SouthernWorldwide.com – Chemotherapy, a life-saving treatment, often comes with significant side effects like nausea, exhaustion, and increased susceptibility to infections. These challenges arise because standard chemotherapy circulates through the bloodstream, affecting both cancerous and healthy cells. However, for some pancreatic cancer patients, this approach may be on the verge of a significant change.
A novel drug-delivery system developed by RenovoRx aims to direct chemotherapy specifically to the tumor site, bypassing systemic circulation. This technology, known as Trans-Arterial Micro-Perfusion (TAMP), is currently under investigation in a Phase III clinical trial for locally advanced pancreatic cancer.
Hernando Salcedo, an 83-year-old patient who experienced debilitating side effects from conventional chemotherapy, found renewed hope through this trial. Enrolling at Miami Cancer Institute, he began to notice remarkable improvements. His appetite returned, his energy levels increased, and he felt more like his usual self. “The difference was tremendous,” Hernando shared. “I completed eight sessions, one every 15 days, and I felt dramatically better than I did with the original chemotherapy.”
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RenovoRx’s innovative platform utilizes the FDA-cleared RenovoCath device. This device allows chemotherapy to be delivered via a catheter precisely guided into an artery adjacent to the tumor under X-ray imaging.
Shaun Bagai, CEO of RenovoRx, explained that the platform’s core design is to concentrate chemotherapy delivery near the tumor, rather than relying on the drug to distribute throughout the entire body.
“Once in position, two small balloons on the catheter are inflated, and the system is adjusted to isolate a targeted segment of artery adjacent to a tumor,” Bagai elaborated. “The chemotherapy drug is then infused between the balloons, creating pressure to push the drug across the vessel wall and near the tumor, directly bathing the target tumor.”
This specialized setup enables physicians to focus treatment on a specific area, significantly reducing the body’s overall exposure to chemotherapy. “The procedure itself is minimally invasive and is typically performed in an outpatient setting without the need for patients to be put under general anesthesia,” Bagai added.
For patients already contending with pain, fatigue, and fear, the prospect of an outpatient procedure can be far less daunting than a major hospital intervention.
To fully appreciate the significance of this new approach, it’s essential to understand the challenges it seeks to address. Dr. Ripal Gandhi, a vascular interventional radiologist and interventional oncologist at Baptist Health Miami Cardiac & Vascular Institute and Miami Cancer Institute, shed light on why standard chemotherapy can be so taxing on the body.
“With IV chemotherapy, the drug travels through the bloodstream, affecting both cancerous and healthy cells, which can lead to side effects,” Dr. Gandhi stated. TAMP, in contrast, employs a more targeted route. A physician inserts a catheter into an artery near the tumor and delivers chemotherapy directly to that localized area, circumventing the need for the drug to circulate systemically.
Dr. Gandhi drew a powerful analogy, comparing it to “a drip irrigation system for individual plants instead of watering an entire lawn.” The goal for patients is to concentrate treatment near the cancer while minimizing exposure to the rest of their body.
Pancreatic cancer is notoriously difficult to treat, partly because the tumor’s structure can impede the effectiveness of conventional treatments.
Dr. Gandhi highlighted this as a major hurdle for standard IV chemotherapy. “Studies have shown that less than 10% of chemotherapy administered intravenously actually reaches tumor cells due to the few blood vessels in the tumor as well as dense fibrous stroma, which serves as a physical barrier in the tumor microenvironment,” Dr. Gandhi noted.
This statistic underscores the potential importance of targeted delivery. TAMP ensures the drug is delivered closer to the tumor, reducing reliance on the bloodstream for transport.
“This targeted approach via TAMP does not rely on chemotherapy circulating through the body to carry the drug to the tumor via tumor feeder vessels,” Dr. Gandhi explained. “Trans-arterial micro-perfusion is a drug-delivery platform that delivers chemotherapy directly near the target tumor where it is needed most.”
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Hernando’s battle with cancer began after he sought medical attention for a swollen abdomen and hip pain, leading to a diagnosis of locally advanced pancreatic cancer. His initial experience with standard chemotherapy, starting in August 2015, was marked by severe side effects. “My body was going through an incredible amount of stress,” Hernando recounted. “My stomach was inflamed, I had persistent pain in my head, and I had almost no energy.”
He was undergoing both chemotherapy and radiation concurrently. “It was a very difficult period, both physically and emotionally,” he recalled. “I remember feeling exhausted, overwhelmed and unsure of what the future would look like.”
When the option of targeted treatment was presented, Hernando viewed it as more than just another medical procedure. “To me, it felt like a new opportunity to live,” he expressed. “It gave me hope at a time when my family and I really needed it.”
He attributes his positive experience to Dr. Gandhi and the team at Miami Cancer Institute. “From the beginning, he was honest, supportive and clear with my wife, my family and me,” Hernando stated. “That meant everything.”
