Sydney, May 16, 2016 - (ABN Newswire) - Regeneus (ASX:RGS), a clinical-stage regenerative medicine company, today announced completion of enrolment of all 20 patients in the STEP trial. Further, a review of the cumulative study safety data by the study safety oversight committee identified no safety concerns.
The STEP trial (Safety, Tolerability and Efficacy of Progenza) is the first clinical trial of Progenza, the company's allogeneic off-the-shelf stem cell product for the treatment of knee osteoarthritis.
The completion of enrolment Cohort 2 ahead of schedule is a positive milestone for the clinical development of the company's allogeneic stem cell therapy. The lack of safety concerns identified from the pre-specified review of the cumulative safety data from all 20 patients is also encouraging. The review included a minimum of 1-month safety data for all patients, and substantially more data for earlier enrolled Cohort 1 patients.
The trial is entitled, "A Phase 1 randomised, double-blind, placebo-controlled single ascending dose study to evaluate the safety, tolerability and preliminary efficacy of intra-articular Progenza in adults with symptomatic knee osteoarthritis".
Leading Sydney-based sports medicine specialist, Dr Donald Kuah, is the Principal Investigator on the trial. Dr Kuah, a principal of Sydney Sportsmed Specialists, has extensive experience in the diagnosis and treatment of patients with osteoarthritis.
The study will complete once the last patient completes 12 months of post treatment follow up, concluding with a second MRI. All 20 participants have knee osteoarthritis and received ultrasound-guided injections of Progenza or placebo directly into their arthritic knee joint. One in five patients received a placebo injection. The primary objective of the trial is to evaluate the safety and tolerability of Progenza. The secondary objectives are to investigate the effect of Progenza on knee pain and function; quality of life; knee joint structures using magnetic resonance imaging; and osteoarthritis biomarkers. Participants will be monitored for 12 months.
About Progenza:
Progenza is an off-the-shelf allogeneic stem cell product with the first targeted treatment being for knee osteoarthritis. The product is produced from mesenchymal stem cells (MSCs) from adipose (fat) tissue from a healthy donor who has been extensively screened. Progenza includes secretions from donor MSCs that improves viability and functionality of the cells after freezing.
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.
About Osteoarthritis:
Osteoarthritis continues to be an unmet medical need and is a significant global concern due to ageing populations. Stem cell products, such as Progenza, may address the treatment gap for patients who have persistent joint pain, and for whom total knee replacement is likely.
About: Regeneus Ltd
Regeneus Ltd (ASX:RGS) is a clinical-stage regenerative medicine company developing a patented portfolio of therapies to address significant unmet medical needs in the human and animal health markets. The company has a number of therapies targeting human conditions in various stages of development including two products in first-in-human Phase I trials: Progenza is an allogeneic off-the-shelf adipose stem cell therapy to treat osteoarthritis and other musculoskeletal conditions; RGSH4K is a human autologous personalised therapeutic cancer vaccine to treat a wide range of cancer types.
Furthermore, Regeneus is developing therapies to target acne and other inflammatory skin conditions in humans, in addition to musculoskeletal and oncology treatments for animals.
The STEP trial (Safety, Tolerability and Efficacy of Progenza) is the first clinical trial of Progenza, the company's allogeneic off-the-shelf stem cell product for the treatment of knee osteoarthritis.
The completion of enrolment Cohort 2 ahead of schedule is a positive milestone for the clinical development of the company's allogeneic stem cell therapy. The lack of safety concerns identified from the pre-specified review of the cumulative safety data from all 20 patients is also encouraging. The review included a minimum of 1-month safety data for all patients, and substantially more data for earlier enrolled Cohort 1 patients.
The trial is entitled, "A Phase 1 randomised, double-blind, placebo-controlled single ascending dose study to evaluate the safety, tolerability and preliminary efficacy of intra-articular Progenza in adults with symptomatic knee osteoarthritis".
Leading Sydney-based sports medicine specialist, Dr Donald Kuah, is the Principal Investigator on the trial. Dr Kuah, a principal of Sydney Sportsmed Specialists, has extensive experience in the diagnosis and treatment of patients with osteoarthritis.
The study will complete once the last patient completes 12 months of post treatment follow up, concluding with a second MRI. All 20 participants have knee osteoarthritis and received ultrasound-guided injections of Progenza or placebo directly into their arthritic knee joint. One in five patients received a placebo injection. The primary objective of the trial is to evaluate the safety and tolerability of Progenza. The secondary objectives are to investigate the effect of Progenza on knee pain and function; quality of life; knee joint structures using magnetic resonance imaging; and osteoarthritis biomarkers. Participants will be monitored for 12 months.
About Progenza:
Progenza is an off-the-shelf allogeneic stem cell product with the first targeted treatment being for knee osteoarthritis. The product is produced from mesenchymal stem cells (MSCs) from adipose (fat) tissue from a healthy donor who has been extensively screened. Progenza includes secretions from donor MSCs that improves viability and functionality of the cells after freezing.
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.
About Osteoarthritis:
Osteoarthritis continues to be an unmet medical need and is a significant global concern due to ageing populations. Stem cell products, such as Progenza, may address the treatment gap for patients who have persistent joint pain, and for whom total knee replacement is likely.
About: Regeneus Ltd
Regeneus Ltd (ASX:RGS) is a clinical-stage regenerative medicine company developing a patented portfolio of therapies to address significant unmet medical needs in the human and animal health markets. The company has a number of therapies targeting human conditions in various stages of development including two products in first-in-human Phase I trials: Progenza is an allogeneic off-the-shelf adipose stem cell therapy to treat osteoarthritis and other musculoskeletal conditions; RGSH4K is a human autologous personalised therapeutic cancer vaccine to treat a wide range of cancer types.
Furthermore, Regeneus is developing therapies to target acne and other inflammatory skin conditions in humans, in addition to musculoskeletal and oncology treatments for animals.
