Zonagen's fibriods patent
Zonagen, from The Woodlands, TX, US, has been issued US Pat No 6,861,415, which claims both compositions of matter and methods of use for Progenta, which Zonagen is currently developing for the treatment of uterine fibroids and endometriosis. Zonagen is the exclusive worldwide licensee of this patent.
Zonagen, from The Woodlands, TX, US, has been issued US Pat No 6,861,415, which claims both compositions of matter and methods of use for Progenta, which Zonagen is currently developing for the treatment of uterine fibroids and endometriosis. Zonagen is the exclusive worldwide licensee of this patent.
The company recently completed a clinical study with Progenta, which yielded statistically significant improvement in the treatment of uterine fibroids as compared with baseline. Progenta's effects on shrinking fibroids were at least equivalent to that observed in women using an approved gonadotropin releasing hormone agonist ('GnRHa'), which is the most effective drug intervention for the condition. The company believes that Progenta's mechanism of action will avoid the adverse limiting side effects of bone loss, which are associated with the GnRHa's and which restrict their use to not longer than six months.
Joseph Podolski, president and ceo of Zonagen, noted: 'We believe that the issuance of the patent which claims both compositions of matter and methods of use offers strong intellectual property protection for our Progenta technology.' He further noted that the company has received notification that the FDA will be reviewing Zonagen's pre-Investigational New Drug ("pre-IND") proposal. The company is seeking guidance from the agency regarding its trial design for Progenta and the suitability of Zonagen's recently completed European clinical study for Progenta in support of an advanced stage clinical trial program in the United States.