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On 1 April 2019, a biopharmaceutical company, Exopharm Limited (ASX:EX1) released a market update on the advancement of the Development program and about its evolution into a clinical stage drug development company.
The key attention of the company is to authenticate the LEAP Technology, along with PLEXARIS and EXOMERES products, in advance of later potential partnership deals.
The company is looking for the enhancement and commercialisation of exosomes as therapeutic agents, initially as PLEXARIS and later as EXOMERES. Both are exosomes and are purified utilizing the LEAP technology, owned by EX1.
The main activities of EX1 are currently aiding later prospective partnership deals including manufacturing of exosome product created with LEAP Technology, clinical testing of PLEXARIS as well as collaborations.
Some of the highlights are as follows: The companyâs product manufacturing facility is functional in Melbourne which would manufacture autologous PLEXARIS in future for PLEXOVAL study. The documentation meant for the approval for conducting PLEXOVAL study has been concluded and evaluated. Also, the recent publications accentuate the possible benefits of exosomes, which could reverse cellular aging in vitro (cells tested in the lab).
On the companyâs strategy front, the board of the company has again confirmed about its focus on taking EX1âs exosome products purified by the application of LEAP technology through into the process of clinical testing as demo programs. The companyâs strategy is to demonstrate the LEAP technology as a platform which manufactures technology applied into an array of utilization in this upcoming field.
The current development program is looking for taking both the products PLEXARIS and EXOMERES for clinical trials procedure for medical conditions like wound healing, to authenticate EX1âs technologies. The program has been designed in such a way that it could assist later prospective allogeneic therapeutic product-based partnership agreements.
Also, the company looks at LEAP as the solution to resolve the bottleneck issue which is causing a delay in producing and purifying of clinical-grade exosomes.
Post breaking the purification bottleneck through LEAP technology, EX1 is all set to become a global leader in the commercialisation of therapeutic exosomes. Also, EX1 is not looking to licence its LEAP Technology to its possible competitors in the market.
The company has made good progress on the downstream process development for its PLEXARIS product via the EX1 manufacturing team situated in Melbourne. The EX1 manufacturing team and EX1âs analytics team had given substantial information for inclusion in the PLEXOVAL study proposal.
PLEXOVAL study is the Prospective Open-Label, single dose proof of concept study to Evaluate the safety, tolerability and biological activity of Platelet-derived EXtracellular Vesicles, on the augmentation of wound healing rate, and effect on scar formation following skin punch biopsy in healthy Volunteer Adults.
After it gets a nod, the study is anticipated to engage around twenty participants who are divided into cohort 1 containing fifteen and cohort 2 containing five people. The study is all set to begin the recruitment process approximately in the middle of 2019, along with the two cohorts to be recruited for the study.
Presently, it cannot be estimated if or when the approvals would be secured to begin the PLEXOVAL study.
Earlier, the company reported positive results in the initial animal study which involved Plexaris or Exomeres.
The stock of the company traded flat during the dayâs trading session. It stood at A$0.400 without any further changes.
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