– Reporting Safety Data from First 20 Patients in Phase 1 Study of
the OvaPrimeSM Treatment; Advancing OvaPrime
into Phase 1b/2a Multi-Center Trial –
– James Lillie, Ph.D., Joining as Chief Scientific Officer to Lead
Ongoing Preclinical Research & Development Efforts –
– Improving Financial Position Through Corporate Restructuring –
WALTHAM, Mass.--(BUSINESS WIRE)--Jan. 3, 2018--
OvaScience (NASDAQ:OVAS), a company focused on the discovery,
development and commercialization of new treatment options for women and
families struggling with infertility, today provided a corporate update.
The Company announced initial clinical data from its ongoing Phase 1
trial of OvaPrimein women with primary ovarian insufficiency
(POI) and poor ovarian response (POR). In an interim safety analysis of
the first 20 patients followed for six months post-egg precursor (EggPCSM)
cell reintroduction, OvaPrime was generally safe and well-tolerated.
OvaScience has decided to close enrollment in this Phase 1 study at 78
patients, for a modified intent-to-treat (mITT) population of 60, and to
progress OvaPrime into a multi-center Phase 1b/2a trial in women with
POI or POR. The Company also announced the appointment of James Lillie,
Ph.D., as Chief Scientific Officer, effective January 16, 2018. Dr.
Lillie brings extensive in vitro and cell biology experience to
OvaScience, and will lead the Company’s preclinical research and
development efforts, including the continued advancement of OvaPrime and
“We are pleased to announce these preliminary first-in-human results for
OvaPrime. Based on these data, coupled with recent improvements to our
cell processing capabilities that will enable us to consistently
administer a higher number of EggPC cells per treatment, we have decided
to close enrollment in our Phase 1 study and advance OvaPrime into a
multi-center Phase 1b/2a trial in women with POI and POR,” said Dr.
Christopher Kroeger, Chief Executive Officer of OvaScience. “I am also
pleased to welcome Dr. Jim Lillie as Chief Scientific Officer. Jim is a
seasoned leader, with over 25 years of experience driving preclinical
research and development across diverse therapeutic areas. His deep
expertise will provide proven leadership to the OvaTure program and our
scientific efforts more broadly.”
“Together, the initiation of our Phase 1b/2a trial and the hiring of Dr.
Lillie represent key advancements in our research and
development-focused strategy and reflect our commitment to building
robust and compelling clinical and preclinical datasets for each of our
Reports Initial Safety Data from Phase 1 Study of OvaPrime
Initial clinical data from OvaScience’s single center, prospective,
blinded and placebo-controlled Phase 1 safety study of the OvaPrimetreatment
in women with POI or POR suggest that the OvaPrime treatment is
generally safe and well-tolerated. Among the first 20 patients evaluable
for safety six-months post-EggPC cell reintroduction, there were no
treatment related serious adverse events (SAEs) and no adverse events
(AEs) related to the EggPC cells. There were seven mild AEs, four of
which were deemed unrelated to OvaPrime and three of which were related
to the standard laparoscopic procedure used to reintroduce EggPC cells
into the ovary. No patients discontinued treatment because of an AE. The
mean duration of follow-up among these 20 patients was nine months.
This Phase 1 study is a single center, prospective, blinded and
placebo-controlled trial evaluating the safety of OvaPrime in 60 women
with either POI or POR. Additional exploratory endpoints include
OvaPrime’s effect on patients’ anti-mullerian hormone (AMH), follicle
stimulating hormone (FSH) and estradiol (E2) levels, as well as
follicular development as measured by ultrasound.
OvaScience has completed biopsies in 58 patients in this Phase 1 study.
The Company expects a readout of six-month safety data of all patients
by year-end 2018 and a readout of embryo transfers by the end of the
third quarter of 2019.
Plans to Initiate Phase 1b/2a Study of OvaPrime
OvaScience plans to initiate a multi-center, prospective, controlled,
Phase 1b/2a clinical trial of OvaPrime to evaluate the safety and
tolerability of administering a higher number of EggPC cells per
OvaPrime treatment in women with POI or POR. Secondary endpoints will
include measures of reproductive physiology and fertility outcomes.
This study will enroll up to 60 women with POI or POR, for a mITT
population of 40. It will include 20 POI patients who are between 21 and
39 years of age at reintroduction and 20 POR patients who are between 38
and 42 years of age at reintroduction and have failed or canceled two to
four in vitro fertilization (IVF) cycles.
OvaScience expects to begin patient enrollment in the first half of 2018
and to report initial clinical data in 2019.
