Data Shows TAMP to be a Promising Approach for Local Delivery of Gemcitabine with Reduced Systemic Toxicity in Patients Diagnosed with Locally Advanced Pancreatic Cancer
Metabolic Imaging, Used to Evaluate Therapeutic Outcome Following Treatment with TAMP, Shows a Notable Reduction in Tumor Activity Suggesting a Potential Treatment Response
The abstract, entitled “What PET/CT Reveals After Transarterial Microperfusion for Pancreatic Cancer,” was presented on
The abstract examined the effectiveness of local, targeted intra-arterial chemotherapy administration using RenovoRx’s patented TAMP (Trans-Arterial Micro-Perfusion) therapy platform. By delivering chemotherapy directly near the tumor site, TAMP helps to overcome the poor vascularity typical of solid tumors like locally advanced pancreatic cancer (LAPC), where intravenous chemotherapy is often less effective. Additionally, the abstract assessed the potential application of metabolic imaging, FDG (fluorodeoxyglucose) PET/CT, in evaluating therapeutic outcomes following targeted intra-arterial drug-delivery via TAMP in patients with refractory disease.
The study concluded that TAMP is a promising approach for localized delivery of chemotherapeutic agents for the treatment of solid tumors such as LAPC, offering the potential for enhanced therapeutic drug-delivery with reduced systemic toxicity. Metabolic imaging further demonstrated dramatic reductions in FDG avidity, suggesting treatment response even when tumor size changed minimally. Eight cycles of intra-arterial chemotherapy were administered over 2 months, using the TAMP therapy platform, which is enabled by the Company’s RenovoCath device. Post-treatment imaging results indicated that PET/CT may detect early treatment response before anatomical changes occur.
“Patients diagnosed with LAPC face a challenging prognosis, due in part to a dense, hypovascular stroma that can restrict the effectiveness of traditional systemic (namely intravenous) chemotherapy,” said
About RenovoCath
Based on its FDA clearance, RenovoCath® is intended for the isolation of blood flow and delivery of fluids, including diagnostic and/or therapeutic agents, to select sites in the peripheral vascular system. RenovoCath is also indicated for temporary vessel occlusion in applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion. For further information regarding our RenovoCath Instructions for Use (“IFU”), please see: IFU-10004-Rev.-G-Universal-IFU.pdf.
About
The IAG combination product candidate, which is enabled by the RenovoCath device, is currently under investigation and has not been approved for commercial sale. RenovoCath with gemcitabine received Orphan Drug Designation for pancreatic cancer and bile duct cancer, which provides seven years of market exclusivity upon new drug application approval by the FDA.
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Cautionary Note Regarding Forward-Looking Statements
This press release and statements of the Company’s management made in connection therewith described herein contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, and Section 21E of the Securities Exchange Act of 1934, including but not limited to statements regarding (i) our clinical trials and studies, including the anticipated benefits to the Company of the results and public presentation of the clinical study abstract described herein, (ii) the potential for our product candidates to treat or provide clinically meaningful outcomes for certain medical conditions or diseases and (iii) our efforts to commercialize RenovoCath and our TAMP technology. Statements that are not purely historical are forward-looking statements. The forward-looking statements contained herein are based upon our current expectations and beliefs regarding future events, many of which, by their nature, are inherently uncertain, outside of our control and involve assumptions that may never materialize or may prove to be incorrect. These may include estimates, projections and statements relating to our research and development plans, intellectual property development, clinical trials, our therapy platform, business plans, financing plans, objectives and expected operating results, which are based on current expectations and assumptions that are subject to known and unknown risks and uncertainties that may cause actual results to differ materially and adversely from those expressed or implied by these forward-looking statements. These statements may be identified using words such as “may,” “expects,” “plans,” “aims,” “anticipates,” “believes,” “forecasts,” “estimates,” “intends,” and “potential,” or the negative of these terms or other comparable terminology regarding RenovoRx’s expectations strategy, plans or intentions, although not all forward-looking statements contain these words. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, that could cause actual events to differ materially from those projected or indicated by such statements, including, among other things: (i) the risk that our commercial sales efforts for RenovoCath and our TAMP technology may not lead to viable, revenue generating operations; (ii) circumstances which would adversely impact our ability to efficiently utilize our cash resources on hand or raise additional funding; (iii) the timing of the initiation, progress and potential results (including the results of interim analyses) of our preclinical studies, clinical trials and our research programs; (iv) the possibility that interim results may not be predictive of the outcome of our clinical trials, which may not demonstrate sufficient safety and efficacy to support regulatory approval of our product candidate; (v) that the applicable regulatory authorities may disagree with our interpretation of the data; research and clinical development plans and timelines, and the regulatory process for our product candidates; (vi) future potential regulatory milestones for our product candidates, including those related to current and planned clinical studies; (vii) our ability to use and expand our therapy platform to build a pipeline of product candidates; (viii) our ability to advance product candidates into, and successfully complete, clinical trials; (ix) the timing or likelihood of regulatory filings and approvals; (x) our estimates of the number of patients who suffer from the diseases we are targeting and the number of patients that may enroll in our clinical trials; (xi) the commercialization potential of our product candidates, if approved; (xii) our ability and the potential to successfully manufacture and supply our product candidates for clinical trials and for commercial use, if approved; (xiii) future strategic arrangements and/or collaborations and the potential benefits of such arrangements; (xiv) our estimates regarding expenses, future revenue, capital requirements and needs for additional financing and our ability to obtain additional capital; (xv) the sufficiency of our existing cash and cash equivalents to fund our future operating expenses and capital expenditure requirements; (xvi) our ability to retain the continued service of our key personnel and to identify, and hire and retain additional qualified personnel; (xvii) the implementation of our strategic plans for our business and product candidates; (xviii) the scope of protection we are able to establish and maintain for intellectual property rights, including our therapy platform, product candidates and research programs; (xix) our ability to contract with third-party suppliers and manufacturers and their ability to perform adequately; (xx) the pricing, coverage and reimbursement of our product candidates, if approved; and (xxi) developments relating to our competitors and our industry, including competing product candidates and therapies. Information regarding the foregoing and additional risks may be found in the section entitled “Risk Factors” in documents that we file from time to time with the Securities and Exchange Commission.
Forward-looking statements included herein are made as of the date hereof, and
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