RenovoRx Engages Oklahoma University (OU) Health as First Clinical Site in Preparation for the Pivotal Phase III CouGar Clinical Trial in Bile Duct Cancer
- RenovoGem received FDA Orphan Drug Designation for pancreatic cancer and bile duct cancer, providing 7 years of market exclusivity upon NDA approval.
- None.
The commencement of the second Phase III trial for RenovoGem, targeting unresectable locally advanced extrahepatic cholangiocarcinoma (eCCA), represents a significant step forward in the treatment of bile duct cancer. The Orphan Drug Designation by the FDA underscores the potential of RenovoGem to address an unmet medical need, given the rarity and severity of this cancer type.
Current standard treatments, primarily systemic chemotherapy, offer limited efficacy due to poor drug delivery to the tumor site. The trial's focus on Trans-Arterial Micro-Perfusion (TAMP) aims to enhance the delivery of chemotherapy directly to the tumor, which could improve outcomes and reduce systemic side effects. If RenovoGem demonstrates a significant improvement in survival rates, it could become a new standard of care for eCCA patients.
In the long-term, success in this trial could pave the way for RenovoRx to secure a strong position in the oncology market, particularly within niche segments granted Orphan Drug status. Investors should monitor the trial's progress closely, as positive results could lead to substantial value creation for the company.
The CouGar Trial by RenovoRx is designed to assess both the safety and efficacy of RenovoGem in combination with durvalumab against a conventional chemotherapy regimen. The trial's outcome has the potential to influence the company's stock performance, as positive data could drive investor optimism and lead to increased market valuation.
Investors should be aware of the inherent risks of clinical trials, particularly Phase III studies which are crucial for FDA approval. A failed trial or adverse safety profile could negatively impact RenovoRx's market capitalization. Conversely, successful trial outcomes could facilitate partnerships or buyout opportunities, especially given the Orphan Drug status that often attracts larger pharmaceutical companies looking to expand their oncology portfolios.
It is also important to note that the seven-year market exclusivity period post-approval could provide a temporary competitive moat for RenovoRx, potentially leading to premium pricing and increased revenue streams, assuming approval and successful commercialization.
RenovoRx's strategic expansion into bile duct cancer treatment with RenovoGem could significantly impact its financial outlook. The Phase III trial's success could lead to a new revenue stream upon FDA approval. Given the Orphan Drug Designation, RenovoRx could benefit from incentives like tax credits for clinical testing, exemption from FDA application fees and potentially higher pricing power due to lack of competition.
Investors should consider the costs associated with conducting a Phase III trial, which are substantial. However, the investment could be justified by the high margins typically associated with oncology drugs, especially those treating rare diseases. The market exclusivity period could also provide a window for RenovoRx to recoup its investment and profit before facing generic competition.
Market reaction to the trial's initiation may be positive, but investors are likely to focus on interim data readouts and final study results to reassess the company's valuation. Long-term valuation will depend on the trial's outcome, regulatory approval and the company's ability to commercialize RenovoGem effectively in a competitive oncology market.
This study will be the Second Clinical Trial Evaluating RenovoGem™, a Combination Drug-Device Product, in a Difficult-to-Access Solid Tumor Cancer
“We are pleased to engage our first clinical site for our second pivotal clinical trial. The CouGar Trial marks an important milestone for RenovoRx as we expand our clinical pipeline for RenovoGem into bile duct cancer, a difficult-to-treat solid tumor cancer,” said Leesa Gentry, Senior Vice President of Clinical Operations at RenovoRx. “I’m extremely proud of our team and our collaborators for their tremendous work reinforcing our mission to improve patient lives by delivering innovative therapies that can potentially change the current paradigm of cancer care.”
The pivotal Phase III CouGar study is a randomized study designed to evaluate the safety and efficacy of unresectable, locally advanced eCCA using intravenous cisplatin, gemcitabine, and durvalumab (all forms of chemotherapy) versus Trans-Arterial Micro-Perfusion via RenovoGem (delivery system and gemcitabine) with intravenous durvalumab.
“Unfortunately, bile duct cancer today has a poor prognosis for patients. Despite early diagnosis, the five-year survival rate is approximately
Dr. David Geller, Director, UPMC Liver Cancer Center, Richard L. Simmons Professor of Surgery, University of Pittsburgh School of Medicine is the CouGar study’s Co-Investigator.
