Vascular Magnetics, Inc.

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December 10, 2012 Issue

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Developing their novel Vascular Magnetic Intervention (VMI) Therapy targeted at Preventing the Re-obstruction of the Artery in Patients with Peripheral Artery Disease, Vascular Magnetics, Inc. is offering hope to 27 to 41 Million Patients in North America and the EU with PAD

About Vascular Magnetics, Inc.:

www.vascularmagnetics.com

Vascular Magnetics, Inc. is magnetically targeting drug-loaded biodegradable particles to develop Vascular Magnetic Intervention (VMI), a novel therapy for peripheral artery disease (PAD). PAD is a common chronic condition characterized by obstruction (stenosis) of the arteries in the legs.

Georges Gemayel, Ph.D.

Executive Chairman
Dr. Gemayel has been the Executive Chairman of the Board of Directors since February 2012.  Dr. Gemayel has held senior positions at pharmaceutical and biotechnology companies over his career of more than 25 years. He is currently Chairman of Syndexa Pharmaceuticals, and serves as a Director of NPS Pharmaceuticals. He previously served as Executive Chairman of FoldRx Pharmaceuticals, Inc., President and Chief Executive Officer of Altus Pharmaceuticals, Inc., Executive Vice President of Genzyme Corporation, Vice President of Roche Specialty Care, and General Manager of Roche Portugal.  Dr. Gemayel previously served as a director at Adolor Corporation, and Chairman of FoldRx Pharmaceuticals, Inc.  Dr. Gemayel received his doctorate in pharmacy at Saint Joseph University in Beirut, Lebanon and earned a Ph.D. in pharmacology at Paris-Sud University in France.

Richard S. Woodward, Ph.D.
COO, President & Co-founder
Dr. Woodward is most recently the founder and principal of The Business/Technology Interface, LLC, a consulting firm providing services to companies in the areas of biotechnology, pharmaceuticals and specialty chemicals. After earning a Ph.D. in Molecular Cell Biology, he was an industrial research scientist before moving into the business side of the biopharmaceutical industry. Dr. Woodward has held executive positions at Quality Biotech (VP, Marketing & Sales) and Polymerix Corporation (VP, Preclinical Development); this latter was a polymer-based biomaterials company that he helped found. He has also held managerial positions in sales, marketing and business development at a number of companies including Pharmacia Biotech, Ajinomoto and DSM Pharma Chemicals. A noted author and speaker on the subject of pharmaceutical outsourcing, Dick has been involved with over a dozen start-up and early-stage companies.

Healthcare / Medical Devices / Drug Delivery

PAD

Vascular Magnetics, Inc.
3711 Market Street,

Philadelphia, PA 19104

856-753-7650

www.vascularmagnetics.com


 

Interview conducted by: Lynn Fosse, Senior Editor, CEOCFO Magazine, Published – December 10, 2012

CEOCFO: What is the vision for Vascular Magnetics?
Dr. Woodward: Our goal is to prove that our technology works in peripheral artery disease (PAD). PAD is a huge unmet medical need that we believe can be addressed by the technology that was developed by our scientific founder.

CEOCFO: Would you explain what you figured out that others have not?
Dr. Woodward: Essentially, we are developing is a technology that allows for magnetically targeting drugs to the wall of the artery. The purpose of those drugs is to prevent the re-obstruction of the artery.

Peripheral artery disease is the result of obstructed arteries, primarily in the legs. PAD is a very bad disease that affects has 10-12 million American, and 27-41 million in North America and the EU. Diabetics and smokers are at an extremely high risk, and you know smoking is not going away as fast as the FDA would like, and diabetes has been called an epidemic, so they are both an issue.

The standard treatment for PAD is typically balloon angioplasty, where you basically take a balloon and expand it inside the obstructed artery to push the obstruction back into the arterial wall. Sometimes, this is accompanied with the use of a stent, which is basically a scaffold that provides structure for the interior of the artery. The problem is, is that the failure rate, the re-obstruction rate if you will, runs at around 40% per year, and that is a pretty poor outcome.

