Hello and welcome to Vivesto's Paccal Vet seminar. If you have any questions, please feel free to use the form that is located to the right, and we'll take that up. Without further ado, please go ahead with your presentation.
Thank you very much. And again, very welcome to the Paccal Vet webinar, where we will talk about Paccal Vet, which is in clinical development, and Paccal Vet, which is a new chemotherapy opportunity for treatment in cancer of dogs. We have an exciting afternoon ahead of us. Our focus will be on the medical need for for this type of a product and the clinical development that the program is currently in, and also the way to commercial approval or marketing approval and commercialization. Oops, sorry. So, first of all, just a reminder: we will make forward-looking statements, which may or may not occur. These are the speakers for today. First of all, we we have to welcome Henrik Rönnberg, who is a professor and a board-certified veterinary oncologist. We have a longstanding relationship with Henrik as an advisor, and he is very important to us.
Key is also Jim Perry, also a board-certified veterinary oncologist and surgeon, who is also a partner and a founder of CASTR, the clinical research organization that we are working with for this program. Joining me also from Vivesto is Heidi Ramstad, who is the Chief Medical Officer, and Johanna Röstin, who is the Chief Regulatory Officer. This is the agenda for today. I will give you a brief introduction of Vivesto, followed by Henrik, who will talk on the medical need for new medications in veterinary oncology. Heidi will take you through our clinical trial, the ongoing clinical trial, give you an overview, and present the design of the study. And Jim Perry will talk to the clinical operations aspect of this trial of the ongoing trial in the U.S. Johanna will talk to the regulatory strategy, the framework, and the status, and the way to market approval.
And then we will have quite some ample time for some Q&A as well. So first of all, we introduced a new strategy last year, a focused strategy, being an R&D company taking programs from preclinical to clinical proof of concept. Our most advanced program is Paccal Vet, and the indication is illustrated to the right in the hemangiosarcoma picture. And what I would like to say here is that we are in a pilot study, a clinical pilot study. There is ongoing in that value enhancing activities. And importantly, we have an upcoming near-term milestone in the interim results that Heidi will address in a while.
What I would like to point out also is that, in line with the strategy, we are looking to partner the study with a partner who has the financial and expertise resources to take this program through the pivotal study and also to commercialization. What is important is also that there is a considerable commercial opportunity in this, in that the veterinary cancer therapeutics market is forecasted to grow to some $2.5 billion by 2030. We have a second program in docetaxel micellar, which is in phase II. The final results will come later this year, and after that, we will decide upon the next steps in this program. A third program is Cantrixil, which is in preclinical development.
We recently reported very optimistic, very positive results in our hematological experiments, and experiments are currently ongoing, and results from those will be presented later this year. Vivesto is a NASDAQ-listed company, NASDAQ Stockholm small cap, with a market cap of about SEK 170 million. We have a cash position of SEK 77 million, which gives us a runway until 2026. So with that, I would like to hand over to Professor Rönnberg, please.
So thank you. Thank you so much, Erik, for that introduction. And my name is Henrik Rönnberg, and I'm a board-certified veterinary oncologist, and I will walk you through the medical needs in veterinary oncology. So there is a high medical need for tailored treatments in dogs with cancer. First of all, cancer is very common in dogs. One out of four dogs will develop neoplasia during the lifespan. Recent data suggest even higher predisposition for cancer. Up to one-third of the dogs will develop tumors. It's also very well known that cancer is a growing older dog disease. So above 10 years of age, the likelihood of getting cancer is 50%. And then finally, first and foremost, the number one reason for death, or cancer is the number one risk of dying in dogs.
All this really makes the number of the dogs with cancer enormous in the clinic, but also it's a concern for owners and for veterinarians that the quality of life is worsened when you get cancer. So therefore is a very, very high need for better treatment and diagnostics for cancer in dogs. There's an increased value of dogs over the years. We've seen that definitely, and I would say skyrocket the last decade. And pet owners expect similar treatments options for the pets as for themselves. Many pet owners call themselves pet parents, also underscoring the value of the dog in the family. So medicines or drugs designed for specifically for veterinary use accounts for species-specific differences, will ensure safety and efficacy in the species that we use the drug for.
That's also very important for the owner of these dogs that we can serve that. Then, unfortunately, there's a limited approved treatment for a limited number of drugs approved for treatment in dogs with cancer. So the medical need is very high. So there's just a couple of drugs registered for treatment in dogs with cancer. And the current landscape of that is in lymphoma, mast cell tumors, and oral melanomas in dogs. In lymphoma, there are two drugs registered. One is Tanovea, which is an injectable, and then verdinexor, which is so-called conditionally approved. It's an oral medication in lymphoma. Both these are currently only available in the U.S. Mast cell tumors, the most common skin tumors in dogs.
