William Prather, of Pluristem Therapeutics, discusses the change in the way pharmaceutical companies look at cell based therapies




Episode Loading...




PharmaTelevision requires Javascript enabled and Adobe Flash Player to watch our programmes. If you do not have Flash installed, you can download it for free from the Adobe Flash homepage.

Improve your Internet experience and start watching exciting new video content.

Video title: William Prather, of Pluristem Therapeutics, discusses the change in the way pharmaceutical companies look at cell based therapies
Released on: September 28, 2011. © PharmaTelevision Ltd
Share/save this page:
Email
Bookmark
Facebook
Twitter
LinkedIn
Follow us:
RSS
Twitter
  • Summary
  • Transcript
  • Participants
  • Company
In this episode of PharmaTelevision News Review, filmed at BIO 2011, Fintan Walton talks to William R. Prather, Senior Vice President Corporate Development of Pluristem Therapeutics inc.
Technology and clinical programs
Fintan Walton:
Hello and welcome to PharmaTelevision News Review here at BIO 2011, here in Washington DC. On this show I have William R. Prather, who is Senior Vice President of Corporate Development of a company called Pluristem , welcome to the show.
William R. Prather:
Thank you.
Fintan Walton:
Pluristem is a stem cell company could you tell us the origins of Pluristem and who is funded it and where it's got you today?
William R. Prather:
Pluristem is a public company we are actually traded on NASDAQ under the symbol PSTI we are also on the Tel-Aviv exchange, in fact on the Tel-Aviv 100. Company actually started back in 2003 as a reverse merger [PharmaDeals ID = 13136] and it's headquartered in Haifa, Israel because the technology, the basic technology came from a co-collaboration between the Weizmann Institute and Technion [PharmaDeals ID = 27307]. And the company has since purchased the IP that was developed at those institutions and of course has developed the technology since that point. The company I think has brought in about $90 million in cash at this point in its life although we have 45 million of that in the bank so that's good, the company strategy is to take we call them mesenchymal stromal cells, we don't really like this, the term stem because we do not differentiate our cells don't turn into other tissues they immune modulate. So we call them stromal cells and we get them from the placenta, right now we are getting them for mom's if had cesarean sections, we have relationships with hospitals in the Haifa area and so it's more convenient for us because then we can screen mom before she has a baby, we can be present when the baby is born, because it's a schedule procedure and then of course be able to screen the placenta in a timely matter by taking it back to our facility in Haifa. If we don't like the placenta we just throw it away, so it's a really, really good source of mesenchymal stromal cells because we are not touching anyone. We don't touch mom, we don't touch baby we are actually taking medical waste and using that.
Fintan Walton:
Okay, so that's the source of your cells this stromal cells, so what are your therapy areas? What areas are you focused on and what are your current clinical programs?
William R. Prather:
Right, what we are doing is we taking those cells that have come from the body of the placenta sometimes people get a little confused and think they might be cord blood cells, but no these are actually from the body of the placenta and then we expand them and grow them in a very proprietary three dimensional environment and that three dimensional environment is the collaboration I mentioned between Technion and Weizmann Institute.
Fintan Walton:
Right, and that's the underlying technology and know-how?
William R. Prather:
That's correct, that's the core IP if you will. The cells that come out of that process we call them PLacental eXpanded cells or PLX cells for short and they are off the shelf without any matching necessary, so there as close as you can get to a quote pharmaceutical of the shelf product as you can. The areas that actually the cells like the sandbox if you will is there is the inflammatory state, okay so Injured, inflamed tissue that where our cells are injected into talk to our cells, our cells then secrete a prescription cocktail of therapeuticsproteins, angiogenic and anti-inflammatory cytokines that's tailored to the patient that induces the patient to then start healing primarily through the generation of new vessels into the injured area.
Fintan Walton:
Okay, so what sort of therapy then how do you apply that with your specific therapy areas or indications?
William R. Prather:
Correct, yes there are several indications of course because of the mechanism of action there is a huge number of indications when you think about using the cells either locally or possibly by inhalation or may be IV systemically and we've adapted the small company to began looking at the indications that require the cells to be used locally, in other words intramuscularly and we are in clinical trials now for peripheral artery disease we are injecting the cells into the extremities, the affected extremities and are, you know progressing on that path.
Deal with United Therapeutics
Fintan Walton:
Okay, so obviously as you've said with that type of clinical approach there is a broad range of particular indications that you can go for clearly you are pursuing your own recently you've done a deal with United Therapeutics, could you tell us what the base of that deal is?
William R. Prather:
Correct, on June the 20th we announced an out-licensing gene collaboration with United Therapeutics [PharmaDeals ID = 41417]. We are actually were approach by United the cells were probably be used systemically for the indication of pulmonary hypertension which is what the licensing deal is for and so we are currently focused on that area right now and so it's really a good deal for us. The licensing economics if you will are $7 million upfront payment and additional $48 million in milestone payments, United pays the cost of the entirely cost of the development of the cells for that indication, we supply the cells for a cost plus basis and then we will enjoy revenue sharing when the part is commercialized.
Fintan Walton:
