Regeneus, a clinical-stage regenerative medicine company, today announced that the previously reported positive results from its Phase 1 safety trial of Progenza in patients with knee osteoarthritis (OA) have been published in the Journal of Translational Medicine.
The STEP trial (Safety, Tolerability and Efficacy of Progenza) is the first clinical trial of Progenza, the company’s allogeneic stem cell technology platform for the treatment of OA and other inflammatory conditions. The publication of the results in a well-respected journal further validates the trial results.
In this study, a single injection into the knee of Progenza (3.9 million cells or 6.7 million cells) in patients was safe and well tolerated. Progenza also showed durable and clinically meaningful pain relief in patients with knee OA. Examination of knee joint structure by MRI showed a statistically significant improvement in lateral tibial cartilage volume for patients treated with 3.9 million cells of Progenza compared to a worsening in placebo patients (p=0.028).
Lead author, Sydney-based sports medicine specialist, Dr. Donald Kuah, the Principal Investigator on the trial commented: “Osteoarthritis is a chronic disease with substantial impact on patients due to pain and functional impairment. Treatment options that can intervene in the process and potentially modify the disease are needed. The STEP trial was a well designed, double-blind trial with long-term follow-up for 12 months after injection. Based on the outcome of the study, Progenza holds promise for osteoarthritis patients”.
a Change from baseline VAS pain scores (data are presented as the least squares mean estimates with 95% confidence intervals and within group p values) and b proportion of pain responders (responders with an improvmeent of at least 30% from baseline VAS score). VAS, visual analogue scale
Regeneus CEO, John Martin said: “The Journal for Translational Medicine was our first choice for publication and we are very pleased to be accepted by this well respected journal. The publication of these positive results is an important milestone for Regeneus and will assist with our clinical licensing discussions for Progenza in Japan”.
About Progenza stem cell technology
Progenza is an allogeneic off-the-shelf stem cell technology platform developed for the treatment of knee osteoarthritis and other inflammatory conditions. Progenza cells work by secreting cytokines, growth factors and exosomes that act in concert to reduce inflammation and pain and encourage accelerated healing and repair of the damaged or diseased tissue.
Progenza is produced from expanded mesenchymal stem cells (MSCs) extracted from adipose (fat) tissue from a healthy donor who has been extensively screened. Unlike other stem cell products, Progenza includes secretions from MSCs that improves viability and functionality of the cells during the freezing and thawing process. Regeneus has shown that a combination of cells and secretions has a more powerful therapeutic effect than cells alone.
There are significant advantages in using adipose-derived MSCs to manufacture Progenza. 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 MSCs are expanded through the company’s proprietary and scalable manufacturing process. The company has demonstrated the capacity to produce millions of therapeutic doses of Progenza from a single donor which helps avoid the need to pool donor material and seek multiple donors. The MSCs used in Progenza have not been reprogrammed as required for induced pluripotent stem cells thereby reducing manufacturing and clinical development risks.
Regeneus has been granted a patent in Australia and Japan covering the manufacture and use of Progenza for the treatment of osteoarthritis and other inflammatory conditions. The patent is also being pursued for grant in other territories including USA and Europe.
Source – Regeneus