There we have three treatment options currently: Stelfonta, which is an injectable to locally destroy the tumor, and then two oral treatments for preferentially mast cell tumors with a mutation in c-kit. Because both of these are oral targeted therapies for tyrosine kinase receptors. Palladia is available both in the U.S. and in Europe and worldwide. The other one, Masivet, is currently only available in Europe. Finally, there's a USDA-approved vaccine for oral melanomas or a subset of oral melanomas in dogs. Locally controlled oral melanomas after surgery or radiotherapy can be used with Oncept. We can get that in Europe under individual licensure. Otherwise, it's available only in the U.S..
Just to touch base a bit on the repurposing of human cancer medicine for veterinary use, there are several opportunities in that because that can accelerate the drug development, because there is a lot of preclinical data that can be used for the same purposes in dogs. So that will accelerate the drug development for a while or a bit. And then, of course, we'll expand the treatment options since I told you about the limited treatment options that we currently have in registered drugs for veterinary use. And then comparative oncology is very interesting because there's a well-known similarity between cancers in dogs and people. Sometimes they are almost identical, and they also are spontaneously developed, which is very important when it comes to research.
There's some challenges in rodent models when you have induced tumors and with immunosuppressed animals when you try out different types of treatment. But the comparative oncology aspect is more and more considered a very, very good way of informing human oncology trials, but also improving the knowledge about drugs developed for animals. At the same time, the innovation and collaboration comes into that comparative oncology spectrum where we can build up new very good networks with human oncology and advancing the knowledge of cancer in general. The challenge is, of course, lack of data because human cancer drugs are developed for humans. Therefore, there's a lack of data for species-specific things in dogs. And that comes both for efficacy, but of course also for safety.
Safety is very important in veterinary medicine, definitely, because we very, very much want to ensure quality of life in our patients. Safety data must be controlled and collected in a very, very meticulous way. That's seldom done in so-called clinical uncontrolled trials. The dosing is also very important that we get the correct dose that will ensure efficacy but reduce toxicity to a minimum. Then cost, unfortunately, repurposing some of the newer cancer, human cancer medicines is just totally cost prohibited in veterinary oncology. So there's some words about paclitaxel since Paccal Vet is based on paclitaxel. So paclitaxel is one of the most effective anti-cancer drugs in human cancers. As I told you in the comparative oncology aspect, the mechanism of cancer are often similar or identical between dogs and humans.
So therefore, paclitaxel should be available to use in dogs as well. One particular hallmark of cancer is cell division, which is common for all cancers almost. Paclitaxel mechanism of action is going towards the cell division. Therefore, since the cell division is much higher in tumors than in the normal tissue, then the cancer will be hit by paclitaxel. Unfortunately, paclitaxel, the formulations currently used in humans cannot be used in dogs specifically due to toxic and allergic reactions. That is not due to paclitaxel in itself. But since paclitaxel must be dissolved in something before injected into the cancer patient, the solution or excipient that's used right now is too toxic for dogs. Some of the dogs will actually die out of the IV injection with the paclitaxel formulations used in humans.
So that has precluded the use of paclitaxel in veterinary oncology. So the next speaker will talk to you more about through the science behind new solutions for making this drug available or possible to give in dogs. So please, Heidi.
Thank you, Henrik. We will now move on to the clinical development part of the webinar. My colleague, Teresa Fernández and I are responsible for planning and conducting the clinical program. In my presentation, I would like to explain why we chose hemangiosarcoma, or also abbreviated HSA for simplicity. Provide an overview of the trial design, and finally, our clinical development plan. But first, I would like to bridge over from Henrik's last slide and start with paclitaxel. As he just described, medicines approved for humans can be used to treat animals. But sometimes the formulations are not tolerable and cause severe side effects. Vivesto has formulated paclitaxel micellar, or Paccal Vet. It's paclitaxel with Vivesto's XR17. And here you can see the, if I can manage to put, if you can see, here is the micelle with the active ingredient in the center.
Vet has been investigated in several clinical trials. It has an acceptable tolerability and safety profile, and anti-tumor activity in various carcinomas has been shown. But it has not yet been tested in sarcomas. So why do we choose hemangiosarcoma? Unknown cancer in humans is angiosarcoma. And that is the closest to a human equivalent to hemangiosarcoma. And what these cancers have in common is the development from or relation to blood vessels. We know that paclitaxel has shown to induce tumor control in human patients with angiosarcomas. And these findings suggest that Paccal Vet could be a promising treatment option for dogs with hemangiosarcoma. So hemangiosarcoma, before I enter into the trial. There are about 75,000 new cases of HSA in the U.S. every year, and equally about 75,000 in Europe. If you look at the dog in this picture, we have marked one organ red. It's the spleen.
