Replicel Life Sciences Inc V.RP

M& D Key Points Nov 30th

[bpeters]

RCT-01: Treatment for Chronic Tendinosis

The Company’s fibroblast technology for tendinosis, which the Company refers to as RCT-01, has been developed over five years of research, experimentation and trials. RCT-01 is a tissue-engineered product made from a procedure using collagen-producing fibroblasts isolated from non-bulbar dermal sheath (NBDS) cells within the hair follicle that are replicated in culture.

•  The use of these fibroblasts are, therefore, ideal for treating chronic tendon disorders that arise due to either a degeneration of collagen producing cells or a deficit of active collagen producing cells.
• Because RCT-01 directly provides a source of collagen expressing cells to the site of injury, addressing the underlying cause of tendinosis, the Company believes it has advantages over current treatments such as the use of non-steroidal anti-inflammatory medication or corticosteroids which are limited in efficacy.
• Another advantage of RCT-01 is the autologous nature of the cellular product, thereby reducing the likelihood of adverse immune reactions upon administration.

Phase 2 Clinical Trial

The Company is now designing a phase 2 clinical trial intended to measure efficacy of RCT-01 in a larger population of patients with chronic Achilles tendinosis and answer critical questions related to dosing and treatment frequency.

RCS-01: Treatment for Aging and Sun Damaged Skin

RCS-01, provides a promising platform to treat intrinsically and extrinsically aged/damaged skin by providing UV-nave collagen-producing fibroblast cells directly to the affected area.

• The Company’s unique manufacturing technology allows for isolation of fibroblasts derived from anagen-hair follicle mesenchymal tissues, which elicit more efficient replication potential in culture.
• Additionally, the Company’s proprietary culture procedures potentiate these cells to maintain plasticity, allowing the cells to adapt to the microenvironment and respond to the mechanical or surrounding stimuli after injection, leading to robust production of type I collagen and elastin and their proper alignment within the tissue.

Phase 2 Clinical Trial

The Company is now designing a multi-centre phase 2 clinical trial intended to measure efficacy of RCS-01 in a larger population of patients with aging and UV-damaged skin and answer critical questions related to dosing and treatment frequency. It is intended that this trial will be conducted using prototypes of the RepliCel’s RCI-02 dermal injector.

RCH-01: Treatment for Hair Loss

The Company believes its dermal sheath cup (DSC) cell therapy offers several advantages over current hair loss solutions. The current gold standard in hair loss treatment is hair transplant surgery which requires the surgical removal of a prominent band of hair-bearing scalp or multiple micro-biopsies from the back of the head. This band of resected tissue or biopsies are then dissected into hair follicles consisting of one to three hairs which are then implanted into balding areas on the scalp. Often a number of similar procedures are required to achieve the desired result and the patient is limited by the number of hairs that can be redistributed.

In contrast, RCH-01 involves the extraction of as few as 20 hair follicles from the back of the patient’s scalp where healthy cycling hair follicles reside.

• The Company believes these cells are responsible for the continued health of the hair follicle and the normal cycling of the hair fiber. DSC cells are isolated from the hair follicles and are then replicated in culture at a cGMP compliant facility utilizing the Company’s proprietary cellular replication process, and are then reintroduced back into balding areas on a patient’s scalp. The implanted cells are expected to rejuvenate damaged quiescent hair follicles leading to the growth of new healthy hair fibers.
• The anticipated long-term result of RCH-01 injections is the restoration and maintenance of a patient’s hair.

Proposed Phase 2 Clinical Trial

The Company has designed a phase 2 clinical trial intended to measure efficacy of RCH-01 in a larger population of patients with mild to moderate androgenetic alopecia and answer critical questions related to dosing and treatment frequency.

The Company is currently engaged in molecular marker research which is expected to lead to improvements in the product identification, manufacturing, and its clinical effectiveness. The Company will await the results of this research prior to submitting the clinical trial application for a phase 2 study of RCH-01 for regulatory approval.

Collaboration Agreement

 

The Company has also entered into a Collaboration and Technology Transfer Agreement with Shiseido Company, Limited (“Shiseido”), one of the world’s largest cosmetic companies. Both companies will work towards establishing a clinical research program in Asia, with the goal of increasing the available human clinical data on RCH-01.

• The Company anticipates that collaborative technology transfer will continue between the companies as any new improvements to the RCH-01 technology are developed by either party.
• This agreement gives Shiseido an exclusive geographic license to use the Company’s RCH-01 hair regeneration technology in Japan, China, South Korea, Taiwan and the ASEAN countries representing a population of approximately 2.1 billion people.
• In mid-2016, Shiseido alleged RepliCel’s breach of obligations in the agreement which Shiseido alleged were potentially terminal to future obligations pursuant to the agreement.  RepliCel has vigorously denied the existence of such breach and insists on the ongoing validity of the respective obligations on both parties pursuant to the agreement. 
  • No litigation or the triggering of other dispute mechanisms has been entered into by either party and RepliCel management is actively seeking to continue discussions and/or negotiations with Shiseido to resolve the matter. Shiseido is currently funding a hospital-sponsored clinical study of RCH-01 in Japan funded by Shiseido.
  • The clinical data produced in such a trial would, by agreement, be made available to the Company. This is anticipated by mid-2018.

RCI-02: Dermal Injector Device
To support the Company’s RCH-01 and RCS-01 products, the Company is developing a second generation dermal injector device.

• The RCI-02 Injector, the production design of which is now complete, will be able to deliver programmable volumes of substances into programed depths to specific layers of the skin in a constant form with minimal pressure or shear stress, ensuring the injected substance is viable and healthy after application.
  • By improving the conditions of substance delivery, the Company improves the chances of success in the treatment of the patient.
  • A significant feature of the new device is the incorporation of a cooling element at the injection site, thus removing the need for an anesthetic.
  • This is a significant improvement over current syringe-type devices where an anesthetic is required prior to injection.

The Company believes that this device will have applications in certain other dermatological procedures requiring injections of specific volumes of material at specific depths and as such, is actively exploring licensing opportunities in these areas.

• In addition to the programmable variables of volume and depth, the device will also have interchangeable heads for different injection procedures (single and multi-needle).
• The Company received fully functioning prototypes in Q3 2017 and is on schedule to finalize and test commercial-ready prototypes over the coming months and submit an application for CE-mark approval in Europe in 2018.

Intellectual Property

The CRI-02 injector has already been the subject of an issued patent in Europe and the United States. The Company has filed patent applications relating to devices for the delivery of therapeutically useful cells, as well as to compositions and methods for repairing tendons.