CollPlant Ltd. (TASE:CLPT; OTC:CQPTY), a regenerative medicine company utilizing its proprietary plant-based rhCollagen technology for tissue repair products, today announced positive interim clinical trial results for Vergenix™STR, intended for the treatment of tendinopathy.
The 20 patient Vergenix™STR 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 Vergenix™STR 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%) 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, noted, “Vergenix™STR is a product with unique mode-of-action, which enables a focused and effective treatment of tendinopathy. The positive interim trial results reported today, testify to the performance of the product that is directed to a worldwide market currently estimated as a $2 billion total.”
Vergenix™STR, 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.
CollPlant is a clinical-stage regenerative medicine company leveraging its proprietary, plant-based rhCollagen technology for the development and commercialization of tissue repair products, initially for the orthobiologics and advanced wound care markets. The Company’s cutting-edge technology is designed to generate and process proprietary recombinant human collagen (rhCollagen), among other patent-protected recombinant proteins. Given that CollPlant’s rhCollagen is identical to the type I collagen produced by the human body, it offers significant advantages compared to currently marketed tissue-derived collagen, including improved biofunctionality, superior homogeneity and reduced risk of immune response. The Company’s broad development pipeline includes biomaterials indicated for orthopedics and advanced wound healing. Lead products include: Vergenix™STR (Soft Tissue Repair Matrix), for the treatment of tendinopathy; Vergenix™FG (Flowable Gel) wound filler, for treatment of acute and chronic wounds, and Vergenix™BVF (Bone Void Filler), for use in spinal fusion procedures and trauma. CollPlant’s business strategy includes proprietary development and manufacturing of tissue repair products and their commercialization and distribution, together with leading third parties, alongside alliances with leading companies for joint development, manufacturing and marketing of additional products.