Shares of Adventrx Pharmaceuticals Inc. (ANX) are trading -87.41 % from their 52-Wk High ($ 4.21). With two possible pending Phase III trial initiations on-tap and some recent insider buying, it appears the heavily shorted stock may be a good bottom bounce candidate at today's price levels.
The specialty pharmaceutical company's product portfolio includes: ANX-530 or Exelbine a novel emulsion formulation of the chemotherapy drug vinorelbine indicated for treatment of advanced non-small cell lung cancer; ANX-514, a novel emulsion formulation of the chemotherapy drug docetaxel indicated for the treatment of advanced cancer; and ANX-188, a novel, purified, rheologic and antithrombotic compound initially being developed as a first-in-class treatment for pediatric patients with sickle cell disease in acute crisis.
Brian M. Culley, the firm's CEO and Director sat down with us to talk about his firm and the antithrombotic and rheologic polymer (ANX-188) which they are planning to test in sickle cell disease soon.
Question: Tell us about your pipeline and where you are as a firm right now.
CEO Culley: Sure. The company is well capitalized. We own the right to develop three different programs and the most important of which is something called ANX-188. It is an antithrombotic and rheologic polymer that we're going to be testing in sickle cell disease.
Question: Okay. Well why don't we talk about ANX-188 for just a moment. You say it's an antithrombotic polymer. Could you explain that just for a moment?
CEO Culley: Sure. It's a very interesting drug. It has the ability to bind to damaged portions on cells, in particular red cells and white cells in the blood stream. What it does is it acts like a membrane sealant. It binds to damaged regions and sort of coats or protects them. By doing so, it lowers viscosity. When you have lower viscosity in the blood stream, your cells are able to transport more easily and they can do their job such as deliver oxygen to tissues. So it is a drug that allows the cells to deliver oxygen to tissues when otherwise they would have some difficulty in doing so due to viscosity. So it lowers viscosity of the cells in the blood stream.
Question: Okay. So in the case of sickle cell anemia, which you are about to begin a phase III trial on later this year, how does it affect that disease?
CEO Culley: Well, patients who have sickle cell disease from time to time; they are afflicted by something called a vaso-occlusive crisis. What happens here is there's a trigger event where the proportion of red blood cells in their blood stream increases. Those red blood cells that are sickled don't have the same ability to transport themselves through the circulatory system. They are long, they are sickled shaped, and they're more rigid because they have polymerized hemoglobin inside of them. The reason why this is a problem for patients is that those sickled cells will log jam. It's exactly like a bunch of logs flowing down a river and hitting a turn. These cells will stick together and they will log jam and the effect of that is the inability of those cells to deliver oxygen to tissues. When you don't get oxygen to tissues, you have starved tissue, you have ischemia, you have necrosis, which is death of tissue and you have pain. So the manifestation of this event for a patient with sickle cells crisis is that he or she will go to the hospital and will lay there for 2, 5, 7, or 8 days suffering in tremendous pain. They receive hydration and they receive opioid analgesia so pain medication, but there's no intervention for that crisis. That patient has to wait until those log jams cleared, the proportion of sickled cells is reduced back to their normal state and the patient is then out of painful crisis.
What we're trying to do with 188 is get this drug, which helps improve the viscosity. It lowers the viscosity so that the cells can move through the circulatory system a lot faster and easier. They can deliver oxygen and the upshot is that the patient should be getting out of crisis sooner. So we want them out of the hospital sooner, we want them back home sooner and this will be the only drug that will be approved to intervene in what's called vaso-occlusive crisis.
Question: So not only will the patient be out of the traumatic pain that they're in faster with your drug but also it will reduce hospital days and reduce costs?
CEO Culley: Yeah. I think it's really important. These days, there's so much on drugs. Not only do drugs offer a clinical or a medical benefit but that they also offer an economic benefit. I think with 188, we really have that in spades. We can demonstrate quite clearly the economic advantages of getting people out of the hospital sooner and of course, the humanistic benefits of getting people out of pain. Well some people would say you can't put a price tag on that, but it's awfully important.
Question: Okay. Could you talk about the trial that's upcoming and what the clinical endpoint is going to be?
CEO Culley: Certainly. We are very eager to start this trial. There are a couple of things that we need to do first. One of those is we need to manufacture the clinical trial material so the work there is ongoing. The other thing that we need to do is to finalize the protocol. You really have to make sure that your protocol is as perfect as it can before you start these studies.
So we're working with key opinion leaders throughout the country. They're helping evaluate our ideas. Of course, we're also working with the FDA getting feedback from them, what do they think is important in the protocol, what do they think is less important in the protocol. So it's an iterative process of refining and improving the protocol. When that process is complete and when the clinical trial material is ready to go then we can start opening up clinical trial sites and enrolling patients. We don't have the final numbers yet, but it's like that the study size is going to be in the 300 to 400-patient range, probably involve 30 or 40 clinical trials sites, and take a couple of years to enroll the full complement of patients.
Question: We were speaking earlier and you told me how you acquired this product. Would you like to take a minute to talk about the history of the product?
CEO Culley: Sure. It's a colorful product. Because it has the ability to improve blood flow, one could apply it in a lot of different settings. A prior sponsor of this product tested it into phase III in sickle cell disease. Now they made a handful of mistakes. You know, to their credit it was the first large-scale sickle cell trial ever done so there were bound some things that didn't work out well for them. But they also didn't enroll the number of patients that they had planned to enroll and they had some, what I believe are, design flaws in the protocol. So although they had some things stacked against them, they very nearly succeeded. They did show a benefit. They did show that you could reduce the duration of crisis and they nearly showed statistical significance with that. It wasn't enough to get the product approved and in fact, it ended up being something that they were not able to go forward with.
But for Adventrx, we feel that we are able to quite well define exactly what the errors were the first time it was tested. So we're looking to improve upon the original design. We've gone out into the community to find out what's changed since the study was done the first time so that we can do it and actually show that the benefit is statistically significant. So we're quite encouraged that the fact that there's been a demonstration that the drug is active and it has a benefit. But as it happens in clinical development, sometimes there are some mistakes that are made and I think we're going to be able to improve upon those. So we are now a vehicle for what I hope will be the final testing of this product in sickle cell disease patients.