Healthcare Industry News: Intranasal
News Release - November 2, 2006
Bentley Pharmaceuticals Expands Phase II Clinical Trials of Intranasal Insulin Spray to the U.S.
EXETER, N.H.--(HSMN NewsFeed)--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.
Founded in 1979 by Dr. Schwartz, the Diabetes & Glandular Disease Clinic is the largest private endocrine clinic in the United States with over 70,000 active patients, eight board certified endocrinologists, seven NPs/PAs and an ADA recognized diabetes education program. The research arm, dgd Research Associates, Inc., has a staff of over 250 employees and has conducted over 1,500 Phase I through III clinical trials, primarily in targeted endocrine populations. Currently work is underway on construction of a new 80,000sq. ft. Phase I unit. For more information visit www.dgdclinic.com.
Bentley Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on advanced drug delivery technologies and generic pharmaceutical products. Bentley's proprietary drug technologies are being developed to enhance or facilitate the absorption of pharmaceutical compounds across various membranes. Bentley also manufactures a growing portfolio of generic and branded generic pharmaceuticals in Europe for the treatment of cardiovascular, gastrointestinal, infectious and neurological diseases through its subsidiary, Laboratorios Belmac, and markets these pharmaceutical products through its subsidiaries, Laboratorios Belmac, Laboratorios Davur, Laboratorios Rimafar and Bentley Pharmaceuticals Ireland; and manufactures and markets active pharmaceutical ingredients through its subsidiary, Bentley API.
Additional information regarding Bentley Pharmaceuticals may be obtained through Bentley's web site at www.bentleypharm.com.
Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995: This press release contains forward looking statements, including without limitation, statements regarding Bentley's Intranasal insulin development program, the potential benefits of the Intranasal insulin product candidate and the prospects of Bentley's drug delivery technology for other small proteins and peptides. These forward-looking statements are subject to a number of risks and uncertainties that could cause actual results to differ materially from future results expressed or implied by such statements. Factors that may cause such differences include, but are not limited to risks associated with the efficacy and safety of Bentley's Intranasal insulin product candidate and its drug delivery technology, the timing and nature of regulatory approvals, development and commercialization of the Intranasal insulin product candidate and other products using Bentley's drug delivery technology, competition from other manufacturers of new insulin products and drug delivery technologies, intellectual property litigation, our relationships with our strategic partners, the unpredictability of patent protection, risks associated with international clinical trials and operations, and other risks detailed under Item 1A "Risk Factors" in Bentley's most recent Annual Report on Form 10-K and its subsequent periodic reports filed with the Securities and Exchange Commission. Bentley cautions investors not to place undue reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this document, and Bentley undertakes no obligation to update or revise the statements, except as may be required by law.
Source: Bentley Pharmaceuticals
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