Exopharm Limited (ASX: EX1), the Australia-based bio-pharmaceutical company, has announced positive outcomes in a first animal study involving Plexaris or Exomeres. It reported about its early-stage proof of concept (POC) animal study that investigated the safety, efficacy and biochemistry of treating rodents with either Plexaris or Exomeres in a model of wound healing.
The study produced significantly positive results: the manufacturing using Exopharm’s LEAP Technology was achieved and the exosome products displayed safety and no adverse consequences.
This paid study was conducted for Exopharm by a Contract Research Organisation (CRO) under the supervision of Animal Ethics Committee and in conformance with the Australian Code for the care and use of animals for scientific purposes. Plexaris and Exomeres were manufactured by the company’s internal manufacturing and were tested for sterility by an external party prior to release.
The sterile Plexaris (exosomes from Platelets) and Exomeres (exosomes from adult stem cells) have been manufactured and administered to animals for the first time in the study.
The test has depicted the application of Exopharm’s LEAP Technology to a biologic product for the first time. It also accessed the in-house upstream process (USP) and downstream process (DSP) developments, the suitability of equipment used in the USP and DSP, and the company’s capacity to enhance the production scale.
Administration of either Plexaris or Exomeres did not produce any noteworthy opposing histological features in the samples evaluated.
Despite the small scale of this present study, wound tissue tensile strength, an essential feature of wound healing and the explorative primary efficacy outcome measure of the study, showed signs of a positive dose response with Plexaris treatment.
Based upon these generally positive consequences, the company now intends to conduct further non-clinical testing of both Plexaris and Exomeres and fast-track preparations for its clinical trial using autologous Plexaris in wound healing.
The evaluation test was structured as a pilot proof of concept assessment to notify future wound healing tests in both small and large animals. Only a total of 20 rats were involved (including two controls) and each dose group only contained 3 animals, so this study was not statistically driven to deliver more than proof of concept results.
The rodents were euthanised post the completion of the testing. An extended future assessment will evaluate in-depth wound healing. Treatments involved single dosing of three concentrations of the exosome product – either Plexaris or Exomeres – and a seven-day period for incision healing. The company is expected to release scientific publication sometimes later.
This was not a maximum tolerated dose (MTD) study, and doses were calculated to be in a range that had been previously tested in in-vitro models in-house.
Exopharm’s Managing Director & CEO, Ian Dixon stated: The positive outcomes of the study open the door to more significant studies with our initial Plexaris product. The company plans to begin the first in-human clinical trial with Plexaris for wound healing, in the first half of CY 2019.
The shares of Exopharm closed the day’s trading session at A$0.590 on 5 February 2019, up by 1.724%. The stock has provided a positive YTD return of 22.11% to its investors till date.
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