RCH-01

Press Release
Publication of Clinical Data Confirms RepliCel’s Treatment for Androgenic Alopecia Effective in Men and Women
A randomized, placebo-controlled, double-blinded clinical study in Japan testing a one-time injection of RCH-01 in...
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A randomized, placebo-controlled, double-blinded clinical study in Japan testing a one-time injection of RCH-01 in 65 patients with pattern hair loss shows increased hair density and diameter through 9 months post-injection

 VANCOUVER, BC – 23 March 2020 – RepliCel Life Sciences Inc (OTCQB: REPCF) (TSX.V: RP) (Frankfurt: P6P1), a clinical-stage regenerative medicine company developing cell therapy products in aesthetics and orthopedics, provided commentary today on the recent publication of a paper in the prestigious Journal of the American Academy of Dermatology, entitled; “Autologous Cell-based Therapy for Male and Female Pattern Hair Loss using Dermal Sheath Cup Cells: A Randomized Placebo-Controlled Double-Blinded Dose Finding Clinical Study” (https://doi.org/10.1016/j.jaad.2020.02.033).

\"We are very pleased that the data from this randomized, placebo-controlled, double-blinded, dose-ranging clinical study of 65 patients (male and female) with pattern hair loss confirms, with statistical significance, the observations from our ph 1 trial in a larger cohort of patients including females, a wide variety of ages and hair loss, and compared with a placebo-control. In summary, the study produced a statistically significant and clinically meaningful increase in hair density and diameter as measured nine months after treatment,” stated RepliCel’s Chief Medical Officer, Dr. Rolf Hoffman.

The study, conducted at Tokyo Medical University and Toho University, with product manufactured and supplied by Shiseido Company in accordance with its license from RepliCel Life Sciences, examined the safety and efficacy of autologous cell-based therapy using dermal sheath cup (DSC) cells to treat male pattern hair loss (MPHL) and female pattern hair loss (FPHL). The study tested a high, medium, low-dose and placebo injection, each in one of four one-centimetre patches located in an area of pattern hair loss on the scalp of each patient. 

“As a dermatologist in practice for over 30 years and specializing specifically in hair loss, I have treated tens of thousands of patients with male and female pattern hair loss. As a researcher who has investigated several different technologies to both prevent hair loss and stimulate hair re-growth, I am highly encouraged by the data from this most recent Shiseido-funded study in Japan of the cell therapy technology licensed from RepliCel Life Sciences for treating male and female pattern hair loss (androgenetic alopecia),” said Dr. Jerry Shapiro, Professor and Director of Disorders of the Hair and Scalp at the Ronald O. Perelman Department of Dermatology at the Grossman New York University School of Medicine. “There have been very few clinical studies in hair loss using cell therapy over the past two decades which have been designed as meticulously as this randomized, double-blinded, placebo-controlled dose-finding study and none which have resulted in results with this kind of statistical significance,” Shapiro stated.

 “When reviewing the data from this study it is important to note that most of the men involved in the study were at advanced stages of hair loss with 58% being at Norwood stages V and VI and 90% at stage IV and above. Similarly, 60% of the participating women were on the more advanced grade of hair loss.  The best responders were in an older population (51 years of age or older) with moderate severity. We know that any technology works better in a less severe pattern of hair loss and that is once again what we see in this study,” continued Shapiro who was a founding shareholder of RepliCel but was not involved in this clinical study. “The best responders were those at stage Norwood III/IV rather than V/VI and the best responders saw a range of 5-13 more hairs per square centimeter at nine-months after treatment. This is a statistically significant result produced from a one-time injection of an experimental treatment that may yet be improved upon in any number of ways including being easily delivered in a series of injections, which I would expect to further increase hair re-growth outcomes. This is an exciting development in the field of hair-loss research.”

In the study, fifty males and fifteen females, aged 33 to 64, were injected. Total hair density and cumulative hair diameter at the low-dose injection site was significantly increased compared with the placebo after 6 and 9 months. Men and women showed similar improvements and there were no serious adverse events.

The autologous cell-based therapy of dermal sheath cup cells used in this study is the product RepliCel refers to as RCH-01 for which Shiseido has licensed the co-development and commercial rights in Asia. RepliCel maintains the complete and unrestricted rights to this product outside of Asia.

This was a well-designed study following the highest clinical standards with an intent to gather data which correlates outcomes with dose involving a cross-section of anticipated patient types as defined by age, hair loss, and gender. The data from this study adds considerably to our body of knowledge from lab research, animal studies, product development, and the phase 1 trial of 19 patients completed in 2017,” stated RepliCel’s Chief Scientific Officer, Dr. Kevin McElwee. “The efficacy data observed in this trial, together with animal research data, suggests that long-term survival of injected cells improves both with smaller dose size and with several sessions of injections spaced-out over a set time course. RepliCel expects the survival of injected cells to be correlative with increased hair density and diameter.”   

