Published: March 17, 2010
CPEX Pharmaceuticals Announces Preliminary Results from its Phase 2a Clinical Trial of Nasulin
EXETER, N.H. - (BUSINESS WIRE) - CPEX Pharmaceuticals Inc. (NASDAQ: CPEX) today reported preliminary
results related to its Phase 2a proof-of-concept clinical trial of the
Company's nasal insulin product, Nasulin . The study was designed to
evaluate the efficacy and safety of Nasulin versus placebo over a 6-week
treatment period in subjects with Type 2 diabetes who were being treated
with basal insulin and oral anti-diabetes agents. The primary objective
was to demonstrate that subjects receiving Nasulin would achieve a
larger increase from baseline in the mean proportion of time spent with
normal glucose levels (or in euglycemia) than those receiving placebo,
as assessed by continuous glucose monitoring. Although subjects in the
placebo group spent less time in euglycemia at the end of the study
compared to subjects in the Nasulin group, the difference between the
two groups was not statistically significant (p-value = 0.2). The
secondary efficacy measurements of change from baseline in average
glucose as measured by continuous glucose monitoring and the change from
baseline in serum fructosamine were consistent with the primary endpoint
analysis.
No critical safety signals were detected with Nasulin in the study. The
most common adverse events were those attributable to administration
site reactions associated with the nasal route of delivery, the majority
of which were mild. The percentage of subjects reporting hypoglycemia
was similar between both the Nasulin and placebo groups.
At the end of the trial, the Company conducted a meal challenge which
demonstrated significant reductions in the maximum concentrations of
serum glucose in the Nasulin group versus placebo, as well as
significant reductions in the overall glucose load during 60, 90 and 240
minutes after dosing. These findings support the pharmacodynamic data
demonstrated in previous Phase 1 clinical studies.
The Phase 2a, double-blind, multi-center, placebo-controlled trial was
initiated in the United States in February 2009 and randomized 94
subjects. Efficacy, as measured by the proportion of time spent with
normal glucose levels, was assessed using continuous glucose monitoring.
Subjects were administered either Nasulin or placebo at the start of
each meal and were treated for 6 weeks during the double-blind period of
the study.
The Company intends to conduct additional analyses on the data from this
trial and together with all other Nasulin data will determine the
appropriate next steps for the Nasulin program. In the interim the
Company will not commence its planned Phase 2b trial or other Nasulin
development initiatives. The Company also intends to present the results
of this study at the AACE 19th Annual Meeting and Clinical Congress,
April 21-25, 2010.
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 facilitate 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 has recently been tested in a Phase 2a clinical trial.
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 for 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 Nasulin, regulatory
approvals may be delayed or not obtained, CPEX's dependence on obtaining
agreements for other parties to conduct clinical trials, manufacture and
commercialize its product candidates that use its drug delivery
technology, competition from other manufacturers of proprietary and
generic 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
Vice President
crubin@troutgroup.com
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