Repros Therapeutics Announces U.S. IND for the Study of Proellex(R) in the Treatment of Endometriosis Has Become Effective
6:00a ET September 12, 2007 (Business Wire)
Repros Therapeutics Inc. (NasdaqGM:RPRX) today announced that the Company's IND for the U.S. study of its drug Proellex(R) has become effective on September 10, 2007. The first study conducted under the new IND will be a Phase II trial that will enroll 75 patients at up to 20 clinical sites in the United States.
The 75-patient Proellex study is designed to assess the improvement of symptoms associated with endometriosis. The study will test two doses of Proellex, 25mg and 50mg, as a once-a-day oral therapy, versus placebo in a double-blind design. The study is of 16-week duration. The trial will use a daily diary into which patients record their endometriosis symptom scores as a primary endpoint. Per a request from the U.S. Food and Drug Administration (FDA), the diary was derived from the previously validated Biberoglu and Behrman Symptom Score (BBSS). The BBSS is a physician-administered questionnaire requiring patient recollection of symptoms over a finite period of time. In addition to the symptom survey, patients will be monitored for changes in the condition of the endometrium, or lining of the uterus. The four-month duration of the trial is consistent with the duration of treatment deduced from previously conducted trials with Proellex. After the treatment period, patients will be followed up to observe for a return of symptoms. An open label extension study for the patients enrolled in the trial will be submitted under a separate protocol. If accepted, the extension study will allow for patients to be treated for two additional four-month cycles with an intervening menstruation between each cycle.
Doses to be used in this trial were previously tested in a European 40-patient, 24-week study of Proellex in women with endometriosis. In the study, Proellex exhibited positive effects on ablation of the symptoms of pelvic abdominal pain associated with the condition. The European study compared Proellex to Lucrin(R), also known as Lupron(R), an approved GnRH agonist, commonly used to treat the symptoms associated with endometriosis. In that trial 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 study. There was no statistical difference between the 25mg 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 study.
Dr. Andre van As, Chief Medical Officer of Repros, commented, "The previously conducted study of the use of Proellex in the treatment of the pain symptoms associated with endometriosis gave a clear and strong efficacy signal. We believe those findings will extend to the outcomes we hope to observe in this trial." He further added, "Our recently described treatment paradigm of sequential four-month treatment cycles each followed by a drug holiday is now in place for all of our studies. This holiday, which allows the endometrium to refresh, is being employed in our ongoing open-label extension study of Proellex in the treatment of uterine fibroids."
Compleware Corporation will conduct this study. Twenty clinical sites have been selected and an investigator meeting was held on September 7th and 8th, 2007, to discuss the key points of the study design. Cities where investigator sites are located include: Columbia, SC; Corpus Christi, TX; Dubuque, IA; Haverhill, MA; Huntsville, AL; Jackson, TN; Lake Worth, FL; Lawrenceville, NJ; Little Rock, AR; Memphis, TN; Miamisburg, OH; Newport Richey, FL; Raleigh, NC; San Antonio, TX; Seattle, WA; Tucson, AZ; and West Palm Beach, FL. Patients interested in participating in the study should contact Sarah Lidtke, Project Administrator for Compleware Corporation. The contact phone number at Compleware Corporation is 319-626-8888.
Repros Conference Call
Repros management will hold a conference call to discuss the company's future product clinical development plans, including plans for Proellex in the treatment of uterine fibroids and endometriosis, and to answer investor questions. The call will be held at 12:00 p.m. Eastern Time on September 17, 2007. Investors can access the call by dialing 866-322-1159 (within North America) or 416-640-3404 (International).
You can access a replay of the taped conference call until 11:00 a.m. Wednesday, September 19, 2007, by dialing 866-244-4494 (North America) and 416-915-1028 (International). The passcode is 805182. You can also access the replay via our website at www.reprosrx.com.
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