OvaScience Completes Enrollment of 70 Patients in OvaPrime Clinical Study in Women with Primary Ovarian Insufficiency or Poor...
June 13 2017 - 7:00AM
Business Wire
– Initial Data from First 20 Patients Expected
by Year-End 2017 –
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 TreatmentOvaPrime 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
ResponsePrimary 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 OvaScienceOvaScienceSM, 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 StatementsThis 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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Media and Investor Contact:OvaScience,
Inc.Jennifer Viera, 617-420-8748jviera@ovascience.com
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