Can you provide a general update on your progress in 2022/so far in 2023 when it comes to the topical product to increase the effectiveness of scalp cooling?
We have developed formulations (nanoparticulates) of three antioxidants. Two of these antioxidants (actives) have been incorporated into nanostructured lipid carriers (NLCs), we have shown that they are robust formulations and stable on storage. These have been tested on skin models and we have demonstrated efficient skin permeation of the antioxidants and successful targeting of hair follicles (compared with actives alone). We are currently working on refining the formulation of a third antioxidant, which has been incorporated into lipid nanoparticles (LNs).
What is the status specifically when it comes to choosing a nanoformulation to reach the hair follicle?
Our nanoparticle-based formulations have been developed using excipients that are not only safe for human skin (with evidence of use in approved pharmaceutical products), but also have the properties required to target the follicles. In particular, we have ensured that nanoparticles exhibit the correct size, and have optimal surface chemistry (electrical charge) to successfully reach the hair follicle. Moreover, we have taken into consideration the chemical properties of each antioxidant and have designed bespoke formulations to efficiently deliver the different antioxidants.
Are you currently aiming for one formulation of the product, or several depending on the chemotherapy type used?
Based on our extensive previous biological work that demonstrated the efficacy of the antioxidants against the most commonly used chemotherapy drugs that cause hair loss, we have several potential options. Although the first topical product(s) used in conjunction with scalp cooling will be single formulations, it is certainly a possibility that combinatorial formulations may be used to ensure better protection against certain chemotherapy regimens. In preparation for this scenario, we have preliminary experimental evidence that we can concurrently target two antioxidants to the follicles.
What will you be focusing on in 2023 in this project?
Our focus will be to work with a commercial partner that has a proven track record in dermatological / skin care products, in order to formulate a product (lotion, serum or cream) for application of the nanoformulation to the hair and scalp. Initially, this will be carried out with one antioxidant to provide a product that can be used clinically and provide proof-of-concept data. This is the most exciting stage of the work where the real product can be available for use! We will also be optimizing the LN-based formulation of the third antioxidant and using the skin models to test for successful targeting to the follicle area, whilst also confirming that the nanoformulation retains stability upon storage.
What are the biggest challenges left before reaching the market with this product? Will you need to do any clinical studies to collect data for market certification, and if so, have you started the planning for this?
The aim is to follow the most straightforward and fastest route-to-market approach. The advantage of our nanoformulations is that they deliver natural antioxidants, thus our plan is to develop and market the formulations as cosmetic haircare products. This approach will not require clinical trial testing and the topical products will comply with cosmetics regulations with clear safety for human use, which negates the need for compliance with regulatory authority requirements and/or market certification.
What is a reasonable time to market the topical product based on the current status of the project?
Although making the product available as a cosmetic (instead of a pharmaceutic) will undoubtedly accelerate the path to patient use, the timelines to market will become clearer and better defined once we have entered a commercial agreement with the partner that will assist in the manufacturing and distribution of the cosmetic formulation.
Can you provide an update on any additional biological R&D activities related to scalp cooling that you have conducted in 2022/so far in 2023?
Our cell biology team has vast expertise in the mechanisms of cell death in human cells and our work has recently led to an exciting discovery. Whilst continuing to investigate the mechanisms by which chemotherapy drugs trigger cytotoxicity in hair follicles (and hair loss), we observed that one of the most frequently used chemotherapy drugs in the clinic activates a new type of cell death. This has not only moved us one step closer in understanding how chemotherapy causes hair loss, but has also provided the exciting possibility of new treatments in combination with scalp cooling.
What biological R&D activities related to scalp cooling in addition to the topical product are you planning in 2023?
Following the exciting discovery described in previous answer, we now aim to further understand the role of this relatively newly discovered type of cell death in chemotherapy drug-mediated hair follicle toxicity. Moreover, we will test inhibitors of this type of cell death for their ability to enhance the ability of cooling to protect cells. This approach is different to using an antioxidant, therefore we face the exciting possibility of a completely novel combinatorial approach to minimise hair loss.
Anything else you would like to add related to biological research and development you are currently carrying out?
Although hair loss represents the most traumatic side effect of chemotherapy for patients, a chronic and severely debilitating effect of the treatment is chemotherapy-induced peripheral neuropathy (CIPN). Our research has therefore recently expanded towards the development of neuronal cell culture models to systematically study for the first time how chemotherapy drugs cause cellular ‘stress’ (which underpins nerve damage caused by CIPN) and how cooling may suppress such cellular stress. This work will complement the exciting clinical trials that Paxman is leading with clinicians at the National University of Singapore (NUS).
To watch the discussions on the latest research into scalp cooling, join the Scalp Cooling Summit here.
For more on the Research and Innovation Centre at the University of Huddersfield, click here.