BioSpecifics Technologies Corp. Initiates Phase 1 Clinical Trial of XIAFLEX for Treatment of Uterine Fibroids
- Category: Proteins and Peptides
- Published on Tuesday, 18 April 2017 18:33
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LYNBROOK, NY, USA I April 18, 2017 I BioSpecifics Technologies Corp. (NASDAQ: BSTC), a biopharmaceutical company that originated and continues to develop collagenase based-therapies with a first in class collagenase-based product marketed as XIAFLEX® in the U.S. and Xiapex® in Europe, today announced that it has initiated an open-label, dose escalation Phase 1 clinical trial of XIAFLEX for the treatment of uterine fibroids.
"The treatment of our first patient in this trial for uterine fibroids is an important milestone for BioSpecifics and supports our business objective to develop XIAFLEX for medically necessary indications," commented Thomas L. Wegman, President of BioSpecifics. "We believe there are strong benefits to XIAFLEX as a potential non-surgical treatment for uterine fibroid patients and that achieving a reduction in the size and stiffness of the fibroids will decrease symptoms of pain and bleeding, avoid the need for surgical procedures and result in a better quality of life for affected women."
The Phase 1 open-label dose escalation study is being conducted at the Department of Gynecology & Obstetrics at Johns Hopkins University and will enroll 15 female subjects treated prior to hysterectomy. Three subjects have been injected with saline only to evaluate the safety and effectiveness of the injection method and the remaining 12 subjects will now be injected with increasing doses of XIAFLEX. The primary endpoint will assess the safety and tolerability of a single injection of XIAFLEX directly into the uterine fibroids at three doses under transvaginal ultrasound guidance. The secondary endpoints will assess symptoms of pain and bleeding, quality of life throughout the study, shrinkage of XIAFLEX treated fibroids in size, increased rates of apoptosis in treated fibroids and a decrease in the collagen content of treated fibroids.
About Uterine Fibroids
Uterine fibroids are very common benign tumors in the reproductive tract that contain large amounts of collagen which may cause pelvic discomfort and pain, decreased fertility, pregnancy complications, an increased rate of miscarriage, uterine bleeding, prolonged menstrual bleeding and frequent urination. Uterine fibroids are the leading cause of hysterectomies in the U.S., accounting for about 250,000 hysterectomies and 30,000 myomectomies performed each year. Uterine fibroids have been estimated to cost up to $9.4 billion annually in direct costs in the U.S. and there is a high level of recurrence with current treatment options.
About BioSpecifics Technologies Corp.
BioSpecifics Technologies Corp. is a biopharmaceutical company that has developed injectable collagenase for twelve clinical indications to date. Injectable collagenase is marketed as XIAFLEX® in the U.S. for the treatment of Dupuytren's contracture and Peyronie's disease by BioSpecifics' partner, Endo International plc (Endo). XIAFLEX® is also commercialized in Japan, Europe, Canada and Australia for Dupuytren's contracture and for Peyronie's disease in Europe and Australia. Endo is partnered with Sobi, Actelion and Asahi Kasei for Dupuytren's contracture and Peyronie's disease outside the U.S. The XIAFLEX research and development pipeline includes several additional promising indications. BioSpecifics is managing the development of XIAFLEX for uterine fibroids and is conducting a Phase 1 clinical trial. For more information, please visit www.biospecifics.com.
SOURCE: BioSpecifics Technologies