Research Triangle Park, NC – February 19, 2004 – NOBEX, a drug development company specializing in medicinal chemistry-based drug delivery, announced today that the results of an exploratory clinical trial for oral insulin were published in the January 2004 edition of the peer-reviewed scientific journal Metabolism. This Phase I/II clinical trial was one of the initial studies to investigate the safety and tolerability of a single oral dose of a modified human insulin in patients with type 1 diabetes mellitus. NOBEX’s lead modified insulin product, known as Hexyl-insulin monoconjugate 2 (HIM2), is an orally-active insulin that has reached Phase II clinical development for the treatment of patients with diabetes mellitus.
The results of the published study suggest that oral HIM2, when added to a basal insulin regimen, was safe and may prove effective in controlling postprandial hyperglycemia (a rise in glucose levels after eating) in patients with diabetes mellitus. The study was performed in type 1 diabetic patients who completely lack endogenous insulin, therefore permitting accurate assessment of the insulin present in blood after the oral dose and the effects of the absorbed insulin on blood glucose levels. The HIM2 product is designed primarily for commercialization as a treatment for type 2 diabetic patients to supplement the insulin that is decreased in secretion but still produced by the pancreas.
“The results of this study confirmed that NOBEX’s HIM2 orally-active insulin is safe and well-tolerated by patients. While an early stage trial, this study demonstrated transient reduction of blood glucose in the type 1 patient, and this has allowed us to design and conduct several additional exploratory studies in both type 1 and type 2 diabetic patients, the results of which have been presented at diabetes conferences and from which we hope to publish full papers in the coming months,” stated Christopher H. Price, Ph.D., President & CEO of NOBEX.
“We retain 100% of the commercialization rights for this promising product and have assembled a significant intellectual property estate around both the HIM2 molecule and a family of new modified insulin molecules to be studied for utility in diabetes, comprised of both composition of matter and method of use patents, protecting NOBEX’s oral insulin product. We believe that our family of new modified insulin molecules has the potential to introduce multiple new products, delivered by oral and other non-injectable routes of delivery. This would allow insulin, a gold standard for treatment of diabetes, to positively impact both the way patients manage their diabetes and the overall therapeutic outcome,” said Dr. Price. He added that NOBEX is currently seeking pharmaceutical partners for the worldwide development and commercialization of its insulin products.
About HIM 2 Orally Active Insulin
NOBEX has developed an orally-delivered form of insulin that closely mimics the natural insulin produced by the body’s own pancreas. This oral insulin product has the potential to provide medical benefits that are currently unattainable by other methods of insulin delivery, including injectable, pulmonary, nasal or buccal (absorption from the mouth). Oral insulin is delivered through the portal vein directly into the liver, following the same pathway into the body as insulin naturally secreted by the pancreas. The liver exerts considerable control over the levels of glucose in the bloodstream and thus, is the first and most important target of pancreas-secreted insulin. All peripheral dosing forms of insulin (injectable, nasal, pulmonary, buccal) deliver little and poorly-timed amounts of insulin to the liver. Results from Phase I and Phase II clinical studies to date have demonstrated that oral insulin has shown no significant side effects; effectively lowers glucose levels; and has demonstrated the ability to stabilize or lower blood glucose in proportion to the amount of drug given.
About NOBEX
NOBEX Corporation is a privately held drug product development company that specializes in medicinal chemistry applied to optimizing the delivery of therapeutic drugs by oral and other non-injectable routes of administration. The company has advanced three products into clinical study including; Oratonin™, an oral modified salmon calcitonin with anti bone-resorptive and analgesic properties; the APAZA™ compound, an oral tablet for inflammatory bowel disease; and insulin in an oral tablet for diabetes. NOBEX has several other products in preclinical development on its own and with partners or collaborators including Pfizer, Duke University, and the Mayo Clinic. For more information, visit www.nobexcorp.com.
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