Regeneus' (ASX:RGS) off-the-shelf allogeneic stem cell treatment for knee osteoarthritis, Progenza, has enhanced its potential for commercialisation for the company after an encouraging review of safety data from an oversight committee in early trialling.
The regenerative medicine technology received no safety concerns after trialling with its first cohort of 10 patients in the trial.
The STEP, or Safety, Tolerability and Efficacy of Progenza, trial seeks to evaluate the treatment's safety and tolerability as well as its effect on knee pain and function.
This progress opens enrolment for a second cohort in the trial and demonstrates a positive advance towards the clinical development of the allogeneic stem cell therapy.
Cohort 2 is expected to be recruited in H1 2016.
The trial includes 20 participants with knee osteoarthritis treated at two different doses of cells.
Participants receive ultrasound-guided injections of Progenza or placebo directly into their arthritic knee joint, with one in five patients receiving a placebo injection.
Progenza is produced from mesenchymal stem cells (MSC) derived from the adipose (fat) tissue of a healthy donor who has been extensively screened.
Adipose tissue is readily available from donors in large quantities and has significantly higher MSCs per gram of tissue than other tissue sources such as bone marrow or cord tissue.
Adipose-derived MSCs also have the added advantage of showing greater capacity for expansion than MSCs from other tissue types.
The company's proprietary and scalable manufacturing process is capable of producing millions of therapeutic doses from one donor.
This makes for a high unmet patient need prior to joint replacement.
This is a strong start to the STEP trial which places Regeneus on the path towards providing a new treatment option for patients with osteoarthritis.
With a global market of 250 million people affected worldwide by osteoarthritis , which has no known disease modifying treatments, Progenza's progress in clinical trials will be keenly watched.
While the key focus will be to monitor Progenza's safety, the trial will also allow Regeneus to assess the treatment for preliminary efficacy as the company targets a massive osteoarthritis market that has an unmet need.
Osteoarthritis is the fastest increasing major health condition due to ageing of the population, increased obesity and lack of physical activity.
Regeneus has multiple technology platforms based on allogeneic off-the-shelf stem cells and immuno-oncology.
Significantly, the platform allows for the scalable production of off the-shelf cell products for other potential therapeutic uses.
A further catalyst and milestones for Progenza is to secure a manufacturing and development partner for Japan.
In addition to the trial's second cohort set to be in place in coming months there are a number of key R&D, clinical and commercial milestones in sight through the company's portfolio.
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