“The current standard of care for bile duct cancer is systemic (intravenous) chemotherapy, which has poor uptake and delivery since there are few blood vessels feeding this type of tumor,” said Dr. Hassan Hatoum, Principal Investigator, Associate Professor and Hematologist and Oncologist at Oklahoma University Health Stephenson Cancer Center – Gastrointestinal Cancer Clinic. “RenovoRx’s clinical trial is evaluating targeted, trans-arterial delivery of chemotherapy that is locally directed to the tumor site. Our team looks forward to participating in the CouGar study to bring this novel therapy to patients.”
RenovoGem received FDA Orphan Drug Designation for pancreatic cancer and bile duct cancer which provides 7 years of market exclusivity upon NDA approval.
About RenovoRx, Inc.
RenovoRx is a clinical-stage biopharmaceutical company developing proprietary targeted combination therapies for high unmet medical need with a goal to improve therapeutic outcomes for cancer patients undergoing treatment. The Company’s proprietary Trans-Arterial Micro-Perfusion (TAMPTM) therapy platform is designed to ensure precise therapeutic delivery to directly target the tumor while potentially minimizing a therapy’s toxicities versus systemic (intravenous (IV) therapy). RenovoRx’s unique approach to targeted treatment offers the potential for increased safety, tolerance, and improved efficacy. Our Phase III lead product candidate, RenovoGemTM, a novel oncology drug-device combination product, is being investigated under a US IND that is regulated by FDA 21 CFR 312 pathway. RenovoGem is currently being evaluated for the treatment of locally advanced pancreatic cancer (LAPC) by the Center for Drug Evaluation and Research (the drug division of FDA.)
RenovoRx is committed to transforming the lives of patients by delivering innovative solutions to change the current paradigm of cancer care. RenovoGem is currently under investigation for TAMP therapeutic delivery of gemcitabine and has not been approved for commercial sale.
For more information, visit www.renovorx.com. Follow RenovoRx on Facebook, LinkedIn, and Twitter.
Forward-Looking Statements
This press release contains 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 our clinical trials and studies, including anticipated timing, statements regarding the potential of RenovoCath®, RenovoGemTM or TAMPTM or regarding our ongoing TIGeR-PaC Phase III clinical trial study in LAPC, statements regarding the potential for our product candidates to treat or provide clinically meaningful outcomes for certain medical conditions or diseases, and our preliminary financial results, cash position and related ability to continue as a going concern. 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, clinical trials, therapy platform, business 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 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: the timing of the initiation, progress and potential results of our preclinical studies, clinical trials and our research programs; the possibility that interim results may not be predictive of the outcome of our clinical trial, which may not demonstrate sufficient safety and efficacy to support regulatory approval of our product candidate, or the regulatory authority may disagree with our interpretation of the data; research and clinical development plans and timelines, and the regulatory process for our product candidates; future potential regulatory milestones for our product candidates, including those related to current and planned clinical studies; our ability to use and expand our therapy platform to build a pipeline of product candidates; our ability to advance product candidates into, and successfully complete, clinical trials; the timing or likelihood of regulatory filings and approvals; 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; the commercialization potential of our product candidates, if approved; our ability and the potential to successfully manufacture and supply our product candidates for clinical trials and for commercial use, if approved; future strategic arrangements and/or collaborations and the potential benefits of such arrangements; our estimates regarding expenses, future revenue, capital requirements and needs for additional financing and our ability to obtain additional capital; the sufficiency of our existing cash and cash equivalents to fund our future operating expenses and capital expenditure requirements; our ability to retain the continued service of our key personnel and to identify, hire and retain additional qualified personnel; the implementation of our strategic plans for our business and product candidates; the scope of protection we are able to establish and maintain for intellectual property rights, including our therapy platform, product candidates and research programs; our ability to contract with third-party suppliers and manufacturers and their ability to perform adequately; the pricing, coverage and reimbursement of our product candidates, if approved; developments relating to our competitors and our industry, including competing product candidates and therapies; negative impacts of the ongoing COVID-19 pandemic on our operations; our ability to comply with the continued listing standards of Nasdaq Stock Market LLC (“Nasdaq”) or the continued listing of our securities on Nasdaq; and other risks. 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 RenovoRx does not undertake any obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as required by law.
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Investor Contact:
KCSA Strategic Communications
Valter Pinto or Jack Perkins
T:212-896-1254
renovorx@kcsa.com
Media Contact:
Kimberly Ha
KKH Advisors
917-291-5744
kimberly.ha@kkhadvisors.com
Source: RenovoRx, Inc.
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