Imagine using healthy cells from your body to heal areas in which other cells are damaged or deficient. That’s what RepliCel Life Sciences Inc. (TSXV: RP) expects to do by developing a new cell-based treatment for chronic tendinosis, in which a patient’s own fibroblast cells from their hair follicles are harvested, replicated, and then reintroduced into the damaged areas within the tendon via ultrasound, which “jump starts” the wound-healing cycle. These cells are replicated but are not altered in any way, so there is no safety issue involved in the re-introduction of a patient’s own cells.
Tendinosis is the result of repetitive injuries and incomplete healing cycles that lead to a degenerative breakdown of the collagen tissue within a tendon, which inevitably leads to pain, dysfunction, and often rupture. The company estimates the potential market for the treatment of tendinosis is in excess of $3 billion per year.
RepliCel’s fibroblast technology uses non-bulbar dermal sheath (NBDS) cells, which are prolific in their expression of type I collagen and are key to creating a complete healing cycle within the damaged and degenerated tendon. These cells are taken from the back of the patient’s scalp with the use of a small punch biopsy. The NBDS cells are unique in that they are capable of dividing and renewing for long periods. In a laboratory, this process can yield millions of cells. These cells, which make up the sheath of a hair follicle, are healthy throughout a person’s life as they are in a continued state of renewal.
“It takes us about five to six weeks to replicate the cells and the cells are returned to the patient via a minimally invasive ultrasound guided injection directly to the area of damage and it takes about six months to return the patient to full functionality,” said RepliCel President and CEO David Hall in a recent interview. Mr. Hall has more than 20 years of biotech experience and is the former Chief Financial Officer at Angiotech Pharmaceuticals Inc.
The Company’s phase 2 tendinosis fibroblast program is being followed into human clinical trials with a treatment for UV damaged and aging skin using the same technology platform. RepliCel has also developed unique injector devices to support the delivery of its treatments. The company expects to complete the development of its injector device, which is programmable to depth and dose and has built-in cooling that replaces the need for an anesthetic. This device could also find a market in the delivery of other cosmetic dermal injectors. The device is expected to be commercialized in the next year, providing additional licensing opportunities for the company and asset value accretion.
RepliCel’s technologies carry issued and filed patent applications. Furthermore, the Company’s cell manufacturing technology is protected by trade secrets and is unique in its ability to quickly replicate fibroblast cells versus other replication technologies.
RepliCel is also entering into a Phase 2 clinical trial for the treatment of pattern baldness using another cell isolated from the hair follicle. The technology was the subject of a Q2, 2013 Collaboration and Technology Development Transfer Agreement with Shiseido Company, Limited of Japan, the third-largest cosmetic company in world, in which Shiseido paid RepliCel an upfront fee of $4,120,400 for a geographic license including Japan, China and the ASEAN countries. Shiseido will initiate its own clinical program in Japan, providing two parallel clinical trials.
RepliCel plans to initiate a Phase 2 trial for chronic tendinosis and a Phase 1 trial for aging and damaged skin in 2014 with results expected in 2015.
“I expect we can get an approval for treating chronic tendinosis within three years,” Mr. Hall added.
RepliCel had $3.2 million in cash and equivalents as of September 30, 2013, and has a cash burn rate of approximately $200,000 per month. The company has 48,118,609 issued and outstanding common shares as of February 1, 2014, and after its listing on the TSX-V in February of this year its stock has surged 50% to its recent price of 90 cents a share.
About RepliCel Life Sciences:
RepliCel Life Sciences Inc. (TSXV: RP) is a clinical stage biopharmaceutical company focused on developing autologous cell therapies that treat functional cellular deficits. RepliCel Tendon-01 (RCT-01) is a cell therapy for the treatment of chronic tendon injuries. RepliCel Hair-01 (RCH-01) is a cellular treatment for androgenetic alopecia (pattern baldness). Shiseido Company, Limited has an exclusive geographic license for RCH-01 in certain Asian countries including Japan, China and South Korea. Both product candidates are based on RepliCel’s innovative technology which utilizes cells isolated from a patient’s own healthy hair follicles to address specific cellular deficits. For additional information please visit www.replicel.com.
Disclosure
RepliCel Life Sciences is a featured sponsored company and has paid SmallCapPower.com a fee for coverage.
