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RepliCel Interview Reprint

RepliCel Interview Reprint

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Published by Alan J Bauman MD
Hair Restoration Physicians, like Dr. Alan J. Bauman, M.D. are watching "hair cloning" research carefully. Companies like RepliCel are on the forefront of this technology and hope to bring some type of cell therapy to the aid of those with hair loss and hair thinning. So far, we've got some peach fuzz on mice ears... but hey, every journey starts with one small step, right? --Dr. Alan J. Bauman - Hair Transplant Surgeon
Hair Restoration Physicians, like Dr. Alan J. Bauman, M.D. are watching "hair cloning" research carefully. Companies like RepliCel are on the forefront of this technology and hope to bring some type of cell therapy to the aid of those with hair loss and hair thinning. So far, we've got some peach fuzz on mice ears... but hey, every journey starts with one small step, right? --Dr. Alan J. Bauman - Hair Transplant Surgeon

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Categories:Types, Research
Published by: Alan J Bauman MD on Nov 23, 2011
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02/11/2014

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This is a transcript of an interview with Dr. Rolf Hoffman, CMO of RepliCel Life Sciences, Inc.Those of us who treat hair loss are watching the development of "hair cloning" technology with the hope that this research may add some insight into the workings of the hair follicle. We also wonder whether this may turn into a viable treatment optionas an adjunct to the safe and effective medical and surgical treatments currently available today.--Dr. Alan J. Bauman, M.D.Medical Director - Bauman Medical Group, P.A. Boca Raton, FLDiplomate, American Board of Hair Restoration Surgery 
Equities Interview with Dr. Rolf Hoffmann, Chief Medical Officer, RepliCel Life Sciences Inc.November 22, 2011Effective treatment for hair loss has advanced considerably over the past several decades,but for all that the multi-billion dollar industry has become, there still lacks a truly viableand permanent solution that addresses the needs of both men and women. For biotechcompany RepliCel Life Sciences, Inc.(REPCF), promising research around the regenerative properties of dermal sheath cup cellscould prove to be the break-through that millions of hair-loss suffers have been waiting for.For over a decade, leading hair biology scientists, Dr. Rolf Hoffmann and Dr. KevinMcElwee, have been studying the potential of dermal sheath cup cells to spark hairregeneration and the rejuvenation of miniaturized hair follicles. Hoffmann, RepliCel's Chief Medical Officer, discusses his research, the process of developing this treatment, and thecritical steps the company is taking along the way to ensure that it is successful.EQ: Can you start off by briefly talking about the history of your research and when yourealized it had this kind of potential?Hoffmann: Back in 1999, Dr. Kevin McElwee was the "postdoc" in my lab, and we found that the specific area on the very deep part of the hair follicle--what we call the "hair cup"--hasthe potential to regenerate hair in animals. So we studied this hypothesis on mice and it showed that the cells, when implanted, traveled to existing hair follicles and made thembigger. In addition, those cells alone, with no other mixture of cells, were able to induce thegrowth of hair follicles in the palms and soles of the mice, showing that these cells wereable to generate hairs de novo (anew). So we conducted our studies in1999 - 2001 and published it in 2003. It's nice to have the animal data, but of course, wewanted to translate it to humans.
 
 EQ: As you said, your initial tests with SCID mice proved to be very successful. Can you tellus how you think that could be translated over to humans?Hoffmann: There's no small animal model for pattern baldness, but on the other hand, themechanisms that lead to hair growth and hair loss are principally the same, meaning allhair cycling, hair follicle morphogenesis and so forth can be compared. That's why we don't study a specific disease. We do not study pattern baldness--we study hair growth. Theresults in the animal models showed that it's parallel to what you expect in humansbecause the principles of hair growth are nearly same. That's why we believe we cantranslate our findings to humans.EQ: Obviously, pattern baldness is the leading disease for hair loss in humans, but yourapproach allows you to address other causes like chemotherapy or scarring as well,correct?Hoffmann: Yes, and in all the instances where we see a hair follicle miniaturization--basically when the hair is getting thinner--it is usually because the cells in the hair root diminish in number and size.Usually, a higher number of cells in the hair root equals thicker hair. In chemotherapy, if the treatment is mild and only some cells die, the hairs do grow back but are miniaturized.Based on our research, the idea would be to get a biopsy of healthy hair follicles from theback of the patient's head before the chemotherapy treatment, grow the cells, and inject those cells into the patient after treatment. This could be a very promising clinical target because there's no treatment for chemotherapy-induced permanent hair loss. Pattern hairloss is of course the most important target for us, and chemotherapy is number two. But there are also other more rare diseases, as well as other causes like scarring or alopeciathat could be treated. Another important area is hair thinning that is due to getting older.EQ: The key difference between RepliCel's research and others seems to revolve around thedermal sheath cup cells as opposed to papilla cells. Why are they such a key component tohair restoration?Hoffmann: Our belief was that the real mesenchymal stem cells, or progenitor cells, are inthe region of the cup at the base of the hair follicle. Once they are activated, they travel intothe papilla and then stimulate hair growth. With every hair cycle, the complete papilla just disintegrates. Hair cycle means that the hair grows for many years, then every hairdisintegrates and falls out, and a new hair grows from the same dermal papilla. In histology(the study of tissue), you don't see the dermal papilla. The cells are more dispersed and webelieve that the quiescent papilla cells reside in these cup regions as a kind of niche andthen they get activated in the papilla. That's why we think that these cells are less matureand hopefully more effective in treating permanent hair loss. Therefore, we don't usepapilla cells.
 
 EQ: Your pre-clinical results have shown evenly distributed hair regeneration. How is thispossible?Hoffmann: Any kind of successful treatment must, of course, be cosmetically acceptable.This means no patchy spots; the hair must be evenly dispersed. What I think is fascinatingin cell-based therapy is that the cells are already programmed. We do not reprogram them.They just do what they do in their normal life. They find the hair roots and don't goelsewhere. That's the reason why they found the miniaturized hair follicles and made thembigger in our animal experiments. These cells are not embryonic stem cells, they're muchmore differentiated. They're programmed in the sense that they allow and promote hairgrowth.EQ: The company's first-in-man, Phase I/IIa clinical trial was started in December 2010,and the last patient was injected in August 2011. What's next for RepliCel in this trial, andwhat are you hoping to see in the results?Hoffmann: Phase I trials are about safety, so a successful trial is, of course, about safety.Most people on the outside are not interested in safety; they're interested in hair growth.For the regulators, the first thing we must prove is that it's safe. A successful trial will provethat it's completely safe, with no adverse effects like ganuloma or tumor formations. A verysuccessful trial would mean we see more hair growth at the levels we would expect to seein a patient treated with Rogaine®. So, a range of 10 percent to 15 percent more hairs percentimeter square is what we would define as very successful. If we see even more hairsthan what is expected from finasteride (Propecia®) treatments, then we'd be very, veryhappy. So first of all, it's a safety treatment. But secondary, we are also looking for hairdensity and more parameters linked to efficacy.EQ: RepliCel is conducting the clinical trial in Georgia, but the company is also workingwithin safety parameters that meet FDA and European regulatory guidelines. Can you tellus more about that?Hoffmann: This trial is currently being conducted in Georgia under Good Clinical Practice(GCP). The protocol has been reviewed by the German authorities who helped form thebasis of our current protocol with regards to the time of follow-up after injection and to thenumber of biopsies because the regulators were interested in seeing what happensunderneath the skin. Therefore, this protocol is in line with all the requirements that thescientific advisor told us some years ago.

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