Regenerative medicine company Regeneus (ASX: RGS) has announced the successful completion of a preclinical study to support its first-in-human safety study of PROGENZA, an allogeneic, off-the-shelf stem cell product for osteoarthritis (OA).
Regeneus said it will now proceed with its ethics application for the commencement of a clinical trial to assess the safety and preliminary efficacy of PROGENZA in patients with knee OA.
According to Janet Wilson, Clinical Research Director at Regeneus, "This is an important milestone in taking PROGENZA through the regulatory approval process."
The Good Laboratory Practice (GLP)-compliant preclinical study was conducted at a US-based facility. The company said the facility has expertise in conducting preclinical studies that replicate human OA.
"The results showed no PROGENZA-related safety or toxicity issues, even at doses well in excess of the intended human dose," the company said. "Further, PROGENZA-treated knees showed no deterioration from the time of injection, in contrast to the vehicle control group, which continued to deteriorate over the 7-week study. These study results support the role of PROGENZA in preventing disease progression."
"...our next step is to seek ethics approval for the first-in-human trial," Wilson said.
She continued, "The planned trial is a single centre study and will include patients with symptomatic knee OA. PROGENZA will be injected once into the knee. Safety will be monitored closely and assessments for preliminary efficacy, such as MRIs pre and post treatment, are also included."
The source material for PROGENZA is adipose tissue (fat) from a healthy donor.
The company said that stem cells from the tissue are expanded through a manufacturing process that allows large numbers of therapeutic doses to be produced from a single donor.
"The production of donor off-the-shelf stem cell product is to be contrasted with autologous stem cell therapy where a patient’s own stem cells are used as the therapeutic product," it said.
Regeneus was founded in 2007 with a focus on using the regenerative capacities of adipose-derived cells to develop innovative cell therapies for humans and animals.