MacuClear :Philip Ralston. Winner of 2012 Rising Star Award




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: MacuClear :Philip Ralston. Winner of 2012 Rising Star Award
Released on: November 15, 2012. © 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 BioPartnering Future Europe in Brussels, Fintan Walton talks to Philip Ralston, CEO of MacuClear
Foundation of MacuClear
Fintan Walton:
Hello and welcome to PharmaTelevision News Review here at BioPartnering Future Europe, in Brussels. On this show I have Philip Ralston, who is President and CEO of a company called MacuClear, welcome.
Philip Ralston:
Good morning.
Fintan Walton:
Good morning to you Philip, you are the co-founder of MacuClear, MacuClear is based in Dallas, Texas you are an emerging company, could you tell us the foundation of MacuClear?
Philip Ralston:
Yes actually MacuClear was a technology developed by Dr. George Chiou, who lead the discovery of Timolol the leading treatment for glaucoma. He had a new technology that was part of a competition at Texas A&M University, I was one of the 140 judges and this technology won the competition, I was looking for an opportunity to do another start-up and I was asked to pitch a proposal for how I would go about it, and that was in late 2006 and we got together, Dr. Chiou and me and we formed the MacuClear, and we started looking for money and working on our IND, and rest is history so far.
Repurposed drugs of MacuClear
Fintan Walton:
The rest is history, so but I suppose there are several things important here, one is the idea behind the company, obviously there is one of the concept was to repurpose certain drugs that already existed?
Philip Ralston:
Actually what happened was Dr. Chiou continued his work in trying to treat glaucoma, saw what was happening with the treatments of AMD and they were all focused on the late stage or wet AMD, and he felt that the best way to prevent wet AMD because there where so many metabolic pathways that were causing this to occur he began to look for treatments that would prevent the disease from progressing, and so he went through a typical drug discovery process, looked at a lot of different compounds and out of the thousands that he looked at he came up with 12 compounds that all had the capability of increasing blood flow, providing anti-inflammatory and anti-oxidative effects, and that became a portfolio of 12 compounds and analyzing those 12 compounds we found that two had been used as, in this case antihypertensive drugs before and knowing that a previously approved drug being repurposed would bring us through the FDA in a much faster, much less costly way. So our lead compound MC-1101 became the 505 (b) 2 out of the 12 compounds that we could have chosen because of its previous FDA status.
Financial Support for MacuClear
Fintan Walton:
Sure, so just lets looking at the funding, because now we've got some idea of the business, what the research and development is taking place in selection of the specific drug, of course you've talked about, now we talk about money you would obviously put the first round of finance into the business, what's happened since in terms of subsequent rounds of financing?
Philip Ralston:
All of our funding to date has been through angels, expect for a $1.7 million investment that the State of Texas made in emerging technology companies. It's quite a competition, we had to go through 62 different interviews if you will to get the award, but all of it has been with angel investors, we found in the very beginning that VC's wanted to take most of the company and we decided that wasn't the best way and so we've been fortunate to have some strong angel investments, now we've raised $8.3 million so far.
Fintan Walton:
Okay, off the 1.7 million which you've got from the State of Texas was that presumably grant money non-dilutive kind of financing?
Philip Ralston:
No, actually this was part of the Texas Emerging Technology Fund.
Fintan Walton:
Okay.
Philip Ralston:
And they do take an equity position in the company.
Fintan Walton:
As well, okay, okay. So the total amount of money that's being raised is largely been from business angels in the end?
Philip Ralston:
That's correct.
Ongoing clinical trials of MC-1101
Fintan Walton:
Okay. So let's talk about your lead compound again MC-1101, it's now been as you've just said is on a fast track, you've got, you've completed Phase I proof of concept, you are now entering basically Phase II, Phase III is that correct?
Philip Ralston:
That's correct.
Fintan Walton:
So give us some idea of what's going to happen now in the clinical trials going forward, and when your expectations of getting this product to market?
Philip Ralston:
We had our typical end of Phase II meeting with the FDA and we got their agreement to look at a novel series of visual, excuse me, visual function endpoints, previously in wet AMD studies they've always looked at wet, visual equity however we know that with dry AMD those are not usable endpoints, so we got the FDA to agree to visual function endpoints. Further we got them to agree that we could do a small study, and when this study is proven we can include those patients in the total of 500 that we are, that are required to file our registration for NDA. We have funding for this first trial when we have, because of our fast track status we were able to take a look-see at one-year which we expect to do, and that data shows good results we will recruit the balance of the patients for registration.
Fintan Walton:
Right, now presumably you still need more additional funding to get that done, is the strategy then to take this product all the way to market at least to registration yourselves, or you looking for partners?
Philip Ralston:
When we started the company, big pharma were making investments in companies at preclinical and Phase I studies, that game has changed. So we've been doing very well, and we will be looking at that decision once we see the data, we are pretty confident that with good efficacy data that are funding for going forward will be pretty well taken care of. I have to admit that with other products in the pipeline we are thinking more and more that we may want to take this at least through the NDA stage.