RepliCel’s specific commentary on several aspects of the study, publication, and data appear below:

Efficacy

The lowest-dose tested in the study showed the best results with a substantial increase in hair density and diameter lasting nine months after treatment. The one-time, low-dose injection resulted in a statistical significant increase in total hair density and cumulative hair diameter compared with placebo. This result represents a clinically meaningful result but one which RepliCel also intends to enhance through planned product and delivery improvements. Efficacy was not expressed in terms of percentage increase by the study authors and RepliCel has not yet had opportunity to provide such analysis based on a review of the data.

One-time Injection vs Series of Injections

The study results are consistent with RepliCel’s phase 1 study of the product which was restricted to only testing a one-time injection of a high dose of cells and saw results peak between 6 and 12 months post-treatment. RepliCel believes that a series of injections has the potential to significantly improve the treatment’s cumulatively impact. In a recent press release issued by Tokyo Medical University, Toho University, and Shiseido Co., Ltd, they also stated a commitment to a future clinical study testing a series of injections with the expectation that this may increase hair density and diameter and/or lengthen the duration of the treatment’s outcome.

Low-Dose

The study results correlating the greatest efficacy with the lowest tested dose is consistent with other cell therapy studies which have shown there is a dose-related efficacy ceiling with many cell therapies. This is also consistent with RepliCel’s study of its other cell-based therapy (RCS-01) for skin rejuvenation which was published the journal, Skin Pharmacology and Physiology entitled; “Autologous Cell Therapy for Aged Human Skin: A Randomized, Placebo-Controlled, Phase-I Study” (https://doi.org/10.1159/000502240).  Similarly, clinicians have also noted decreased efficacy of platelet rich plasma (PRP) injections when doses exceed certain thresholds.

In a subsequent study, it will make sense to test even lower doses, particularly when combined with injecting the product in a series of injections over several months in a highly controlled manner. 

Delivery

It is worth noting that this study utilized a rudimentary single-needle, manually-driven injection system which is slow and subject to user-based inconsistency. While the lowest cell dose tested in this study resulted in the best outcome, RepliCel believes even lower doses, when injected using a highly consistent delivery system, may be important to maximizing results. Indeed, RepliCel is of the view that this kind of micro-dosing, enabled by an automated injector such as RepliCel’s RCI-01 with multi-needle head capacity, may be the best way to maximize the results of this cell-based therapy. For this reason, RepliCel is committed to future clinical testing using its proprietary dermal injector and related consumables for the delivery of its cell-based therapies for hair re-growth and skin rejuvenation. 

Cryopreservation

This study represents the first time this product, comprised of dermal sheath cup cells, was used clinically after being cryopreserved. In the phase I study, RepliCel shipped product under cool controlled-temperature conditions but not cryopreserved. Following the phase 1 trial, RepliCel conducted several studies at the University of British Columbia and its European-based contract manufacturer which demonstrated the stability and viability of thawed cells after control-rate freezing and cryopreserved storage. 

The ability to store product long-term for future use and ship it over long-distances in highly-controlled formats provides distinct advantages to the products’ commercial margins and model.  This technology and data was part of RepliCel’s technology transfer to Shiseido’s manufacturing facility and personnel. This study represents the first clinical confirmation of the product’s efficacy after cryopreservation.

Background

RepliCel conducted a first-in-human phase 1 clinical trial of RCH-01 starting in late 2011 which completed in 2017. After the announcement of preliminary clinical data in 2013, Shiseido Company, licensed the commercial rights to RCH-01 for Asia while RepliCel maintained the commercial rights for the rest of the world. The agreement involved Shiseido paying an upfront licensing fee, post-commercial milestone payments, sales royalties, and costs (in Asia) for all clinical testing, regulatory approvals, manufacturing, sales and marketing, distribution, etc. The two companies agreed to collaborate on the product’s further development and clinical testing and share data while doing so until the product was fully commercialized. Shiseido's obligations as a licensee to pay sales royalties would last for 10 years after the launch of the product in any country within Asia. 

Upon execution of the agreement, RepliCel worked extensively on the technology transfer of all aspects of RCH-01 production and quality control to Shiseido, assisted with the necessary regulatory approvals for the product’s manufacturing and clinical testing, trained all physicians involved at the clinical sites, and critically supported Shiseido’s facility design, build, validation, and personnel training. The clinical study described in the medical journal publication was launched in 2016 in Japan using product manufactured by Shiseido pursuant to the license and co-development agreement in place with RepliCel. 

Since the completion of this phase I study, RepliCel has continued to invest in gene marker studies as well as manufacturing and other product optimizations which are all expected to result in increased efficacy and cheaper manufacturing. Additionally, RepliCel has continued to invest in bringing its highly automated dermal injector to market which the company believes will be important to optimizing the product's clinical efficacy and commercial advantages. 

