Solascure Ltd (Solascure), a biotechnology company developing new treatment to transform chronic wound healing, has today announced the start of a new clinical trial of phase II, Cleanvlu2. The entrance of the first patient from the study means a new clinical milestone in the development of a research product, Aurase Round Gel, to treat chronic wounds.
Auraza gel in the morning is a hydrogel releasing tarumaz, a recombinant enzyme originally cloned from medical worms, which selectively attacks fibrin, collagen and elastin in wounds to promote healing through the skull and preparing wounds. Cleanvlu2 adds further insight into a successful clinical examination of the Iia, Cleanvlu, which determined the proof of the concept, a strong safety profile and painless use. Will examine a new randomized controlled test effectiveness Tarumaza at higher concentration, in patients with venous leg ulcers.
Chronic wounds affect about 100 million people around the world, which is a significant challenge of healthcare with limited safe, painless and effective treatment. Clinical data suggest that after 6 weeks of the current standard of treatment treatment, the general closing of the wound is achieved only 41% of chronic or difficult wounds. This study will generate key data on effectiveness to further demonstrate the potential of the wounded Aurazy gel as the first treatment in which all aspects of the preparation of the deposit of wounds, including purification, informing investors and potential strategic partners.
The trial is conducted in cooperation with the South Leicestershire Medical Group in Great Britain as part of the social service. After completing the Cleanvlu2 study, a further test of phase II is planned in the long run, with the stratification of factors that may affect the purification and healing of wounds, before the transition to confirming clinical phase tests III for the regulatory approval.
Andy Weymann MD, MBA, chairman of the board, Solascure