Physicians attempt to put a drug on the inside of the arterial wall to slow down or stop the re-obstruction process. As you probably know, drug-eluting stents have become the standard of care in the coronary space. They do not seem to work as well in the peripheral space, and that appears to be caused by the failure to get enough drug at the arterial lesion site to make a difference over a long period of time.

Our technology is quite a bit different from that, and it is actually a three-part technology.

The first part is what we call our Magnetic Targeting Catheter (MTC). This is the catheter that is put down into the leg following the balloon angioplasty. This catheter is tipped with a mesh made out of a type of alloy that cannot be permanently magnetized, but if you place it in the presence of an external magnetic field, this alloy mesh develops very strong magnetic gradients. These gradients are actually used to help deliver the drug, and I will talk about that when I get to the third part of the technology.

The second part is an external magnet that fits around the patient’s leg, typically the thigh. That magnet is about 1/15 the strength of a clinical MRI. It is a relatively small permanent magnet that weighs about fifty pounds, so it is not a huge expensive piece of equipment. This magnet and the Magnetic Targeting Catheter work in conjunction to deliver the payload of our technology, which is the third part of our system.

The payload is made of a suspension of magnetically responsive biodegradable particles loaded with paclitaxel, a standard drug used to prevent or hinder the re-obstruction process.

So this is how the VMI system works: after balloon angioplasty, our catheter is placed into the area to be treated. The targeting mesh is expanded to contact the arterial wall, and the magnet is placed around the patient’s leg thus creating the magnetic gradients.  The magnetic particles are delivered through a lumen in the catheter and pulled to the arterial wall by those strong magnetic gradients.

After the treatment period, which can last from few minutes to half an hour, the magnet is removed, the mesh is collapsed and the particles stay in and on the arterial wall, releasing drug for a period of many days. That sustained release is very important, because the cellular mechanisms, which lead to re-obstruction of the artery are not instantaneous mechanisms; they take place over a period of days. It is important to have drug being delivered to the artery during that entire time. The particles biodegrade slowly and are excreted through normal body mechanisms.

CEOCFO: Is the magnetic concept new or has it been tried before? Have you figured out the idea to use the magnetic concept or actually the way to make it happen?
Dr. Woodward: Attempts at magnetic targeting have been tried before, especially in oncology. It has been almost uniformly ineffective. These previous approaches involved placing a magnet over a tumor and systemically injecting some sort of a magnetically responsive therapeutic and hope that it gets pulled to the magnet. These were not finely targeted approaches and acted more like a shotgun. Our technology is different in that it actually uses this mesh, which you can liken to a magnetic antenna, to focus the magnetic field exactly where the particles need to be delivered. This is amplified by the magnet that we use. It is what is called a dipole, there is a magnet on each side of the patient’s leg, and they are connected by an iron yoke. This generates a very uniform magnetic field within the targeting mesh and drives the particles to the wall. If the field was only coming from one direction, one would expect that the particle delivery would be asymmetric, and frankly, without that targeting mesh functioning as an antenna the particles would be unlikely to be particularly effective at getting to the arterial wall.  

CEOCFO: Where are you in the development process and what are the results you have seen so far?
Dr. Woodward: Dr. Robert Levy, our founding scientist and his team are the inventors of this entire technology. They have published some early work in the proceedings of the National Academy in 2010, and that work demonstrated in a small animal model the feasibility of the whole magnetic targeting process. We are now moving towards a more commercially viable methodology of targeting, and we are making plans to begin our critical preclinical animal studies within the next few months.

CEOCFO: Are there any potential side effects that you are aware of and if so, are taking care of with this therapy?
Dr. Woodward: No, the point of this particular technology is that while paclitaxel is a very potent anticancer drug, we are typically using doses well below the dose that is routinely used for cancer treatment. The magnetic “core”, if you will, of the particles is actually very similar to the product that is used as an MRI contrast. So, everything in these particles is well known to the regulators, and in addition, the doses used are much lower than those in currently prescribed products. We really do not expect any special safety issues. Preliminary studies have shown that we can expand and collapse these catheters within a pig’s artery without causing any harm for the duration of our observations so far.

