Regeneus (ASX:RGS), a clinical-stage regenerative medicine company, has announced 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.
In the 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, said the company, adding it 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 w ith 3.9 million cells of Progenza compared to a worsening in placebo patients (p=0.028)," it said.
Lead author and principal trial investigator, Sydney-based sports medicine specialist Dr Donald Kuah, said, "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."
According to Regeneus CEO, John Martin, "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."