Regenerative medicine company Exopharm Limited (ASX:EX1) announced the first dosing has occurred in the PLEXOVAL Phase I clinical trial using exosomes isolated from human platelets for wound healing. The sponsor expects more participant dosing soon as they seek to enroll up to 20 patients. This PLEXOVAL study places Exopharm in a worldwide leadership position in the exosome field—first dosing is a critical milestone in this early-stage study.

TrialSite News provides a breakdown of this information for our readers.

Exosomes

Recent animal studies reveal that the regenerative power and safety of exosomes released by stem cells reports Exopharm Limited (Exopharm). These exosomes are tiny packets of proteins and genetic material that have powerful regenerative properties that promote wound healing, brain injury recovery following stroke, and recovery from heart attack, to name just some potential therapeutic applications. In a nutshell, companies such as Exopharm are banking that exosomes that are released by stem cells have now been shown to deliver the regenerative powers long associated with stem cells.

Exosomes show great promise across a range of age-related medical conditions including problems with mobility (e.g. osteoarthritis) and sensory function (e.g. erectile dysfunction, eye disease, hearing loss and age-related macular degeneration), but the number of companies capable of manufacturing sufficient quality and quantities of exosome products at the clinical level is still very limited. This makes Exopharm an ideal potential partner for exosome products in areas such as neurodegeneration, cardiac repair, wound healing and transplant rejection.

For a description of exosomes, see the link

What is the significance of the first dosing for Exopharm?

According to their recent press release and a quote from Dr. Ian Dixon, founder and CEO, “The first dosing of the PLEXOVAL study positions Exopharm as a clinical stage leader in the cell-free exosome field of regenerative medicine. It is a great achievement for our team to test our exosome product in this Phase I study, which is a world first. Our LEAP technology allows us to manufacture an advanced exosome product? We believe our progress will be closely watched by industry players and potential partners.”

What is Exopharm’s LEAP Technology?

According to the company’s marketing material on the website, exosomes (also known as extracellular vesicles or EVs) from stem cells are poised to become a new form of regenerative medicine—or known as “the secret sauce” from stem cells. The field however has been hindered by a lack of suitable purification technology. Enter Exopharm’s LEAP Technology to remove the purification bottleneck that is holding back the field back.

For the LEAP Technology platform, Exopharm uses a chromatography-based purification method known as Ligand based Exosome Affinity Purification (LEAP). See the link for more details.

Why is Exopharm seeking partnerships?

Exopharm seeks to find companies and research sponsors that want to leverage its exosome technology platform to develop additional products from a variety of cell sources into advanced regenerative medicines. Exopharm believes it is an ideal partner for exosome products in areas such as neurodegeneration, cardiac repair, wound healing and transplant rejection. TrialSite News notes the company is thinly capitalized and should be in search of paying partnerships.

Approval for Study in Australia

Exopharm was granted Human Research Ethics Committee approval to commence the PLEXOVAL wound healing study with its Plexaris™ (exosomes from platelets) autologous product under the Australian Clinical Trials Notification (CTN) scheme in 2019. 

The PLEXOVAL Study

Dosing of Cohort 2, with up to five participants commences first. Recruitment will  now be completed on a rolling basis.  Cohort testing includes histology of biopsied post treatment wound tissue for assessment of biological activity within the healed wound.   The main readouts of the study will be safety, wound closure and scarring. Subject to successful recruitment and throughput, a study report will be provided to Exopharm at this stage expected after mid-2020.

About Exopharm Limited

Based in the biotech hub of Australia in Melbourne, Exopharm is on a mission to be a leader in the field of clinical human therapeutics using exosomes as regenerative medicine products. They are a clinical-stage Australian regenerative medicine company developing therapeutic exosome products as alternatives to stem-cell therapies. Exosomes are small particles naturally produced by cells, which deliver therapeutic ‘cargoes’ to other cells to reduce inflammation and promote regeneration. Exosomes are plentiful in our youth but decline with age. Recent research points to exosomes as a way to extend the number of healthy, functional years (extending health span). Exosomes secreted by stem cells could be used instead of stem-cell therapy with equal or greater benefit – and without the problems of stem-cell therapies. They could be used to deliver targeted ‘novel’ drugs and have potential as diagnostics.

While trillions of exosomes are produced by stem cells, the real challenge is to ‘purify’ them as drug products. Exopharm owns a purification technology called Ligand-based Exosome Affinity Purification (LEAP). LEAP technology and associated know-how places Exopharm at the forefront of this emerging field worldwide. Exopharm is at clinical stage with pending and current trials for wound healing, dry aged-related macular degeneration and osteoporosis.

Exopharm was founded in 2013 by Dr Ian Dixon, co-founder of the ASX-listed stem-cell therapy developer Cynata Therapeutics. He was also a director of Cell Therapies, which produced adult stem cells for ASXlisted stem cell company Mesoblast. Exopharm listed on the ASX in December 2018.

Business & Finance

Traded on the Australian market, the company is thinly capitalized, losing about $2.2 million in 2019 left with cash position of about $4.5 million cash in bank. The company trades are well under a dollar for a $26 million valuation.

Source: BusinessWire

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