Dr. Gemayel: We are too early to make a definitive statement.  Our preclinical studies in pigs look good so far, but we are far from being able to give you a clear answer about how it will behave in patients. What Dick has said is true, we expect that there will be a very favorable safety profile just because of the doses we are giving, but we are far from demonstrating that in humans.

CEOCFO: Has the medical community paid attention yet, or is it too early for that as well?
Dr. Woodward: Our advisors are very hopeful that our technology will help their patients in a significant way. In addition, we met as well with a number of potential strategic partners, and I think, Georges correct me if I am wrong, it is fair to say that they were all very interested in the technology, including companies that are developing competing technology.

Dr. Gemayel: I think the medical need is huge. Nothing has really been working very well so far, and any technology that is really going to give relief to these patients will be very accepted. People are looking for an alternative treatment, and we hope this is the technology that will provide it.

CEOCFO: I know you had a funding back in February; how far will that take you?
Dr. Woodward: That is projected to take us through our first in human clinical trial, which we are currently targeting to start in the early of the second quarter of 2014.

CEOCFO: So, you are in fairly good shape for a company in this stage?
Dr. Woodward: We think that is true. We are very fortunate that Devon Park Bioventures, the venture group that funded us saw the potential in this project, and in the way, we are planning to develop it. They took the entire round and are extremely supportive of what we are doing.

CEOCFO: What lessons have both of you learned in your past ventures that you are able to bring to the table here at Vascular to help 1) the science, and 2) the development commercialization process?
Dr. Gemayel: Dick always says that one needs to have a management team focusing on doing one thing and one thing only and doing it well. This is really what we have been trying to do at Vascular Magnetics, and it is the summary of both of our experiences for many years in the pharma world. We have surrounded ourselves with a group of extremely talented and competent consultants, the best in their fields. We have a very focused plan for the development of this drug/device, which we call Vascular Magnetic Intervention, and while we could think about several possible applications for this technology, we are really focusing on PAD and are driving to accomplish it as quickly and efficiently as possible. We are very judicious in the way we are using our funds that have to get us to our endpoint. The aim is to be as focused and as competent as possible to get results as soon as possible.

CEOCFO: You mentioned 2014; what is going to happen six months to a year from now and is there a timetable? Do you see taking on any partners?
Dr. Woodward: I think like all small companies, at least most small companies, we do not really plan to become the next household name medical device company. We believe that this technology that we are developing, as Georges implied, has a lot of uses over and above vascular disease. We have spoken to a number of potential strategic partners about this, and in some cases, the potential other uses appear to be more exciting to them than the vascular application, although they do recognize the importance of that. Our goal is to form a strategic partnership with a major company to develop this technology further

Dr. Gemayel: Our development strategy is to get our technology to a place where it could be taken by a larger corporate partner and further developed and taken to the market.

Dr. Woodward: Our strategy is to develop this as a turnkey system. There are three components to this system: the magnet, the catheter and the particles. We are actually developing this so a strategic partner could start to work immediately without having to lose any time in technology transfers. That way, a company that is familiar with catheters and medical devices does not how to figure out how to make the particles because we will already have a contractor in place ready to go with it, and likewise with the catheter and the magnet.

CEOCFO: Why should investors and people in the business, drug development and medical device communities pay attention to Vascular Magnetics today?
Dr. Gemayel: It is a very innovative breakthrough technology to treat a dire disease affecting millions of people, and costing hundreds of billions of dollars a year. It is a very simple way of treating this disease, and the proof of concept is going to be established within a couple of years. Should the proof of concept be established, it will open the way to a major market with an unmet medical need.

Dr. Woodward: Just to amplify that, there have been some studies that have shown that the economic impact of PAD in the United States is comparable to the economic impact of cancer. Those are both around two hundred billion dollars per year; it is a substantial portion of our healthcare costs that we hope to be able to address.

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Essentially, we are developing is a technology that allows for magnetically targeting drugs to the wall of the artery. The purpose of those drugs is to prevent the re-obstruction of the artery. - Richard S. Woodward, Ph.D.

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