It's a blood-filled organ in the abdominal cavity of the dog. More than half of all hemangiosarcomas develop in the spleen. This is the disease we will focus on: splenic hemangiosarcoma. As an example, one in five Golden Retrievers is diagnosed with HSA, and 90% of them are actually splenic. When the hemangiosarcoma develops in the spleen, the dog owner doesn't usually suspect the dog being ill until it's either found by a coincidence, the tumor I mean, or typically presents with an acute abdominal bleeding when the tumor within the spleen has ruptured. The dog is then taken to the emergency vet clinic and acutely operated and then diagnosed. After surgery, the dog may be treated with non-veterinary-approved chemotherapy. That is not that well tolerated in all dogs due to some toxicity specific to this drug. What we can say is that it's a devastating disease.
Survival is expected to be just a few weeks to months. But that depends, of course, on the stage of the disease at the time of diagnosis. Our trial. In the ongoing pilot trial, our aim is to investigate the safety and activity of Paccal Vet in splenic hemangiosarcomas. It's an open trial with no placebo control. It's divided into two cohorts. And now, how are the two cohorts composed? Each cohort is a group where the dogs have certain things in common. In this trial, the cohort is determined by the severity of the disease. Or also, what we say, the stage of the disease. And hemangiosarcomas can be stage I, II, or III. On the left-hand side of the screen, you can see an illustration of cohort one. This is the cohort in which we are currently recruiting patients.
It's a dog with stage I or II disease, illustrated by the red dots in the spleen. These dogs have more limited disease than the dogs that we may recruit in the cohort two. On the right-hand side, that's stage III, and the cancer has spread. The tumor in the spleen is spread to more remote organs. This is shown with the red dots. Dogs in both cohorts will follow the same schedule with four treatments with Paccal Vet, with 21 days interval, and follow up regularly for up to 12 months. So then to our clinical development. Where are we now? Here is the blue arrow, and that's where we are now. We're commencing with the pilot trial. Dogs are being recruited at six sites in the U.S., namely in Oregon and Washington.
We aim to have the first results of the study with an interim analysis late this year. That's indicated with the white star. This is also the decision point on activation of the second cohort. After the pilot, what are the next steps? We will proceed to perform the pivotal trial where Paccal Vet will be compared to standard of care. We expect the pivotal trial to be run in both the U.S. and Europe. We aim to start planning for it sometime early next year. This trial is a requirement for regulatory approval. Johanna Röstin, our Chief Regulatory Officer, will provide more details in her presentation. With this, we hope you have a better understanding of the rationale behind choosing the HSA indication, splenic hemangiosarcoma. The first results from the pilot will be analyzed year-end in an interim analysis.
The pilot will be followed by a pivotal trial that leads to regulatory submission. With this, I'm pleased to hand over to Dr. Jim Perry in the U.S., with even a minus eight time difference to Sweden. Jim is representing our CRO, CASTR Alliance, where he is the CEO. He is also the medical director of the pilot trial. Thank you.
Hi, good afternoon. Thanks for having me. My name is Jim Perry. I'm a veterinarian and researcher, and I'm also the CEO of CASTR Alliance, who has been contracted to run this exciting study looking at Paccal Vet in dogs with hemangiosarcoma. Once again, thanks for having me. My goal today is just to talk a little bit about the logistics and the starting of this trial. So I'm happy to share with you kind of where we are at this point. First and foremost, I am a veterinary oncologist. So I practice clinical medicine kind of part-time and then run CASTR the rest of my professional time. As Henrik clearly stated, cancer in pet dogs and veterinary patients in general is exceedingly common.
There is clearly an unmet need to develop new therapeutic options for the diseases. As in many cases, specifically hemangiosarcoma and a lot of the other aggressive cancers we see, the clinical improvement with new therapies has not seen progress in really over 30 years in many cases. So this hits particularly close to home with me, especially with hemangiosarcoma. And I'll tell you later with other cancers. But this, in this picture, the Border Collie was my last dog that I had, and she actually passed from stage III hemangiosarcoma. So this disease particularly kind of is heavy on my heart because I lost a pet to it. So really, based on this unmet need for new therapies and an overall positive veterinary clinical trials happening and centers to facilitate them. And this is really despite a great enthusiasm among veterinary clinicians like myself and other oncologists.
