Tissue Therapies’ Novel Platform




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Video title: Tissue Therapies’ Novel Platform
Released on: February 01, 2008. © PharmaVentures Ltd
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In this interview, Fintan Walton talks to Steven Mercer, CEO of Tissue Therapies. They begin with a discussion of the origin of the company, which was established to commercialise research developed at the Queensland University of Technology (QUT). Steven explains in detail the company’s platform technology, VitroGro®, its application in therapeutics and tissue culture media, and its versatility. The discussion then covers the worldwide sales and distribution agreement that Tissue Therapies made with Invitrogen in 2007, including the revenues that the company is entitled to from Invitrogen. The patent protection that applies to VitroGro is outlined, in particular the broadness of the cover of the family of patents. Steven then talks about a recombinant protein based on VitroGro technology being developed by the company for diabetic venous and pressure ulcers. The interview concludes with his ideas on VitroGro’s commercial potential.
Origins of Tissue Therapies .
Fintan Walton:
Hello and welcome to PharmaVentures Business Review here in Brisbane, Australia. On this show I have Steven Mercer, who is the CEO of Tissue Therapies based here in Brisbane, welcome to the show.
Steven Mercer:
Thank you.
Fintan Walton:
Steven Mercer, your company is obviously involved in tissue and particularly growth factors.
Steven Mercer:
Yes.
Fintan Walton:
Could you tell us a little bit first of all about the origins of the company when it was originally founded and how it has evolved?
Steven Mercer:
Certainly the company was formed in 2002 with the objective of commercializing the discoveries of Professors Eitan and her research team and those discoveries really go back about 10-years. The company was actually been floated in 2004 so it really was on the Australian Stock Exchange. The technology we call VitroGro is a generic name but it really comes of a whole set of a fundamental new understandings as to how growth factors affect animal cells and how that effect, growth factor affects cell biology.
Tissue Therapies 's platform technology in development of growth factors for tissue culture medium.
Fintan Walton:
Now at the moment you are developing specific growth factors both for therapeutic use but also for tissue culture medium?
Steven Mercer:
That's right and the beauty of this platform is it is really so versatile it can be optimized quite easily for a specific indications, applications or cell types. And the scientists in our team have been able to identify the specific active binding and other regions that are important for turning on the appropriate intracellular machinery as growth factors do in all animals. This is a highly regulated co-activation process, they run multiple active sites that have to be stimulated simultaneously at the cell surface and when you can do that the effects are profound and extremely efficient so we can gain the benefits of that by tapping into the normal cell physiology.
The VitroGro technology: Its application in therapeutics and tissue culture media, and its versatility.
Fintan Walton:
Right. The program that you've got currently in the growth media outside of the business, could you tell us about that because that's a very defined activity?
Steven Mercer:
Yes, yes it is and it's important to us because it's our first really important commercial deal, so we have an exclusive worldwide sales and distribution arrangement with Invitrogen corporation [PharmaDeals ID = 29557] and as a result of that there will be a role at of their new range of GIBCO cell medium products around the world and those products will be based on the VitroGro technology so that they will be completely recombinant defined GMP and when I say defined I mean capital D defined not mostly defined with some purified animal modelproteins in there I mean pharmaceutical grade defined.
Fintan Walton:
So you are operating in this area of where the whole industry is going which is of getting be more clearly understanding what's actually going into the culture medium?
Steven Mercer:
Yes it is, it's not just regulatory though this is fundamentally important and as so have been ongoing frustration for a long time for biological scientists worldwide. The problem with an undefined media is that batches vary, when you change batches and something is different with your experimental data you don't know if it's the media or your cells or something you've done. And if you are developing therapeutics say for example you are in a NIH laboratory scientist in the United States and you are not working in a defined environment then you can have significant difficulties if you are successful in developing that therapeutic because the >FDA will want you to repeat potentially repeat your results in a defined environment. And so it has been a mark shift driven by these frustrations that scientists have had worldwide cell biology scientists to really demanding a truly defined media preferably GMP so that they can have absolute confidence that every time they take a bottle of the stuff of the shelf it will work exactly the same way.
Tissue Therapies deal with Invitrogen and the potential revenues.
Fintan Walton:
Now because of this deal with Invitrogen you have potential premium revenues?
Steven Mercer:
Yes certainly and
Fintan Walton:
And in the short-term?
