluating intra-arterial gemcitabine for locally advanced pancreatic cancer. - RenovoRx now holds 19 issued patents and 12 pending patents, providing robust IP protection as the company began generating revenue from RenovoCath device sales in December 2024.
- Johns Hopkins Medicine has initiated patient enrollment for RenovoRx's Phase III TIGeR-PaC clinical trial, evaluating a novel targeted therapy approach for locally advanced pancreatic cancer. - Dr. Valerie Lee will serve as Principal Investigator at Johns Hopkins, joining Dr. Michael Pishvaian who continues as overall Trial Chairman, strengthening the prestigious network of clinical sites. - The trial, which has currently enrolled 90 of the required 114 patients, is testing RenovoRx's proprietary Trans-Arterial Micro-Perfusion therapy platform that delivers gemcitabine directly to tumor sites.
- RenovoRx's Chief Clinical Officer emphasizes the importance of realistic expectations, responsiveness, and transparency in managing clinical trial site relationships and performance. - Post-COVID-19 staffing reductions at trial sites have led to increased burnout and workload challenges, complicated by increasingly complex trial protocols and multiple technology requirements. - Sponsors must prioritize rapid communication, reasonable budgets, and localized support to become preferred partners, while acknowledging that some sites may still underperform despite best efforts.
- RenovoRx has announced a public offering of 11.52 million shares at $1.05 per share, aiming to raise $12.1 million in gross proceeds for its clinical research initiatives. - The funding will primarily support the advancement of the company's Phase III TIGeR-PaC study and commercial development of the RenovoCath device. - The strategic financing move is expected to close by February 10, 2025, strengthening RenovoRx's position in developing innovative pancreatic cancer treatments.
- Arena International's OCT West Coast 2025 conference will convene in San Francisco on February 11-12, featuring four specialized streams addressing clinical operations, innovation, patient engagement, and medical devices. - RenovoRx's Chief Clinical Officer emphasizes the critical need for site-centric efficiency in clinical trials, highlighting the importance of adapting to local requirements and leveraging AI for improved trial operations. - The conference will address key industry challenges including regulatory changes under the new administration, WHO's diversity guidance implementation, and strategies for enhancing patient-centric trial designs.
- RenovoRx's TAMP platform delivers targeted therapy directly to tumors, potentially minimizing systemic toxicities compared to IV treatments. - The Phase III lead product candidate, a drug-device combination, is under FDA investigation for treating locally advanced pancreatic cancer (LAPC). - The RenovoCath device, part of the TAMP platform, is FDA-cleared for vessel occlusion and chemotherapeutic drug infusion. - RenovoRx is exploring further applications of its TAMP technology and RenovoCath device for various commercialization strategies.
