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RepliCel’s Cell-Based Solution to Hair Loss

After two decades of research and collaboration, RepliCel Life Sciences Inc. (OTCBB: REPCF) in the first quarter next year will learn whether its natural hair cell replication technology has the potential to become the world’s first, minimally invasive solution for pattern baldness and general hair loss in men and women.

“Our autologous cell implantation technology extracts a patient’s hair cells from their own healthy hair follicles and after replication and reintroduction of those cells into areas of hair loss, we hope to initiate natural hair regeneration and rejuvenation of existing quiescent hair follicles,” CEO David Hall says in an exclusive interview with BioTuesdays.com.

Last month, the company injected the final patient with their own replicated hair cells in the first human clinical study of its technology. To date, no serious adverse events have been reported post-injection in any of the 10 men and nine women in the study. The company plans to release initial safety data after the final patient completes a six-month follow-up next February. It also plans to analyze whether the procedure achieved hair growth at the treatment sites. The study will conclude in August, 2013.

“Safety is our primary end point, but from my point of view you have to have some indication that you’re on the right track for neogenesis of hair follicles and waking up quiescent hair follicles,” Mr. Hall says.

“In pattern baldness, what happens is that the hair cycle creates ever smaller hair follicles and eventually, stops cycling,” he adds. “What we’re looking for in the clinical trial is not just the growth of new hair follicles, but rejuvenation of the existing quiescent baby hair follicles.”

Mr. Hall contends a “moderately successful” clinical trial would result in a 10% increase in hair growth in six-to-12 months, which would be equivalent to Rogaine, the first topical FDA-approved product to re-grow hair in both men and women. A “very successful” trial, he figures would result in a 10% to 15% increase in hair growth in six-to-12 months, which is equivalent to Propecia, the only FDA-approved, once-a-day pill to help reduce dihydrotestosterone, a key cause of hair loss. An “extremely successful” trial would be a 20%-plus increase in hair growth in six-to-12 months, he adds.

RepliCel’s technology is based on research of its two founding scientists, Dr. Rolf Hoffmann and Dr. Kevin McElwee, who focused on a region of the hair follicle that had been largely ignored – the dermal sheath cup. These cells are located at the lower pole of the hair bulb, surrounding the hair bulb in a cup-like manner.

In pre-clinical studies, the scientists found that dermal sheath cup-derived cells carry the potential to induce the formation of new hair follicles. Dermal sheath cup-derived cells were also found to induce better quality hair growth than cells derived from the dermal papilla in the follicle. Their studies suggested that dermal sheath cup cells are the source for the formation of the dermal papilla in natural hair follicle cycling. Their research was published in the peer-reviewed Journal of Investigative Dermatology in 2003.

“That’s what differentiates us from the competition,” Mr. Hall says. “We are using a specific source of cells from hair follicles that no one else is, we have patent protection on it, and we think these dermal sheath cup cells are the progenitor cells for the development of new hair follicles. Without those we were unable to develop natural new hair follicles in our pre-clinical animal models.”. He notes that Dr. McElwee, who is RepliCel’s chief scientific officer and Dr. Hoffmann, who is chief medical officer, repeated their animal model experiments many times and “100% of the time, they increased hair growth and density by 50%, which is effectively a home run.”

There are two current treatments for hair loss, of which the most common form is pattern baldness or alopecia. The first is surgical hair restoration which involves surgical removal of large portions of hair-bearing scalp from the back of the head, dissection of scalp skin into smaller hair follicle clusters, which are transplanted to the balding areas of a patient’s scalp. The second is non-surgical restoration with Rogaine and Propecia which requires continual use otherwise, any new hair growth will possibly fall out.

RepliCel begins its treatment procedure in humans by taking a small biopsy of skin and hair follicles from the back of a patient’s scalp that still grows healthy hair. The biopsy tissue is shipped in a special European Union- approved container to Innovacell of Austria, where the cells are separated and the dermal sheath cup cells are cultured for about three months. The millions of replicated cells are returned to RepliCel and re-injected into areas of hair loss on a patient’s scalp by a patented device in a procedure that takes 30-to-40 minutes.

Mr. Hall says an important advantage of their cell replication technology is that by rejuvenating damaged hair follicles, it would enable early intervention in pattern baldness prior to the development of extensive hair loss.

He also contends their procedure has the potential to give patients “permanent results,” with no need for continued daily maintenance treatments as with drugs. The cost of the RepliCel™ treatment hasn’t been set yet but “it has the potential to be a permanent cure for pattern baldness,” he adds.

For doctors, he says the advantage is that the procedure can be done quickly, allowing more patients to be treated daily than hair transplants. “It’s a simple procedure, requires less training and support staff, and can be provided by one person with one assistant.”

Successful Phase 1 results would set the stage for a Phase 2b dose ranging clinical trial next fall. The company plans to run the protocols through the FDA and Health Canada, even though Mr. Hall is leaning towards doing the trial in Europe. “So, whatever data is generated in Europe could be used for pivotal trial approval in the Western jurisdictions,” he adds.

Asked about safety issues with autologous cell therapy, he says “we are taking cells that are already programmed to generate hair follicles and hair growth, replicating them into the millions, and returning them like a cellular transplant. We’re not asking them to do anything other than what they already do.”

He also notes that RepliCel, unlike several competitors, is the only company that has filed its clinical trial protocols on the FDA website. “That also means we are the only company that can publish study results with any meaningful peer-review.”

Mr. Hall contends the cost of developing this technology will be far less than an average drug, biologic or even a stem cell therapy product, with the projected cost of the Phase 2 trial at around $5 million. “I think that’s great value to our shareholders in terms of the risk/reward,” he adds.

“In our animal studies, we’ve been successful 100% of the time in generating new hair growth and creating increased density. Certainly, we expect to see hair growth [in human testing] but we don’t know what it will be. What I want to see is enough that lets me do the Phase II dosing trial. That’s the evolution of the science. If we can do that, we will probably attract some attention from Big Pharma next year.”

Source:
http://www.replicel.com/biotuesday-blog ... ences-inc/