– 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 –
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 OvaPrime in 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 OvaTureSM.
“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 treatments.”
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 OvaPrime treatment 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.”
About OvaScienceOvaScienceSM, 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 StatementsThis 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.
###
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version on businesswire.com: http://www.businesswire.com/news/home/20180103006219/en/
OvaScience, Inc.Jennifer Viera,
617-420-8728jviera@ovascience.com
Ovascience Inc. (delisted) (NASDAQ:OVAS)
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