That just came out we'd like to share. Up for FDA review in April. Monitor them closely at 1.90.
NBT Two-Minute Drill with David Hall, CEO of Replicel Life Sciences
January 30, 2012
We recently interviewed David Hall, CEO of Replicel Life Sciences Inc. (OTCBB:REPCF), on their upcoming Phase I/IIa clinical trial results “reveal” 90 or so days away.
With positive results expected from their current Phase I/IIa trial, Replicel will move immediately into a 100-patient dosing trial. Replicel hopes to build an overwhelming set of successful data for the patented RepliCel™ procedure for minimally invasive hair cell growth and implantation.
With two successful data-sets in hand, Replicel intends to sell its entire hair growth and implantation business to the highest Big Pharma/Big Bio bidder. NBT analyses the value of the follicular regeneration industry at about $500 million—or more than $10 a share with an expected 10 million share dilution from money raising activities in 2012.
NBT: In your pre-clinical trials with specially modified mice you saw 50% hair growth with cosmetically attractive density 100% of the time…Replicel is now roughly 90 days away from the release of your Phase I/IIa human trial results from 19 human patients. What should investors be looking at most?
DHall: These are the key data points: First and foremost, interim analysis is human safety. To date, we have seen no safety issues and frankly, we do not expect any. The second key interim object is an indication of efficacy at 6 months or specifically, the increase in density of existing hair and indication of new hair follicles. We will use all that data in the filing of our Investigational Medical Product Dossier which will go to the regulators for our Phase II/b 100-pateint dosing trial.
Remember this is the first look at 6 months for all the clinical trial patients…all patients will be measured again for hair growth and density at 12 and 24 months as well. We establish a baseline of results from day zero and then you measure results at 6, 12 and 24 months against that original baseline.
NBT: How do you measure results at the initial look?
DHall: The contract research organization (“CRO”) takes microscopic images of every patient…each patient dossier is reviewed at 6 months and all data is cleaned for 100% properly entered data. If any data is missing, the CRO and the clinic coordinate to enter the missing data.
Each patient has had one side of their scalp injected with a placebo and one side injected with their own dermal sheath cup cells. Our patents, as you know, are around the growth and implantation of the highly specialized dermal sheath cup cells vs. less-specialized cells. The CRO does 100% of the data collection. All data is blinded so RepliCel cannot review the data until it is un-blinded.
NBT: How much hair growth do you expect at 6 months?
DHall: Well first you have to answer that question in the context of existing “gold standard” surgical hair transplantation. In state-of-the-art micro-surgical procedures, in the first few months all the hair fibre in the area of the surgery falls out and begins to reappear around the six month time frame. It normally can take up to 18 months for the success or failure of the micro-surgery to become evident. In that context, virtually any amount of hair growth or hair density at 6 months for the RepliCel™ procedure would give us the data we need to immediately pursue the Phase II/b 100-patient dose-ranging clinical trial. What we are looking for is demonstration of increased fiber density of the existing hair from base line, as well as indication of new follicular growth.
We have also taken biopsies from a random sampling of patients to look, at a microscopic level, to see growth below the scalp. We are looking at these biopsies multi-dimensionally. That is to say, we are not just looking at the topical site—we are looking at small biopsies of the injection sites…looking at the angles of hair growth. It’s not good enough to grow hair, you have to have the appropriate growth orientations. That means cosmetically acceptable results…the animal trial got appropriate angles growing in a natural angle…not clustered in one little patchy area.
What we are ultimately looking for is evidence of cosmetically acceptable hair regeneration and increased density of hair follicles initially in the transplanted region of the scalp. Eventually, we expect to see actual regeneration of existing hair follicles NEAR the implanted region…as we saw in the pre-clinical animal trials. Regeneration of dormant hair follicles is the “secret sauce” of our procedure.
Even in the worst case scenario—i.e. zero response above the initial baseline at 6 months, we continue to gather the data through 12 and 24 months. Responders can come later, as is seen with micro transplants.
In short…this is pretty straight forward science: if you have ANY growth from the implanted autologous dermal sheath cup cells, one should expect to have MORE growth of both those new follicles and from dormant hair follicles that have regenerated.
NBT: What else is Replicel working on in the hair regeneration arena?
DHall: In parallel to our clinical trials, we are validating a number of cell markers for dermal sheath cup cells. These markers are very important because with their unique expression we could accelerate both our dermal sheath cup cell isolation and replication protocols. Speeding-up/improving both these aspects of the RepliCel™ procedure are helpful for its commercial application.
Each of these dermal sheath cells express certain proteins, proteins you ONLY find in the dermal sheath cup cells. To date, we have identified quite a number of unique protein markers. With these unique identifiers or “markers” we can almost completely automate our process and thus greatly accelerate the RepliCel™ procedure for the patient/clinician.
In short, as we create more efficiency and speed in the isolation and replication of the dermal sheath cup cells significant value is created for the company—more procedures per day/week/month means more revenues for the clinician.
NBT: When do you get an endpoint for this “hunt”?
DHall: There is no magic number for protein markers…we already have many targets. But by year end, we will get to the final end points. Remember, automating our isolation and growth procedures really adds significant value to the eventual sale of the RepliCel™ procedure. Automating the cell isolation also helps in the regulatory process…both in speed and in validating that the dermal sheath cells we are isolating and growing are ALWAYS the same cells and not a mix with other unwanted cell. We have a manual process right now for the isolation and regeneration protocol. For the next clinical trial they will use the manual procedure and we will seek to integrate the automated process in a new set of trials.
NBT: Anything else on your regulatory approval risk?
DHall: The beauty of working with autologous cells…meaning the patient’s own cells…is that we are using a particular cell population whose only purpose in life is to instruct a cellular cascade to grow hair fibers. Ours is a 100% completely different regulatory environment than if we were taking one type of cell and try to manipulate it into another type of cell…that kind of cell-based therapy is a VERY difficult regulatory environment…because every step of the way the cells have to be proven to be the SAME induced cell.
It’s really simple: in using a patient’s own cells we are only increasing the concentration of the cells…NOT changing those cells…all of which has MUCH lower safety and regulatory hurdles.
NBT: You have made it clear that assuming you have the clinical data to prove your procedure is the new standard in hair regeneration you will seek to sell the division in its entirety to a multi-national Big Pharma player. Why?
DHall: The biotech space is growing again…Big Pharm/Big Bio have BIG PROBLEMS with their patent cliffs and there is only so much M&A they can do at the high end. So, they have begun to change their strategies by partnering and acquiring technology further upstream.
If we show hair growth and continued growth in our 50 men/50 women dosing trials conducted under a clinical trial harmonized both for European and US FDA regulations, it will be an attractive asset. There is a very Darwinian nature in the Big Pharma/Big Bio ecosystem. Big Pharma and Big Bio are on the top of the “food chain”…and it is NO secret they need BIG numbers from new long-lived patented products to move the needle for their valuation. That is why we are doing everything to FDA standards. No shortcuts. If our science wins the day, the valuation of the RepliCel™ procedure given the $5 billion worldwide annual market for hair restoration products and services will be obviously enormous.
If we work hard and smart every day, we get a little closer to that reality.
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