Contributed by Phyllis Leppert, President of The Campion Fund.
Since the majority of women have uterine fibroids (70% of white women and 80% of black women in the US are estimated to have fibroids by age 50 years), it is indeed good news that more treatments are on the horizon to treat these pesky tumors. Here are some in the pipeline:
1. AbbVie, Inc. is conducting Phase III clinical studies of Elagolix for the treatment of uterine fibroids. Elagolix, a GnRH antagonist, is given orally along with estradiol/norethindrone acetate as part of the drug treatment so called “add back treatment.” Treatment sites for this trial are located in US, Canada, Puerto Rico, Chile and the United Kingdom. In earlier phase II studies, enrolled women treated with Elagolix had significant reduction in heavy menstrual bleeding, one of the serious symptoms of uterine fibroids. Information regarding this study is available at: http://www.neurocrine.com/pipeline/elagolix-gnrh-antagonist/uterine-fibroids/clinical-trials/
https://clinicaltrials.gov/ct2/show/NCT02691494
The fact that AbbVie is conducting phase III trials indicates that the company is getting close to the time for FDA approval if the studies pan out. We hope this occurs. Clinical studies are necessary to determine the proper dose of drugs, what side effects may occur and the overall safety of the drug. We do need to wait and see, but we are hopeful.
2. Repros Therapeutics is developing Telapristone, marketed as Proellex. Telapristone selectively blocks the progesterone receptor. This drug reduces the heavy bleeding associated with fibroids as well as shrinks the tumor size by about 20%. The clinical trials conducted so far utilized both oral and vaginal delivery methods and provide another medical approach to fibroid treatment. Repros has just launched a Phase III trial. Clinical sites are in the US and include Florida, Georgia, Louisiana, Michigan, North Carolina and Texas. Information about this treatment study is available at: http://www.prnewswire.com/news-releases/uterine-leiomyoma-uterine-fibroids-therapeutic-pipeline-h1-2015-review-research-report-295352951.html
https://clinicaltrials.gov/ct2/show/NCT02323646
3. Advance Biofactures Corporation has initiated a Phase I safety and tolerability study (FDA IND number 127524) of EN3835 based on the findings of proof of principle preclinical studies. This drug is an enzyme, purified bacterial collagenase and is to be injected directly into uterine fibroid tissue under ultrasound guidance to shrink the tumor size and prevent bulk symptoms as well as treat bleeding. The study has one site which is Johns Hopkins Hospital, Baltimore Maryland. Information about this trial is available by contacting James Segars at
4. Both Phillips, which markets Sonalleve, and Insightec, producer of ExAblate, manufacture the medical equipment that provides high intensity focused ultrasound that is used to treat uterine fibroids by heat coagulation. These companies have recently conducted clinical trials that studied the efficacy of newer generations of their equipment and the techniques used to accomplish the treatments. Further information of these studies can be found at: http://www.prnewswire.com/news-releases/fda-approves-insightecs-next-generation-exablate-fibroid-treatment-system-and-removes-requirement-for-patients-to-be-family-complete-531046341.html
https://clinicaltrials.gov/ct2/show/NCT01504308
5. Radiofrequency ablation, called VizAblate by Gynesonics, Inc. manufacturer of the equipment used to provide the radiofrequency utilized in this treatment of fibroids is conducting a study to determine if radiofrequency delivered by a vaginal probe will eliminate uterine fibroids. There are 22 sites throughout the US. Additional information about this study is available at: http://evtoday.com/2014/10/22/fda-approves-pivotal-sonata-study-for-gynesonics-vizablate-system-to-treat-uterine-fibroids
https://clinicaltrials.gov/ct2/show/NCT02228174
Finally, the publication of “An Open Letter to the FDA” (1) from 45 leaders in obstetrics and gynecology with interest and expertise in uterine fibroid research and treatment has caused many professionals to consider the appropriate and safe use of uterine fibroid morcellation for certain women who need treatment of their uterine fibroids. This appropriate use would include careful informed consent, careful patient screening, precise surgical technique and excellent follow up. As President of the Campion Fund, I was proud to be a member of the group that wrote the letter and to be a part of the extensive follow up discussions.
(1)Parker W, Berek JS, Pritts E, Olive D, Kaunitz AM, Chalas E, Clarke-Pearson D, Goff B, Bristow R, Taylor HS, Farias-Eisner R, Fader AN, Maxwell GL, Goodwin SC, Love S, Gibbons WE, Foshag LJ, Leppert PC, Norsigian J, Nager CW, Johnson T, Guzick DS, As-Sanie S, Paulson RJ, Farquhar C, Bradley L, Scheib SA, Bilchik AJ, Rice LW, Dionne C, Jacoby A, Ascher-Walsh C, Kilpatrick SJ, Adamson GD, Siedhoff M, Israel R, Paraiso MF, Frumovitz MM, Lurain JR, Al-Hendy A, Benrubi GI, Raman SS, Kho RM, Anderson TL, Reynolds RK, DeLancey J. An Open Letter to the Food and Drug Administration Regarding the Use of Morcellation Procedures in Women Having Surgery for Presumed Uterine Myomas. J Minim Invasive Gynecol. 2016 Mar-Apr;23(3):303-8. doi: 10.1016/j.jmig.2015.12.012. Epub 2016 Jan 8.