They do want these studies, but they're just not many out there, not being organized or funded. That's why my colleague and I, Jessica, started CASTR Alliance, really with the mission to facilitate the discovery and study of novel treatments for human and veterinary patients by providing turnkey management of sponsored veterinary clinical studies. So what are our standards? One of the reasons we started CASTR Alliance, not only is there, you know, few veterinary clinical trials being done overall, but of the majority of the clinical studies that we see in veterinary medicine and particularly oncology, a lot of the studies are relatively poorly powered or they're retrospective in nature. So even when data is acquired and contributed to the literature, there's a lot of caveats as far as knowing how strong we should believe the data and what therapies are truly beneficial.
So really, our goal for CASTR is not only to run more studies, but also to run studies where we can trust the data and also follow what's called Good Clinical Practices, which is a standard that has been set by regulatory agencies. AVMA has contributed, but basically to make it such that not only are we collecting high-quality data for the study, but we are also ensuring the right safety and well-being of our patients. So including that we have a very well-documented informed consent process to make sure clients know the risks and potential benefits of a trial. And then also just ensuring that the data that we collect throughout the study is trustable, essentially.
So all the studies that CASTR Alliance runs are based on this good clinical practice standards to assure good quality data and, again, the well-being and safety of our patients as much as we can. So CASTR, we have a network of private practice clinical sites throughout the U.S. We are primarily based in the Northwest, Pacific Northwest region of the U.S., but several of our contracts do include nationwide sites. So we're excited to bring a large network of potential clinics that can run these studies. Like I said, we utilize private specialty hospitals, mainly because these specialty hospitals tend to be in the areas that are most in proximity to large metropolitan areas.
So U.S.-based veterinary schools where a lot of studies have been done historically, they tend to be in more rural agriculture-based areas based on how the university, the land grant university system was set up a long time ago in the U.S. And for example, looking at the Northwest, where a lot of our studies are based out of, the veterinary schools within Oregon and Washington, so the major metropolitan areas are Seattle, which is up here, and then Portland here. The closest veterinary schools is in Corvallis, which is about an hour and a half south of Portland. Or the Washington-based school is all the way in eastern Washington in Pullman, which is a good four-hour drive, four- to five-hour drive from Seattle or Portland. And that's going over major mountain passes.
Clearly not an ideal situation for clinical trials to be run for patients that live in Seattle or Portland. We're utilizing sites both in the Seattle and Portland metropolitan areas to basically allow these high-populated areas to enroll in clinical trials when they would not otherwise be able to. The other benefit of doing these private practices is that oftentimes the clinicians, where there's a lot of specialists in these practices, they're also very enthusiastic as far as expanding their clinic base to experimental and trials in general. That just helps, I think, from talking with different clinicians and myself too. It provides a new enthusiasm or excitement to practicing. You're not just doing the routine, mundane treatments. You're trying new things and advancing therapies for their patients. Another big plus for me and a lot of the clinicians I work with.
As far as the Paccal Vet study specifically, we've enrolled six sites or activated six sites. Again, two of them are in the main Portland area, three up in the Seattle metro area, and then one in a growing part of Oregon, central Oregon, near Bend, which is a large specialty clinic out there too. Lots of draw from these metropolitan areas to hopefully enroll this study fairly quickly. As I mentioned earlier, we are active at multiple of these sites, and we are currently planned to have the remaining sites fully active and ready to enroll patients within the next few weeks. Essentially right now, we've obviously with the activation of the sites, we have a finalized protocol and thorough informed consent form to let the patients know what they're set up to do as far as the trial.
We have overall across the six sites that we have present, there's 10 participating veterinary oncologists and over 40 support staff. So we're really excited to have a large number of clinical staff that are excited to get this study rolling in patients. And that's one of the, especially for me, when we're activating these sites, seeing how the staff is excited to participate is really enjoyable to me. And it reiterates, you know, why we're doing this. So we have this in the picture to the left. This is the announcement for the study. It's published on the AVMA Clinical Trials website. So for more information, if you're interested in seeing the specifics of the study or any potential client that might want to enroll in the study, can go to this website to see the specifics and what the criteria and obligations are for enrollment in the study.
It also shows that, yes, this is a fully funded study, which is great for a number of reasons, but in particular that really the patient participation can occur regardless of demographics or, you know, money that the patient or the parents might have to enroll their patient. So exciting to be able to offer this study across the board without any bias toward affluence or any of that. So as part of this, I wanted to just update you on the first patient. So again, our first site was activated just earlier this month. And basically immediately after activation, we had our first patient. This was activated or enrolled at the Bend, Oregon site, Veterinary Referral Center of Central Oregon. And excitingly, the patient was diagnosed with its splenic mass even before the site was activated.
