pSivida Corp. (NASDAQ:PSDV) (ASX:PVA), a leader in the development
of sustained release drug delivery products, and Hospital for
Special Surgery (HSS), the national leader for orthopedics, today
announced the results of a Phase I safety and exploratory efficacy
pilot study for a sustained release implant integrating pSivida’s
Durasert™ delivery technology and an HSS-designed implantable
device.
The implant was designed to deliver a
continuous-low dose of dexamethasone into the knee joint for
several months. Six subjects, screened for radiologically-confirmed
and symptomatic osteoarthritis (OA) of the knee, were enrolled for
a study duration of six months. Average weekly pain scores were
compared against baseline values using a survey of pain at rest, at
night, and during activity on a 0-10 scale taken biweekly. Safety
monitoring included serial radiographs and plasma dexamethasone
concentrations.
Subjects experienced an average 3.8 point
reduction in average weekly pain by week 4 that did not diminish
over the 24 week period (4.7 and 5.0 point reductions at weeks 12
and 24, respectively). Based on OMERACT-OARSI strict responder
criteria using the average weekly pain score, four subjects were
considered strict responders by week 4, while all six subjects were
strict responders on weeks 12 and 24. Plasma dexamethasone
concentrations were found to be lower than those reported by other
standard-of-care treatments and no adverse events were
reported.
Based on the study findings, the implant was
well tolerated and showed potential analgesic effects through the
six-month study period.
“This system has the potential to fill a
much-needed therapeutic gap for knee OA patients,” commented Dr.
Mark P. Figgie, principal investigator, study sponsor and Chief of
the Surgical Arthritis Service at HSS.
“This is a very promising start of a
collaboration, combining the know-how, experience and technology of
the pSivida team with the clinical expertise and insight of HSS.
With the ageing and more active population, we are in need of novel
and perhaps superior treatment alternatives for pain relief in
arthritis,” commented Dr. Robert N. Hotchkiss, co-inventor of the
implant and Medical Director of Innovation at HSS.
“The positive Phase I data demonstrates that
Durasert™ technology has applications beyond our core
back-of-the-eye disease markets,” commented Nancy Lurker, pSivida’s
President and CEO. “We believe patients suffering from severe knee
OA deserve better non-narcotic, non-opioid options to help manage
their pain, and our collaboration with HSS to apply our technology
to these patients has the potential to provide longer-term relief
of their pain.”
Knee OA is a degenerative joint disease that
results from the breakdown of joint cartilage and underlying bone,
with joint pain and stiffness the most common symptoms. More than
10 million people have knee OA and there is a high unmet need
for a non-narcotic treatment option given the potential risk of
addiction with opioids. No current cure exists, but pain and
movement restriction associated with the disease are currently
treated with oral analgesics, non-steroidal anti-inflammatory
drugs, corticosteroids taken orally or injected into the knee, or
hyaluronic acid injected into the knee. With degeneration, damage
and pain from knee OA can become severe, making it the leading
cause of total knee replacement surgery.
More than 600,000 of these surgeries were
performed last year in the U.S. and the number is expected to grow.
Given this anticipated increase a longer-term option is desirable.
The Durasert™ product together with the HSS-designed implantable
devices offers a potential new approach for the longer-term
management of knee pain associated with OA. In addition, the
implant has the potential to treat patients who are unable to
undergo total knee replacement surgery for medical reasons or those
who need more time to improve their health prior to knee
replacement.
About the Hospital for Special
SurgeryHospital for Special Surgery (HSS) is the world’s
leading academic medical center focused on musculoskeletal health.
HSS is nationally ranked No. 1 in orthopedics and No. 3 in
rheumatology by U.S. News & World Report (2017-2018), and is
the first hospital in New York State to receive Magnet Recognition
for Excellence in Nursing Service from the American Nurses
Credentialing Center four consecutive times. HSS has one of the
lowest infection rates in the country. HSS is an affiliate of Weill
Cornell Medical College and as such all Hospital for Special
Surgery medical staff are faculty of Weill Cornell. The hospital's
research division is internationally recognized as a leader in the
investigation of musculoskeletal and autoimmune diseases. HSS has
locations in New York, New Jersey and Connecticut.
www.hss.edu
About pSivida
Corp. pSivida Corp. (www.psivida.com),
headquartered in Watertown, MA, is a leader in the development
of sustained release drug products for treating eye diseases.
