The US biopharmaceutical company, with key operations based in Israel, plans to be moving into Phase I/II clinical trials with its Biopump platform technology in the second quarter of next year. The technology is a protein biofactory whereby a toothpick-sized skin biopsy is taken from a patient and a particular gene is inserted into the cells and then re-implanted into the patient. The cell uses its own machinery to produce the therapeutic protein in question. "The Biopump aims to solve all the problems [associated with conventional forms of protein therapy]," Medgenics chief executive and president Dr Andrew Pearlman told in-PharmaTechnologist.com. While most conventional methods of protein therapy involve injecting the therapeutic protein into the patient, the Biopump is designed to enable patients to produce the protein in their own bodies on a long-term basis. The issues of protein half-life, administration via injection, dosing levels and cost, were just some advantages of the system, Pearlman said. A big advantage would be the elimination of the need for costly manufacturing facilities to produce therapeutic proteins, he said. The system works by taking a very small toothpick-sized dermal skin sample, usually from the abdominal area. Using a gutless adenovector - a virus with no genes - a gene is introduced into the tissue's cells, specifically fibroblasts. The gene is not incorporated into the cell's chromosome but rather resides in the nucleus and uses the cell's machinery to produce therapeutic proteins. According to Pearlman, the cells should be able to produce therapeutic proteins for at least six months, by which time, because the gene is not passed on during cell division, the fibroblasts die off and a new implant would be required. In studies using baboons, the implant was shown to be effective for two years, Pearlman said. The number of Biopumps implanted under the patient's skin would depend on the rate of protein production and the patient's individual requirement. The company is currently looking at the production of erythropoietin (EPO) using the Biopump as a treatment for anaemia and aims to commence Phase I/II clinical trials in the second quarter of next year with initial safety and proof of efficacy results expected three to five months later. The company is also looking at a treatment for hepatitis C with the protein interferon-alpha (IFN-a), but in the future Biopump could be used to treat multiple sclerosis, growth hormone and insulin deficiencies as well as genetic diseases, Pearlman said. The system could also be used to incorporate more than one gene in the virus vector for production and in the future the system could use more sophisticated technology to turn specific genes on and off, he said. The company is working on a method for widespread use so that procedures would not be limited to just one location. Due to the drug device being designated as a tissue implant, approval would fall under the medical devices category.