But knowing that the study was upcoming, they were informed of the study, excited about it, and basically ready to enroll as soon as the study became active. So the patient, Tango, is a 10-year-old German Shepherd dog and actually had a splenic mass diagnosed incidentally on a CT scan that was done to work up a mass that was diagnosed in his anal gland, which is another common tumor site we see in dogs. But essentially, the study was discussed. At that point, we didn't know what the type of tumor was in the spleen or the anal gland, for that matter. The dog underwent splenectomy. This is a CT picture showing this is a normal-looking spleen in an older dog with the mass that was found on the tail of the spleen.
The dog underwent a splenectomy, so removal of the spleen and also removal of the nodule in his anal gland. The biopsy confirmed the splenic mass was hemangiosarcoma. This would be considered a stage I hemangiosarcoma since it wasn't bleeding at the time of surgery. The nodule in the anal sac was actually benign. That allowed the dog to not have a concurrent cancer that would need treatment and thus could enroll in the study, the Paccal Vet study for the hemangiosarcoma. That dog has undergone his first treatment. That was two weeks ago at the first recheck. At the seven-day mark, we recheck the blood counts to make sure to see how they tolerated the drug and also assess quality of life and just overall how the dog did with the first treatment.
Dog did very well, did have some mild GI, gastrointestinal upset for about a day, but very manageable at home. No other major side effects with the owner being overall happy and portraying Tango's quality of life as good throughout the treatment so far. The plan for that dog, the next treatment is on the 27th, so later this week. We'll undergo a total of four treatments, as mentioned previously, and then we'll follow him throughout the course for up to a year with recheck imaging to see if and when the disease progresses. With that, again, we're ongoing enrolling, and obviously we'll probably be keeping you posted with the study patients that come in. In addition to that, I just also wanted to say specifically aside, just thank Vivesto and the Vivesto team for sponsoring this study.
I mean, from a veterinary professional and a clinician, again, I can't reiterate how nice it is to have these studies out there with the potential optimism that we may have more new therapies out there. And again, above all, these studies really do bring us hope for a better future. And I'll leave you with just a picture. This is my current dog. This is Cadence, and I actually adopted her as she was relinquished when she was diagnosed with osteosarcoma. So another very, very common tumor we see in dogs and golden specifically. And this is just showing her she had an osteosarcoma bone tumor of her shoulder. She's two years old. And this is her about three weeks after her surgery. So obviously just doing very well. And it just reiterates how amazing dogs are in their tolerance of dealing with cancers and the treatment.
And then additionally, she was also enrolled in a different clinical trial for osteosarcoma, which, you know, hopefully will be, you know, similar to the Paccal Vet study, an option to improve survival down the future with these diseases. So with that, just want to say thank you. And please let me know if you have any questions.
Thank you, Jim. That was really fun to listen to. Very inspiring. Now we will switch over to the regulatory part of this presentation. My name is Johanna Röstin, and I'm responsible for regulatory affairs at Vivesto. In these next few slides, I want to give you a brief introduction to the regulatory framework in the U.S. and Europe for veterinary products. Also an overview of what is required to bring Paccal Vet to market approval. And last, I want to give a summary of the current regulatory status for Paccal Vet. So this first slide provides a high-level introduction to the regulatory framework for veterinary products in the U.S. and Europe. Veterinary medicines are, in fact, very carefully regulated by the same authorities as human drugs are. In the U.S., it's the Food and Drug Administration, FDA, and in Europe, it's the EMA.
Both authorities have their respective veterinary expert teams that perform scientific review of the regulatory product dossiers and participate in the decision for market approval. In the U.S., the regulatory product dossier is referred to as New Animal Drug Application or NADA. It would be NDA, BLA for human drugs. In Europe, it's Marketing Authorization Application. Both authorities also have regulatory pathways that apply to small products for rare diseases and can be compared to the human equivalent of the orphan drug legislations. FDA has a procedure of MUMS designation. We applied for MUMS for Paccal Vet last year and got it granted for use in splenic HSA. This actually provides a strong incentive of getting seven years market exclusivity at approval. This would mean that Paccal Vet would be protected from generic competition as well as similar products for the first seven years on the market after approval.