Right, so they will be responsible for all of the regulatory passage and also into register product and they presumably are involved in the marketing and selling of the product?
William R. Prather:
That's correct. We are I mean our niche is I mean we are the experts in procuring and growing, and making available commercial grade cells to our partners and we would like to emulate that licensing deal with others on an indication for indication basis.
Fintan Walton:
So for pharmaceutical companies this is not normal place for them to be in, are you seeing a change in the way pharmaceutical companies look at cell based therapies?
William R. Prather:
Absolutely, I mean couple of years ago I think the mindset was still that cells you know turned into different tissues, heart tissues, liver or whatever and I think people's understanding of you know the place of cell therapy is getting a little more solidifying, so big pharma is definitely a lot more interested than they were few years ago.
Business model
Fintan Walton:
Okay, so for a company like yours you say you are a small company obviously reasonably well funded from what you've said, what is the way forward for you and will you continue with this business model of licensing out to various other companies, tell me more?
William R. Prather:
Yes we are gonna continue to and that's one of the main reasons we are here at BIO is to talk to other potential collaborators that would wanna use our cells for other indications, while that's happening we are continuing to develop the product for ourselves and we have animal models of a variety of different states where the cells are used for example in the area of inflammatory bowel disease or other pulmonary disorders , central nervous system diseases , cardiac disorders , I mean again the list is pretty long.
Are there regulatory hurdles for cell based therapies?
Fintan Walton:
Yes, indeed and in terms of the regulatory pathway is that clear, I mean is very clear for small molecules, it's clear for biologics when it comes to cell based therapies are there still hurdles to be overcome for those for the companies like yours in order to make sure that the regulatory authorities feel comfortable with the therapy approach?
William R. Prather:
Yes, of course there is always hurdles with the regulators, but we are fortunate, I mean we are actually I think the only cell therapy company that is working both tracks both in Europe as well as in the United States to obtain regulatory approval and we actually were successful in November to get both members of the FDA as well as the EMA in a joint session to suggest or recommend what we do going forward in the area of peripheral vascular disease and it's been that way, we've been very, very either lucky or you know, but you know well, well a very good relationship with the regulators.
Future plans
Fintan Walton:
Right, so you see this as the future that we will have seen more and more cell based therapies?
William R. Prather:
Absolutely, I really believe that cell therapy is the way with the future much like monoclonal antibodies were earlier on and I think collaborators have began to understand that the hurdle is actually getting them to believe that cell therapy is going to be around and once they really believe that it's relatively easy decision to find, I mean to find us then believe that we are the cell therapy company that they should be dealing with again because of our significant IP, but even also the manufacturing efficiencies that we can employ. There is right now we are taking one placenta and with one placenta we are gonna able to manufacture at a dose of 300 million cells 10,000 doses from placenta and that's a batch and then we don't mix placentas and we've been able to successfully prove to the regulators that we do have batch to batch consistency.
Fintan Walton:
Bill Prather, thank you very much indeed for coming on the show.
William R. Prather:
Thank you.
Fintan Walton
Dr Fintan 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).
William R Prather
Senior Vice President
William R. Prather currently serves as Senior VP Corporate Development at Pluristem Therapeutics Inc. William R. Prather RPh, MD, is a Registered Pharmacist as well as a Board Certified Internist and Geriatrician. Dr. Prather received his BS in Pharmacy (1970) and medical degree (1973) from the University of Missouri. He practiced internal medicine in the Kansas City, MO and Vail, CO areas until leaving Internal Medicine in 1987 to pursue a Fellowship in Geriatric Medicine at Harvard University. He completed this Fellowship in 1989. In 1992 Dr. Prather left the practice of medicine to pursue a career in the financial industry where he has held Senior Healthcare research positions for a variety of investment banks. Dr. Prather co-founded Panacos Inc (NASDAQ:PANC), a public pharmaceutical company. Additionally, he has been on the Boards of several public and private companies, including Boston Biomedica Inc (a public medical diagnostics company), PriMed (a private medical device company), MdBio (a Maryland healthcare venture firm), and sat on the Advisory Board of MDS Capital Management, (a Canadian venture firm).
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.
Pluristem Therapeutics Inc
Pluristem Therapeutics Inc is a leading developer of standardized cell therapy products for the treatment of life threatening diseases. The company's patented PLX (PLacental eXpanded) cells drug delivery platform releases a cocktail of therapeutic proteins in response to a host of local and systemic inflammatory diseases. PLX cells are grown using the company's proprietary 3D micro-environmental technology and are an off-the-shelf product that requires no tissue matching prior to administration. Data from two phase I studies indicate that Pluristem 's first PLX product candidate, PLX-PAD, is safe and potentially effective for the treatment of end stage iperipheral artery disease. Pluristem 's pre-clinical animal models have demonstrated PLX cells are also potentially effective in nerve pain and muscle damage , when administered locally, and in inflammatory bowel disease , MS and stroke , when administered systemically. Pluristem has a strong patent portfolio, GMP certified manufacturing and research facilities, strategic relationships with major research institutions and a seasoned management team.