OvaScience Completes Enrollment Of 70 Patients In Ovaprime Clinical Study In Women With Primary Ovarian Insufficiency Or Poor Ovarian Response
– Initial Data from First 20 Patients Expected by Year-End 2017 –
WALTHAM, Mass.--(BUSINESS WIRE)--OvaScienceSM Inc. (NASDAQ: OVAS), a global fertility company focused on the discovery, development and commercialization of new treatment options, today announced it has completed enrollment of 70 patients in its ongoing clinical study of the OvaPrimeSM treatment, designed to assess the safety of OvaPrime in women with either primary ovarian insufficiency (POI) or poor ovarian response (POR). OvaPrime is a potential fertility treatment that could enable a woman who makes too few or no eggs to increase her egg reserve by using her own egg precursor (EggPCSM) cells – immature egg cells found inside the protective ovarian lining. EggPC cells are the foundation for each of OvaScience’s fertility treatments.
"We are pleased to have completed target enrollment in our OvaPrime clinical trial. Some women do not make enough healthy, mature eggs to undergo standard in vitro fertilization. By increasing ovarian reserve, we believe OvaPrime may allow these women to have their own biological children,” said Michelle Dipp, M.D., Ph.D., Co-founder and Executive Chair of OvaScience. “We look forward to the initial data readout in 20 patients from this study by year-end.”
This single center, prospective, controlled, blinded and randomized clinical study is designed to evaluate the safety of OvaPrime in women diagnosed with either POI or POR. Secondary endpoints include OvaPrime’s effect on patients’ anti-mullerian (AMH), follicle stimulating (FSH), and estradiol (E2) hormone levels, as well as follicular development as observed by ultrasound. An initial data readout from 20 patients, including safety data from six months post-EggPC cell reintroduction, is expected by year-end 2017. The Company expects to complete biopsies in 70 patients by the end of 2017 and reintroductions in 70 patients by the end of the first half of 2018.
About the OvaPrime Treatment
OvaPrime is designed to work by transferring a woman’s own EggPC cells from her ovarian cortex to the inside of her ovary where they may mature into fertilizable eggs. Specifically, during OvaPrime, EggPC cells are isolated from the ovarian cortex via biopsy. The EggPC cells are then isolated and reintroduced into the follicular development zone of the woman's ovary where they may develop and mature into fertilizable eggs, either naturally or through controlled ovarian hyperstimulation using standard in vitro fertilization (IVF) protocols.
About Primary Ovarian Insufficiency and Poor Ovarian Response
Primary ovarian insufficiency is defined by the American College of Obstetricians and Gynecologists as the depletion or dysfunction of ovarian follicles with cessation of menses before age 40. It has previously been referred to as premature menopause or premature ovarian failure. According to the European Society of Human Reproduction and Embryology’s Bologna Criteria, women are considered to have poor ovarian response if they fulfill two of the following criteria: advanced maternal age (=40 years); have undergone a previous IVF cycle with a standard of care controlled ovarian hyperstimulation protocol that yielded three or fewer eggs; and/or have an abnormal ovarian reserve test, defined as an antral follicular count of less than five to seven follicles, an anti-mullerian hormone of less than 0.5 to 1.1 ng/ml, or a highest ever baseline follicle stimulating hormone level of greater than 15.0 ml U/ml.
OvaScienceSM, Inc. is a global fertility company dedicated to improving treatment options for women around the world. OvaScience is discovering, developing and commercializing new fertility treatments because it believes women deserve more options. Each OvaScience treatment is based on the Company’s proprietary technology platform that leverages the breakthrough discovery of egg precursor (EggPCSM) cells – immature egg cells found inside the protective ovarian lining. OvaScience is developing OvaTureSM, a potential next-generation IVF treatment that could help a woman produce healthy, young, fertilizable eggs without hormone injections and OvaPrimeSM, which could increase a woman’s egg reserve. OvaScience’s AUGMENTSM treatment, a fertility option designed to improve IVF success rates, is available in certain IVF clinics in select international regions. OvaScience treatments are not available in the U.S. For more information, visit www.ovascience.com.
This press release includes forward-looking statements about the Company’s plans for the OvaPrime treatment, OvaTure treatment and AUGMENT treatment, including statements relating to the Company’s plans to complete biopsies in 70 patients in the ongoing Canadian study of OvaPrime by year-end and complete reintroductions in 70 patients by the end of the first half of 2018; to present initial data from 20 OvaPrime patients, including six months of post-EggPC reintroduction safety data, by year-end. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including risks related to: the science underlying our treatments (including the OvaPrime, OvaTure and AUGMENT treatments), which is unproven; our ability to obtain regulatory approval or licenses where necessary for our treatments; our ability to develop our treatments on the timelines we expect, if at all; our ability to commercialize our treatments, on the timelines we expect, if at all; as well as those risks more fully discussed in the “Risk Factors” section of our most recently filed Quarterly Report on Form 10-Q and/or Annual Report on Form 10-K. The forward-looking statements contained in this press release reflect our current views with respect to future events. We anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward-looking statements in the future, we specifically disclaim any obligation to do so. These forward-looking statements should not be relied upon as representing our view as of any date subsequent to the date hereof.