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Transition Therapeutics Inc. (TTH) |
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CEOCFO Current
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This is a printer friendly page! Transition Therapeutics – with one
of the leading regenerative therapies for the treatment of diabetes currently in Phase I
clinical trials BIO: CEOCFOinterviews: Dr.
Cruz, please tell us about your vision, when Transition Therapeutics was founded, and
where you are today. Dr. Cruz: “The vision of the company was to focus on therapeutics that could change outcomes in specific diseases where there was a major need and major markets. We focused on diseases such as diabetes, multiple sclerosis and restenosis. We looked for technologies that would be novel and make an impact on those diseases. The company invested significantly into obtaining leading technologies in regenerative therapies for the treatment of diabetes, which I think represents a new paradigm for the treatment of many of these diseases. In the case of insulin dependent diabetes, by the time a patient shows up at the doctor, they have already lost most of their islet cells and the ability to produce insulin, and therefore, the only way you can increase the outcomes in those patients is by transplantation or stimulating regeneration of insulin producing cells in the pancreas. We have acquired a number of regenerative technologies for diabetes, stroke and Parkinson’s to become a leader in the development of regenerative therapies.” CEOCFOinterviews: Currently, where are you in your clinical trials? Dr. Cruz: “We have one of the leading regenerative therapies for the treatment of diabetes that is currently in Phase I clinical trials. We hope to be in Phase II by late summer to early fall. This treatment can take a diabetic animal that is fully dependent on insulin, and reverse the disease to insulin independence with a 14-28 day treatment. We have done this with a number of diabetic animal models and with human cells. We hope that we will be able to reproduce this in diabetics.” CEOCFOinterviews: What is the treatment? Dr. Cruz: “The treatment involves the use of two hormones or growth factors, that can stimulate the expansion of your islet precursor cells, which are present in the pancreas; you then have a second factor, which will stimulate the differentiation of these precursor cells into insulin producing islet cells. The combination of these two factors, one that increases the precursor cells and one that stimulates their differentiation into mature islet cells that produces insulin, allows us to significantly increase the number of islet cells in your own body. The advantage of our therapy over cell based therapies or transplantation is that you don’t need any immunosuppression, lack of donors, and avoid the regulatory and manufacturing hurdles. Here you are increasing your own endogenous repair system that you have in-place, to produce enough islet cells to regulate glucose levels.” CEOCFOinterviews: How does the timetable work for Phase II? Dr. Cruz: “We are
already planning Phase II trials. Our Phase II studies will be performed in insulin
dependant diabetics. INT will be a short-term treatment of 14 days, with a primary end
point of safety and increased insulin production. We think that by early next year we
should have the data to support whether the INT technology is effective in diabetics.
We would then continue the trials with a Phase II B study determining which
diabetic patient population would benefit most from this treatment. The data from these
studies would set the basis for a Phase III pivotal study. We are hoping by early next
year that we will have the human data to allow us to determine how well this technology
works in humans with diabetes.” CEOCFOinterviews: How are you funding all of this? Dr. Cruz: “We have advanced the products in the company through two different routes. The first has been through a private placements and public markets where we have raised a total of approximately $13 million. The second route, which has been extremely important in the development of our company, has been to acquire other companies that had more advanced and synergistic technologies to increase our platform and at the same time have advanced technologies that were closer to the clinic. We acquired a company in Boston called Waratah Pharmaceuticals, Inc. to bring in the diabetes program, Islet Cell Neogenesis .We acquired another company in Calgary called Stem Cell Therapeutics Inc., which brought us the additional regenerative technologies for the treatment of stroke and Parkinson’s, and expanded our regenerative platform “ CEOCFOinterviews: Do you see the need for further acquisitions? Dr. Cruz: “I think we will rest here for while, we have our hands full at the moment and most importantly these products are really demonstrating a lot of promise in animal models, the clinic and also an interest from potential pharmaceutical partners. We feel that there are potential partnerships on the horizon for at least one or two of these technologies. We have spoken to a number of companies about some of these products and they are very interested. We feel like it will be just a matter of time before we start licensing some of these products, in which case we would then develop some of the other pre-clinical programs that we have in-place prior to further acquisitions." CEOCFOinterviews: Will the money that you have now be sufficient to see you through this? Dr. Cruz: “We expect to have a financing and/or a partnership in-place in the near term to enable us to fund our lead programs to the completion of Phase II." CEOCFOinterviews: You mentioned that there are other regenerative therapies; why does yours standout? Dr. Cruz: “The
major focus for the development of regenerative therapies, has actually been to develop
cell-based therapies from stem cells. They have had major hurdles to overcome, and so the
progression of these cell-based products into the clinic has been extremely slow. The
advantage of our technology is two fold; first, it is the leading regenerative therapy
demonstrating efficacy in diabetic animal models and, secondly, it is doing it right in
the body. It is much more of a pharmacological approach vs. a cell-based approach or
transplantation. In diabetes, when you visit to the doctor for the first time, you have
already lost as much as 80% of your islet cells, therefore simply inhibiting the disease,
the way we traditionally treat diseases, is not going to be good enough. You have to
transplant or regenerate those cells or replace them to acquire a normal function. CEOCFOinterviews: Is your treatment a lengthy process? Dr. Cruz: “That is a very attractive part of our therapy; it is a short treatment of 14 to 28 days that we anticipate being given 1 or 2 times annually. This we hope will be sufficient to regenerate enough islet cells to produce insulin to modify disease outcomes. The clinical trials are not going to be very long because the therapy itself takes a short time, there are little or no alternatives for these patients and thus enrolment should not be difficult. There are four million patients with diabetes that are insulin dependent; there are about seventeen million that are diabetic.” CEOCFOinterviews: Do you do any work with the American Diabetes Association and other agencies? Dr. Cruz: “We just started that process. In fact, we have a very strong scientific advisory board with some very prominent members of the diabetic community. We have had discussions at looking to get support from those agencies, but we have not yet done so. It is in the plans as we move forward into the clinic, to try to work with those agencies. But in reality, a significant portion of this technology was already funded initially through research grants in universities” CEOCFOinterviews: Will you please tell us more about the licensing of your technologies? Dr. Cruz: “We don’t want to be a fully integrated pharmaceutical company; our objective is to validate technology, build value and then transfer the technologies into the hands of people that can distribute it as widely as possible. Once we have this technology validated, the idea is to license it to a pharmaceutical company, which will then further develop and distribute it. That is part of our business platform CEOCFOinterviews: In closing, what should shareholders and potential investors know about Transition Therapeutics? Dr. Cruz: “First, potential investors should know that we are effective at taking a product from the beginning to the clinic very rapidly in a cost effective manner. That is one of the reasons why we have been able to carry several programs with a very low burn rate. The second is the question of where we are going to build value in the next ten to twelve months; the answer to that is we have two products going into Phase II in very large markets. One is in diabetes, which I think is a leader in a new paradigm of treatment of diabetes and another is multiple sclerosis, which is enhancing a current product. We have a third product and a partnership with another company, which is to develop a non-toxic agent that can inhibit restenosis. Recent validation studies in animal models have shown that at some of the agents can completely inhibit restenosis without any necrosis or thinning of the vessel cell wall. Thus discussions with leading stent manufacturers have intensified. In summary, we have three areas that can move into a very strong partnership situation over the next year, as well as validation in humans or appropriate models to build value in the company. We expect that this will be an excellent year for Transition.”
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