Steven Mercer:
Yes. And revenue has already started in a small way and the basis of that agreement in the publically announced aspects over that are the revenue to physiotherapies it will be of three types, there is a manufacturing margin and there are royalty payments and there are milestone payments out of that. And there is an awful lot of world class science and a significant amount of money we have invested in the process development in those manufacturing processes and so obviously we wanted to reap some reward for that and at the same time demonstrate to our investors in the market as well as to company that we are actually capable of doing commercial deals and that's just the first one.
The broadness of the cover of the family of patents and the patent protection that applies to VitroGro.
Fintan Walton:
Sure and to be clear about this is the behind all of this is the intellectual property rights around how you produce this?
Steven Mercer:
Yes. Where our family patents are very broad it includes composition method and antagonists for this growth factor machinery. And so it is particularly powerful IP family it ends really I ensure there will be future commercial applications of this technology but really have not even thought of yet, certainly the longer-term ones we are working on include things such as tissue engineering applications, production of conventional vaccines and therapeutic vaccines. We have already been involved in one clinical trial here in Brisbane with The Queensland Institute of Medical Research where they were taking cells from patient who had disseminated melanoma, multiple metastases patients who were any minute danger of dying from their advanced melanoma. That was a dendritic cell trial there are number of centres around the world working on this type of immune generic response and treatment of cancers and they found that the VitroGro media was by far the best environment for them to generate dendritic cells for this type of work because these are very sick patients and then in that situation for that type of therapeutic vaccine the name of the game is how many sensitize cells can we produce more is much, much better and VitroGro produced a lot more.
Fintan Walton:
Okay. Now just want to get truly understand the IP here because what is the things you bring to the table?
Steven Mercer:
Well it's a family of patents for which we have exclusive rights that are originally filed by QUT, Queensland University of Technology [PharmaDeals ID = 35574],there are six requirements for that IP to transfer into tissue therapies. Five of those six are already been satisfied, the sixth is a six month awaited at a share price of $1 which haven't quite done yet. But the patent as I said broadly they cover how this machinery works manner meets probably method of composition and antagonist and I say antagonists because the over stimulation of this machinery is potentially very important in a number of pathologies including epithelial cell cancers for example breast and prostate cancer. We know this machinery is always simulated within atherosclerosis parts as well and so there are a number of significant potential antagonist applications which are all covered in the IP which may well lead to future therapeutic applications as well.
VitroGro technology developed by Tissue Therapies for diabetic, venous and pressure ulcers.
Fintan Walton:
Now you've also got a novel growth factor compound that you are developing recombinant compound that you are developing for wound care want you to tell us about that particular clinical program.
Steven Mercer:
Yes well that's one application of the VitroGroprotein technology and it's specifically directed at a human trial for the treatment diabetic, venous & pressure ulcers that will start shortly in Toronto it is at the clinical investigator, Chief Clinical Investor is Dr Gary Sibbald generally considered one of the most eminent wound care clinicians and prominent leaders in the world. We also have advice to the board clinical advice from probably another the other most eminent wound care physicians in the world Professor Keith Harding from Cardiff University and a clinical trial monetized Dr Douglas Queen extremely experienced team in doing many wound care trials. The classification with health Canada has also worked to our advantage the risk profile of the VitroGro product is such that health Canada has classified as a low risk biologic meaning the requirement is for pharmaceutical drug manufacturing which we have already done and from there will be treated really like a class 3 device.
The mechanism of action of recombinant protein based on VitroGro technology.
Fintan Walton:
Okay. So that's interesting. The actual active compound the protein actually this is recombinant protein is that correct?
Steven Mercer:
It is.
Fintan Walton:
Could you tell us little bit about that and the mechanism of action?
Steven Mercer:
Sure. Well that generally speaking growth factors can only do three things, they rather try to get more cells or proteins or you get cells to move which is one of the fundamental requirements for epithelialization or healing of particularly chronic wounds. And VitroGro does that particularly efficiently so that the protein platform we are delivering on to these wounds will be in nanogram doses per square cm because it is so efficient. It's a very sticky platform and so it heals to the wound surface, it will be delivered as a liquid in single use sterile appliance which would be applied to the wound that gives the conditions freedom in the future in clinic applications to prepare the wound in whatever way they think appropriate then apply VitroGro and then use whatever primary and secondary dressings they thing are most appropriate for that wound. The protein complex will deliver the active regions of Vitronectin including some of the integrin binding regions polyanionic region and some of the active regions of IGF-1 and EGF and so because it is a recombinant protein it is as I said manufactured to GMP standard and the risk profile is such that it is not absorbed it's a tiny dose and really fundamentally all we are doing is restoring to the affected tissues a protein complex that was originally there prior to the disease process or the injury.