Conditional approval or MUMS also provides the opportunity for conditional approval. This is based on a limited clinical data package and enables reaching the market at an early stage. During this conditional approval, which has a time limit of five years, the company can sell the drug but in parallel must perform a pivotal study to generate the remaining clinical data required for a full approval. In Europe, all EMA-approved veterinary products have 10 years of protection from generics. The EMA version of the small market product has a limited market classification pathway. This also allows for reduced data requirements and a faster way to the market. What is required to bring Paccal Vet to regulatory approval? There are three major blocks of data that are required in a regulatory dossier. It's chemistry manufacturing controls or CMC, which describes the manufacturing process, analytical methods, and drug quality.
It's safety data where the data is generated early in preclinical studies and throughout the clinical development. Then the clinical trials, which thoroughly describe the clinical safety and efficacy of the drug. Given that the Paccal Vet project has been ongoing for quite some time, we do have a lot of data in place already. For the CMC manufacturing part, we are in a really good position of having a scaled up and validated process. We know we can manufacture the drug at a large scale and in a well-controlled way. We are also in good shape when it comes to the safety data. We have an extensive safety database based on previous clinical development. Over 300 dogs have been treated with Paccal Vet already. As Heidi presented, we are now conducting a pilot study to evaluate Paccal Vet for the treatment of hemangiosarcoma.
In order to obtain the full market approval, we need to continue with a pivotal study in which Paccal Vet would be compared to the standard of care treatment. This is like a phase III study. Interactions with the authorities, EMA, and FDA are super important. We as a company need to assure that we meet the regulatory expectations and requirements for drug development and approval. We definitely will have interactions with both authorities as this program develops. As Erik mentioned, we will need to have a partner for going into the pivotal study, regulatory submission, and commercialization. Lastly, this is a summary of the current regulatory status. The FDA and EMA have knowledge about Paccal Vet from previous interactions. Both authorities have scientifically reviewed and discussed Paccal Vet in detail. Particularly with the FDA, we communicate on a regular basis.
We had a pre-submission conference or scientific advice meeting last summer. We have quarterly updates with the project manager at CVM to inform about the progress. I can just mention that it's been really quite encouraging to interact with the FDA. They have been very supportive and very interested in Paccal Vet. I believe this reflects the high unmet need and the need for regulatory-approved veterinary drugs. MUMS was granted by FDA late last year. With the EMA, we have not yet had any interactions, but the limited market classification opportunity is being assessed. Work is in progress there. At the latest stage of the pilot study, we plan to go for new authority meetings. And with that, I hand over to Erik.
Thank you, Johanna. And thank you also, Henrik, Heidi, and Jim for excellent and very interesting presentations. I think by now you understand why we are excited about Paccal Vet. And I believe that you will be more excited about the program as well after this webinar. So in summary, I'd just like to say that what we heard today is that there's a high unmet medical need for new cancer medications in dogs. And certainly, Paccal Vet could be a program that meets those high unmet medical needs. Paccal Vet is a new chemotherapy opportunity, and it's now in clinical development. And what we're looking forward to is, as outlined by Heidi, the interim results from that pilot study by the end of this year.
What I would like to add to this is the compelling commercial opportunity that resides within the program as well, and which will be more obvious as we do these value-enhancing activities that we're doing now in the pilot study. Bloomberg forecasts a veterinary pharmaceuticals market of $25 billion by 2030. The cancer therapeutics market is a considerable part of that, forecast to grow with some 11% per year to $2.5 billion by 2030. From a pricing perspective, one can make the comparison with Tanovea, which Henrik brought up, which is a drug for lymphoma, where a full treatment of five cycles is in the price range of $3,000 per treatment. With that summary, I'd like to welcome the present presenters again for our Q&A session, which will be moderated by Finn Meyer. Please, over to you.
Thank you very much for that presentation. Like I said, now we'll jump into the Q&A section here. We'll start with the first question here. Will veterinarians be interested in a product like Paccal Vet?
Well, I guess I can start up on answering that. As I said in my presentation, we have a limited amount of veterinary-registered products available. None of those are within the class of taxane or paclitaxel. The mode of action is very particular for paclitaxel. And when we use that in oncology, we, of course, hope that using another class that we don't have yet will increase the efficacy in the tumors that we currently treat. But also, one of the biggest reasons for stopping chemotherapy in cancer treatment is something called resistance. So resistance to chemotherapy. And the resistance is, of course, against the mode of action of that particular drug.
So having another drug class in the toolbox with a completely different mode of action from the ones that we already have would potentially make it possible to use it also for tumors that undergo resistance for other treatment options. So therefore, I think veterinarians in general are very interested in getting more treatment options at all, but for this drug class particularly, since we haven't had that at all before.
