CollPlant Ltd., a regenerative medicine company utilising its proprietary plant-based rhCollagen technology for tissue repair products, announced positive interim clinical trial results for VergenixSTR, intended for the treatment of tendinopathy.
The 20-patient VergenixSTR trial, in which all patients have now been enrolled and treated, is a prospective, open label, single arm study. The objective of the trial, conducted at three leading Israeli hospitals, is to demonstrate the safety and performance of VergenixSTR in patients suffering from inflammation of the elbow tendon (i.e. tennis elbow). All patients will be followed for a total of six months after initial treatment. Product performance will be assessed by measuring reduction in pain, recovery of motion (strength test) and a specific patient related tennis elbow questionnaire (PRTEE).
Interim clinical results for the first 10 patients who reached their three-month follow up, indicate that the vast majority (80 per cent) of subjects reported improvement in pain and arm functionality, including increase in arm strength. The company intends to submit an application for CE Mark approval in Europe during 2015.
Yehiel Tal, chief executive officer of CollPlant, said "VergenixSTR is a product with unique mode-of-action, which enables a focused and effective treatment of tendinopathy. The positive interim trial results reported, testify to the performance of the product that is directed to a worldwide market currently estimated as a $2 billion total."
VergenixSTR, intended for the treatment of a range of tendon injuries, incorporates CollPlant's recombinant human collagen in combination with platelet-rich plasma derived from the patient's blood. Following its injection into the injured site, the product transitions from a fluid to a solid phase, whereupon it releases, in a controlled fashion, platelet-derived proteins. These proteins, in combination with collagen, induce the healing effect on the tendon.