In memory of Devon Grimme who passed away after this interview was published.
Follicle Thought is proud to present this exclusive interview with the two major figures of Follicept, Devon Grimme and Dr. Stephen Hsu. There’s a few goodies in here that I have not seen mentioned on the Follicept message board. I just wanna say thanks to Devon and Dr. Hsu once more and without further ado here is the interview:
Joseph: You guys have been pretty busy over the past couple months. What’s the current focus going on at Follicept these days?
Devon: We are still monitoring results of preliminary testing of ~10 men who are family and friends to gain insights that can help shape the protocol and logistics for the clinical trial, and looking into manufacturing and distribution. Not to mention the company’s other projects including the insulin patch and some other exciting therapies we are testing (not related to hair loss). Additionally, we have been talking to some regulatory agencies about doing a trial that could possibly allow us to be FDA approved, without taking years like it usually does. That’s really new so we don’t have much info there yet.
Joseph: You’ve been kind of ‘catapulted’ by the speed that this research has developed and now you stand in the spotlight of the online hair restoration community. What’s that ride been like so far?
Devon: It’s been pretty intense, and mostly positive. We initially made an announcement looking to attract partners and investors, and had no clue the hair restoration community was so active and well-informed. We did the only thing that felt right, which was to engage and be as transparent as possible with everyone. Though it gets intense at times, it’s been an overwhelmingly positive experience so far. We really hope Follicept will be another tool in the fight against hair loss, if not the only one needed.
Joseph: The initial pilot trial for Follicept has been going on for a little over two months and you’ve been posting the updates on your website. You’re going to extend that trial dosing time for the participants by a couple weeks, is that correct?
Devon:That’s correct, but let’s be clear that this is not any kind of controlled trial; just a series of anecdotal cases among a diverse group of men with hair loss. We just gave most of the participants another 4 week course. In one of Dr. Hsu’s initial ideas about it, it would be one month on, one month off. We have actually gone about 2 months off, but we will see what this next month does for us all. We want the treatment to be as infrequent as possible to maximize safety and convenience and minimize costs for users. However, in the formal clinical trial, we may have a treatment group with continuous therapy. Dr. Hsu tends to err on the side of caution, but preliminary observations of responders suggests that continuous therapy may give the best results.
Joseph: Can you give us the basic specs of the official clinical trial you’re gearing up for and when you plan to initiate it?
Devon: We are still working that out, but the general idea is a rigorous double-blind trial with volunteers randomized to placebo and a couple different doses as well as continuous vs. alternate month therapy, conducted as outpatient visits, using trichoscan to quantify early appearance of terminal hair growth. The main hurdle right now is funding, so as soon as that gets worked out- hopefully another month or so.
Joseph: I heard Dr. Hsu mention something interesting about noticing growth in the latest video update. Is it safe to say at this point that Follicept has definitely grown at least some hair, for sure?
Devon: It definitely seems that way. We wouldn’t be working as hard as we are if we weren’t encouraged by the results. Of course it is hard to quantify without trichoscan, and it’s also only 3 months in. Most treatments say 4-6 months for anything noticeable. Let’s see what a second month of treatment does here.
Joseph: Dr. Hsu, at this point are you exploring any other potential compounds for hair growth?
Dr.Hsu: Not yet. All papers I have read seem to be linked to IGF-1 one way or another, so we need to fully test this theory before trying other compounds alone or in combinations with IGF-1. That recent paper on the association of low-dose finasteride used as a hair grower by young men with permanent sexual dysfunction and increased suicidal ideation is a perfect example of why I want to stick to studying natural hormones critical for hair growth. If we can do it with just IGF-1, all the better.
Joseph: From a business standpoint, are you currently looking for investors or partners to move things forward with Follicept?
Devon: Definitely. We are seeking a few accredited investors to help us get through this trial, as well as move forward on other Prometheon projects, on which we are close to a couple deals. We are also looking for manufacturing and marketing partners. We have identified a few potential ones, but are always open for discussion.
Joseph: Any final thoughts or announcements?
Devon: Nope, just bear with us. There are no secret agendas or announcements with us, we share everything we know as we know it, good or bad. We know this is a tough condition and we are an atypical company, but hang in there with us and hopefully we will have something awesome that helps us all!