Product portfolio and future products of MacuClear
Fintan Walton:
Sure, of course Philip you have more than just one compound in development now, you've got other products, could you tell us about that portfolio?
Philip Ralston:
Yes, originally the 12 compounds that I previously mentioned where all intended to address AMD, each of the compounds had different levels of performance, but we have since discovered that we have a drug that would apply to glaucoma, which was unexpected, and then another one of our compounds that has a stronger anti-inflammatory effect then say the increase of blood flow looks like it would be a very strong candidate for treating diabetes diseases of the eye, it's an interleukin 1 inhibitor that is showing up as a key component of diabetes. Thirdly we have a proposal into the Foundation Fighting Blindness to look at Stargardt's diseases, because the disease mimics adult AMD so closely, so we are excited we have the exploratory studies in each of those disease stage going on right now.
Fintan Walton:
Right, now you've talked about your company, your company is watched by many people, and at here at BioPartnering Future Europe you've just won the Rising Star Award for 2012, well done?
Philip Ralston:
Thank you, we are very grateful for this honor.
Fintan Walton:
So obviously that means, you know your company obviously is in the limelight, what's your plan? What's your vision now yourself for MacuClear going into the future?
Philip Ralston:
What's been really gratifying is the attention we are getting, in the beginning it was very challenging to get support because our treatment challenges the conventional wisdom about the physio the pathogenesis of this disease, we get challenge on that quite a bit, but as more and more people understand what we are really doing, we are gaining much more attention. Our goal now is to prove it works and with that we believe that we will be helping millions to see, and at this point exactly how that goes as I said before, we are keeping all options on the table.
Fintan Walton:
Philip Ralston, thank you very much indeed for coming on the show.
Philip Ralston:
Thank you very much for having me.
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).
Philip Ralston
Chief Executive Officer
At the time of this PTV Interview Philip Ralston serves as CEO of MacuClear. Philip G. Ralston, Jr., has spent more than 35 years in the life science industry as a senior executive, inventor, company founder, venture capitalist and business coach. He has represented companies in public, private and non-profit sectors. Ralston holds 18 patents on various medical products, including drug delivery, monitoring and cardiovascular devices. Prior to becoming an entrepreneur in medical related businesses, Ralston served as director of biomedical engineering at Baxter Healthcare where he was part of a corporate level group focused on strategic projects, product development and technology commercialization. A proven team builder, he is known for his "teamthink" approach to developing people and has started several programs to accelerate team-based product commercialization. Since leaving Baxter, Ralston has started five companies, has been the senior operating executive of two mid-size medical device companies, and for the last decade has been a business coach for several Fortune 500, mid-size and start-up clients. He has significant hands-on knowledge and experience in all facets of operations and marketing for pharmaceutical, biotechnology and biomedical products from start-ups to mature manufacturing entities. Highly effective in assessing risk and viability probability for start-up life science companies and products, Ralston successfully operated a new technology accelerator at Houston Advanced Research Center (HARC) and designed the Center for New Enterprise Development in the same community. He frequently speaks on "passing attack" product development, an effective, concurrent engineering process for moving ideas from proof of feasibility to proof of efficacy; and "customer delight", or how to achieve outstanding customer loyalty. A true team player, Ralston has always placed a high priority on the development of his and his client's teammates. He is committed to helping an organization's human capital achieve its highest potential in performance driven cultures. Ralston holds a Master of Business Administration from the Kellogg School of Management at Northwestern University and a Bachelor of Science in Chemistry from Brigham Young University. He is a charter board member of the Medical Device Manufacturers Association and currently serves on the advisory board of the Houston Technology Center. He is a Director and Senior Business Advisor with the North Texas Enterprise Center. He is also an executive committee member of the Center for New Ventures and Entrepreneurship at Texas A&M University. He has taught Small Business Growth and Management at the Mays School of Business at Texas A&M University.
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 commercialization.
MacuClear
MacuClear Inc." is a specialty clinical-stage pharmaceutical company focused on discovering and developing novel solutions for vascular disorders of the eye. MacuClear has an active IND for MC-1101 and has completed a novel and successful Phase Ib/POC human clinical trial. MC-1101, MacuClear's lead compound, is a patented, topically delivered drug for treating and stopping the progression of dry Age-related Macular Degeneration (AMD). Subsequent targets beyond dry AMD include diabetic macular edema. In April 2007, MacuClear completed a private placement of funds to complete preclinical studies and to advance promising pipeline products through FDA Investigational New Drug (IND) application and subsequent IND activation and into human clinical development. In January 2009, MacuClear received approval for $1.7M from the Texas Emerging Technology Fund (TETF) to further the development of MC-1101. The Company met the TETF Qualifying Funding Transaction by raising more than $500K of new money in October of 2010. MacuClear qualified for the IRS/HHS Qualifying Therapeutic Development Project and has received a grant of $245K against its clinical development costs in 2009. This is non-dilutive and tax-free funding...and further indication of the importance of MacuClear's approach to addressing dry AMD.