Pipeline

Regen has a unique technology platform that has developed an effective non-surgical solution to stimulate cartilage and bone growth quickly with formulations that are safe and inexpensive.

Clinical Development Strategy. Regen's flagship product controls pain, stiffness and improves physical function of the treated joints. Regen has conducted three clinical trials evaluating over 300 joints in patients aged between 18-85 years with severe arthritis or light cartilage compromise, resulting in diminished physical function due to pain and / or stiffness. All patients experienced full  joint improvement, according to MRI and/or PROs (patient reported outcomes).

Lead Product Candidates. Regen’s proprietary technology benefits patients, physicians, healthcare payor systems and health-related industries. Regen’s novel formulation for articular cartilage regeneration was tested in preclinical and Phase I-III human clinical trials. The intra-articular application of the product significantly increased cartilage thickness (12-38%) in different osteoarthritis (OA) animal models, compared with articular cartilage treated with saline. Intra-articular injection was well tolerated, with a success rate similar to total arthroplasty for the treatment of severe knee OA. Regen has data showing regeneration of cartilage and bone in 400 patients over 3-5 years with no adverse events.

Clinical Trials. Throughout Phase I-III* human clinical trials, Regen's novel formulation for articular cartilage regeneration showed overwhelmingly positive responses. Conclusive evidence shows that the product is safe and ameliorates the quality of life, while regenerating tissues. The results of the clinical trials conducted are as follows:

*Phase III according to number of patients and evaluation of effectivity when concomitant with other pathologies.

Phase I-II Clinical Trial

  • Prospective, randomized, 3-arm, parallel group clinical trial examining 24 patients with severe knee OA, according to a Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score of 65.9 ± 17
  • RTI312 was applied at months 0, 3 and 6. Articular cartilage volume was evaluated by MRI at the beginning of the study and at month 12
  • RTI312 significantly improved the full joint performance and increased the size of articular cartilage  by an average of 22% (MRI; 26.1 ± 10 vs 31.9 ± 10 cm2; P < 0.001). RTI312 was safe and as effective  as total joint replacement

Phase II Clinical Trial

  • Open-label, nonrandomized, baseline-controlled, parallel group study on 52 patients with mild, moderate, or severe knee OA. Treated with RTI312 at day 0, month 2 and month 4; and followed up after month 6 to evaluate improve in the WOMAC score and in MCII (minimal clinically important improvement)
  • The mean decrease in the total WOMAC score was 16.4%, 49.9% and 62.7% in patients with mild,  moderate, and severe disease, respectively. The MCII was 18%, 78% and 100% for mild, moderate  and severe disease, respectively
  • RTI312 generates better patient-reported health outcomes in the more severe cases of knee OA, without adverse effects

Phase III Clinical Trial

  • Prospective, randomized, 2 arm parallel group phase III clinical trial with 212 patients, 105 patients receiving ‘usual medical care’ (paracetamol / NSAIDs and general care) and 107 patients receiving the usual medical care + intra-articular RTI312 application at 0, 1 and 2 months
  • Patients were followed 1 year, by outcome measurements MCII and PASS (Patient Acceptable Symptom State), and tested whether its efficacy was affected in subgroups of patients presenting with comorbidities that exacerbate OA
  • Usual medical care + RTI312 administration produced MCII and PASS in 53.3% of all treated  patients, compared with 4.7% of those treated with usual medical care alone. Effectivity of RTI312  increased to 92.5% when treated patients had no obesity class II nor malalignment. No serious, adverse effects were observed and was easy to implement together with usual medical care for knee OA

Three to Five Year Follow Up Study

  • Patients from clinical trial II were followed for three years after treatment where 85% of patients maintained a benefit from the treatment
  • Patients from clinical trial I-II were evaluated five years post treatment and showed no statistical significance in the increase of pathology severity, with respect to improvement achieved one year post treatment