RepliCel’s phase 1 trial, was designed to gather data related to the product's safety and potential efficacy through 24 months post-injection but was not designed for statistical significance related to any efficacy endpoints. The efficacy data collected from all 19 patients, while not statistically significant, provided useful and potentially exciting insights into the product's potential for the treatment of those with androgenetic alopecia. The phase I trial involved the injection of a very high dose of dermal sheath cup cells in order to identify any potential toxicity in accordance with the primary safety objectives of the trial.  

Neither the phase 1 trial nor the recent study produced any significant adverse events. Both resulted in a wide range of clinical responses including a subset of patients with sustained double-digit increases in hair density and diameter. 

The results from the Japanese study recently published supports RepliCel's hypotheses about the product and confirms the phase 1 observations in a larger cohort of patients, in a placebo-controlled study, and in both male and female patients.

About RCH-01

The product, referred to as RCH-01, was RepliCel’s first product developed and taken to clinical trial. It is a cell therapy product manufactured from the patient’s own dermal sheath cup cells isolated from a biopsy taken from back of the scalp. The dermal sheath cup cells are ultimately responsible for hair fiber growth and these cells in hair follicles at the back of the scalp are resistant to attack by androgen hormones. Androgen hormone activity causes pattern hair loss by promoting the disappearance of cells from hair follicles on the top of the head in patients afflicted with the condition. Data has indicated that, by growing dermal sheath cup cells taken from hair follicles at the back of the scalp and injecting them into areas of the scalp affected by hair loss, the injected cells enable hair growth and regeneration. 

About RepliCel Life Sciences

RepliCel is a regenerative medicine company focused on developing cell therapies for aesthetic and orthopedic conditions affecting what the Company believes is approximately one in three people in industrialized nations, including aging/sun-damaged skin, pattern baldness, and chronic tendon degeneration.  These conditions, often associated with aging, are caused by a deficit of healthy cells required for normal tissue healing and function. These cell therapy product candidates are based on RepliCel’s innovative technology, utilizing cell populations isolated from a patient’s healthy hair follicles. 

The Company’s product pipeline is comprised of RCT-01 for tendon repair, RCS-01 for skin rejuvenation, and RCH-01 for hair restoration. RCH-01 is exclusively licensed in Asia to Shiseido Company. RepliCel and Shiseido agreed to co-develop the product in Japan. RepliCel maintains the rights to RCH-01 for the rest of the world.  RCT-01 and RCS-01 are exclusively licensed in Greater China to YOFOTO (China) Health Company. RepliCel and YOFOTO are currently co-developing these products in China. RepliCel maintains the rights to these products outside of Greater China. 

RepliCel has also developed a proprietary injection device, RCI-02, and related consumables, which is expected to improve the administration of its cell therapy products and certain other injectables. YOFOTO has exclusively licensed the commercial rights for the RCI-02 device and consumables in Greater China for dermatology applications and is expected to first launch the product in Hong Kong upon it being CE marked. Please visit www.replicel.com for additional information. 

For more information, please contact: 

Telephone: 604-248-8693 / info@replicel.com  

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release. 

This press release contains forward-looking statements and information that involve various risks and uncertainties regarding future events, including, but not limited to, statements regarding: 

These statements are only predictions and involve known and unknown risks which may cause actual results and the Company’s plans and objectives to differ materially from those expressed in the forward-looking statements, including: risks that the Company’s products may not perform as, or have the benefits, expected; risks that the Company’s products may not be accepted and adopted by the public; the risk that the Company will not obtain regulatory marketing approval for its injector device as anticipated or at all; the risk that there will be delays enrolling clinical trial participants or commencing any clinical or research programs as anticipated or at all; the risk that the Company will receive negative results from the Company’s clinical trials; risks associated with the Company obtaining all necessary regulatory approvals for its various programs; risks associated with the Company’s ability to obtain and protect rights to its intellectual property; risks and uncertainties associated with the Company’s ability to raise additional capital; and other factors beyond the Company’s control. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee future results, levels of activity or performance. Further, any forward-looking statement speaks only as of the date on which such statement is made and, except as required by applicable law, the Company undertakes no obligation to update any forward-looking statement to reflect events or circumstances after the date on which such statement is made or to reflect the occurrence of unanticipated events. New factors emerge from time to time, and it is not possible for management to predict all of such factors and to assess in advance the impact of such factors on the Company’s business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statement. Readers should consult all of the information set forth herein and should also refer to the risk factor disclosure outlined in the Company’s annual report on Form 20-F for the fiscal year ended December 31, 2018 and other periodic reports filed from time-to-time with the Securities and Exchange Commission on Edgar at www.sec.gov and with the British Columbia Securities Commission on SEDAR at www.sedar.com.

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