• Skip to primary navigation
  • Skip to main content
  • Skip to footer
Exopharm

Exopharm

  • Home
  • Products
  • Partnering
  • Science
  • Resources
    • ASX Announcements
    • Investor Information
    • News & Articles
    • Careers
  • About Us
    • Our Values
    • Our Team
    • Board of Directors
    • Scientific Advisory Board
  • Contact

Australian Regenerative Medicine: Questions and Answers

January 31, 2019 By Dr. Ian Dixon

Regenerative Medicine: Questions and Answers


What is regenerative medicine?

Regenerative medicine is a term used to cover different ways scientists can harness the body’s own regenerative capabilities.

What are some examples of regenerative medicines?

An old example is blood. Blood (or blood plasma) from donors is used routinely in hospitals if the patient needs more blood urgently. Another example would be cell therapy, where cells are injected or infused into the patient to trigger regeneration or replace lost cells.

What problems does regenerative medicine seek to solve?

Examples would be osteoporosis (bone density reduction), sarcopenia (muscle loss), arthritis, neurodegeneration, diabetes, heart degeneration, macular degeneration, tendonitis (degeneration of tendons), autoimmune disease (e.g. multiple sclerosis). Many of these are age-related conditions.

Why are there so many medical problems still poorly treated?

This is true, and needs to change. Finding new answers to old problems requires innovation and new thinking. At Exopharm we believe that exosomes (extracellular vesicles naturally secreted by cells and naturally present in our bodies) are a potential game-changer innovation in medicine.

Why are there no exosome products on the market for regenerative medicine yet?

Before a new drug can be sold (registered for sales), it needs to progress through clinical trials to demonstrate safety and efficacy. Running clinical trials through to registration typically requires treating hundreds (or even thousands) of patients.

Whilst exosomes are naturally occurring and plentiful, the technology to harvest and purify exosomes as a proper biologic product has been missing until recently.

Only when the “purification technology” problem is solved can sufficient exosomes be available to run proper clinical trials.

What is the “purification technology” problem?

Exosomes are invisible nano-sized natural lipid particles produced by stem cells and other cells in our bodies.

Whilst exosomes are described as “cell juice”, the limitation has been a proprietary commercial-scale purification process that produces a biologic product.

The process needs to be proprietary (i.e. patentable) to protect the investment to run clinical trials and commercialise. The process needs to be commercial-scale, as bench-scale production is unsuited to treating millions of patients.

The process needs to produce a biologic product – not some heterogeneous variable “soup” of molecules and contaminates.

Why is Exopharm seen as an innovator in this field?

Exopharm has acquired the LEAP Technology from Dr Ian Dixon. The LEAP Technology solves the “purification technology” problem and is a proprietary commercial-scale purification process that produces a biologic product.

Other companies and researchers are using purification technologies that are different from the LEAP Technology, and in many cases clearly inferior (e.g. ultracentrifuge or tangential flow filtration).

Having solved the “purification technology” problem, Exopharm is positioned to manufacture its exosome products (Plexaris and Exomeres) and run clinical trials to test safety and efficacy of these biologic products.

What is Plexaris?

Plexaris is our trade mark name for the exosome product from blood platelets purified with our LEAP Technology.

What is Exomeres?

Exomere is our trade mark name for the exosome product from stem cells (not embryonic stem cells) purified with our LEAP Technology.

How do Plexaris and Exomeres compare ? Why have both?

We expect that Plexaris may suit treating some conditions better than Exomeres, and may also be less expensive to produce. The strategy is to partner Plexaris and Exomeres separately, leaving room for two transactions instead of one.

Why does Exopharm believe its products will be safe?

Previous testing of platelet derived and adult stem cell derived exosomes/extracellular vesicles in animal studies have not demonstrated safety problems or toxicity to date.

Exopharm is presently conducting testing of its own. There have also been some recent small-scale human studies involving adult stem cell derived exosomes/extracellular vesicles and no serious adverse events were recorded in publications.

Why does Exopharm believe its products will work?

Previous testing of platelet derived and adult stem cell derived exosomes/extracellular vesicles in animal studies have demonstrated signals of efficacy in a range of models.

There have also been some recent small-scale human studies involving adult stem cell derived exosomes/extracellular vesicles and these studies have demonstrated signals of efficacy in a range of medical conditions including chronic kidney disease and graft versus host disease.

Is there interest from bigger companies?

Yes, some of the bigger companies are following the field.

Will Exopharm sell exosomes to others?

Our present strategy is not to supply clinical grade exosome product(s) to potential competitors. However, there may be ways to support companies we see as outside of our own focus areas.

What is the difference between autologous and allogeneic?

Autologous means the donor and the recipient are the same person (i.e. matched). Allogeneic means the donor and the recipient are different people.

What is a biologic product?

Biologic products come from living things e.g. proteins from cells. A synthesised peptide is not a biologic. Exosomes are biologics because they are secreted by cells naturally.

Filed Under: News

Footer

Resources

  • ASX Announcements
  • Investor Information
  • Board of Directors
  • News & Articles

Information

  • Contact
  • Partnering
  • Join Our Mailing List
  • Privacy, Terms and Conditions
  • Facebook
  • LinkedIn
  • Twitter
  • Vimeo
Copyright © 2022 · Exopharm · ACN 163 765 991 · info@exopharm.com
Level 17/31 Queen St, Melbourne VIC Australia 3000 · P: +61 (0)3 9111 0026 ·

Web Design by Mallee Blue Media
We use cookies on our website to give you the most relevant experience by remembering your preferences and repeat visits. By clicking “Accept”, you consent to the use of ALL the cookies.
Do not sell my personal information.
Cookie SettingsAccept
Manage consent

Privacy Overview

This website uses cookies to improve your experience while you navigate through the website. Out of these, the cookies that are categorized as necessary are stored on your browser as they are essential for the working of basic functionalities of the website. We also use third-party cookies that help us analyze and understand how you use this website. These cookies will be stored in your browser only with your consent. You also have the option to opt-out of these cookies. But opting out of some of these cookies may affect your browsing experience.
Necessary
Always Enabled
Necessary cookies are absolutely essential for the website to function properly. These cookies ensure basic functionalities and security features of the website, anonymously.
CookieDurationDescription
cookielawinfo-checkbox-analytics11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Analytics".
cookielawinfo-checkbox-functional11 monthsThe cookie is set by GDPR cookie consent to record the user consent for the cookies in the category "Functional".
cookielawinfo-checkbox-necessary11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookies is used to store the user consent for the cookies in the category "Necessary".
cookielawinfo-checkbox-others11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Other.
cookielawinfo-checkbox-performance11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Performance".
viewed_cookie_policy11 monthsThe cookie is set by the GDPR Cookie Consent plugin and is used to store whether or not user has consented to the use of cookies. It does not store any personal data.
Functional
Functional cookies help to perform certain functionalities like sharing the content of the website on social media platforms, collect feedbacks, and other third-party features.
Performance
Performance cookies are used to understand and analyze the key performance indexes of the website which helps in delivering a better user experience for the visitors.
Analytics
Analytical cookies are used to understand how visitors interact with the website. These cookies help provide information on metrics the number of visitors, bounce rate, traffic source, etc.
Advertisement
Advertisement cookies are used to provide visitors with relevant ads and marketing campaigns. These cookies track visitors across websites and collect information to provide customized ads.
Others
Other uncategorized cookies are those that are being analyzed and have not been classified into a category as yet.
SAVE & ACCEPT