Additional Clinical Reports of OvaScience AUGMENT Fertility Treatment Show Improved Pregnancy Rates in Women with Multiple Pr...
March 28 2015 - 10:50AM
Business Wire
OvaScienceSM (NASDAQ: OVAS), a global fertility company focused
on the discovery, development and commercialization of new
treatment options, announced today that additional clinical
experience of the Company’s AUGMENTSM treatment demonstrated
improved pregnancy rates in women who had failed three to seven
prior in vitro fertilization (IVF) cycles. These results were
reported at the Society for Reproductive Investigation (SRI) 62nd
Annual Scientific Meeting being held in San Francisco, CA. The
AUGMENT treatment is not available in the United States.
Kutluk Oktay, M.D., F.A.C.O.G, of Gen-art IVF in Ankara, Turkey,
and one of the initial IVF specialists to use the AUGMENT treatment
in clinical practice, presented initial clinical experience in
eight women whose ages ranged between 27 and 41 years with three or
more IVF failures and poor egg and embryo quality. In eight women
who received the AUGMENT treatment, there were two clinical
pregnancies out of eight embryo transfers (25%).1 Most notably, the
two pregnancies occurred with single embryo transfers in women aged
34 and 41 who had previously failed to become pregnant following
seven and three IVF cycles, respectively. One patient has an
ongoing clinical pregnancy.2
“These initial AUGMENT pregnancy rates are quite encouraging,
especially given that these were women who had failed multiple IVF
cycles and were running out of options to use their own eggs,” said
Dr. Oktay. “We were also pleased to see these pregnancy rates
achieved with single embryo transfers during IVF, a practice that
may limit the number of multiple births, which can cause health
risks to the mother and infant during pregnancy and delivery and
after. Based on our experiences to date, the AUGMENT treatment
appears to benefit women with poor egg quality and we look forward
to continuing to share our clinical experiences.”
The results reported in the poster presentation represent
experiences from a small number of patients with different
diagnoses, ages and prior IVF history. As of this reporting,
pregnancy rates across IVF clinics that offer the AUGMENT treatment
currently range from 25% - 53%, which includes clinics that are
treating some of the more challenging infertility patients.
OvaScience is collecting AUGMENT patient experience in a
first-of-its-kind international registry, and anticipates sharing
information from a broader patient experience when it is
available.
The AUGMENT treatment is a fertility treatment specifically
designed to use the mitochondria, or energy, from a woman’s own egg
precursor cells – immature egg cells found inside the protective
ovarian lining – to improve egg health. The treatment is available
to patients in select international IVF clinics. Additional
information can be found at www.augmenttreatment.com.
“The positive clinical evidence continues to build in support of
our AUGMENT treatment,” stated Michelle Dipp, M.D., Ph.D., Chief
Executive Officer of OvaScience. “These improved pregnancy rates in
women who have failed IVF multiple times, coupled with similar
encouraging clinical AUGMENT experiences at other IVF clinics,
provide physicians and patients with important information about
how the AUGMENT treatment may improve egg health in women with
infertility.”
Dr. Oktay’s poster presentation follows an AUGMENT presentation
made by Robert Casper, M.D., F.R.C.S.(C), Medical Director of TCART
Fertility Partners, at the SRI meeting. Both presentations can be
found at www.ovascience.com/technology/publications. The AUGMENT
treatment presentations at SRI are based on self-reported patient
experiences and physician evaluations.
About OvaScience
OvaScience (NASDAQ: OVAS) 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 we believe 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. The AUGMENTSM
treatment, a fertility option specifically designed to improve egg
health, is available in certain IVF clinics in select international
regions outside of the United States. OvaScience is developing the
OvaPrimeSM treatment, which could increase a woman’s egg reserve,
and the OvaTureSM treatment, a potential next-generation IVF
treatment that could help a woman produce healthy, young,
fertilizable eggs without hormone injections. For more information,
please visit www.ovascience.com and www.augmenttreatment.com and
connect with us on Twitter and Facebook.
Forward-Looking Statements
This press release includes forward-looking statements about the
Company’s plans for the AUGMENT treatment and future pregnancy
rates. 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 possibility that
international IVF clinics that we work with may determine not to
begin or continue providing the AUGMENT treatment for commercial or
other reasons; our expectation that the AUGMENT treatment and
OvaPrime treatment meet the requirements of a class of products
exempt from premarket review and approval under applicable
regulations in those countries where we have launched or plan to
introduce the AUGMENT treatment and plan to introduce the OvaPrime
treatment; the commercial ramp up of the AUGMENT treatment, which
we expect will depend upon the successful transition of ACE clinics
to commercial operations, the addition of new ACE clinics, and the
results from ACE clinic experience as they become available; the
science underlying our treatment and treatments in development
(including the AUGMENT, OvaPrime and OvaTure treatments), which is
unproven; our ability to obtain regulatory approval where necessary
for our potential treatments; our ability to develop our potential
treatments, including the OvaPrime and OvaTure treatments, on the
timelines we expect, if at all; our ability to commercialize the
AUGMENT treatment and our potential treatments, including the
OvaPrime treatment, 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.
###
1 Outcomes presented show percentage of clinical pregnancies
from embryo transfer.
2 Clinical pregnancy is defined as a pregnancy diagnosed by
ultrasound.
http://www.eshre.eu/Guidelines-and-Legal/ART-glossary.aspx
OvaScienceTheresa McNeely, 617-299-7356EVP, Chief Communications
Officertmcneely@ovascience.comorMediaCara Mayfield,
617-714-9638Director, Corporate
Communicationscmayfield@ovascience.com
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