pSivida has developed three of only four FDA-approved
sustained-release treatments for back-of-the-eye diseases. The most
recent, ILUVIEN®, a micro-insert for diabetic macular edema,
licensed to Alimera Sciences, is currently sold directly in
the U.S. and three EU countries. Retisert ®, an
implant for posterior uveitis, is licensed to and sold
by Bausch & Lomb. pSivida's lead product candidate,
Durasert™ micro-insert for posterior segment uveitis, is being
independently developed. Two pivotal Phase 3 studies with Durasert
achieved their primary efficacy endpoint of prevention of
recurrence of uveitis at six months of follow-up with statistical
significance, and the Company plans to file an NDA by late December
2017/early January 2018. pSivida's pre-clinical development
program is focused on using its core platform technology Durasert™
to deliver drugs to treat wet age-related macular degeneration,
glaucoma, osteoarthritis and other diseases. To learn more about
pSivida, please visit www.psivida.com and connect on Twitter,
LinkedIn, Facebook and Google+.
SAFE HARBOR STATEMENTS UNDER THE PRIVATE
SECURITIES LITIGATION REFORM ACT OF 1995: Various statements made
in this release are forward-looking, and are inherently subject to
risks, uncertainties and potentially inaccurate assumptions. All
statements that address activities, events or developments that we
intend, expect or believe may occur in the future are
forward-looking statements. Some of the factors that could cause
actual results to differ materially from the anticipated results or
other expectations expressed, anticipated or implied in our
forward-looking statements include uncertainties with respect to:
our ability to achieve profitable operations and access to needed
capital; fluctuations in our operating results; successful
commercialization of, and receipt of revenues from, ILUVIEN® for
diabetic macular edema ("DME"), which depends on Alimera's ability
to continue as a going concern; Alimera's ability to obtain
marketing approvals and the effect of pricing and reimbursement
decisions on sales of ILUVIEN; the number of clinical trials and
data required for the Durasert three-year uveitis marketing
approval application in the U.S.; our ability to file and the
timing of filing and acceptance of the Durasert three-year uveitis
NDA in the U.S.; our ability to use data in
a U.S. NDA from clinical trials outside the U.S.;
our ability to successfully commercialize Durasert three-year
uveitis, if approved, in the U.S.; potential off-label sales
of ILUVIEN for uveitis; consequences of fluocinolone acetonide side
effects; the development of our next-generation Durasert
shorter-duration treatment for posterior segment uveitis; potential
declines in Retisert® royalties; efficacy and our future
development of an implant to treat severe osteoarthritis; our
ability to successfully develop product candidates, initiate and
complete clinical trials and receive regulatory approvals; our
ability to market and sell products; the success of current and
future license agreements, including our agreement with Alimera;
termination or breach of current license agreements, including our
agreement with Alimera; our dependence on contract research
organizations, vendors and investigators; effects of competition
and other developments affecting sales of products; market
acceptance of products; effects of guidelines, recommendations and
studies; protection of intellectual property and avoiding
intellectual property infringement; retention of key personnel;
product liability; industry consolidation; compliance with
environmental laws; manufacturing risks; risks and costs of
international business operations; effects of the
potential U.K. exit from the EU; legislative or
regulatory changes; volatility of stock price; possible dilution;
absence of dividends; and other factors described in our filings
with the Securities and Exchange Commission. You should read
and interpret any forward-looking statements in light of these
risks. Should known or unknown risks materialize, or should
underlying assumptions prove inaccurate, actual results could
differ materially from past results and those anticipated,
estimated or projected in the forward-looking statements. You
should bear this in mind as you consider any forward-looking
statements. Our forward-looking statements speak only as of the
dates on which they are made. We do not undertake any obligation to
publicly update or revise our forward-looking statements even if
experience or future changes makes it clear that any projected
results expressed or implied in such statements will not be
realized.
Contact:EVC
GroupMichael Polyviou/Doug Sherk –
Investorsmpolyviou@evcgroup.com; dsherk@evcgroup.com212.850.6020;
646-445-4800
Thomas Gibson –
Mediatom@tomgibsoncommunications.com201-476-0322
Tracy Hickenbottom – Director, Public
Relations/HSSmediarelations@hss.edu(212) 606-1197
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