Endometriosis
Proellex is currently in a Phase 2 clinical trial. Pending positive final results from this trial and FDA acceptance of clinical protocols, we plan to initiate registration Phase 3 pivotal trials and file a NDA in late 2010.
Estimated Market Size
According to The Endometriosis Association, endometriosis affects 5.5 million women in the United States and Canada and millions more worldwide.
- 71-87% of women with chronic pelvic pain suffer from endometriosis.
- 25-40% of infertility cases are believed to be the result of endometriosis.
- Endometriosis is believed to be the cause in 53% of the cases of teenagers with severe cramps.
Current Standard of Care
- Pain medication
- 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
- Treatment limited to not more than six months concurrently.
- Upon cessation of treatment, symptoms typically return within a short time period.
- Conservative surgery
- Hysterectomy
Key Data Collected to Date
- In a 40 patient, 24-week clinical trial evaluating two doses of Proellex, 25 mg and 50 mg as compared to Lucrin® (also known as Lupron®), an approved GnRH agonist, commonly used to treat the symptoms associated with endometriosis, the following observations were made:
- Proellex exhibited positive effects on ablation of the symptoms of pelvic abdominal pain associated with the condition.
- The 50mg dose of Proellex achieved statistical significance (p=0.0012) when compared to Lucrin in reducing the number of days of pelvic abdominal pain over the course of the trial.
- There was no statistical difference between the 25 mg dose of Proellex and Lucrin.
- There was a clear dose response in the Proellex treatment groups, and Proellex was well tolerated over the course of the trial.