What's your perspective on the adherence of veterinarians to using regulatory-approved treatments over well-established alternatives like doxorubicin?
Well, I can speak for that being a veterinary oncologist. In Europe, we are obliged to use a veterinary-registered product first through the so-called Cascade Principle. So we're legally obliged to do that. In the U.S., that's less of a problem or less of an issue with the Cascade Principle. But again, I think it's very, very good to use evidence-based veterinary medicine in general. And the highest level of evidence is when you have controlled clinical trials behind what you are using. And I think that's what most veterinarians want to use. When it comes to doxorubicin instead of paclitaxel, I guess the question is in Hemangiosarcoma for the indication that the pilot trial is in right now. And one of the off-label drugs that we use in Hemangiosarcoma after surgery is doxorubicin.
One needs to understand that the benefit of using doxorubicin after surgery in this very, very difficult disease is unfortunately modest. So you increase the survival in those cases for a couple of weeks to maybe months. So therefore, a lot of veterinarians and owners today don't go for doxorubicin treatment because of that. So we, of course, hope that Paccal Vet will give us a better opportunity and a better difference between non-treated and treated animals with this new mode of action that we have in paclitaxel. So we anticipate the result of the trial.
Do you think that there will be a willingness to pay for a product like Paccal Vet?
Well, I guess that I'm not the only one answering this, but I guess that the pricing will be similar to the cost of veterinary-registered products used today.
Yes, that's what we think as well. And we did actually do a small focus study already at this stage. And there is clearly, given obviously the outcome of the study, a preparedness to pay prices in that range.
Yeah. And I would also say that there's an increased interest in veterinary insurance around the world. And particularly that increase is notable in the U.S. We have had that for a longer time in Scandinavia in particular, but now coming more and more in Europe. So that will mean that more and more people will be able to afford more advanced treatments in veterinary medicine. And that is true also for oncology, of course. And when I deal with insurance companies, they are very interested in supporting evidence-based medicine again. So it's important also for them to actually support treatments that there is a proven scientific result saying that this is efficacious instead of support costly treatments with not so much evidence behind it that is efficacious. So therefore, I think it's also very important to first use veterinary-registered products.
How many patients do you believe will be needed in a pivotal trial to obtain regulatory approval?
I think I can answer that. It's a little bit early to estimate the number of patients needed for the pivotal trial. Firstly, we need to have a look at the results from the pilot trial, which is a kind of proof of concept. Then we will work together with the statistician. And of course, also have a meeting with the authorities before we decide on the number of dogs to be included. This is something that we hope to be starting next year to plan for. But what we can say, depending on how many sites, as you heard previously, this study will take place both in Europe and the U.S. We can say that a pivotal trial takes two to three years, but this all depends on many different factors.
I'm sorry, I can't give a precise number, but you will be updated, I believe, next year sometime.
Yeah. Maybe if we can add to that this sort of a rule of thumb, a bare minimum of how many dogs need to be included. That is governed by the safety database. Given that we have quite a number of dogs, as Johanna outlined earlier on, more than 300, I think that if we have a very efficacious drug, the pivotal study will be quite limited, actually.
Yes.
Do you plan to file for a Conditional Approval?
Maybe I can start off. That's a good question, of course. It is an apparent opportunity to file for a conditional approval as it would allow us to sell the drug. But what will remain is the need to actually do a pivotal study anyway to document it. And as you've heard Henrik outline, there's an urge from veterinarians to get well-documented drugs as new tools in the toolbox as well. And that's from several perspectives. So there is the possibility. But what I said earlier on also is that in line with our strategy, what we want to do is to find a partner. And it will be very much in dialogue with the partner what regulatory route we actually choose to go for. And some differences also in the European and U.S. regulations as well. Maybe you want to add to that.
No, I agree with all you said. I think we will continuously evaluate the possibility and opportunity to file for Conditional Approval. It will depend on the robustness of the data, the regulatory feedback that we get, and the capabilities of this partner.
Yeah. And when do you expect to have a market-approved product ready for commercialization?
That goes a bit together with the previous question, I would say, in what type of a strategy the partner would like to set up. But obviously, there will be at some point a need for a pivotal trial. And maybe you can comment on that again.
Yeah, it's really repeating myself a little bit. But when we need one pivotal trial, and when we have the results from this, the clinical study report from this pivotal trial, we will prepare the dossier and submit. And as I said, it may take two to three years with the pivotal trial. But of course, if you increase the number of sites, that is also a cost issue. And there are a number of factors that decide, actually. But I would say two to three years.