Fintan Walton:
Okay. So the clinical trials are about to begin or how is it programmed?
Steven Mercer:
Yes, they will begin in January.
Fintan Walton:
That's Phase I clinical trial or Phase II, Phase II clinical trial?
Steven Mercer:
We are applying as a Phase I but it may become a Phase II it depends on the outcomes. I think we will end up at Phase I to come back to trial but we are not force to commit to that yet.
VitroGro's commercial potential.
Fintan Walton:
So clearly then you got the because we have already covered the Tissue Therapies 's therapeutic application of your technologies of one and the other is in culture media basically in a very defined way but and what else is coming behind that?
Steven Mercer:
Well there a number of things as I've mentioned there are the potential to produce conventional vaccine particularly antibody vaccines, new vaccines produced in the live cell system in other words. And then of course there are newer technology therapeutic type vaccines now they are in the investigative stage but clearly they would demand the type of biological performance that we can deliver and we know that already from the trial I mentioned. And then of course there is potential in tissue engineering and other applications as well. And then of course the rather antagonist type potential applications even things like atherosclerosis and the metastasization of cancer. From the data we have so far it's seems likely that antagonist therapeutic action for treating cancer would probably have to be relatively early in the cancer life cycle because we do understand that epithelial cell cancers due tend to become resistant to this machinery as they go through the metastasization process but certainly we think there is sufficient basic science and some clinical science there to pursue that, yes.
Fintan Walton:
Okay. Well Steven Mercer, thanks a lot for coming on to the show and telling us all about Tissue Therapies . Thank you very much indeed.
Steven Mercer:
Thanks for your time.
Fintan Walton
Dr Walton is the Founder and CEO of PharmaVentures . After completing his doctoral research on the genetics of cell proliferation at the University of Michigan(US)and Trinity College (Dublin, Ireland), Dr Walton gained broad commercial experience in biotechnology in management positions at Bass and Celltech plc (1982-1992).
Steven Mercer
CEO
Dr. Steven Mercer worked as a Managing Director of Mercy Tissue Engineering, a successful tissue engineering company with commercial operations in Melbourne and Singapore. He has had a successful career with multinational companies, including 6 years with Smith & Nephew as General Manager, Smith & Nephew Surgical, during which he successfully grew Smith & Nephew Surgical in terms of sales per employee, profit per employee and market share. Before that, Dr Steven Mercer had 7 years as a health industry specialist with IBM. In addition to Dr Steven Mercer 's extensive commercial experience in healthcare and biotechnology, he is a Registered Medical Practitioner (Australia and US) and a former Surgical Registrar. Among his commercial achievements, Dr Steven Mercer managed the commercialization of the first (Australian) Therapeutic Goods Administration (TGA)-approved human cell biotechnology laboratory in Australia, including securing the licensing of living cell implants for human use, and managing rapid growth in sales and profit derived from the facility.
PharmaVentures
PharmaVentures is a corporate finance and transactions advisory firm that has served hundreds of clients worldwide in relation to their strategic deal making in the pharmaceutical, life science and healthcare sectors. Our key offerings include: Transactions / deal negotiations; Product / technology valuations; Deal term advice; Due diligence & expert reports; Strategy formulation; Alliance management; and Expert opinion for litigation/arbitration cases. PharmaVentures provides the global expertise to ensure our clients generate the highest possible return on investment from all their deal making activities. We have experience of all therapeutic areas and can offer advice on both product and technology commercialisation.
Tissue Therapies
Tissue Therapies , is an Australian company developing biomedical technologies for wound healing, tissue and various cell culture applications. The company has worldwide exclusive rights to commercialize VitroGro a platform technology developed by tissue engineering experts at Queensland University of Technology (QUT) for enhancing cell growth, protein expression and cell migration. VitroGro is a patented, defined, set of protein complexes that produce a high rate of cell replication, protein expression and cell migration, both in vitro and in vivo, without the use of fetal bovine serum (FBS) or serum derivatives. Based on the platform technology, Tissue Therapies is developing more effective medical treatments for wounds and burns, tissue regeneration, integration of orthopedic and medical implants, and other applications such as cosmeceuticals. Tissue Therapies also provides cell culture reagents to enhance the growth of cells for emerging cell-based therapies, along with research and industrial cell culture markets internationally.