Published:
CPEX's Nasulin Insulin Therapy Featured in an Oral Presentation and Four Abstracts at the Ninth Annual Diabetes Technology Meeting
EXETER, N.H. - (BUSINESS WIRE) - CPEX Pharmaceuticals, Inc. (NASDAQ: CPEX) today announced that its
intranasal insulin product candidate, NasulinTM, will be
featured in an oral presentation and four abstracts at the Ninth Annual
Diabetes Technology Meeting, November 5-7, 2009 at the Hyatt Regency
Airport in San Francisco, California. Dr. Lance Berman, Senior Vice
President and Chief Medical Officer, is scheduled to deliver an oral
presentation entitled "The Technology and Clinical Aspects of Nasal
Insulin Therapy" at 9:30 a.m. PST on Saturday, November 7.
Further details on the abstracts are provided below.
A Randomized 6-Way Crossover Study of NasulinTM,
Saline and Lispro in Subjects with Type 2 Diabetes to Determine Optimum
Dose Timing
A similar glucose-lowering effect may be achieved
by administering Nasulin either just before or at the end of the meal
offering more flexibility of dosing than with injectable insulins.
Two Randomized Crossover Glucose Clamp Studies of NasulinTM
and Lispro
In both Type1 diabetic patients and healthy
volunteers, peak glucose metabolism rates occurred earlier with
ultra-rapid acting Nasulin than with rapid acting lispro. The
pharmacodynamic profile indicates Nasulin has optimum activity when
glucose levels rise during a meal with less potential for hypoglycemia
in the hours after the meal has ended.
Dose-Exposure for Single and Dual Nostril Administration of Nasal
Insulin (NasulinTM)
The findings from
this study demonstrated significantly enhanced insulin absorption when a
50 IU dose is administered as 2 sprays of 25 IU given in the same
nostril rather than one spray in each nostril. In addition, the study
also demonstrated that nasal administration of up to 200 microliters per
nostril was well tolerated allowing the administration of doses up to
100 IU. Together these findings provide an improved dosing methodology
and a higher maximum dose for evaluation in future clinical trials.
Dose-Exposure for Two Dose Strengths of Nasal Insulin (NasulinTM)
These
data demonstrated that the original Nasulin concentration (1.0%) and the
new concentration (0.7%) revealed proportional dose-dependent increases
in insulin exposures.
Dr. Berman commented, "The data from these studies provide important
information on Nasulin's ability to rapidly lower glucose following a
meal. With the completion of each study, we gain additional insight into
the potential benefits Nasulin could offer to patients with diabetes.
The most exciting aspect of these results is the second dose
concentration, which will provide subjects in future clinical trials
with a wider dose range to individually titrate their insulin needs to
maximize glucose reduction without increasing the risk of hypoglycemia.
These potential advantages of Nasulin's ultra-rapid time-action profile
may provide treating physicians and their patients safer alternatives
for controlling their diabetes."
About the Diabetes Technology Meeting
The Diabetes Technology Meeting is the second largest scientific
diabetes meeting in the United States, after the American Diabetes
Association's annual Scientific Sessions meeting. Clinicians, industry
leaders, and regulatory experts from all over the world attend this
conference each year. This event is the only scientific meeting in the
world that focuses on such a broad range of issues for diabetes
treatment: engineering, regulatory, clinical, and business aspects of
emerging diabetes devices for measuring glucose and other analyses;
delivering insulin and other metabolic peptides; transmitting
physiological data; increasing adherence to therapy; and closing the
loop for automated treatment of diabetes. The meeting is presented by
the Diabetes Technology Society in cooperation with Centers for Disease
Control, U.S. Army, National Space Biomedical Research Institute,
University of California at Berkeley, the Georgia Tech/Emory Center for
Engineering of Living Tissues, and Mills-Peninsula Health Services.
About CPEX Pharmaceuticals
CPEX Pharmaceuticals, Inc. is an emerging specialty pharmaceutical
company focused on the development, licensing and commercialization of
pharmaceutical products utilizing CPEX's validated drug delivery
platform technology. CPEX has U.S. and international patents and other
proprietary rights to technology that facilitates the absorption of
drugs. CPEX has licensed applications of its proprietary CPE-215
drug delivery technology to Auxilium Pharmaceuticals, Inc. which
launched Testim, a topical testosterone gel, in 2003. CPEX
is also developing a proprietary intranasal insulin product candidate,
Nasulin , which is currently in Phase 2 clinical trials. CPEX maintains
its headquarters in Exeter, NH. For more information about CPEX, please
visit www.cpexpharm.com.
Safe Harbor Statement under the U.S. Private Securities Litigation
Reform Act of 1995:
This press release contains forward-looking statements, including,
without limitation, statements regarding the prospects for CPEX's
development activities of Nasulin and the potential benefits Nasulin
could offer patients with diabetes. 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 following: clinical trials
may not demonstrate the efficacy and safety of CPEX products, regulatory
approvals may be delayed or not obtained, CPEX's dependence on obtaining
agreements with other parties to conduct clinical trials and
commercialize its product candidates that use its drug delivery
technology, competition from other manufacturers of proprietary
pharmaceuticals, CPEX's products may not achieve market acceptance or
favorable reimbursement rates from health insurers, intellectual
property litigation, and other uncertainties detailed under "Risk
Factors" in CPEX's Annual Report on Form 10-K filed with the Securities
and Exchange Commission dated March 25, 2009. CPEX 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 CPEX undertakes no obligation to update or revise the
statements, except as may be required by law.
CPEX Pharmaceuticals, Inc.
Bob Hebert, 603-658-6100
Chief
Financial Officer
rhebert@cpexpharm.com
or
The
Trout Group
Chad Rubin, 646-378-2947
crubin@troutgroup.com
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