Hires New Chief Scientific Officer to Lead Preclinical Programs
OvaScience also announced the appointment of James Lillie, Ph.D., as
Chief Scientific Officer, effective January 16, 2018. Dr. Lillie will be
responsible for leading the Company’s preclinical efforts with the EggPC
technology platform, including the ongoing OvaTure program.
Dr. Lillie joins OvaScience from Sanofi Genzyme where he was Vice
President, In Vitro Biology. In this role, Dr. Lillie was responsible
for developing a scientific strategy for creating a sustainable, high
value portfolio in rare diseases. He established a strong pipeline of
small molecule drugs and supported the U.S. Food and Drug
Administration’s approval of Eliglustat and acceptance of two
investigational new drug applications. Previously, he was Senior
Director, In Vitro Biology at Sanofi Genzyme and, before that, he held
roles of increasing responsibility at Millennium Pharmaceuticals, Inc.
Earlier, he worked as Senior Director, Biology at Scriptgen
Pharmaceuticals, and as co-founder at AMIRA, which was later sold to
Repligen Corporation. Dr. Lillie holds a Ph.D. in Biochemistry and
Molecular Biology from Harvard University and B.A. in German Literature
from Wesleyan University.
“I’m excited to join OvaScience at this pivotal time in the Company’s
evolution,” said Dr. Lillie. “OvaScience’s novel EggPC technology has
demonstrated enormous potential to revolutionize the infertility
landscape by providing women with opportunities to have genetic children
of their own. I look forward to working with the Company’s scientists to
further develop the EggPC platform and advance OvaTure and OvaPrime for
women and couples in need.”
Under Dr. Lillie’s leadership, OvaScience will continue to progress the
preclinical development of OvaTure through its ongoing efforts to
fertilize both bovine and human EggPC cell-derived eggs. The Company’s
work will focus on optimizing culture conditions for maturing human and
bovine EggPC cells into fertilizable eggs, as well as several other
maturation strategies, including approaches developed in collaboration
with its academic partners. OvaScience will also continue to work with
its academic partners toward securing authorization to fertilize human
EggPC cell-derived eggs outside of the United States.
Implements Corporate Restructuring to Strengthen Financial Position
OvaScience has decided to implement a corporate restructuring to
streamline its operations and reduce its cost structure. As part of this
restructuring, OvaScience is reducing headcount by approximately 50
percent. The majority of the reduction in personnel is expected to be
completed by March 2018. As a result, the Company expects to realize
annualized cost savings beginning in the second quarter of 2018.
OvaScience estimates that it will incur one-time costs of approximately
$1.0 million to $1.5 million related to the restructuring plan.
“In its early years, OvaScience grew rapidly to accommodate the global
commercialization of the AUGMENT treatment. Following the strategic
decision to focus our resources on the advancement of OvaPrime and
OvaTure, however, we are now operating with a tighter research and
development focus,” continued Dr. Kroeger. “After a careful review of
our business, we have determined that our revised strategy can be
executed most efficiently by a leaner, more versatile organization.
While the decision to reduce headcount is extremely difficult, we
believe this corporate restructuring will provide us additional
financial flexibility, enabling us to achieve an initial data readout on
our Phase 1b/2a OvaPrime clinical trial and advance our OvaTure program
without additional financing.”
OvaScienceSM, Inc. (NASDAQ:OVAS)
is a company focused on the discovery, development and commercialization
of new treatment options for women and families struggling with
infertility. 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 OvaPrimeSM, which could increase a woman’s egg
reserve and OvaTureSM, a potential in vitro
fertilization (IVF) treatment that could help a woman produce new,
fertilizable eggs without hormone injections. OvaScience’s AUGMENTSM
treatment, a fertility option designed to improve IVF success rates, is
available in certain IVF clinics in Canada and Japan. 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 its OvaPrime
and OvaTure programs, including statements relating to the Company’s
(i) plans to initiate a new Phase 1(b)/2(a) multi-center OvaPrime
clinical trial, and expected patient composition, timing of enrollment
and report of initial clinical data, (ii) expected timing of safety data
and embryo transfers in the ongoing OvaPrime Phase 1 study, (iii) belief
that the corporate restructuring will enable the achievement of an
initial data readout of the planned Phase 1(b)/2(a) multi-center
OvaPrime clinical trial and advance the OvaTure program prior to needing
additional financing, (iv) expected restructuring costs, (v) planned
start date for the Company’s new Chief Scientific Officer, and (vi)
plans to advance the OvaTure program under new scientific leadership.
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; risks associated with clinical and
other studies, including risks relating to patient enrollment, trial
site additions and data readouts; development risk; risks associated
with dependence on third parties, including our commercial and academic
partners; operational risks; 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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20180103006219/en/
Jennifer Viera, 617-420-8728