Maybe a half year with the regulatory agencies as well.
Yes, it's six to twelve months, depending on which agency we're talking about.
What does it mean that it's an open study?
An open trial. The pivotal trial now, the pilot trial ongoing is an open trial. There are no placebo controls. So this means all patients get what we call the investigational veterinary product, which is Paccal Vet. So every dog enrolled is treated with the same medicine. And we will, of course, collect this data. And we have planned together with the statistician that when we have 10, I think 10 dogs that have been completing all treatments, we will do an interim analysis towards the end of the year. And of course, we will not stop after recruiting 10 patients now, maybe in the middle of the summer. We will continue recruiting the total number of patients and follow up. But the first 10 patients and results from that will be analyzed late this year.
And they compare to historical data.
Yeah, and compare it to historical data. Thank you.
An open trial also means that both the veterinarian and the owner know what type of treatment the dog gets.
Yeah. No secrets.
No, it's not blinded.
Paccal Vet has not been prioritized in the past years. Why is now a good time to focus on Paccal Vet? Why should Vivesto succeed with Paccal Vet at this time?
That's a good question, obviously. It's been part of our sort of rethinking and the new strategy from last year. We are now a much more focused company in focusing on R&D. As I said, going to proof of concept and the equivalent in this case would be the pilot study. After that, rather than going for a pivotal study and commercialization ourselves, to actually seek a partner. In parallel with this, the interest, as outlined, has increased dramatically for new veterinary oncology medicines as well. I think both Henrik and Jim presented that as well. So that, in combination, led us to the conclusion that this is a quite low-risk, relatively speaking, program with a high commercial opportunity in that it really does have the potential to fulfill a high unmet medical need. Anyone want to add to that?
No.
Looking at previous studies with Paccal Vet in canines, the dose of 150 milligrams per square meter every three weeks was chosen. How do you view that regimen?
Yeah, Henrik can.
Yeah. As speakers before me during this session, as shown, we have a lot of clinical data on the treatment of Paccal Vet, most in that dosing regimen. So therefore, we have safety data for that dose and also target animal safety study based on that dose. And that will put Vivesto in a better position when it comes to drive the trial forward and benefit from earlier collected data. But maybe you can comment more on that.
No, I think that summarizes it well. We have a big safety database, and it's on this current dosing regimen. So we stick to that.
We'll take one final question here. What's your impression of the proportion of dogs with cancer-surviving treatments compared to the total number of dogs with cancer?
Oh, that's a tricky question.
Statistics. I can begin where at least we know that, like Henrik presented, almost 50% of dogs aged 10 years or older, they die from cancer. But there aren't really many good registries on cancer treatments in dogs. So maybe the clinician can help us more on that.
I would say that no one really knows today. If someone says that they know it, I think they're not really correct. The reason is that it's hard because the general practitioner doesn't treat advanced cancer diseases. It refers it to the specialist. The specialist only treats advanced cases or with advanced treatment options. So if you ask a specialist, 100% of the tumor cases will get advanced treatment. If you ask the general practitioner, maybe they say no one gets it because they don't treat it. So the answer is in between. The thing is, what we know is that we have an increased number of older dogs because of the value of the dog in the family. So owners keep their dogs longer.
Also, we know the pandemic boomers because there was a high increase in number of pets in general during the pandemic a couple of years ago. Those will become around seven, eight years in a couple of years where they will have a high risk of start developing cancer. So the number of cancer cases will increase. That will, of course, increase the number of cases that will be treated with chemotherapy. One last thing is that it has been a very increased interest recently in diagnosing cancer earlier. That's because some new tumor biomarkers have become available on the market for us veterinarians, and in particular when it comes to tumor DNA measurements in the blood, which will make owners coming to veterinarians more often to diagnose or try to diagnose cancer. There will be more cancer diagnosed.
Therefore, the number of cancer patients will increase. That will increase the number of potential cases treated with chemotherapy. The exact number, I don't think anyone knows.
So even if we don't know the exact number, there will be more dogs, older dogs, more pet owners who want their dogs treated. The willingness to pay and perhaps also the insurance company's willingness to pay for well-documented drugs will increase, although.
The possibility for people to afford treatment, if afford more advanced diagnosis and treatment options, increases.
That's given that there must be some treatment options available. Then we can start talking. But perhaps it's time to start a registry on cancer in dogs.
Okay. With that, thank you again very much for excellent and very exciting presentations. Thanks, everyone, for joining as well.
Excellent questions.
Excellent questions as well. Thank you, Finn Meyer, for helping us with this webinar.