Anemia Associated with Uterine Fibroids (Pre-surgical)
Proellex is currently in registration Phase 3 pivotal trials for this indication and we anticipate filing a New Drug Application, or NDA, near the end 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.
- 40% of the 700,000 (280,000) will have anemia severe enough to pose a surgical risk.
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.
- Iron supplementation
Key Data Collected to Date
- A U.S. 128 patient Phase 2 clinical trial with Proellex for the treatment of uterine fibroids was completed in 2007 with the following observations:
- A subset of anemic patients (hemoglobin levels less than 11.5 g/dl) receiving treatment saw an improvement in their hemoglobin level of up to 2 g/dl, or the equivalent of approximately two pints of blood, after three months of treatment with Proellex.
- For this subset of patients (15-17 patients per treatment arm) the improvement of hemoglobin at both the 12.5 mg and 25 mg doses was both clinically and statistically highly significant (p<0.002) compared with placebo.
- Oral iron supplements for correction of anemia were used by a similar number of women patients in the placebo and 25 mg Proellex arms of the trial. A slightly higher percentage of women in the Proellex 12.5 mg arm used oral iron supplements which suggests that reversal of the anemia with Proellex treatment was largely due to the very effective prevention of severe blood loss experienced by those patients with symptomatic uterine fibroids.