Product Development

Royer Biomedical, Inc. has three top priority products in human health- R-Gel Antibiotic, R-Gel 5-FU, and R-Gel Bupivacaine.

R-Gel Antibiotic contains tobramycin and clindamycin as the active ingredients. The broad coverage of pathogens by this combination of antibiotics is an advantage, especially when the target indications are orthopedic infections and diabetic foot infections. Clinical results with diabetic foot infections have been very encouraging. Approximately 50% of patients slated for higher level amputation were cured in a small study (n=14). A 510(k) application is in preparation will hopefully be filed in early 2008.

R-Gel 5-FU is targeted to glioblastoma, a form of brain cancer with very poor prognosis with an incidence of 20,000 cases per year in the U.S. The approach will be to fill the post-resection cavity with R-Gel 5-FU which makes intimate contact with the margins of the original tumor bed. Glioblastoma patients also receive adjuvant radiation. As 5-FU is also a radiation sensitizer in addition to being a cytotoxic agent (anti-mitotic) there is a two-fold benefit for the patient. Radiation at lower doses can achieve the same effect as radiation at higher doses with less damage to normal tissue when a radiation sensitizer is present.

Toxicity studies have been done at Johns Hopkins University (neurotox), and general toxicity studies have been done at NAMSA. The results indicate that R-Gel is very well tolerated. The clinical studies will be done under the direction of Dr. Stuart Grossman at Johns Hopkins University. Dr. Grossman is the director of the Brain Tumor Consortium- New Approaches to Brain Tumor Therapy (NABTT) funded by NCI.

Animal studies with R-Gel Bupivacaine have yielded very promising results, also at Johns Hopkins University. Dr. S. Raja and Dr. J. Borzan in the Pain Division of the Department of Anesthesiology did the studies. The next phase of the pre-clinical work will be a second study using an optimized version of R-Gel Bupivacaine, which is more convenient to administer as compared to the original formulation. Following this study an IND will be prepared and filed. The target indication will be post- surgical incisional pain and the Phase I trial will be conducted at Johns Hopkins University.