Bentley Pharmaceuticals, Inc. (NYSE: BNT), a specialty pharmaceutical company, announced that, following successful review of its Investigational New Drug (IND) application by the U.S. Food and Drug Administration, a Phase II program is now in effect and under way evaluating Bentley's human recombinant Intranasal Insulin Spray for the treatment of postprandial hyperglycemia in diabetics.

Bentley's Chief Medical Officer, Dr. Robert Stote said, 'Bentley's intranasal method of insulin administration is designed to provide a quick and easy self-medication to improve patient compliance. In general, drugs entering the nasal cavity are readily absorbed across the highly vascularized nasal mucosa directly into the circulatory system, avoiding first-pass metabolism in the liver. The rapid absorption affords a fast onset of action comparable to the very rapid-acting, injectable insulin formulations. Using Bentley's CPE-215® drug delivery platform, initial studies have indicated that our intranasal insulin spray passes quickly through the nasal mucosa, delivering a larger payload compared to other non-injectable delivery systems. Further, we believe that targeting the nasal mucosa can avoid concerns for lung deposition and potential impacts on respiratory function in chronic treatment.'

The initial Phase II studies have been planned and are being carried out in Texas at the Diabetes and Glandular Disease Clinic of San Antonio, P.A. under the direction of Dr. Sherwyn Schwartz as Principal Investigator. Dr. Schwartz states, "Nasal insulin has the potential of helping a lot of people, particularly those who are afraid of needles or who have lung disease."

The U.S. Phase II study is designed to enroll twenty-four patients with Type I diabetes in a randomized single dose 4-way crossover study to determine the dose equivalency of intranasal insulin in comparison to subcutaneous insulin injections and to elucidate an optimal dosing sequence. Over the next twelve months, Bentley expects to complete Phase II clinical studies for both Type I and Type II diabetic patients.

Two earlier studies conducted in Ireland with normal subjects and Type I diabetic patients demonstrated rapid absorption from the nasal spray and the expected glucose response. Peak insulin levels were generally attained in 15 to 20 minutes, remaining elevated for approximately 1 hour; the resultant impact on glucose peaked in 40 minutes and decreased 1.5 to 2 hours after dosing. Calculated relative bioavailability of insulin using Bentley's nasal spray formulation was in the range of 15-20% of subcutaneously injected insulin.

President John Sedor commented, ?Available insulin treatments for both Type I and Type II diabetic patients have not fully met patients' needs and have resulted in poor compliance, leading to under-treatment that can cause serious diabetic complications and result in large impacts on the health care system. Bentley?s product candidate is designed to facilitate compliance by providing a stable liquid emulsion in a commercially available multi-dose delivery device which is convenient to carry and to use.'

James R. Murphy, CEO, remarked, 'Consistent performance through several insulin studies is further validating our CPE-215 drug delivery technology. The intranasal delivery of insulin was selected as a model peptide because it is well characterized and easily compared to other alternative delivery systems. The advancements to date have encouraged us to be optimistic about applying our platform delivery technology to other small proteins and peptides that historically, have been limited to injection.'

The delivery of injectable therapeutic peptides by intranasal administration of stable emulsions without using irritating enhancers or preservatives is a principal focus of Bentley Pharmaceuticals' drug delivery platform for treating a variety of medical conditions.