“Before, I was losing weight, had no appetite and felt drained,” Hernando continued. “After switching treatments, things began to change. I stopped losing weight, my appetite came back, my color improved and I had more energy.”
Cancer treatment can often dominate a patient’s life. As side effects subside, patients can reclaim aspects of their normal lives. “After about eight weeks, we could see real progress,” Hernando said. “I was eating more, moving more and feeling excited about life again.”
A particularly poignant memory for Hernando was being able to attend a family wedding and dance throughout the entire event. “That moment meant everything to me,” he shared. “After everything I had been through, being able to celebrate with my family in that way felt like a gift.” For Hernando, it was a chance to feel like himself again. “That night at the wedding, I was not thinking only about cancer or treatment,” Hernando reflected. “I was living.”
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Preliminary data from RenovoRx’s Phase III TIGeR-PaC trial suggest that this targeted approach may offer both survival and tolerability advantages for certain patients.
Dr. Gandhi commented that completed clinical studies involving TAMP in pancreatic cancer have demonstrated “a potential for better outcomes and less side effects for patients.”
“In the initial interim analysis of the TIGeR-PaC clinical trial, there was a trend towards improved overall survival by 6 months and improvement in the progression free survival by 8.1 months with 65% fewer adverse events in the TAMP arm of the study,” Dr. Gandhi reported.
It is important to note that this approach is not suitable for all pancreatic cancer patients. Physicians must carefully consider factors such as cancer stage, tumor location, treatment history, and whether the cancer has metastasized.
Dr. Gandhi identified Hernando as an ideal candidate for this treatment. “He is precisely the type of patient who would benefit best from this approach because he has a tumor which is too far advanced to be treated surgically, but it has not spread to other organs,” Dr. Gandhi explained.
He also emphasized the value of clinical trials for pancreatic cancer patients. “I discussed with him that the recommendation of the National Comprehensive Cancer Network is that the best management for pancreatic cancer patients is participation in a clinical trial whenever possible and he was an ideal candidate,” Dr. Gandhi stated.
He further added that TAMP could be a viable option for patients who are not candidates for surgery, those who have not responded well to chemotherapy, or those seeking to discontinue IV chemotherapy due to its side effects.
“TAMP can be used at any point within the treatment landscape, before, during or after other treatment modalities such as IV chemotherapy or radiation,” he concluded.
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RenovoRx has announced that its RenovoCath catheter has already received FDA clearance for general therapy and chemotherapy delivery. The company is also nearing the completion of patient enrollment for its Phase III TIGeR-PaC trial.
This trial is specifically evaluating intra-arterial gemcitabine (IAG) delivered via RenovoCath for locally advanced pancreatic cancer. Bagai indicated that enrollment is anticipated to conclude by mid-2026, with final results expected in 2027.
“If positive, data generated from this trial could potentially support a new drug application for this combination product to the FDA for IAG,” Bagai stated. RenovoRx also foresees applications beyond pancreatic cancer. “The challenge we are addressing is not unique to pancreatic cancer,” Bagai remarked.
He suggested that the platform could be applicable to other solid tumors with limited blood supply, including bile duct cancer, certain lung cancers, and sarcomas. “The platform is designed to work with different types of therapies, not just one drug,” Bagai added. “That opens the door to future combinations and potential partnerships, with the goal of expanding options for patients who have limited treatment choices.”
For individuals diagnosed with pancreatic cancer or their loved ones, this development warrants close attention. Clinical trials can offer vital alternatives when standard treatments become too difficult to tolerate or cease to be effective.
The efficacy of drug delivery is as crucial as the drug itself. Where a medication is delivered within the body significantly impacts side effects, energy levels, and overall quality of life. Targeted chemotherapy delivery remains a specialized treatment approach, and its availability may vary across cancer centers. Not every diagnosis will be a suitable candidate for this method. A patient’s care team must evaluate imaging, staging, prior treatments, and overall health to determine its appropriateness.
It is advisable to ask direct questions to your medical team. Inquire about the suitability of clinical trials and explore options for targeted delivery or seek a second opinion from a pancreatic cancer specialist.
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Pancreatic cancer has a profound ability to disrupt normal life rapidly. One day, a family might be making future plans, and the next, they are grappling with understanding scans, treatment options, and side effects that feel overwhelming. This is what makes Hernando’s story so compelling. What resonates most is not solely the technology, but the fact that he regained his appetite, experienced an increase in energy, felt more like himself, and was able to dance at a wedding after facing uncertainty about his future. The final results from the Phase III trial will be significant in determining the broader applicability of this approach. However, its promise is clear: if chemotherapy can be delivered more precisely to the tumor while minimizing its impact on the rest of the body, patients may gain something as valuable as the treatment itself – an increase in their good days.
If you or someone you know has undergone chemotherapy, does the concept of targeted delivery alter your perspective on cancer treatment? We encourage you to share your thoughts by contacting us at Cyberguy.com
