Uterine Fibroids
Proellex is currently in registration Phase 3 pivotal trials for this indication and we anticipate filing a New Drug Application, or NDA, in the fourth quarter of 2009. Interim data from our current 12-month Open Label Safety Study is anticipated at the end of the first quarter of 2008.
Estimated Market Size
The National Uterine Fibroids Foundation estimates that as many as 80% of all women in the United States have uterine fibroids, and one in four of these women have symptoms severe enough to require treatment.
- 700,000 women in the seven major market countries have symptoms severe enough to require surgery or radical treatment.
- Average age at presentation is 39 while average age at menopause is 49. Treatment for the 10 year period would preserve the uterus until menopause, when fibroids typically resolve spontaneously.
Current Standard of Care
- Hormone therapy
- Oral contraceptives and progestins
- Androgens
- Gonadotropin releasing hormone agonists, (GnRH agonists), for example, Lupron® (leuprolide acetate). Chronic administration of GnRH agonists reduces the number of GnRH receptors and thereby blocks the action of GnRH in stimulating the pituitary to secrete FSH and LH.
- GnRH agonists tend to promote bone loss after six months of use
- Upon cessation of treatment, fibroids typically regenerate rapidly.
- Uterine artery embolization
- Myomectomy
- Hysterectomy
Key Data Collected to Date
- In a 128 patient U.S. Phase 2 clinical trial (completed 2007) with Proellex, designed to assess both improvement of symptoms associated with uterine fibroids as well as effects on the actual fibroids, and comparing two doses of Proellex, 12.5 mg and 25 mg, to placebo over a 3-month period, the following observations were made:
- The clinical trial data demonstrated statistically significant reductions in excessive menstrual bleeding and an improvement in quality of life scores versus placebo.
- Furthermore, after three months of treatment, no statistically significant change in endometrial thickness was observed.