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.
About OvaScience
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.
Forward-Looking Statements
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.
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