Vyteris, a biotechnology company, has initiated a Phase II clinical trial sponsored by its development partner, Ferring Pharmaceuticals. The trial evaluates Vyteris’s smart patch technology for the safety and efficacy of a pulsatile delivery of a peptide hormone for the treatment of infertility in women.
The trial will be a multi-center clinical trial conducted at approximately 35 centers throughout the US and will enroll approximately 500 female patients between the ages of 18 and 38 years with anovulatory or oligoovulatory infertility.
In this clinical trial, the safety and tolerability of Vyteris’s transdermal delivery system will be evaluated over the trial period. The trial is currently enrolling subjects and is expected to be fully enrolled by July 2009.
With the initiation of the Phase II clinical trial, Vyteris earned a $2.5m milestone payment from Ferring, which had been previously advanced in July 2008 in the form of an interest bearing loan, the principal amount of which has now been satisfied through application of this milestone payment.
Haro Hartounian, CEO of Vyteris, said: The initiation of this Phase II clinical trial is an important milestone for Vyteris in developing an effective peptide transdermal delivery system. We look forward to continuing our strong partnership with Ferring to achieve success with this project for the benefit of infertility patients.