Cpex Pharmaceuticals initiates Phase II diabetes trial

This Phase IIa, double-blind, placebo-controlled study will enroll up to 150 subjects with type 2 diabetes who are currently being treated with basal insulin and oral anti-diabetes agents.

The study is designed to assess the efficacy and safety of Nasulin versus placebo over a six-week treatment period. Efficacy, as indicated by duration of normal glucose levels, or euglycemia, will be assessed using continuous glucose monitoring and serum fructosamine levels. The study is being conducted at multiple centers in the US.

John Sedor, president and CEO of Cpex Pharmaceuticals, said: We are excited to continue our Phase II clinical work on our intranasal insulin candidate, Nasulin, a drug we believe has the potential to not only be more convenient for patients with diabetes but also potentially offer an improved product profile, including reduced weight gain and less risk of hypoglycemia. We look forward to the continued progress of our Nasulin clinical program including the initiation of a Phase IIb (HbA1c) trial in the second half of 2009.

Cpex Pharmaceuticals is an emerging specialty pharmaceutical company focused on the development, licensing and commercialization of pharmaceutical products. Cpex has U.S. and international patents and other proprietary rights to technologies that facilitate the absorption of drugs. Cpex has a license of its proprietary CPE-215 drug delivery technology to Auxilium Pharmaceuticals for use in Testim. Cpex also is developing an intranasal insulin product candidate, Nasulin, which is in Phase II clinical trials.