AIM ImmunoTech is a late-stage immunopharma company. We have a very wide net that our drug Ampligen, rintatolimod, has shown efficacy and safety in. We focused going forward with a repurposing from chronic fatigue syndrome into oncology in 2016-2017. Over the past several years, we've had a number of successful studies at major research centers in various solid tumors, with industry collaborators such as Merck and AstraZeneca, and top research institutes such as Roswell, University of Pittsburgh Medical Center, and Erasmus Medical Center. Next slide, please. Based upon the extremely positive data, both as to safety and efficacy, developed in the relatively large number of solid tumors that we did clinical work in, we have focused now on a priority goal of seeking a new drug approval for pancreatic cancer.
Our pancreatic cancer program began in 2017, with a Dutch government approval of an early access program for late-stage pancreatic cancer patients. We treated 57 subjects there, and then moved into a program, phase I/II program, combining Ampligen with AstraZeneca's drug Imfinzi, also known as durvalumab, in a phase II trial that's ongoing right now at Erasmus Medical Center, in collaboration with AstraZeneca. Next slide, please. Now, the mechanism of action of Ampligen in oncology is something that the work that we've done at this point, we have approximately 75 subjects that have been in treatment. And as a result of that clinical work, we have a very good idea, and well-established by immunological markers idea, of why Ampligen is working, not just in pancreatic cancer, but in other solid tumors as well. The mechanism of action is the same.
Ampligen, to use oncology slang, is converting cold tumors or immunosilent tumors into hot tumors. The way it does this is described in detail as we go further. It's basically a shift in the microenvironment of the tumor, where the ratio between suppressor T cells and killer T cells is altered. Cold tumors have higher levels of suppressor T cells in relationship to lower levels of killer T cells when compared to a hot tumor. Ampligen is reversing that ratio, making cold tumors hot. Various biomarkers are identified that heighten our understanding of what particular biomarkers show Ampligen to be a more effective therapeutic agent. Next slide, please. Our work has identified, in particular, certain specific markers that are associated with tumor response. Next slide, please.
We are combining that indication in pancreatic cancer, in terms of the immunological markers for efficacy, with probably one of the best safety profiles and most well-developed safety profiles that's out there. Our safety profile in oncology is extremely well-developed. We have over 100,000 IV doses. Infusion therapy is typically the method of administration in serious oncology scenarios. We also have safety approvals in a phase I intranasal and in intraperitoneal studies, which have been conducted in ovarian cancer. Next slide, please. Now, late-stage metastatic pancreatic cancer is right now not just our primary focus, but in the coming months will be our sole focus, in terms of seeking new drug approval. This is a very important opportunity for AIM ImmunoTech to serve a patient population that has a serious unmet need in a very lethal malignancy.
But additionally, it creates a tremendous opportunity, as we move into these pivotal trials in pancreatic cancer, to establish Ampligen as a therapy in a big market, and also in a market where we have both patent and orphan drug designations protecting market exclusivity for Ampligen, which adds to the value if we're able to do some form of a transaction related to Ampligen in this indication with a big pharma partner. Next slide, please. Now, patent protection is very important. We are working on our oncology patent portfolios. But recently, the United States issued a patent that covers Ampligen plus PD-L1 in the treatment of pancreatic cancer, renal cell carcinoma, colorectal cancer, and/or melanoma. That's valid to 2039.
So this is exactly the therapeutic model that we're using in our phase II clinical trial being conducted in the Netherlands at Erasmus Medical Center right now, in collaboration with AstraZeneca. It's Ampligen plus their checkpoint inhibitor, PD-L1 checkpoint inhibitor, Imfinzi, a.k.a. durvalumab. We also have a Netherlands patent that's been granted, which covers this specific utilization as well. Perhaps even more significant is we have orphan drug designations issued by both the United States and the European Union. The orphan drug designation is a particular important because, unlike a patent, which, given the long amount of time sometimes required for drug approval, could be eroded, orphan drug designations, their periods of exclusivity begin or commence with drug approval. So once and should we get drug approval in the United States for pancreatic cancer, for example, that period of exclusivity would begin to run after drug approval.
It's up to 10 years of market protection in the European Union, all of which creates great value for our stockholders, we believe, if we're successful in this pancreatic cancer clinical program that we're implementing right now in order to get a new drug approval for pancreatic cancer in both the United States and Europe. Next slide, please. Now, our foundation for success in pancreatic cancer is established with our initial work, which was at Erasmus Medical Center. The Dutch government gave, based on our safety profile principally, and our theory of why Ampligen would work in pancreatic cancer, granted us an Early Access Program approval for late-stage pancreatic cancer. We began treating patients in 2017 in that program. In that program, we treated 57 adult subjects.
The progress there was extremely well respected because overall survival for the 57 subjects median was 19.7 months, compared to the standard of care, which is 12.5 months. This created an 8.6-month survival benefit compared to the standard of care. That's a very large survival benefit in a highly lethal disease. What is also, and perhaps just as important, if not more important, is consistently, patients that were being treated with Ampligen reported very high indications of improved quality of life. Quality of life in late-stage pancreatic cancer is extremely poor. Providing these individuals not only with extended survival, but with significant improvements in their quality of life is very meaningful. Next slide, please. Now, this is an analysis of the historical controls that were used in the Early Access Program analysis. They were extremely well-matched. Next slide, please.
