AppliGel-G (Gentamicin): a wound dressing for sustained bactericidal levels for management of Diabetic Foot Ulcers. AppliGel-G has gone through pre-IND assessment by the FDA, and is currently nearing the conclusion of FDA mandated animal testing in anticipation of a Q1-2 2012 IND approval and initiation of human testing for management of new-onset Diabetic Foot Ulcers at Georgetown University Hospital.
Diabetic Foot Ulceration (DFU) is a major and increasing source of morbidity in the United States. In 2006 there were over 18 million diabetic patients, and approximately 25% will develop foot ulceration during their lifetime. Serious foot and lower extremity problems account for the majority of hospitalizations in diabetic patients. The International Diabetes Federation predicts that by 2030 the global prevalence of Diabetes will double from 193 million people (2003) to 366 million people. The total cost of foot ulcer care in the United States has been estimated at almost $5 billion annually. An extensive review by Brem, Sheehan et al (2004) found that annually, 82,000 amputations are performed in patients with diabetes. Further, amputation from diabetic complications carries a five-year mortality rate of between 39% and 68% in various studies, and is associated with an increased risk of further amputations.
Over 35 different classes of wound dressings are being used in the treatment of DFU. In medicine, if there are 35 different solutions solutions to the same problem then none of them is very efficacious. There is only one commercial dressing which incorporates an antibiotic, Cogenzia (Innocoll), in a resorbable gentamicin-collagen (immunogenic animal product) sponge. At last publication this preparation was proposed for further study. Unlike Cogenzia, which is made from animal products and releases all contained antibiotic in the first 24 hours, AppliGel-G has a multi-day release profile, is not made from any animal products, and hence is not immunogenic.
AppliGel – 5-FU for Glioblastoma Multiforme (GBM)
AppliGel+5-FU (5-Fluorouracil) will be studied at John Hopkins University Hospital with Dr. Stuart Grossman as principal investigator starting with in vitro studies scheduled to start in 2012. 5-FU is being used initially as it may be tracked with non-invasive imaging techniques such as Magnetic Resonance Spectroscopy. Eventually Dr. Grossman and others envision using a variety of chemotherapeutic agents including Taxotere for optimal therapy.
The concept is to introduce AppliGel 5-FU into the post-resection cavity after surgical treatment of GBM, a routinely fatal malignancy with a two-year survival of only 20%. It is well known that 5-FU is active against Glioblastoma but does not effectively cross the blood/brain barrier. Direct installation of a timed-release formulation of this and other anti-neoplastic agents is an attractive option. Within the cancer treatment community a great deal of investigation is ongoing into local therapies for GBM as most recurrences are local, but currently the company is aware that only one FDA approved treatment has been developed, Gliadel Wafers, and this therapy has proven to be only minimally effective, prolonging survival just a few months. Nonetheless, given the bleak outlook for patients with GBM, the FDA approved this therapy. Pre-clinical toxicity studies in animal models have already been completed at Johns Hopkins, and the results indicate that the product is well tolerated.