ghp July 2015 pdf

ghp July 2015 | 35 project development Vergenix STR, intended for the treatment of a range of tendon injuries, has had a successful interim clinical trial, offering hope for millions of sufferers and potential ground breaking results for the health- care industry. The 20 patient trial in which all patients have now been enrolled and treated, is a prospective, open label, single arm study. The objective of the trial, which is ongoing and being conducted at three lead- ing Israeli hospitals, is to demonstrate the safety and performance of Vergenix™STR in patients suffering from inflammation of the elbow tendon, also known as tennis elbow. Vergenix™STR, which is 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 prod- uct transitions from a fluid to a solid phase, whereup- on it releases, in a controlled fashion, platelet-de- rived proteins. These proteins, in combination with collagen, induce the healing effect on the tendon which relieves the symptoms of pain and inflexibility. All patients will be followed for a total of six months after initial treatment to examine the effects the product has had on their long-term symptoms. Product performance will be assessed by measuring reduction in pain, recovery of motion in the form of a strength test and a specific patient related tennis elbow questionnaire known as ‘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 an increase in arm strength. The Company intends to submit an application for CE Mark approval in Europe during 2015, which would allow the firm to sell the product as a treatment for Tendinopathy. Tendinopathy is pain and stiffness in the joints which is often a result of overuse. Yehiel Tal, Chief Execu- tive Officer of CollPlant, made it clear that the launch of this product could potentially allow the firm access to a huge market, with sufferers of the condition will- ing to pay large sums in order to relieve their pain. ‘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.’ CollPlant reports Vergenix STR trial was unqualified success, with 80% of patients tested reporting improved functionality and reduced pain, which could offer relief for millions of sufferers. CollPlant’s technology is mostly produced using plant-based rhCollagen technology and is specifically developed for the creation and commercialization of tissue repair products, initially aimed at the ortho- biologics and advanced wound care markets. Given that CollPlant’s rhCollagen is identical to the type one collagen produced by the human body, it offers sig- nificant advantages compared to currently marketed tissue-derived collagen, including improved biofunc- tionality, superior homogeneity and reduced risk of immune response. CollPlant is also in the process of producing Vergenix™FG, a flowable gel which acts as a wound filler, for treatment of acute and chronic wounds, and Vergenix™BVF, a bone void filler, for use in spinal fusion procedures and trauma. The results of the new trial will affect healthcare firms who are often used to putting patients through surgery in order to alleviate serious symptoms. In more minor cases the condition is often treated sim- ply using pain killing medication. This new product could offer industry potential for related products or treatment cycles which revolve around the product. A reduction in surgical procedures used to treat this condition could reduce the costs in the health- care industry, and the use of natural collagens in the product will doubtless induce a new line of study into the affects this can have on the body’s healing process. Tendon pains are often the result of sporting injuries, which could potentially lead to a more commercial line for the product. Currently there are numerous gels, pastes and pills designed to help relieve the symptoms of tendinopathy but few which actually have proven results as good as the ones reported by CollPlant. However, the trials are still in the very early stages and there is still much more still to be done before this is hailed as a true miracle of modern science. For now, there is much potential for academic inter- est and commercial healthcare providers will have to wait to find out just how effective the product truly is.