Endometriosis
Proellex is currently in a Phase 2 clinical trial. Initial interim data from this trial is anticipated to be available at the end of the second quarter of 2008. Pending positive final results from this trial and FDA acceptance of clinical protocols, we plan to initiate registration Phase 3 pivotal trials in the first quarter of 2009 and file a NDA during the first half of 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.