SIOUX FALLS, South Dakota, June 13, 2017 /PRNewswire/
Kasten Inc. (OTC Pink:KAST)/DAKOTA Life Sciences, a division of Kasten Corporation, has announced its regulatory plan for its first prescription product to reduce the dangers of foot ulcers among those patients with diabetes, pre-diabetes or other immuno-compromising medical conditions. In the United States alone, there are over 26 million diabetics, 80 million pre-diabetics and an estimated additional 20 million immuno-compromised people at risk of small cuts or abrasions on their feet or lower legs rapidly leading to serious ulcers and infected wounds.
Kasten’s DAKOTA Life Sciences has developed and internationally tested a product that will be for prescription use in the United States, following successful completion of the required FDA protocols and trials. Designed by using the proprietary Site Specific Penetration Technology (SSPT™) initially introduced by DAKOTA Life Sciences, this prescription product is targeted for initial use on infected Diabetic Foot Ulcers (‘iDFUs’). It will also use a well-studied and widely tolerated antibiotic that will demonstrate substantial increase in efficacy due to the SSPT drug delivery system.
“Precision drug delivery is our tool to overcoming topical non-healing lesions and infections, and in many cases infections that are resistant to known medications,” according to President Steven Keough of Kasten/DAKOTA Life Sciences.
Pre-IND work is nearing completion and is expected to enable this prescription drug product candidate to qualify for the accelerated Infectious Disease Program of trials. In addition to Over-The-Counter product revenue, this first-of-several prescription products is expected to be a strong driver of revenue for Kasten/DAKOTA Life Sciences following approval.
As Kasten/DAKOTA Life Sciences moves into its U.S. clinical studies, the Company believes that the care taken to conduct all prior studies will optimize the speed and success of such future trials. The Company’s base-case model for this product shows a $3 billion gross receipt potential as well as millions of patients able to maintain a higher quality of life and productivity.
While the final product name remains confidential, initial Pharmacokinetic testing of the Site Specific Penetration Technology antibiotic delivery system was performed at South Dakota State University College of Pharmacy. It is expected that this proven delivery system will provide synergistic positive effect to the well-understood mechanisms of action of the drug being delivered. This will result in healing of sites of cuts or abrasions that would otherwise endanger this large class of patients with dangerous morbidities, including loss of limbs.
“Based on results to date, we are very optimistic that our powerful prescription drug product will demonstrate renewed efficacy for known drugs across a broad spectrum of resistant and non-resistant pathogens,” added Keough. “And we are very optimistic about its potential impact on the 8-9 million cases of infected diabetic foot ulcers annually in the United States.”