These charts demonstrate the impact of Ampligen in terms of overall survival and progression-free survival when compared with historical controls. At your leisure, you can look at these. This slide deck is on our website. I recommend you take your time to analyze this carefully. But there's a very important impact in terms of both progression-free survival and overall survival generally. Next slide, please. Similarly, immunomarkers that were significant and predictive of Ampligen response, which is the neutrophil-lymphocyte ratio, suggest a very important impact, not just in progression-free survival, but most significantly in overall survival. Next slide, please. Furthermore, another clear indicator that identifies who's going to respond to Ampligen and the level of response is shown in these slides. And that's using CA 19-9, which is a classic tumor marker.
Those CA 19-9 levels, where it's less than 1,000, suggest a very important impact in overall survival, as well as progression-free survival. Next slide, please. The phase II that's ongoing right now in the Netherlands is at Erasmus Medical Center. We're in collaboration with AstraZeneca. That program has been ongoing for more than a year now. The impact of it is extremely positive. Next slide, please. The DURIPANC interim results show not only improved quality of life, consistently seen with these patients, but we're also getting extremely positive safety data, sufficient to move from the phase I to the phase II, as well as efficacy data that was sufficient to move from phase I to phase II. The most recent report, the year-end report, the data and projections from Erasmus were very promising in terms of the progression-free survival.
But also, and this is extremely important, is the DURIPANC study is allowing us to see very clearly important immunological details related to the mechanism of action, whereby Ampligen alone has an impact on these tumors, but also how Ampligen working in conjunction with checkpoint inhibitors is able to improve results related to the application of checkpoint inhibitors in a cancer that is notoriously non-responsive to checkpoint inhibitors. Next slide, please. Our management team is a proven team, well-balanced. Proud to say that we have, as our Chairman, a medical officer, and science officer, some of the top scientists in the United States in the field of oncology research and development and we're very excited to move forward and seek to achieve this next goal that we have, which is a phase III pivotal trial in pancreatic cancer.
While we're finishing up the phase II, we're already beginning the process of implementing design and plan for the phase III. We'll be able to provide you with milestones in the future as to our phase III program. Next slide, please. I think that's all, folks.
Thanks, Tom. Very exciting updates. Justin will be able to help you with the Q&A section.
All right. Thank you.
Great. Thank you. Great presentation, Tom.
Thank you very much.
Our first question: What aspects of the data presented give you the most confidence as you move forward?
Well, we know you don't have to be a scientist to know what a diagnosis of pancreatic cancer means, because most diagnoses of pancreatic cancer are made when the disease is in the late stages, and the life expectancy is very short. Now, the work that we've done, we began treating subjects at Erasmus in 2017 in the Early Access Program. Those 57 subjects showed that Ampligen in that program, as a monotherapy, extended life beyond the standard of care approximately eight months greater than what was expected from the standard of care. The controls were very well-matched. Those were the controls. That was the data that was used to get approval of orphan drug designations, both from the United States and from the European Union.
So, you know, that extension of life, combined with what we saw in the early access program as a very significant impact in improving the quality of life for subjects, made it clear that we needed to move forward, which was the basis for the collaboration with AstraZeneca and the phase II at Erasmus, which is ongoing right now. Now, the quality of life aspect of this needs to be highlighted because we're showing an extension of progression-free survival and overall survival. In other words, we're, as a maintenance therapy after the standard of care, we're taking people's lifespan out, in some instances, quite significantly. But doing it with high quality of life makes a big difference. Late-stage pancreatic cancer is a horribly painful and burdensome disease.
To be able to relieve the pain, which is typically caused by an aggressive tumor both impinging upon and compressing nerve bundles that surround the pancreas in the area of the solar plexus, helps to alleviate the pain as a result of the disease stabilization. Also, Ampligen has been shown to be a very powerful antiviral agent. Therefore, it has an impact on a number of the comorbidities that are also a plague upon these late-stage pancreatic cancer patients. We see that we have an impact on survival that is quite significant, combined with improved quality of life for people who have a very harsh environment otherwise.
Thank you, Tom. We have time for one more question. Looking ahead over the next 12-18 months, what milestones from DURIPANC or other programs should investors be watching more closely?
Well, the DURIPANC milestones are already in place. We're looking to have, by the end of this year, the last subject treated. The DURIPANC program is a 25-subject program. Right now, we have 18 subjects that are in treatment of the 25. We have every expectation because enrollment has been successful in the Netherlands. We have every expectation of having everybody enrolled and treated, and by the end of the year, treatment completed. That's an important milestone. The database will be articulated in detail at that time. Thus far, everything looks very promising. These are open-label studies. As the interim reports suggest, we're moving forward positively. But until it's over, we won't be able to make any specific projections. What we do know is that progression-free survival seems to be strong, safety is extremely strong, and quality of life is extremely strong as we move forward.
It'll move into 2027 before we have the ability to project the impact on overall survival due to the fact that we have to wait a certain period of time under the protocol. What's more important is, today, as I've stated, we are in the process of beginning our planning and design for the phase III trial that we hope to initiate in the near future. That phase III design will have milestones built into it that take us to what I think is the money shot here, which is getting into a phase III trial with the ability to show that we're having the same positive impact that we've had so far in our clinical programs.
Remember, you know, the work that we've done here is somewhat de-risked by the fact that at this point right now, I think we have treated 75 subjects with Ampligen in pancreatic cancer. That gives us confidence moving into the phase III part of this program.
All right, great. That's all the time we have for Q&A. Tom, thank you again for your time and presentation.
Thank you very much for your interest in AIM ImmunoTech and the work we're doing in pancreatic cancer.
Great. Thank you. For more information on AIM ImmunoTech, please visit their Corporate Connect page on the app. That concludes Day Two of our Corporate Connect Service Healthcare webinar. Please stay tuned for more upcoming CCS investment webinars featuring a variety of sectors at www.webull.com/webinar or in the Learn section of the Webull app. Thank you for joining us, and have a great rest of your day.