Cytheris: Encouraging responses and orphan drug designation in Europe for CYT107 for the treatment of PML




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Video title: Cytheris: Encouraging responses and orphan drug designation in Europe for CYT107 for the treatment of PML
Released on: July 12, 2012. © PharmaTelevision Ltd
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In this episode of PharmaTelevision News Review, filmed at #BIO2012 Convention in Boston, Fintan Walton talks to Damian Marron, CEO of Cytheris about encouraging responses and orphan drug designation in Europe for CYT107 for the treatment of Progressive Multifocal Leucoencephalopathy (PML).
Cytheris's product targeted at treatment of lymphopenia
Fintan Walton:
Hello and welcome to Pharmatelevision News Review here at BIO in Boston in 2012. On this show I have Damian Marron, who is the CEO of a company called Cytheris, which is based in France. It's a company that's been around for sometime it's trying to raise its profile I suppose, could you tell us more about Cytheris, when was it founded?
Damian Marron:
Indeed Cytheris was founded in 1999, it actually started with a product and a founder coming out of Sanofi, the product being a recombinant human Interleukin-7 even Cytheris has spent a number of years developing the product testing it in a variety of different indications and we have developed a very robust base of evidence in over 240 patients in a number of different indications that the product consistently increases the number of CD4 and CD8 T-cells making it a targeted treatment for lymphopenia which can then help in a number of different conditions which themselves induce lymphopenia and induce the mobility and mortality that can then go with such a condition.
Fintan Walton:
Okay, so obviously these conditions are rare conditions?
Damian Marron:
Generally yes.
Fintan Walton:
And so presumably this product is going through orphan status?
Damian Marron:
Right, the company has recently applied for Orphan Drug Designation for the treatment of progressive multifocal leukoencephalopathy which comes in after reactivation of the JC virus infection which occurs in very severely lymphopenic patients and here therefore we are talking about a population of about 4000 in the EU and the US, the EU the COMP has granted or made in a recommendation to adopt that Orphan Drug Designation we are just waiting now for the European Commission's final approval of that. We have also undertaken a scientific advice with the European Medicines Agency for a pivotal trial in that indication and so that is something which we will be looking to launch starting from next year.
Fundings and investors
Fintan Walton:
Right, now obviously to do these clinical trials you need some money, so how are you funded, how do you where is your source of funds?
Damian Marron:
We have a good investor base at the moment which consists of a leading French investors and also investors from Holland the Forbion and from Canada as well, so we are you know taking that taking forward and as we believe that this program in JCV , PML will be very attractive to other investors and to the industry and we will be looking for as we go forward obviously to get together the financing to ensure we can take that program forward which we believe can be in registration as earlier as 2015.
Product testings and success ratio
Fintan Walton:
Okay, so obviously some people would make the remark that you know you are basically a one product company, I mean how do you perceive the risk with this particular product, how likely to be successful?
Damian Marron:
Yes, I mean I think that's you know a very fair question and the product you know has been tested in a variety of indications we could say four or five as I said earlier we've generated clinical data already in over 240 patients, so I believe we've got a very good base of tolerability, we have a very good base of knowing that the product reliably increases the T-cell count and not these not just increases the T-cell count but that these are definitely functional T-cells which then should lead on to good biological and clinical effect. So we believe that actually we have you know quite strongly de-risked where we are going and further more is in talking of our lead indication of PML we have treated five patients with compassionate use treatment and we have shown very encouraging responses in these patients, we've seen clearance of the JC virus all the patients are still alive which in a disease where 40, 30, 40% are dead within three months, 50% in six months and 60% by a year you know you are talking about really a dramatic effect in an area where there is no treatment at all today. So overall I would say that, yes it is one product but we believe that you know we have narrowed down to a very good lead indication here in PML while still possessing the possibility to work in other lymphopenic conditions in the future.
Fintan Walton:
So on that basis you are gonna look for additional products to build your pipeline?
Damian Marron:
Not necessarily straight away our real emphasis at this moment is let's get this PML program move forward, let's make sure that we make sure that we get that financed a bit through financial investors or be that through industrial partnerships so that we can move this product, this program forward once we do that we will have a strong base then to decide which options we use to further advance the company.
Future plans including obtaining orphan designation for products in Europe
Fintan Walton:
Okay, so obviously the next step is obtaining orphan designation for your products here in Europe?
Damian Marron:
Yes.
Fintan Walton:
And that's the key next step will that then require additional funding at that point, you've mentioned the two ways which you're gonna take this forward have you got sufficient funds to now take this product forward after that?
Damian Marron:
Yes we are going to move forward straight away with the funding that we have to put the trial into place and as we do that we will be looking for the additional funding to ensure that we can take that program right through and create that value that will come from such a program.
Fintan Walton:
Damian, that's you know a big challenge but also it's a very important disease area that you are focused on, so we wish you luck with that.
Damian Marron:
Thank you very much Fintan.
Fintan Walton:
Thanks for coming on the show.
Damian Marron:
You're welcome.
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).
Damian Marron
Chief Executive Officer
At the time of recording this PTV interview Damian Marron serves as Chief Executive Officer of Cytheris. Damian Marron is a highly experienced executive with strong experience in orphan diseases. He was previously CEO of Trophos from June 2008. Under his tenure, Trophos spearheaded a major EU funded consortia of leading global experts and specialists working on orphan diseases including Amyotrophic Lateral Sclerosis (ALS). He has also pushed through a Phase III trial for ALS and was instrumental in attracting EUR 34 million in funding. This includes EUR ten million from Actelion Ltd for an exclusive option agreement to purchase Trophos for a price that could have reached up to EUR 195 million. Damian has extensive experience in the biotechnology and international pharmaceutical industry, including financing, corporate development, product and technology licensing, research and development and sales and marketing. Prior to Trophos, he was executive vice president corporate development at NicOx SA,where he was responsible for the establishment of major collaborations with Merck and Co. Inc and Pfizer Inc and participated in financing rounds raising in excess of EUR 175 million. Previously, he held various business development and operational roles at 3M Pharmaceuticals, Orphan Europe, Rhone-Poulenc-Rorer and Glaxo.
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.
Cytheris
Cytheris SA is a privately held clinical-stage biopharmaceutical company focused on research and development of new therapies for immune modulation. These drugs aim at reconstituting and enhancing the immune system of patients suffering from cancer, chronic viral infections such as HCV, HBV and HIV, or lympho-depleting treatments such as chemotherapy, radiotherapy, bone marrow transplantation (BMT) and hematopoietic cell transplantation (HCT). The company operates from its headquarters and laboratories in Issy-les-Moulineaux, a suburb of Paris, and its U.S. subsidiary in Rockville, Maryland.